Clinical Research Coordinator Resume Samples
4.8
(125 votes) for
Clinical Research Coordinator Resume Samples
The Guide To Resume Tailoring
Guide the recruiter to the conclusion that you are the best candidate for the clinical research coordinator job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.
Craft your perfect resume by picking job responsibilities written by professional recruiters
Pick from the thousands of curated job responsibilities used by the leading companies
Tailor your resume & cover letter with wording that best fits for each job you apply
Resume Builder
Create a Resume in Minutes with Professional Resume Templates
CHOOSE THE BEST TEMPLATE
- Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS
- Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES
- Instantly download in PDF format or share a custom link.
MB
M Bruen
Madisyn
Bruen
41690 Wilderman Dam
New York
NY
+1 (555) 346 7595
41690 Wilderman Dam
New York
NY
Phone
p
+1 (555) 346 7595
Experience
Experience
New York, NY
Clinical Research Coordinator
New York, NY
Rau-Rau
New York, NY
Clinical Research Coordinator
- Works with Program Manager and PI to prepare study reports and assists with drafting grant applications
- Assists Management with Business Development efforts
- Participate in quality and process improvement efforts to create and maintain a high-performing and efficient team
- Developing simple user interfaces for data entry, workflow management and querying
- Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care
- Provides guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies. Assists in training new personnel
- Creates and processes paperwork necessary for purchase orders, check requests, travel reimbursement etc. Tracks all expenditures and reconciles with funds
present
Houston, TX
Clinical Research Coordinator
Houston, TX
Reynolds Inc
present
Houston, TX
Clinical Research Coordinator
present
- Data Management. Performs or assists in data entry, management, and data analysis
- Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality
- Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality
- Additionally assist with data management related activities in the network
- Assist in the development and coordination of program-related events and workshops for patients with metastatic breast cancer
- Assist with the development and management of research subcontracts
- Works with department supervisor/manager to assist and train new hires in the research department/across all specialties
Education
Education
Bachelor’s Degree in Basic Sciences
Bachelor’s Degree in Basic Sciences
University of Memphis
Bachelor’s Degree in Basic Sciences
Skills
Skills
- Knowledge of and ability to adhere to good clinical practices (GCP)
- Excellent organizational skills and attention to detail in maintaining accurate, retrievable records
- Excellent attention to detail and ability to interpret and master complex research protocol information
- Ability to attend to detail and be precise with the ability to work independently, exercising judgment in establishing priorities
- Demonstrated strong attention to detail and ability to adhere to project deadlines
- Strong analytical skills and the ability to resolve technical or research problems and issues, and to interpret the acceptability of data results
- Strong working knowledge of good clinical practice (GCP)
- Ability to prioritize quickly and appropriately
- Completion of a Certified Clinical Research Coordinator (CCRC) training program or equivalent is highly desirable
- Strong ability to multi-task
15 Clinical Research Coordinator resume templates
Read our complete resume writing guides
1
Clinical Research Coordinator Resume Examples & Samples
- Creating new protocols, consents, and accompanying documents with investigators
- Navigating a protocol with an interdisciplinary team
- Obtaining consent
- Managing regulatory binders
- Managing study conduct throughout the study providing subject care as appropriate
- Creating study specific source documents and CRF's
- Establishing protocol specific classes for the staff
- 2-6 years of clinical nursing experience
- New York State Registered Nurse license
- High proficiency in Microsoft Word, Excel and other databases
- Bachelor's degree in Nursing
- Proactive professional who is ready to get their hands dirty
- Educational emphasis in clinical research and/or nursing
2
Clinical Research Coordinator Resume Examples & Samples
- Experience in Cardiology Clinical Research
- Prior cardiovascular experience
- Knowledge of Microsoft Office
- Registered Nurse or Physician Assistant license
3
Clinical Research Coordinator Resume Examples & Samples
- Plans, organizes and schedules assessments/tests/activities to meet research objectives and study protocol compliance. Communicates with study team personnel to ensure study procedures are followed and research is performed as described in protocol. Serves as contact for subjects, study personnel, Institutional Review Board (IRB) and study sponsor
- Prepares and submits timely, accurate, and complete documentation of study continuing review and study amendments to Institutional Review Board (IRB). Assists investigators with reportable event submissions to IRB
- Assists with preparation of study documents such as informed consent, recruitment script, and other materials. Assists with preparation of proposal, protocol, case report forms and progress notes, as needed. Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies
- Provides ongoing education to study subjects about clinical trials and provides significant new information that may affect a subject’s willingness to participate in a study, when needed. Evaluates subject compliance and promotes compliance through education. Coordinates in-service classes for nurses, pharmacists and others regarding the study and/or investigational product
- Prepares site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors
- Coordinates sample collection, processing and shipment for each study
- Arranges and attends meetings, seminars, symposia and other events related to project efforts. Participates in educational opportunities to increase knowledge about clinical trials and regulations. Remains current with federal, state, and institutional regulations and best practices
- Completes Research Order Form (ROF) for each subject visit and submits subject enrollment documentation as required
4
Clinical Research Coordinator Resume Examples & Samples
- Assists with data collection for research studies following established data collection and management procedures. Collects, records, enters and prepares data for analysis. Performs preliminary study analysis under the direction of the Principal Investigator or senior coordinators. Collects pertinent information from study participants through interviews, administration of tests or surveys or questionnaires, medical records review, or other collection procedures
- Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies
- Provides ongoing education to study subjects about clinical trials and provides significant new information that may affect a subject’s willingness to participate in a study, when needed. Evaluates subject compliance and promotes compliance through education
- Assists in the preparation of site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors
- Updates automated databases and other records for reporting and compliance purposes. Generates reports and analysis of data according to project schedules or on an ad hoc basis
- Assists by arranging and attending meetings, seminars, symposia and other events related to project efforts. Participates in educational opportunities to increase knowledge about clinical trials and regulations. Remains current with federal, state, and institutional regulations and best practices
5
Clinical Research Coordinator Resume Examples & Samples
- Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners' (HCP) commitment to superior customer service, including quality, care and concern with each and every internal and external customer
- Assists the Clinical Research Coordinators in protocol assessments, planning activities and coordinating multiple research studies
- Assists the Clinical Research Coordinators in preparing and submitting documents to institutional review board
- Attends and participates in investigator meetings as directed
- Participates in subject / patient recruitment and evaluation of eligibility
- Collaborates with the senior level clinical research coordinators to review and verify required source documents in subject's medical record to confirm study eligibility
- Reviews inclusion / exclusion criteria with investigator and department NP / PA / RN to assure subject eligibility
- Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits
- Obtains informed consent from research subjects prior to any study-related procedures and documents appropriately
- Maintains patient screening enrollment logs
- Conducts screening, eligibility and enrollment procedures as directed
- Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects
- Follows randomization procedures and dispenses study drugs per protocol
- Reviews diaries and questionnaires completed by subject as appropriate
- Performs phlebotomy functions (if licensed to do so) as indicated by the study protocol
- Ensures appropriate specimen collection, batching and shipping as required
- Schedules subjects for follow-up visits
- Assesses subject compliance with the test drug on follow-up visits
- Collects and documents adverse event information for evaluation by the investigator and department NP / PA / RN
- Protects subject confidentiality
- Protects patient privacy during initial and follow-up interviews and visits
- Secures safe storage of study-related documents
- Assures appropriate disposal of sensitive documents
- Documents and maintains all study-related procedures, processes and events
- Documents protocol deviations and exemptions and assists with quality assurance
- Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results)
- Records accurate and timely data onto case report forms
- Maintains source documentation for all case report entries
- Transmits data via fax, mail or electronically as requested by sponsor or CRO
- Resolves data queries
- Completes and maintains all study drug accountability records including drug dispensing drug
- Reviews returned drugs for compliance and documents findings
- Maintains files for all study-related documentation
- Communicates effectively with subjects, research team, IRB's and sponsors
- Provides subjects with information about reporting study-related events to research team
- Follows the mechanism established to contact subjects for follow-up visits and new information
- Utilizes a phone log to document telephone communications
- Meets regularly with investigator and research team to discuss subject participation and protocol progress
- Submits protocol amendments and progress report to IRB as directed
- Notifies the investigator, sponsor and IRB timely of adverse events as outlined in the protocol, as directed
6
Clinical Research Coordinator Resume Examples & Samples
- Minimum of an RN license required
- Two years in a clinical research setting, preferably working as a clinical research coordinator on Industry-Sponsored clinical trials
- Urology experience preferred
- Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors
- Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
- Familiarity with the Microsoft Office Suite
- Previous work with CRFs and EDC
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
- Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians
- Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
- Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study
- Develops clinical study budgets based on proposed study protocols
- Coordinates approval of new study agreements and contracts
- Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits
- Completes case report forms. Extracts data from patient charts in a timely manner
- Responds to data clarification requests in a timely manner
- May attend Investigator meetings requiring travel and report pertinent information back to research team members
- Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, BFS and sponsoring agency policies and procedures
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training
- Maintains subject screening logs and protocol deviation logs
- Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials
- Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors
- Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations
- Cooperates with sponsoring agency's compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office
- Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis
- Ensures that all materials for each clinical trial protocol are available for subject enrollment
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data
- Performs specimen processing and shipment of biological specimen duties
- Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures
- Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research
7
Clinical Research Coordinator Resume Examples & Samples
- Provides overall management and execution of the studies in the geographic area
- Demonstrate good clinical practices (GCP) and ensure study teams comply with GCP
- Helps project team to overcome organizational obstacles
- Accountable for the success of the studies, assists in selection and placement of clinical trials
- Facilitates the team process
- Acts as a liaison between the physicians, sponsors and TM's
- A deliverable revenue/EBITDA goal for each budget year
- Mentor and build the capacity of village TM's to assist in the conduct of clinical trials
8
Clinical Research Coordinator Resume Examples & Samples
- Perform subject interviews and assessments (i.e. adverse events and concomitant medications) at study visits for data required by protocol
- Screen and identify potential subjects from review of protected health information based on protocol eligibility criteria
- Evaluate protocol, determine staff, facility, and subject population availability
- Monitor study team compliance with required study procedures and GCP standards
- Extract data from source documents, complete case report forms, resolve sponsor queries -Review subject SAE information and assist PI in submission and/or determination of SAE
9
Clinical Research Coordinator Resume Examples & Samples
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required
- Early Intervention (E.I.) credentialed
- 1 year research study experience
10
Clinical Research Coordinator Resume Examples & Samples
- Experience with scheduling complex clinical research visits, both inpatient and outpatient, up to one-week in length, with patients of all ages who have complicated, rare, and long-term conditions
- Experience collecting biological samples including (but not limited to) blood and urine
- Experience coordinating with clinical staff for additional clinical or research procedures and sample collections such as ECG, EEGs, imaging, radiology, skin/tissue biopsies
- Experience and comfort working with large, multidisciplinary teams – almost all disciplines of medicine are to be encountered over time, but especially Neurology, Medical Genetics, Cardiology, Rheumatology, Immunology, Gastroenterology, and Dermatology
- Ability and motivation to learn quickly and problem solve as required for each unique case
- Experience and comfort with medical terminologies
- Knowledge and interest of genetic conditions and the implications to families
- Familiarity of federal and local laws pertaining to genetic discrimination and patient privacy
- Advanced use of REDCap Database systems, particularly the ability to design and/or maintain large, complex projects
- Experience working with very sick children and their parents
- Team-oriented, enthusiastic, and patient friendly – this position is a point person for patient contact and experience
- Up-to-date documented knowledge of federal research and clinical regulations (CITI, HIPAA, & GCP certifications; note, external applicants would be required to update training to Stanford requirements)
- California phlebotomy licensure desired
- Interest in contributing to publications, posters, and abstracts a plus
- Advanced degree encouraged though specifically not required if the above are adequately met (e.g. MS, RN, CGC)
- Three-five years or more experience desired
11
Clinical Research Coordinator Resume Examples & Samples
- Experience using Electroencephalography (EEG) in individuals with autism and/or developmental disabilities
- Experience in clinical research, particularly with children
- Experience with SPSS, Excel and REDCap
12
Clinical Research Coordinator Resume Examples & Samples
- Experience/knowledge of Anesthesia clinical trials
- Experience/knowledge of clinical trials including recruitment and informed consent
- Minimum of one year related experience
13
Clinical Research Coordinator Resume Examples & Samples
- 2-4 years of clinical research coordination experience; bilingual (English/Spanish) preferred
- Demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment
- Ability to work effectively with a wide range of individuals at all levels of authority
- A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, and exercise sound judgement in setting priorities
14
Clinical Research Coordinator Resume Examples & Samples
- Experience with University research policies and procedures
- Candidates must possess strong organizational skills and a demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment
- A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail
- Excellent communication and problem-solving skills
- Experience in CV is desired
15
Clinical Research Coordinator Resume Examples & Samples
- Experience with research protocols and regulatory of governing bodies, which includes, HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
- May have experience with research protocols and regulatory of governing bodies, which includes, HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
- Experience with statistical analysis software, such as SAS
- Proficiency with Microsoft Office (especially Excel), REDCap and electronic data capture database applications
- Familiarity with internal School of Medicine clinical trial standards, including SPECTRUM, Patient Financial Services, HSSC and ISO data safety and security best practices
- Demonstrate sound judgement and problem-solving skills that will protect volunteer safety and promote highest standard of clinical trial compliance
16
Clinical Research Coordinator Resume Examples & Samples
- Ability to organize work and multi-task
- Ability to produce timely and accurate reports to monitor regulatory and clinical processes
- Proficiency in Microsoft Office (especially Excel), REDCap and electronic database capture applications
- Extensive experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
- Practical knowledge and experience with internal School of Medicine clinical trial standards, including SPECTRUM, Patient Financial Services, HSSC and ISO data safety and security best practices
17
Clinical Research Coordinator Resume Examples & Samples
- As one of the main studies is in the East Asian population, bilingual in Mandarin, Korean or Japanese preferred
- Must have excellent communication skills on phone and in person
- Must have prior clinical research experience or coursework
18
Clinical Research Coordinator Resume Examples & Samples
- Master's degree in public health or statistics is preferred
- Proficiency with Word and Excel for data management
- Experience with data management, internet research, manuscript preparation
- Experience with data analysis and ideally, familiarity with statistical programs (e.g. SPSS, STATA, R, and/or SAS)
- Proficiency in Microsoft Office, Excel, and database applications
19
Clinical Research Coordinator Resume Examples & Samples
- Two or more years related experience preferred
- Knowledge of ethical principles and federal and state regulations governing the participation of human subjects in biomedical research
- Excellent interpersonal and oral communication skills to effectively work with other research and administrative support staff
- Experience with research protocols and regulatory bodies, including HIPAA regulations, Institutional Review Board requirements and Good Clinical Practices
- Ability to work both independently and as part of a multidisciplinary team
- Ability to determine workload priorities in an appropriate way to accomplish tasks and goals, meet deadlines, and anticipate and solve potential problems
- Good oral and written communications kills to effectively work with physicians, clinical staff and other health care professionals
20
Clinical Research Coordinator Resume Examples & Samples
- Follow plans and standard operating procedures under the guidance of study leadership to recruit, enroll, consent, collect data, and retain participants
- Collaborate effectively with others to ensure proper progress & completion of studies
- On a periodic basis, adjust regular working schedule to provide weekend enrollment coverage as needed
- Implement successful plan in line with approved protocol to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly
- Following standard operating procedures, participate directly in recruitment/enrollment
- Communicate with participants and families in culturally sensitive manner
- Communicate study-related issues to investigators, study coordinators, clinical team, managers and other institutions in a timely fashion
- Perform data entry and validation to ensure accuracy, quality and compliance of data collection process
- Bachelor’s degree in a field appropriate to the area of assignment AND two years related research experience; OR,
- Six years research experience appropriate to the area of assignment
- Previous human subjects training (e.g., CITI certification) and two years’ experience as a research coordinator with direct recruitment and enrollment responsibilities
- Phlebotomy training and experience
- Strong organization skills and significant attention to detail for data entry
- High level of integrity, ethics and professionalism
21
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s Degree in Health Education, Social Work, Nursing, Medicine or Public Health
- Experience in Program Management and 1-3 years supervision required
- Ability to maintain interpersonal relationships and utilize proper channels of communication
- Ability to maintain confidentiality of information
- Ability to work independently but function as integral member of the team
- Reliable transportation, driver’s license and proof of auto insurance required. Must be able to use own transportation to travel to training programs throughout the state of Ohio. Will be reimbursed University mileage reimbursement rate for travel to and from training programs off site at the current rate per mile
- Some overnight travel required with meal and lodging per diem per policy
- Proficiency in use of Microsoft word, PowerPoint and Excel
- Willingness to complete necessary/required training for job specific duties
- Basic knowledge of HIV
- Experience as a trainer, education or practice transformation coach
22
Clinical Research Coordinator Resume Examples & Samples
- Plan and coordinate research projects
- Coordinate the generation of support data for manuscripts and proposals
- May assist in developing reports
- Assist with modifications of protocols
- Perform related duties based on departmental need
23
Clinical Research Coordinator Resume Examples & Samples
- Collaborates with CTRC and hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG’s, drug administration, Infusions, pharmacokinetic sampling, and protocol specific tests and procedures
- May be called upon to perform the following specific tests and procedures: A) blood pressure, pulse, height, weight, and temperature measurements, b) specimen processing and shipping, c) pulse oximetry
- Experience: One year of research coordinator experience
- 1 or more years’ experience in support of cardiology clinical trials (interventional cardiology & imaging research, electrophysiology, and heart failure)
- Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials
- Experience working with physicians and nurses in clinical research
- Knowledge of Good Clinical Practice (GCP)/ICH guidelines in clinical research
- Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task
- Ability to work both independently upon training and part of a multi-disciplinary team
- Ability to operationalize written protocols
- Must be able to work under pressure in a deadline oriented environment
24
Clinical Research Coordinator Resume Examples & Samples
- Four (4) years of general clerical or administrative service experience, which includes one (1) year of experience working in an academic research or related environment
- Bachelor's degree from an accredited college or university in a related field
- Three (3) or more years' of experience working in a research environment
- Experience communicating with industry sponsors
- Experience with clinical trial budgeting and negotiation
- Experience in the conduct or oversight of clinical research studies
- Certified Clinical Research Professional (CCRP)
- Experience routing contracts through central grants and contracts office
- Demonstrated ability to work effectively with a diverse population of faculty, staff and students
- Excellent knowledge regarding clinical research regulations and principals of ethical conduct
- Knowledge, experience, and ability to manage complex information and computer systems
- Effective communication/presentation skills and a proven track record of forming collaborative and effective working relationships with physicians and administrative leaders
25
Clinical Research Coordinator Resume Examples & Samples
- Bachelor Degree in any field
- Two (2) years of clinical and/or research experience required
- Bachelor’s degree in a science or health related field
- Oncology Clinical Research experience
- Excellent attention to detail and ability to interpret and master complex research protocol information
26
Clinical Research Coordinator Resume Examples & Samples
- This position is for the research study therapist role on a clinical research intervention trial of smoking cessation and depression. The position requires a therapist, counselor, or clinical social worker to administer the study's protocol for smoking cessation, working with individuals with depression. The intervention involves two different behavioral therapy protocols, administering psychiatric diagnostic interviews, and addressing medication adherence
- Please submit a cover letter for full consideration
- Successful completion of a full 4-year course of study in a social or health science from an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience
- 2 years' experience; or 4 years’ practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required
- A master's degree in clinical psychology, counseling psychology, or clinical social work, or related field or the equivalent combination of education, training and experience from which comparable skills can be acquired
27
Clinical Research Coordinator Resume Examples & Samples
- Please note: Some travel required throughout the year to attend investigator meetings or other study conferences. These meetings are not typically held within the immediate Chicago metropolitan area
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a social or health science + 2 years’ experience; or 4 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required. OR appropriate combination of education and experience
- Ability to become certified as a study coordinator within two years of employment in the department
28
Clinical Research Coordinator Resume Examples & Samples
- One year in health-care or health-care research
- Knowledge of the principles of clinical research and federal regulations. Good understanding of how information is collected in clinical settings
- Excellent written and oral communications skills; must be comfortable presenting complex material to a variety of audiences
- Must be computer literate and able to learn to use unfamiliar applications quickly
- Exceptional organizational skills and the ability to perform many tasks simultaneously and independently
- Previous experience as an educator to other health care professionals
29
Clinical Research Coordinator Resume Examples & Samples
- 3-5 years experience
- Prior critical care nursing experience
- Experience with developing and conducting clinical trials including site monitoring strategies and risk mitigation
- REDCap database management
30
Clinical Research Coordinator Resume Examples & Samples
- Orients and assists in training new staff
- Bachelor's Degree required and at least 1-3 years of equivalent experience required. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed
- Excellent organization and communications skills required. Strong interpersonal skills - ability to effectively interact with all levels of staff and externals contacts. Must be detail oriented and have the ability to follow-through. Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times. Must have computer skills including the use of Microsoft Office
- Proficient in understanding of phases of clinical trials
- Ability to coordinate PI initiated studies
31
Clinical Research Coordinator Resume Examples & Samples
- Serve as the study coordinator for a few longitudinal clinical research studies
- Screen, recruit, and enroll eligible patients and track participation over time
- Conduct face-to-face interviews with patients and discuss topics that include: prognostic understanding, treatment preferences, end-of-life care, clinical symptoms, and quality of life
- Coordinate with oncology providers and research staff in the gynecologic oncology clinic to recruit and enroll patients
- Prepare reports that provide current snapshots of a study’s data, participation, and progress
- Report study progress to the Gynecologic Oncology Clinical Research Team during weekly meetings and meet one-on-one with the clinical investigator
- Perform preliminary quantitative and qualitative analyses of study data
- Review and abstract health information from patients’ electronic medical records
- Maintain patient charts and study databases and ensure data is complete and accurate
- Support the development and submission of publications, presentations, reports, and other study-related documents
- Enter data and perform literature searches, administrative duties, and additional tasks as needed
- BA or BS degree required, with 0-2 years of related experience preferred. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred
- Interest in academic research, medicine, health care, or public health
- Capable of discussing personal topics with patients in a compassionate, sensitive manner
- Must be detail oriented, have the ability to follow-through, and have strong problem-solving skills. Proficiency in Microsoft Excel, Word, and PowerPoint and willingness to learn RedCap and other technologies as necessary
- Reliable, self-motivated, and able to prioritize tasks and meet deadlines
- Post-undergraduate experience a plus
32
Clinical Research Coordinator Resume Examples & Samples
- Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: assisting in the recruitment and screening of volunteers; registering patients; providing information on clinical trials and protocols to interested participants in a timely and helpful manner; obtaining relevant medical history on candidates by phone and in person; collecting previous relevant medical records data on patient; explaining procedures and consent forms; compiling all information prior to the initial visit; responding to inquiries from study participants or collateral informants in a timely and helpful manner; updating databases with patient information; and/or, performing other related activities
- Performs tasks required by protocol, which may include obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment on patients. Collects vital signs. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required
- Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed
- Provides educational information to patients and their families. Serves as a resource and support person for patients and families by being a consistent person they can contact within the clinical research program. Provides information to the patient and family related to the healthcare of the patient such as health maintenance, prevention, and anticipatory guidance relevant to study-related diseases
- Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate IRB (Institutional Review Board) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process
- Serves as a liaison to other departments and programmatic areas, as well as community agencies
- Ensures that primary referring physicians receive timely progress notes on the patients diagnosis and treatment
- May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner
33
Clinical Research Coordinator Resume Examples & Samples
- Associate's Degree required
- Oncology research background preferred
- Background in research methodology, preferred
- Must be able to work with latex products
34
Clinical Research Coordinator Resume Examples & Samples
- Under the direction and supervision of the Clinical Research Department Manager, provide administrative support for variety of industry-sponsored and investigator-initiated studies including development and maintenance of Allegro and EPIC study visits and billing calendars; maintain accurate and current information of EHR and database management system, per study protocols and budget and Sutter Health approved procedures
- Follow up with Clinical Research Department colleagues, Research Institute and Sutter centralized Research Administration staff, study subjects, physicians and other providers on a variety of key activities related to study protocols and/or department activities, as required
- Under the close guidance of the Clinical Research Department Manager, provide assistance in the submission of protocols to the Sutter Health Institutional Review Board
- Other duties, as required by department, Sutter Research Enterprise, PAMFRI and/or Sutter Health
- 1+ years working in a team-based environment; demonstrated keen attention to detail; proven ability to multi-task; high degree of comfort in Ability to work in fast-paced environment in which priorities can change frequently; ability to collaborate successfully with multiple constituents who represent specific areas of expertise and are passionate about very fast turnarounds and high levels of responsiveness
35
Clinical Research Coordinator Resume Examples & Samples
- Certified Medical Assistant or Licensed Practical Nurse with current credentials to practice in the state of Ohio
- Demonstrated proficiency in venipuncture or willingness to be trained in venipuncture with successful completion of training within 3 months
- Twelve months health care experience
- Infectious Diseases experience strongly preferred but not required
36
Clinical Research Coordinator Resume Examples & Samples
- A BS/AAS is preferred in animal science, zoological, biological sciences, veterinary technology specifically related to Laboratory Animal Research required. Bachelor with certification as ALAT, LAT or LATG with AALAS may be given preference during the technical evaluation
- A minimum of two years’ experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification may be given preference during the technical evaluation
- Working knowledge of PHS, OLAW, AWA, USDA, Guide and AAALAC
- Working knowledge of IACUC rules and regulations
- Experience with submission of protocol amendments
- Experience with exotics, small animal ruminants, and large animal models
- Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and Investigational New Drug (IND) requirements
- Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings
- Skills in counseling, guidance, and maintaining interpersonal relationships
- Good typing skills to allow online documentation of patient interactions
- Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, and be adept at prioritizing and multitasking. Must be comfortable with changing conditions and research workload
37
Clinical Research Coordinator Resume Examples & Samples
- A Bachelors Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Masters Degree or certification as a Registered Nurse will be given preference
- A minimum of two years ofexperience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI); Certified Clinical Research Coordinator (CCRC); or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
- Skills in counseling; guidance; and maintaining interpersonal relationships
- Good typing skills to allow online documentation of patient interactions. Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date
- Work requires concentration; periods of standing and walking on a regular basis. Must work well under pressure; often changing conditions and research workload
38
Clinical Research Coordinator Resume Examples & Samples
- Responsible for coordinating the research activities of assigned basic science, IRB and Institutional Animal Care and Use Committee (IACUC)-approved study protocols. Protocols will include both pediatric and adult patients, animals and human anatomical specimens (including cadavers)
- Accountable for research matters to the PIs of each research protocol. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness
- Proficient in appointment booking, appointing referrals, documenting Telephone Consults and other patient interactions, coordinate laboratory studies, x-rays, and other tests. Personnel must be proficient in the use of clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
- Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the Principal Investigator for final evaluation. Returns telephone calls from research participants in an efficient and timely manner and documents interactions appropriately
- Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented. Conduct telephone, face-to-face interviews or mail information for follow-up visits
- In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol and maintain accurate documentation record of drugs received
- Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator
- Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol
- Process and prepare specimens for lab analysis and shipping. Observe universal precautions and OSHA standards when processing or handling specimens
- Collect clinical data in a timely and accurate manner and submit information to coordinating centers as required. Assist with data collection in animal and bioskills laboratory as needed
- Report adverse events to governing agencies and sponsors as required by protocol and regulations
- Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Principal Investigator’s File Binder/Regulatory Binder
- Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol
- Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency
- Provide other administrative duties that are within the scope of work
- Completed human protection training developed by the Collaborative Institutional Training Initiative (CITI)
39
Clinical Research Coordinator Resume Examples & Samples
- Clinical Research Project Plan and Preparation
- Responsible for monitoring subjects’ compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate
- Provides accurate and timely project status updates to Project Managers and sponsor
- Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals
- Accommodates flexible schedule (available days, afternoons, nights, and weekends)
40
Clinical Research Coordinator Resume Examples & Samples
- Clinic logistics planning, schedule of clinic activities, and team training
- Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules
- In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study
- Confirms all required regulatory and contractual documentation is present prior to study start
- Clinical Conduct
41
Clinical Research Coordinator Resume Examples & Samples
- Recruits and evaluates potential study subjects. Per protocol instruction, conducts telephone interviews or schedules patient for study visit and screening. May be required to perform clinical tests such as phlebotomy, EKGs, neurocognative tests, etc
- Interacts with subjects with regard to study, including subject education, procedural instruction, follow-up. May serve as a liaison between subject and other research staff including the sponsor, IRB, study PI and clinical trials project manager
- Responsible for collecting data and maintaining patient information database for study. May be required to input data, do minimum analysis and run various reports. Maintains subjects records as part of record keeping function
- Ensure compliance with the Partners IRB, Dana-Farber’s IRB and other federal and institutional guidelines. Assists with research billing and study fund maintenance on assigned clinical trials
- Responsible for coordinating study start up procedures and addressing logistical concerns brought up by pharmacy, radiology, industry sponsors, billing compliance and other collaborating departments like neurology, neuro-oncology
- Maintains inventory and orders supplies when necessary
- Position may require some on-call work
- Position may require some domestic travel
- New graduate with relevant course or project work
- Prior experience working in translational or clinical research preferred, but not required
- Experience working in a healthcare setting preferred
- Available for some on-call work if required by clinical trials
- Available for minimal domestic travel to other Partners Institutes
- Experience with Power Point, Excel and other Microsoft office programs
- Please include a cover letter noting any plans for school applications (strongly preferred)
- Knowledge of computer programs, databases, etc
42
Clinical Research Coordinator Resume Examples & Samples
- Previous experience with working with families and children with autism
- Research experience
- Demonstrated success in following through and completing routine tasks
43
Clinical Research Coordinator Resume Examples & Samples
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience
- Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
- Highly proficient with Microsoft Office suite (Word, Excel, PowerPoint, Outlook)
44
Clinical Research Coordinator Resume Examples & Samples
- Assist in prospective collection of data on intubated patients for the purpose to be entered into the NEAR registry
- Collect all forms weekly and enter electronically into the NEAR web‐based data management tool
- Retrieve the patient medical record number in StudyTRAX to retrospectively identify and input missing data from the patient’s Emergency Department (AHLTA) chart
- Bachelor degree in scientific or health care field
- A minimum of five (5) years of experience in clinical research and research design with familiarity in medical terminology and common medical abbreviations
45
Clinical Research Coordinator Resume Examples & Samples
- 3 years of experience in clinical research
- Advanced degree in Health/Medical field
- Fluent in both writing and/or speaking Spanish strongly preferred
- Knowledge of how to interpret sponsor agreements strongly preferred
- Strong background in clinical trials research, including protocol design; recruitment and screening of potential participants; identification and communication of adverse health effects
- Must have the ability to directly coordinate clinical trials within a clinical research setting; demonstrated ability to work effectively within a moderately autonomous environment, in addition to having a complete commitment to achieving goals
- Must be flexible, dependable & able to handle multiple priorities with conflicting deadlines
- This position has a need for flexible work hours, which may involve day or nighttime coverage. There is the possibility that the shifts may change based on the research needs of the division
46
Clinical Research Coordinator Resume Examples & Samples
- For consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc
- Work with the PI to develop and implement recruitment strategies in accordance with IRB/HRPO requirements and approvals
- Recruit and screen research subjects using protocol inclusion/exclusion criteria. Refer eligible subjects to the PI for final evaluation, enrollment, and randomization per protocol design
- Ensure the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented
- In collaboration with the research pharmacist, ensure correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability
- Ensure subjects receive education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable
- Ensure adequate inventory of study supplies, including drugs, devices, etc
- Prepare other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs
- Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the execution of a study related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Train appropriate personnel as needed. Maintain documentation of training
- Coordinate the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol
- Observe universal precautions and OSHA standards when handling specimens
- Obtain laboratory results and consult with the PI for follow-up care as per protocol
- Collect data in a timely and accurate manner and submit information to coordinating centers as required
- Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations
- Evaluate compliance of research subject and complete documentation of status and progress
- Respond to compliance Officer audit findings and, after consultation with PI, implement approved recommendations
- Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol
- Maintain detailed documentation of the research study including but not limited to subject study charts and databases as required by the protocol, and the Investigator’s File Binder or Regulatory Binder
- Interact on a regular basis with the PI and study team members regarding the conduct of the research study
- Attend conferences and other meetings as required by the protocol, the PI, or sponsoring agency
- Return telephone calls from research participants in an efficient and timely manner and documents interactions appropriately
- Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons
- Assist the compliance Officer with monitoring process to ensure protocol compliance
- Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols
- Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency as authorized by contract
- Perform other research related duties as needed
- A minimum of two years’ experience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
- Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date and additional protocol specific training as required
47
Clinical Research Coordinator Resume Examples & Samples
- Collaborate with the Site Manager and other staff members to prepare for and execute assigned studies
- Assist in ensuring that study objectives are met on time, within budget and according to applicable regulations and quality standards
- Captain/lead studies, including
- Review study protocols, case report forms (CRF), other study documents, and electronic data capture systems
- Attend all relevant study meetings
- Collect and submit regulatory/ethics documentation
- Recruit and screen patients for trials and maintain patient screening log
- Orient patients to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
- Design and maintain source documentation based on protocol requirements
- Schedule and execute study visits and perform study procedures
- Collect, record and maintain patient study data according to study protocol and SOPs, ensuring quality control for content, accuracy and completeness
- Handle labs, including preparation of specimen collection tubes and lab logistics
- Monitor patient safety and report adverse reactions to appropriate medical personnel
- Correspond with patients and troubleshoot issues on study
- Participate in huddles to ensure daily tasks are assigned to team members and are executed to the expected standards
- Assist with data quality checking and query resolution
- Perform a variety of complex clinical procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring. Record, report and interpret findings appropriately to develop study-specific database
- Maintain and restock medical supplies as needed. Maintain cleanliness and sanitation of the unit
- Provide training to new staff members on study-specific topics and new clinical skills. Assist in ensuring compliance with staff training requirements by auditing and maintaining training records
- Prepare for and attend monitoring visits, audits, and inspections
- Participate in quality and process improvement efforts to create and maintain a high-performing and efficient team
- Assist with planning related to staffing and scheduling
- Working knowledge of clinical drug trials
- Experience working on an oncology study required
- LPN preferred
- Working knowledge of the principles of Good Clinical Practices (GCP)
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
- Good skill in using MS Windows and Office applications such as Access, Outlook and Word
- Bachelor’s degree or educational equivalent; or High school diploma and 3 years’ relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience
- Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies
48
Clinical Research Coordinator Resume Examples & Samples
- Clinical research operations. Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol- specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. May provide training to personnel
- Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify shortcomings of proposals and protocols
- Leadership and professionalism
49
Clinical Research Coordinator Resume Examples & Samples
- Communicates concerns regarding ethical violations to Manager/ Principal Investigator
- Participates in meetings with research residents and research staff prior to implementation of protocol as necessary
- Assembles source documents as necessary
- Adheres to schedule and required procedures and follows research protocols
- Maintains neat, Organizational, accurate and detailed source documentation, records and forms
- Ensures proper collection, processing and shipment of specimen
- Assists as needed in preparing for FDA and internal audits
- Maintains data integrity where applicable
- Ensures study supplies, office supplies and research equipment for research personnel/projects are maintained
- Assists with grant applications, compiling literature reviews or the preparation of abstracts, entering information and/or maintaining databases for research department, ordering patient charts and placing reminder calls to patients as necessary
- Promotes patient recruitment by preparing patient mailers, postcards or mass communications and participating in presentations as necessary
- Screens and assigns patents to appropriate research protocols
- Provides general support functions, including copying, filing correspondence transcriptions, obtaining required signatures as required
- Works with department supervisor/manager to assist and train new hires in the research department/across all specialties
- Reports and records adverse events/severe adverse events to Regulatory Coordinator, IRB Sponsor and PI and other agencies as required
- Serves as primary contract for patient while enrolled in clinical trial
- Reports all abnormal values to the PI in a timely manner
- Attends conferences and meetings related to research as required
- Experience working with Federal Regulations and IRB's preferred
50
Clinical Research Coordinator Resume Examples & Samples
- Oversee day-to-day operation of the project
- Oversee IRB and other regulatory submissions
- Oversee entry and update of study into ClinicalTrials.gov
- Monitor expenditures across sites and maintain adherence to study budgets
- Ensure compliance with research protocols, reviewing case report forms and auditing for accuracy with source documents
- Compile study Manual of Procedures (MOP) and distributes to ADC site coordinators
- Maintain communication and coordination with coordinators at three project sites outside of Atlanta and organizes bi-weekly project calls
- Identify and coordinate study-related equipment and facility needs, including the approval of orders for supplies and equipment maintenance
- Manage random assignment of subjects, in collaboration with project statistician
- Perform ADRC site responsibilities
- Experience managing human subject-based randomized trial
- Experience with study data management, preferably using Excel, SAS and/or SPSS
- Personnel management, preferably research personnel
- Knowledge of IRB and other regulatory guidelines
- Meticulous attention to the details of data acquisition, entry, and management
- Ability to produce written and graphic materials for a variety of retention and dissemination activities
- Experience with dementia/ caregivers and/or older adults a plus
- Experience in multi-site studies a plus
51
Clinical Research Coordinator Resume Examples & Samples
- Serves as a liaison with nurses, staff, physicians, pharmaceutical companies and federal agencies regarding patients who are on clinical trials, schedules in-service for appropriate staff, and provides patient education about treatment and possible side effects
- Assists in the consent process and coordinates a variety of clinical research activities, ensuring that established protocols are implemented and followed
- Participates in site initiation visits, monitoring visits and audits; maintains Human Subject Protection compliance; and adheres to patient confidentiality throughout the research process
- Screens patients for clinical trials, ensuring patient eligibility; and maintains patient safety and protocol compliance
- Collects, prepares, and organizes data, ensuring that data is collected into the appropriate format, electronic or paper submission of Case Report Forms
- Assists physicians in completing flow-sheets in medical records and progress notes, and schedules audits with pharmaceutical sponsors and other agencies
- Monitors, records and reports patient’s condition and reaction to drugs and treatments to the appropriate physician or nurse
- Reports and documents serious adverse events and documents adverse events in patient CRF
- Ensures that all requirements for pre-study laboratory/medical tests and eligibility are completed, and arranges pre- and post-procedure laboratory/medical tests
52
Clinical Research Coordinator Resume Examples & Samples
- Screens patients for clinical trials, to include patient eligibility, and assists in the consent process
- Collects, prepares, and organizes data into case report forms, databases, and other required formats
- Assists physicians in completing flow-sheets in medical records and progress notes
- Participates in site initiation visits, monitoring visits and audits, and schedules audits with pharmaceutical sponsors and other agencies
- Reports and documents serious adverse events
- Monitors, records and reports patient’s condition and reaction to drugs and treatments to the appropriate physician/nurse
- Ensures that all pre-study laboratory/medical tests are completed and that eligibility requirements are completed
- Arranges pre- and post-procedure laboratory/medical tests
- Acts as a liaison with nurses, staff, physicians, pharmaceutical companies and federal agencies in regards to patients that are on clinical trials
- Schedules in-service for appropriate staff, provides patient education about treatment and possible side effects
- Performs all duties in accordance with all applicable laws and regulations and with Georgetown University Medical Center’s philosophy, policies, procedures and standards – to include Protection of Human Subjects and patient confidentiality
53
Clinical Research Coordinator Resume Examples & Samples
- Knowledge of MedStar
- Experience with drug and device studies
- Strong computer skills, including word processing, spreadsheets, and database use
54
Clinical Research Coordinator Resume Examples & Samples
- Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies
- Disseminates information about the protocol to junior research staff
- Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties
- Coordinates with data managers to monitor participant progression throughout study and conducts evaluation at end of study
- Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study
- Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed
- Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations
- Assures proper laboratory samples are collected and results reported to the proper entities
- Assists the Principal Investigator in the development of study materials
55
Clinical Research Coordinator Resume Examples & Samples
- Oversees compliance to multiple protocols, as defined by on-going and projected trials; manages quality control, completion and submission of study related documentation; prepares reports for research manager, Principal Investigators and sponsors, as requested
- Develops study budgets in conjunction with research manager; monitors budget expenses for allied services; negotiates payment schedule with sponsor and fees for internal services
- Disseminates information about protocols to diabetes clinic staff where applicable
- Assesses protocol-driven eligibility criteria for multiple studies to screen and recruit study participants, coordinate with various providers and auxiliary services to schedule visits, creates source documents for data collection, conducts study visits, completes source documents and ensure accurate transcription of data into EDC within specific time parameters
- Coordinates with CROs to monitor participant progression throughout study; investigates and resolves all study-related queries that may result from monitoring visits and/or internal audits
- Develops and maintains a system to track patient visits and data entry for multiple studies; audits for completeness, and accuracy; may assist Research Manager in payment reconciliation for specific projects
- Prepares for and coordinates site visits made by CROs, sponsors and/or federal agencies during the course of and at the close of the study
- Works with investigational pharmacy to establish procedures for study drug delivery and/or administration
- Assures proper laboratory samples are collected and results are reported to the proper entities
- Assists the Principal Investigator in the development of study materials and protocols
- Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Endocrinology Research Manager
- Supports both the clinical and research services offered through the division’s Bone & Body Composition Suite by training with the Research Manager to operate the DXA, pQCT, ultrasound and air displacement plethysmographer; must demonstrate a high degree of precision and independence for operating DXA within 6 months of hire
- Pass the Radiology Practical Technician exam in order to be eligible for licensing to operate bone densitometry equipment within 6 months of hire
- Attends an internationally recognized bone densitometry course offered by the ISCD and sit for the exam in order to be eligible for national certification in the field of bone densitometry (Certified Bone Densitometry Technician—CBDT) within 1 year of hire
- Demonstrates proficiency in scanning techniques utilized for various ages and health conditions in pediatric-specific population
- Completes protocol-specific and/or study sponsor-specific DXA training under the guidance of the Research Manager
- Prepares and disseminates bone densitometry reports following clinical review by division chief; attends weekly meetings with division chief and Research Manager to review patient reports, identifies quality issues, and troubleshoots as needed
56
Clinical Research Coordinator Resume Examples & Samples
- Under the guidance of the clinical research manager, provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level
- Prepares, submits, and maintains IRB, FDA, and other regulatory documents and research correspondence
- Reviews site files and records for completeness, accuracy, consistency and compliance; identifies deficiencies or discrepancies and facilitates their resolution
- Assures that adverse events are reported to the sponsor
- Works with programmers to develop and test databases and other collection tools
- Analyzes incoming data to identify trends, problems, or other issues
- Prepares and interprets reports and queries for Investigators and Research Coordinators, which include, but not limited to monthly enrollment reports, reports of various data elements, query reports, etc
- Ensures that captured data is accurate and corrects erroneous or conflicting data
- Communicates with study sites frequently to discuss and follow-up on data issues and troubleshoots possible solutions
- Works with site monitors to ensure protocol and regulatory compliance, data quality, and patient safety
- Performs remote monitoring of site data in coordination with appropriate personnel
- Attends required meetings and conferences as appropriate
- Licensed professionals may be assigned medical reviews
- Develops study budgets; monitors budget expenses and billing for allied services: negotiates payment schedule with sponsor and fees for internal services
- Supervises, mentors and trains new or junior research staff
- Assists the Investigators in the development of study protocols
57
Clinical Research Coordinator Resume Examples & Samples
- Assist principal investigator with the day to day operation of her research lab and projects
- Lead the communication coding lab and supervise research assistants; assess inter-rater reliability; assign hospice visit and phone recordings to be coded; conduct audits on coding progress
- Liaison with National Palliative Care Research Cooperative to ensure cohesive study management and adherence to data collection protocols
- Travel to research sites within the United States (locations yet to be determined). Train site staff on recruitment, enrollment, and study protocols
- Basic knowledge of statistical analysis and ability to use various statistical analysis programs
- Coordinate team meetings. Facilitate communication with internal and external stakeholders
- Responsible for all study related reporting, including (but not limited to) IRB and NIH. Maintain compliance with all regulatory agencies
- Preparation of scientific documents including peer-reviewed manuscripts
- Financial management of NIH funded research study, including purchasing and human resources management
- Complete all other duties as assigned
58
Clinical Research Coordinator Resume Examples & Samples
- Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records
- Disseminates information about the protocol auxiliary personnel
- Works with the Data Coordinating Center to monitor participant progression throughout the study and conducts evaluation at pre-specified intervals and at end of study
- Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection
- Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed
- Assures proper laboratory samples are collected, labeled and shipped per study protocol and results are reported to the proper entities
- Coordinates with physicians to provide information regarding available research projects and to maintain a strong referral basis
- Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Cardiology Research Manager. This may include travel
- Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator
59
Clinical Research Coordinator Resume Examples & Samples
- Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services
- Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study
- Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues
- Assists the Principal Investigator in the development of study protocols
60
Clinical Research Coordinator Resume Examples & Samples
- In collaboration with the attending physician, recruits study subjects and ensures that all eligibility parameters are met. Ensures that informed consent is obtained prior to patient enrollment
- Registers patients on clinical trials utilizing the appropriate registration process determined by the study group. Discusses the study with subject and obtains informed consent; schedules assessment/visits; assures study visits and tests are done at appropriate time intervals
- Prepares packets for each newly diagnosed patient to include protocol consent, eligibility and
- Daily review of next day’s clinic records to ensure that current and correct roadmap is available. Assists Care Coordinators and LIPs in obtaining current roadmap for all inpatients
- Downloads information from clinical trial websites and maintains communication with the Children’s Oncology Group, the Therapeutic Advances in Childhood Leukemia (TACL), Pacific Pediatric Neurooncology Consortium (PNOC), Sunshine Pediatric Sarcoma consortium, and Medulloblastoma Neuroblastoma Consortium. Maintains protocols by ensuring that new protocols, amendments and closures are updated on notification from consortia
- Responsible for all aspects of regulatory compliance for consortia within Primary Children’s Hospital
- Tracks all regulatory activity generated from consortia or other study governing bodies. Prepares and submits protocols, protocol amendments and necessary progress reports for all protocols to IRB for approval in accordance with regulatory and/or IRB requirements
- Assists physician investigator with communications to the various study chairs or group office as needed. Provides feedback to medical team on QA issues, protocol violations and documentation issues
- Prepares all necessary documents for an Institutional Audit and/or site visit Peer Review Direct
- Provides cross-coverage as needed to ensure that the work requirements are met. Attends to other duties as assigned by supervisor
61
Clinical Research Coordinator Resume Examples & Samples
- Monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services
- Recruits participants and monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining participant population availability, developing informed consents and screening materials, screening (and recruiting) participants, scheduling study visits, obtaining informed consent, answering participant inquiries, overseeing study visits and acting as a liaison between participants and study-related parties
- Provides oversight of all regulatory aspects of the research including maintenance of information on each protocol in ERICA
- Creates the agenda scribes minutes and coordinates the Data Safety and Monitoring Board for all lab protocols
- Manages the participant payment process
- Handles Administrative functions for the lab
62
Clinical Research Coordinator Resume Examples & Samples
- Work with identified hospital staff to determine the best times to complete observations within the unit
- Accompany clinical staff to patient rooms only when the Michigan BioTrust and newborn screening is being discussed
- Complete an observation form for each patient interaction
- Record observations for 30 to 40 consents
- Enter data into a spreadsheet and complete preliminary data analysis as guided by Erin Rothwell
63
Clinical Research Coordinator Resume Examples & Samples
- Develops study budgets; monitors budget expenses for allied services; negotiates payment schedule with sponsor and fees for internal services
- Disseminates information about the protocol to junior research staff and auxiliary personnel
- Creates a system to track data entry and audit for completeness, accuracy, and timeliness of data collection
- Attends all appropriate meetings as determined by the Principal Investigator and Pediatric Cardiology Research Manager
64
Clinical Research Coordinator Resume Examples & Samples
- Compliance to study protocol; manages quality control, completion and submission of study related documentation; prepares reports for P.I., organizations and agencies
- Adheres to enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities relate to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, obtaining blood/saliva/urine specimens, answering subject inquiries, overseeing study visits, and acting as a liaison between participants and study-related parties
- Assists and coordinates with the team for site visits made by sponsors or federal agencies during course and at close of the study
- Maintains patient databases and patients research study files
- Travel between clinics is a must so own transportation is needed for those days (rotating schedule). Occasional patient recruitment my occur evenings and week-ends, must be available to assist
65
Clinical Research Coordinator Resume Examples & Samples
- Provide support to clinical research project manager and PI by reviewing study budgets, industry proposals, and federal grants
- Work with project manager to assist with study start up: shepherding study agreements through the pulmonary and medicine Clinical Research Units, drafting Case Report Forms, Duke IRB and other regulatory documents
- Independently responsible for subject enrollment, data collection, data entry into paper or electronic CRFs and the Palmer lab database, and all other operational study components
- Prepare and organize all IRB documentation. -Independently procure, process, and inventory biological samples
- Work with database manager to extract data from the database for data analyses
- Assist with data analyses and construct tables and figures for presentations or manuscripts
66
Clinical Research Coordinator Resume Examples & Samples
- Recruit study participants by establishing referral methods and working with our clinical partners, as well as implementing a successful plan in line with approved protocol to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly
- Work closely with the Center Administrator and Clinical Research Coordinator, Sr. to support the activities of all team members
- Ensure each participant meets eligibility requirements prior to scheduling of screening visits
- Explain project to participant and enroll them into the study
- Schedule and/or coordinate the scheduling of required laboratory tests and/or exams. Maintain contact and develop rapport with participants throughout the project; searches for participants that have changed addresses during the project
- Mail questionnaires to participants to complete or ask them questions by telephone or in person; compile results of questionnaires
- Complete case report forms for each study participant and maintain and organize participant binders, ensuring that protocol is being followed and consents are up-to-date
- Enter data from case report forms into electronic database and prepare quarterly reports utilizing the database
- Work with Clinical Research Coordinator, Sr. to maintain inventory of data collection supplies and requisition supplies and equipment as needed
- Proactively track initiative to ensure recruitment stays on track with project timelines
- Previous human subjects training (e.g. CITI certification) and two years experience as a research coordinator with direct recruitment and enrollment responsibilities
- Familiarity with UA and external (FDA, NIH) clinical research regulatory bodies, and experience with use of electronic data capture systems (such as REDCaps)
- The ideal candidate will be fluent in English and Spanish with excellent organizational and interpersonal skills
67
Clinical Research Coordinator Resume Examples & Samples
- Minimum of 5 years clinical research experience
- Bachelor’s degree in neuroscience or healthcare related field
- Certified Clinical Research Coordinator (CRC)
68
Clinical Research Coordinator Resume Examples & Samples
- Regulatory affairs
- Patient recruitment and enrollment
- Long distance travel logistics
- Study visit interviews
- Data abstraction
- Surgical procedure arrangements
69
Clinical Research Coordinator Resume Examples & Samples
- "Provides superior customer service to internal and external clients, customers, and patients as referenced in the Service Excellence Standards."
- Performs duties as needed to coordinate clinical research studies/clinical trials to include but not limited to the following
- Ability to work closely and productively with other members of an interdisciplinary team
- Ability to analyze operational issues and solve them creatively
- Accuracy and attention to detail
70
Clinical Research Coordinator Resume Examples & Samples
- On a periodic basis and with notice, adjust regular working schedule to provide weekend or evening enrollment coverage as needed
- Maintain a detailed tracking data entry for participants. Track progress at regular intervals and report out to PI and study team
- Bachelor’s degree in a field appropriate to the area of assignment AND two years related research experience; OR, Six years research experience appropriate to the area of assignment; OR, Any equivalent combination of experience, training and/or education approved by Human Resources
71
Clinical Research Coordinator Resume Examples & Samples
- Collaborates closely with Ironwood Clinical Study Managers, study teams and CRO partners
- Supports implementation and management of clinical research studies through file management and clinical project document control
- Assists the Ironwood clinical project teams in project related activities, such as creating study binders, shipping study documents, and drafting newsletters
- Reviews and tracks clinical trial regulatory documents
- Re Assists in the planning and preparation for investigator meetings
- Maintains study tracking tools and study calendars
- Works closely with Ironwood Records Management, Ironwood Regulatory, and CROs to ensure adequate clinical trial documentation
- Completion of telephone logs, notes to file, and status reports
- Participates in study team meetings and drafts meeting minutes and agendas
72
Clinical Research Coordinator Resume Examples & Samples
- Organizes research information for clinical projects
- Selects and observes subjects and assists with data analysis and reporting
- Oversees experiment scheduling and collection of data
- Familiar with standard concepts, practices, and procedures within a particular field. Relies on limited experience and judgment to plan and accomplish goals
- Works under general supervision
- A certain degree of creativity and latitude is required
- 3 years of work experience in clinical research setting as research coordinator
73
Clinical Research Coordinator Resume Examples & Samples
- Develop and maintain training manuals for study sites. Train study sites in correct collection, processing and shipping of bio-specimen and data. Update study protocols and consents as necessary to meet changing needs of the study
- Provide consent template language to study sites. Prepare study progress reports and present information on a weekly basis to the study sponsor and PIs of study sites
- Work directly with study participants to determine subject eligibility and obtain consent. Educate participant and families on disease and study protocol
- Maintain current scientific knowledge of bio-specimen collection and uses. Educate participants and families on study protocol. Monitor sites for study compliance, regulatory compliance and quality control. Position involves ability to make decision that directly impact the study and subsequently the study funding
74
Clinical Research Coordinator Resume Examples & Samples
- Good social skills, including the ability to work easily with research participants and research team members
- Well organized, attention to detail, excellent verbal and written communication skills in English
- Experience managing a small team
- Preference given to applicants with previous clinical research experience with older adults or those with motor and/or cognitive disabilities
- Strong analytical skills and experience with computer spreadsheets and database software
- Ability to work empathetically and professionally with older adults who may have neurological impairment (e.g. Parkinson’s disease) or cognitive impairment
75
Clinical Research Coordinator Resume Examples & Samples
- Direct contact with patients to gather medical history data and provide therapeutic guidance under the supervision of the clinical leads
- Arranging appropriate clinical and laboratory follow up
- Monitoring and Reporting of adverse events
- Communicating Treatment Plans to the patient’s primary care providers
- Data gathering for quality control
- Leading interface with Project Team to provide real time updates regarding recruitment, patient experience, and other metrics
- Provides excellent customer service. Ensures customer/patient satisfaction and compliance with protocols
- Works in daily collaboration with Physician Lead and Manager to resolve issues related to the patient recruitment and experience
- Acts as a patient advocate for any questions or issues regarding service and recruitment delivery
- Develops tools and resources for all protocol staff
- Responsible for reviewing weekly ACD reports and quality audit reports. Responsible for reviewing quarterly audits with staff and providing one on one retraining when applicable. Oversees operational changes associated with call center operations and Watkins Center practice standards
- Provides orientation, training and coaching of all new team members. Mentors all team members and assists in identifying re-training subject matter
- Actively participate in regular protocol meetings
- Assists physician lead and manager with special projects as assigned
- Performs all other duties and tasks as requested to ensure the efficient overall performance meeting targets
- Potentially schedules study visits for study subjects
- Enters data into databases created in Microsoft Access and other systems
- Schedules study visits by interacting (via phone, email, or fax) with the following persons and entities: study subjects, Study staff, including research coordinators, study physicians, and other support staff
- Assists with IRB preparation of amendments
- May lead work study students engaged in data entry or other tasks
- Prepares study summary reports regarding recruitment status and study’s progress. Takes an active role in subject recruitment methods
- Stays current and up to date with position’s trainings and certifications
- Performs other administrative functions as required, e.g., reconciling invoices, organizing investigator and staff meetings, assisting with web searches
- Maintains confidentiality with regard to patient information and other sensitive information
- Greets and provides assistance to visitors, subjects and employees in a professional and courteous manner
- Develops and implements measures to improve efficiency in office operations
- Performs other task as requested
- 2-5 Years Healthcare experience
- Verbal skills: Ability to interpret information as appropriate, answer more complex questions in the most professional manner and communicate in a professional, courteous, clear and concise manner
- Organization Skills: Ability to manage work processes in a neat and orderly way and to sort and alphabetize. Ability to manage multiple tasks effectively, follow established protocols and Unit’s SOPs, and work within systems
- Intermediate understanding and use of medical terminology
76
Clinical Research Coordinator Resume Examples & Samples
- Academic and/or work experience related to medicine, science and statistics
- Experience with specialized word processing and spreadsheets
- Keen interest in medicine/life sciences
77
Clinical Research Coordinator Resume Examples & Samples
- Data management and informatics. Use and train others in ElectronicData Capture (EDC)systems, technologies, and software necessary for study operations.Enter data accurately. Scoretests and measures according to protocol and appropriate to role.Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions. May independently design ECRFs andEDCs to collect data and select methods of data capture and discuss advantages and disadvantages of each.Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality ofdata. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate.Use required processes, policies, and systems to ensure data securityand data provenance.Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance.Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised. May be responsible for determining solutions to vulnerabilities related to security of data and data provenance.Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are inplace (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions(IDEs), etc.)
- Scientific concepts and research design. Understand and train other sin the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify short comings of proposals and protocols.Identify various stakeholders (statistical, operational, etc.) to ensure adequate design,implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies
- Leadership and professionalism. Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead acommittee, task force, or ad hoc group. Encourage career development by actively seek out continuing education opportunities for self and study team members.Participate in or lead scientific presentations and publications
78
Clinical Research Coordinator Resume Examples & Samples
- Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
- Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
- Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
- Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at Compass Research
- Complete all monitor and sponsor queries in a timely manner
- Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient’s participation in study
- Learn and support the mission and goals of Compass Research’s program
- Ability to communicate clearly/effectively (written and oral)
- Some prior experience in a clinical environment required – preferably in a clinical research setting in the position of Research Assistant or CRC
- LPN, RN, or other medical license or certification preferred
79
Clinical Research Coordinator Resume Examples & Samples
- Associate's Degree in Nursing and/or Bachelor's degree in a health related field
- Active New York State Registered Nurse license
- 1+ year of clinical research experience
- Certification in the Protection of Human Research Subjects
- Knowledge of computer programs such as Microsoft Word and Excel
- Proficiency in the use of computer programs for documentation development, documentation, and the creation and use of spreadsheets
- Excellent organizational, interpersonal, verbal and written communication skills
80
Clinical Research Coordinator Resume Examples & Samples
- Six (6) years equivalent combination of experience in research, training and/or education approved by Human Resources; OR
- Bachelor’s degree in a field appropriate to the area of assignment and two years related research experience
- Knowledge of the principles, practices and techniques of research clinical skills
- Experience with research protocols, development, regulations
- Motivated to provide high quality, compliant research
81
Clinical Research Coordinator Resume Examples & Samples
- Adheres to and supports the mission, purpose, philosophy, objectives, policies, and procedures of Tenet Physician Resources
- Adheres to the Tenet HIPAA Compliance Plan and the Privacy Standards Confidentiality Agreement
- Demonstrates support for the Tenet Corporate Compliance Program by being knowledgeable of compliance responsibilities as expressed in the Code of Conduct; adhering to federal and state laws, rules, regulations, and corporate policies and procedures policies that affect his/her specific job functions/responsibilities; and reporting compliance issues/concerns in a timely and appropriate manner
- Be knowledgeable of protocols and adhere to Tenet Clinical and Administrative Standards of Practice
- Develop recruitment plans, assemble and organize materials
- Meet with Sponsors, Groups, Hospital officials, meet with PIs and ancillary staff prior to study initiation
- Assist in writing informed consent forms
- Screen and recruit study subjects, obtain and document informed consent
- Document clinical research processes, medical procedures in source documents
- Complete case report forms within 10 working days of study visits
- Conduct study visit assessments, data collection, process central lab samples, obtain results
- Do simple clinical tests
- Administer study medication, including parenteral administration
- Educate patients and family on study processes, study drug, informed consent process, study progress, visit appointments, contact numbers, issues under study and drug interactions
- Maintain ongoing oversight of study project activities, status and timeliness
- Reach recruitment goals or make recommendations on re-setting recruitment goals
- Interface with research manager, PIs and research committee
- Locate missing patients and document lost-to-follow-up
- Attend research meetings, staff meetings, PI meetings, monitor meetings, conference calls
- Carry beeper and be responsive to digital pages, rotate onto call schedule, as appropriate
- Attend monitor and FDA audits
- Reconcile study queries from sponsors
- Interface with IRBs and Regulatory Affairs Coordinator
- Perform drug accountability processes
- Maintain study-associated supplies and inventory
- Make prospective study appointments and notify/remind patients of their appointments
- Delegate responsibilities to support staff, as appropriate
- Participate in assessing new study feasibility
- Adhere to compliance policies and procedures. Report any incident that appears
- Knowledge of medical office procedures and process
- Knowledge of clinical equipment, supplies, and instruments
- Understanding of documentation required for physician office visits
- Knowledge of the purposes, organization, and policies of the local community's health systems sufficient to interact with other health care
- Skill in computer hardware and software use
- Skill in verbal and written communication
- Skill in exercising a high degree of initiative, judgment, discretion, and decision-making to achieve organizational objectives
- Skill in analyzing situations accurately and taking effective action
- Skill in establishing and maintaining effective working relationships with employees, policy-making bodies, third-party payers, patients, and the
- Skill in exercising judgment and discretion in developing, applying, interpreting, and coordinating departmental policies and procedures
- Ability to obtain vital signs and record them correctly
- Ability to administer IV and Injections appropriately
- Ability to mix medications
- Ability to use medical equipment, supplies and instruments
- Ability to understand and carry out written, oral and/or graphic instructions
- Ability to multi-task, manage details and organize efficiently and effectively
- Ability to read, interprets, and apply policies and procedures
- Ability to set priorities among multiple requests
- Ability to interact with patients, medical and administrative staff, and the public effectively
- Ability to use EMR, other relevant computer hardware and software, telephone, copier, fax machine and other standard medical office equipment
82
Clinical Research Coordinator Resume Examples & Samples
- Knowledge of psychiatric and medical nursing procedures is preferred
- Knowledge of regulatory guidelines regarding research (e.g. “Common Rule”, “GCP” etc.)
- Knowledgeable on medical coding and billing procedures in a physician practice setting
- Ability to evaluate the effectiveness of existing methods and procedures
- Ability to communicate effectively with patients, clinical and administrative staff and the public
- Ability to interpret, adapt and apply guidelines and policies and procedures
- Skill in dealing with interpersonal issues and customer relations
- Ability to handle multiple priorities at once with minimal supervision
- Ability to plan, organize, delegate and supervise
- Minimum of two to three solid years of medical office experience in a supervisor or lead role
- Proven performance in solving operational issues within a healthcare setting
- Proven performance leading a successful team in a fast paced healthcare setting
83
Clinical Research Coordinator Resume Examples & Samples
- Oversees compliance to study protocols: manages quality control, completion and submission of study-related documentation; prepares reports for organizations and agencies
- Collaborates with study sponsors and PIs to establish study objectives, procedures, and deadlines for each project. Oversees day-to-day research activities, ensuring that progress is made to achieve study objectives and deadlines while preserving the integrity of scientific research
- Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and carries out responsibilities related to research participants, including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, obtaining informed consent, answering subject inquiries, overseeing study visits, and acting as a liaison between participants and all study-related parties
- Provides study-specific education and training for faculty, fellows, Primary Children’s Hospital clinical and ancillary staff, and students
- Develops and maintains study databases for all research projects, including data collection, query management, establishing and monitoring timeline development, and data quality
- Recognizes, tracks, and reports adverse events and protocol deviations
- Prepares for and coordinates site visits made by sponsors or federal agencies
- Prepares, submits and maintains IRB, FDA, NIH and all other regulatory processes to ensure compliance with good clinical research standards and practices
- Collaborates with division manager to monitor study expenditures, order supplies, assist with budget / funding updates and analysis of appropriate expenditure of funds
- Coordinates and prepares reports for internal and external customers, including division chief and manager, project investigators, university offices, study sponsors and collaborating institutions
- Assists in assessing, planning, designing, budgeting, and initiating future studies, and assists with grant application activities
- Performs other necessary research support functions as assigned by division chief, manager, or project investigators
- Establishes and maintains collaborative community relationships, particularly with Intermountain Healthcare / Primary Children’s Hospital, and the PECARN research network. Travels to required meetings for training and collaboration
- Provides continual didactic education and on-the-job training and feedback to Academic Associate students, providing continual feedback and study updates in order to enhance their learning experience and guarantee the quality of their work
84
Clinical Research Coordinator Resume Examples & Samples
- Assists in the development of study materials and protocols; oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies
- Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study
- Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed. Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection
- Performs medical reviews analyzing or evaluating clinical data and serves as a team resource for non-clinician staff
- Administers investigational drugs and monitors side effects
- Performs investigational surgical or radiological procedures and detailed clinical assessments
- Provides nursing care as necessitated by the response of the participant to the study intervention
85
Clinical Research Coordinator Resume Examples & Samples
- Determine patient eligibility and obtain informed consent for clinical trial participation
- Conduct clinical visits according to approved research protocols in an emergency department setting
- Handling and processing of biomedical specimens
- Review medical records and document protected health information for study records
- Bachelor’s degree in health-related field
- One year of clinical research experience
86
Clinical Research Coordinator Resume Examples & Samples
- Ensure each collection site is properly set up and maintained in accordance with standards set by the FDA, Health Resources and Services Administration (HRSA), the Federation for the Accreditation of Cellular Therapies (FACT), and the National Marrow Donor Program (NMDP). This includes equipment, safety procedures, and cleanliness
- Prepare sites for annual audits and inspections, communicate with QSU, respond to findings and complete reports
- Ensure collection SOPs meet requirements according to FDA and other accrediting agencies
- Develop, validate, and implement policies and procedures and work in collaboration with the Collection Site Coordinator to develop, train and implement new site processes and CCBB expansion
- Review and ensure collection paperwork and data entries are accurate
- Initiate and complete deviations related to the collection and transportation process
- Collaborate with QSU, as needed, to investigate errors and develop and implement CAPAs
- Followup with training, as necessary
- Oversee Medical History approvals, CBU exclusions and CBU status in collaboration with the Medical Director and CCBB processing lab
- Coordinate research studies at collection sites by liaising with the researchers, the laboratory and the collection site staff
- Create and maintain training documentation and records, in collaboration with the Training Coordinator, for sites both with and without Master Control access and for NMDPMD/CNM training
- Supervise kit and kit collection sites programs
- Ensure goals are met
- Manage CCBB personnel working on these programs
- Supervise couriers
- Allocate and maintain EMMES study IDs for CCBB staff and providers
- Coordinate approval, collection and processing of directed donations
- Oversee that supplies are stocked, ordered and available for collections, at all sites
- Coordinate the efficient transportation of cord blood units to North Pavilion
- Maintain records management for confidential packets and ISBT barcodes
- Completion of a Bachelor's degree; or Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
- Experience in cord blood banking is highly desirable, but not required
87
Clinical Research Coordinator Resume Examples & Samples
- Oversee the general operation of the CCBB at the UNC site
- Oversee other Duke personnel working at this site
- Plan and manage monthly site schedule
- Perform general site supervision activities
- Be an ambassador for the CCBB program
- Establish good working relationships with UNC personnel involved in the cord blood collection process
- Develop and enhance all aspects of CCBB UNC with the goal of promoting public cord blood banking
- Represent CCBB in interactions with other UNC departments
- Make presentations to hospital staff and community groups to increase awareness of CCBB at UNC
- Educate potential donors about public cord blood banking by telephone, in OB offices, and in community groups
- Educate the potential mother/donor about public cord blood banking so that she can make an informed choice regarding the volunteer donation of her infant's cord blood
- Assist UNC staff obtain informed consent from mother/donor by providing information and discussion of the consent form, culminating with a written and signed document
- Obtain a detailed medical history from mother/donors following delivery and informed consent
- Record information on the Medical History Form and accurately enter into CCBB database
- Obtain delivery and neonatal information by reviewing the medical records of the mother and infant donor, and accurately record information on the appropriate form, performing follow up with OB clinical staff when needed
- Enter collection and donor information in the CCBB data systems
- Perform final reviews on all paperwork leaving the collection site, ensuring accuracy and completeness of all recorded information before it is delivered to the Collections Site Coordinator
- Ensure delivery of the informed consent, medical history, and delivery information forms to the CCBB laboratory and administrative offices for verification and inclusion into the cord blood unit files
- Ensure that maternal blood samples for infectious disease testing are collected by the collection site phlebotomist according to standard operating procedures. If samples are missed or are otherwise unusable, facilitate the collection of new samples
- Educate and advise UNC personnel on the most effective collection techniques
- Ensure supplies are readily available at the site for UNC personnel to collect the umbilical cord according to CCBB collection procedures
- Prepare the collected umbilical cord blood for delivery to the cord blood processing laboratory for processing and storage
- Ensure and maintain complete confidentiality with regard to identity of the maternal/infant donor pair, as well as results of any tests and procedures, in accordance with CCBB standard operating procedures
- Assist with other obstetrics (OB) research projects as assigned
- Participate in the Quality Assurance Program for the development, implementation, and evaluation of cord blood banking, which may include writing and editing of standard operating procedures as directed by the Quality Manager for the CCBB program
- Completion of a Bachelor's degree, or
- Completion of an Associates degree plus a minimum of two years relevant experience (e.g.,research, clinical, interaction with study population, program coordination)
88
Clinical Research Coordinator Resume Examples & Samples
- Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance
- Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties
- Collect, process, and ship blood, urine and tissue specimens as outlined in oncology clinical trial protocols
- Process samples per study instructions. This may include using centrifuge, liquid nitrogen, making slides
- Packaging and shipping specimens with IATA regulations
- Must be able to work independently and have strong communication and human relations skills
89
Clinical Research Coordinator Resume Examples & Samples
- Responsible for coordinating the research activities of assigned IRB-approved study protocols Reports and is responsible to the Principal Investigator (PI) and supports the CID department head in accordance with federal and local regulatory guidelines
- Coordinate research activities and direct patient care of assigned IRB approved protocols such as physical assessments, vital signs, assessing specific signs and symptoms, and drawing blood (if applicable)
- Administers investigational drugs as specified in the protocols
- Use managerial, communication (written and verbal) and leadership skills in all PI and human subject interaction
- Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
- Recruit and screen research subjects using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design
- Process and prepare specimens for lab analysis and shipping as applicable
- Observe universal precautions and OSHA standards when processing or handling specimens
- Report adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations
- Return telephone calls from research participants in an efficient and timely manner and document interactions appropriately
- Must be a U.S. citizen. / Must be able to obtain a National Security Clearance
- Ability to communicate effectively in written and oral modes and to teach in formal and informal settings
- Skills in counseling, guidance and maintaining interpersonal relationships
90
Clinical Research Coordinator Resume Examples & Samples
- Nights and Weekends are required as calls are primarily to West Coast research participants
- No experience necessary
- 2 year health-related Associate's degree, or certification, or equivalent experience
91
Clinical Research Coordinator Resume Examples & Samples
- At least two (2) full years of CRC experience required
- LPN, RN, or other medical licensure or certification strongly preferred
- CCRC certification strongly preferred
92
Clinical Research Coordinator Resume Examples & Samples
- Screen participants for minimal risk studies
- May screen participants for studies with greater than minimal risk, under supervision
- Maintain subject level documentation for all studies independently
- Schedule participants and conduct visits for minimal risk studies independently
- Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks
- Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc
- Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs
- Conduct and document consent for participants in minimal risk studies
- May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC
- Prepare for study monitoring and study audit visits
- Collect, prepare or process adverse event information under supervision
- Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision
- Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications
- Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations
- Understand that the safety of research participants is a priority
- Identify and explain the risk and benefits to a subject as these pertain to your clinical trial
- Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis
- Use EDC systems and enter data accurately and train others in these tasks
- Detect issues related to data capture, collection or management and suggest solutions
- Use required processes, policies, and systems to ensure data security and provenance
- Recognize and report vulnerabilities related to security of physical and electronic data
- Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data
- Run summaries and reports on existing data
- Assist with development of and follow SOPs for data quality assurance
- May serve as mentor to other staff
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research
- Maintain Duke and project specific training requirements
- Collect information to determine appropriate feasibility, recruitment and retention strategies
- Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.)
- Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties
- Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms
- Prepare for closeout and document storage
- Participate in study team meetings
- Respond to routine questions related to study protocol and refer more complex questions to others as appropriate
- Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution
93
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s degree or equivalent and minimum 3 years’ experience in the field of nursing, public health, psychology, maternal and child health etc
- Must be proficient in Microsoft office suite (Word, PowerPoint, EXCEL, Access etc.)
- Experience in a health related setting coordinating research activities and training research staff with understanding of child development, developmental disabilities, or perinatal health
- Mature and personable with good oral and written communication skills; must be at ease and professional when talking on the phone or in person with professionals, non-professionals, and families
- Prior experience in development, implementation, management, and evaluation of research studies or public health activities
- Attention to detail, accuracy, organization skills, multi-tasking
94
Clinical Research Coordinator Resume Examples & Samples
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including
- Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data
- Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research
- Recruit and screen patients for clinical trials and maintain subject screening logs
- Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
- Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness
- Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics
- Monitor subject safety and report adverse reactions to appropriate medical personnel
- Correspond with research subjects and troubleshoot study-related questions or issues
- Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards
- Assist with study data quality checking and query resolution
- Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring
- Record, report and interpret study findings appropriately to develop a study-specific database
- Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards
- Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records
- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies
- Assist research site with coverage planning related to staffing and scheduling for research projects
- Working knowledge of clinical trials
95
Clinical Research Coordinator Resume Examples & Samples
- Oversees compliance to protocols; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies
- Prepares for and assists affiliate site staff in coordination of site visits made by sponsors or federal agencies during course and at the close of the study
- Represents the Clinical Trials Office at HCI to the HCI affiliates within national research consortia
- Has working knowledge to prepares, submit and maintain IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
- Understands clinical trial sample processing requirements per study instructions
96
Clinical Research Coordinator Resume Examples & Samples
- Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines
- Collaborates with research team to assess feasibility and management of research protocols
- Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports
- Screens, enrolls, and recruits research participants
- Coordinates schedules and monitors research activities and subject participation
- Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately
- Manages, monitors, and reports research data to maintain quality and compliance
- Provides education/training for others within the department
- Performs administrative and regulatory duties related to the study as appropriate. Some travel may be required
- Ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements
- Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements
- Participates in other protocol development activities and executes other assignments as warranted and assigned
97
Clinical Research Coordinator Resume Examples & Samples
- Experience with social science research or clinical trials
- Experience with Qualtrics and/or RedCap
- Experience or desire to work with patients with sleep disorders
98
Clinical Research Coordinator Resume Examples & Samples
- Coordination of patient visits and scheduling
- Quality data collection and transcription
- Preparation for monitor visits and follow-up
- Protocol adherence
- Subject recruitment
- SAE/AE reports
- Facilitates and coordinates the daily activities for clinical studies (including recruiting and scheduling study subjects) and play acritical role in the conduct of the study
- Adherence and Compliance with FDA regulations, ICH, GCP, and company SOPs
- Drawing and processing lab samples (IV a plus)
- Conducting ECGs and BP/Vitals
- Willingness to work a flexible schedule when certain studies require it
- Minimum of Three plus years of site experience
- Strong interpersonal, written/verbal communication and organizational skills
- Candidate must effectively manage time and have the ability to multi-task
99
Clinical Research Coordinator Resume Examples & Samples
- Location/Facility – Baylor Research Institute
- For more information on the facility, please click our Locations link
- Specialty/Department/Practice – Surgical Research
- Benefits –Our competitive benefits package includes*
- Immediate eligibility for health and welfare benefits
- 401(k) savings plan with dollar-for-dollar match up to 5%
- Tuition Reimbursement
- PTO accrual beginning Day 1
- Note: Benefits may vary based upon position type and/or level
100
Clinical Research Coordinator Resume Examples & Samples
- Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience
- A bachelor's degree in a social or health science + 2 years’ experience; or 4 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required
- Familiarity with hospital electronic systems (i.e. electronic medical records, IDX, Cadence)
101
Clinical Research Coordinator Resume Examples & Samples
- Collaborates closely with Ironwood Clinical Study Managers, study teams, and CRO partners
- Assists in the planning and preparation for investigator meetings
- Completes telephone logs, notes to file, and status reports
- B.S. / M.S. or equivalent
- Internship(s) or equivalent entry level experience in clinical research at a hospital, CRO, or biopharmaceutical company is strongly preferred
- Superior understanding of Microsoft Office products
- Aptitude for organizational detail
- Capacity to complete tasks independently in a highly-regulated environment
- Flexibility to function well within a team environment and within condensed timelines
- Ability to verbalize complex study issues and demonstrated problem-solving ability
- Basic understanding or willingness to learn FDA regulatory requirements and good clinical practice (GCP)
102
Clinical Research Coordinator Resume Examples & Samples
- Clinical or research experience in oncology
- Ability to problem solve and multi-task; demonstrates strength in resolving problems swiftly and independently
- Ability to work productively, and turn out high-quality results on challenging, time-critical assignments
- Strong organizational and attention to detail
103
Clinical Research Coordinator Resume Examples & Samples
- Must be proficient in appointment booking, appointing referrals, documenting telephone consults and other patient interactions, and coordinating laboratory studies, x-rays, and other tests. In order to accomplish these tasks, the contractor personnel must be proficient in the use of clinical computer systems, including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
- Personal contacts are with patients, their families and/or significant others, providers, clinical nurses, nursing department head, corps staff, respiratory staff and clerical staff. The CRC will also have frequent contacts with research personnel from government agencies, granting agencies and industry sponsors. Contacts will be for the purpose of consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to elicit positive behavioral response such as guiding patients through a research protocol. Shall report data on research patients in accordance with IRB-approved protocols and applicable regulations
- Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation
- Collect clinical data in a timely and accurate manner and submit information to coordinating centers as required. Consult with the PI regarding follow-up care. Assist with data collection in animal and bioskills laboratory as needed
- Assign appropriate patient randomization number per protocol design
- Maintain official protocol binder with all required documentation per NMOTC and NMCP research instructions
- Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented
- Ensure procedural adherence to the protocol; when protocol deviations occur, ensure deviations are appropriately reported and documented in the official protocol binder
- In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol
- If applicable, maintain accurate documentation record of drugs received
- Process and prepare specimens for lab analysis and shipping
- Enter data into Microsoft Excel and Statistical Package for the Social Sciences (SPSS) databases
- Transfer data from questionnaires and data sheets to the databases
- Conduct telephone, face-to-face interviews or mail information for follow-up visits
- Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigator’s File Binder/Regulatory Binder
- Interact on a regular basis with the PI regarding the conduct of the research study
- Returns telephone calls from research participants in an efficient and timely manner and documents interactions appropriately
- Work is performed in ambulatory care spaces, inpatient wards, animal vivarium and bioskills laboratory with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons
- If properly trained, and required by the protocol, may extract blood or place bandages on animal subjects, assist with the restraint and handling of laboratory animals, surgical preparation, induction and maintenance of anesthesia, operation of physiologic monitoring equipment, collection and recording of anesthetic and experimental data and parameters
- Must be proficient in the use of clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
- Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date
104
Clinical Research Coordinator Resume Examples & Samples
- Minimum of 1 year of research experience or relevant experience preferred
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines preferred
- Knowledge of medical terminology / environment preferred
- Understanding of the IRB submission and review process and when and how to apply for IRB review preferred
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation preferred
105
Clinical Research Coordinator Resume Examples & Samples
- Responsible for coordinating the research activities of assigned basic science, IRB and Institutional Animal Care and Use Committee (IACUC)-approved study protocols. Specific protocols may include both pediatric and adult patients, animals and human anatomical specimens (including cadavers)
- Supports and is accountable for research matters to the PIs of each research protocol in accordance with written policies and procedures. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with scientific and ethical requirements as well as professional standards in terms of quality and appropriateness. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties
- Will be adept in the use of managerial skills, communication skills and leadership skills as the coordinator of complex research protocols involving human beings, animals and human anatomical specimens
- Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol. Process and prepare specimens for lab analysis and shipping. Observe universal precautions and OSHA standards when processing or handling specimens
- Ensure that drugs are correctly dispensed as per protocol. If applicable, maintain accurate documentation record of drugs received. Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator
- Enter data into Microsoft Excel and Statistical Package for the Social Sciences (SPSS) databases. Transfer data from questionnaires and data sheets to the databases
106
Clinical Research Coordinator Resume Examples & Samples
- Leads the research team in the execution of trials within the scope of the established study protocol. Adheres to all human subjects regulations as defined by University and the federal government that pertain to research studies
- Plans and track all assigned clinical activities in the lifecycle phases of start up, interim and close out
- Confirms subject eligibility, coordinates subject enrollment and discusses discrepancies with investigators and nursing staff
- Monitors patient toxicity on trial according to Common Toxicity criteria, including adding data from source, confirming grading and attribution and ensuring consistency of data across medial record. Identifies discrepancies in data and reconciles with investigator and nursing staff
107
Clinical Research Coordinator Resume Examples & Samples
- Assists Management with Business Development efforts
- Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate
- Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol
- Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance
- Communicates with the Sponsor or their representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s representatives
- Complies with the Hospital’s Research Finance Compliance policies and procedures
- Interacts with patients and families to recruit study subjects and ensures compliance with the protocol
- Responsible for speedy and adequate patient enrollment as determined by the Chief Research Officer in all assigned studies
- Submits new protocols to WIRB and verifies that the proper document was received with the proper MCH format. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures
- Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows MCH RI’s Standard Operating Procedures, AAHRPP, HIPPA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines
- 2 years in research experience preferred
- Bilingual in English/Spanish preferred
- Clinical research certification (such as CCRC, CCRP, CRA) and IATA certification preferred
- Excellent communication skills in working with both children and adults
- Experience in pediatric clinical research in a hospital setting preferred
- Good organizational skills, detail-oriented, people-oriented, self-confident, flexible and adaptable to change, with time management skills. High energy level professional
- Knowledge of protocols and its process
- Personal computers, and basic software applications, including word processing, scheduling and contact database, email, web browsing, hospital records, other database software, and office equipment
- Relevant hospital equipment for each clinical trial project
108
Clinical Research Coordinator Resume Examples & Samples
- 3-4 years of clinical research coordination experience, interventional drug/device trial experience strongly preferred
- A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, and exercise sound judgment in setting priorities
- Familiarity with EDC systems
- Must be able to travel between different local research sites on a regular basis
- Bilingual preferred
109
Clinical Research Coordinator Resume Examples & Samples
- 3-4 years of clinical research coordination experience, interventional drug/device trial experience preferred
- Must be familiar with smartphone and mobile health app technology
- Must have an understanding of the role of digital health in clinical research
110
Clinical Research Coordinator Resume Examples & Samples
- Perform study specific regulatory processes across multiple sites (approximately 20) and multiple studies and different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes
- Assist in the development and implementation of policy and procedures and implementation of committee decisions and maintain accurate and complete records
- Promote the ethical conduct of research and ensure compliance with federal, state, and institutional regulatory requirements
- Additionally assist with data management related activities in the network
- Create and update clinical trials database for studies pending, and hold primary responsibility for moving studies through this process (approximately 15 at any given time point)
- Prepare documents for CPC and IRB submission for industry protocols not opened at Duke. This includes developing consent forms that comply with federal and local guidelines
- Coordinate the development and oversee implementation of study specific safety data reconciliation processes of moderate to complex nature across the DCN sites
- Assist with regulatory audits at clinical and affiliate sites
- Assure compliance of general and study specific regulatory processes with SOPs, FDA, NIH, and global regulations
- Develop work plans to address findings
- Determine from monthly cooperative group protocol web postings, CTSU bi- monthly postings, investigator-initiated protocols and industry protocols which protocol activations, closures, and amendments are to be processed for the Duke Cancer Network (DCN) Sites
- Coordinate with DCN Research Staff which newly activated studies are to be opened at institution
- Maintain Certificate of Insurance from each site and obtain study/site specific waivers when indicated. For newly activated protocols, prepare submission materials for initial submission to sites for approval. This would include Clinical Research Collaboration Agreements and Individual Protocol Agreements
- Prepare documents to notify sites of protocol closures as they occur
- Maintain annual IRB approvals for those studies that have patients remaining in follow-up status
111
Clinical Research Coordinator Resume Examples & Samples
- Strong background in science
- Ability to attend to detail and be precise with the ability to work independently, exercising judgment in establishing priorities
- Must possess the analytical ability to resolve minor technical equipment problems and interpret acceptability of data results
- Should have word processing capabilities; general computer experience in Excel and Access highly desirable
- Should have experience working with MS Office tools
- Ability to write and communicate effectively
- Must have excellent interpersonal skills for working with study participants and explaining procedures
112
Clinical Research Coordinator Resume Examples & Samples
- Ability to work with cross-functional teams and remote team members
- Experience with MS Office
- Strong organizational and record-keeping skills
- Strong communication, writing and interpersonal skills
- Ability to succeed in a fast-paced work environment
- Ability and willingness to navigate sensitive discussion with patients and their families regarding cancer care
- Prior research experience (clinical or academic) preferred
- Prior experience with EPIC and/or Power chart preferred but not required
- Familiarity with HIPAA policies and/or best practices for handling protected health information
- Ability to prioritize and meet deadlines
- Exhibits energy and desire to achieve, sets ambitious goals and acts decisively
- Able to adapt to changing environment and demands
- Knowledge of gynecology and/or oncology preferred but not required
113
Clinical Research Coordinator Resume Examples & Samples
- Oversight of the research study start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities
- Responsible for participant recruitment, data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries
- Coordination and management of studies, including communication with Sponsors and regulatory authorities
- Close-out of studies, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved
- Bachelor’s degree required, with a focus in public health, social science, or natural science preferred
- 1-2 years of research experience strongly preferred
- Familiarity with ICH GCP guidelines and FDA CFRs preferred
- Able to work both independently and as part of a team
- Excellent interpersonal skills and the ability to communicate and relate effectively with diverse groups of patients, medical personnel, and research staff via in-person, phone, and e-mail contact
- Strong computer skills, including proficiency with Microsoft Office products
- Dependable, motivated, and willing to learn new processes and procedures as needed
- Detail oriented with excellent organizational, communication, problem-solving, and time management skills
- Ability to approach projects in a responsible, thoughtful, and thorough manner
114
Clinical Research Coordinator Resume Examples & Samples
- Describe your background and qualifications and why you believe you would be a good fit for this position at the FCVC
- Describe a situation in which a customer or colleague was upset and the steps you took to resolve the issue to a reasonable conclusion
- Describe your key impressions of the FCVC presentation found here: http://www.med.umich.edu/cvc/cvcpotentialteam.pdf
- Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data
- Bachelor’s degree in a science or health-related field or equivalent education and experience
- Previous experience with coordination and management of device trials (IDE and HDE) desired
115
Clinical Research Coordinator Resume Examples & Samples
- Education: bachelor’s degree from an accredited college or university
- Experience: minimum of two years’ experience with coordinating/managing clinical research activities with at least 6 months of patient interaction. Clinical trial experience is desired
- Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
- Phlebotomy certification
- Familiarity with FDA, OHRP, GCP, International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH), and HIPAA regulations
- Knowledge and experience with IRB policies and procedures
- Strong computer skills. Proficiency with use of Microsoft Excel, Outlook, Word, and other University and Sponsor systems, as required
116
Clinical Research Coordinator Resume Examples & Samples
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conductingresearch. Train junior staff inthe ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May develop, or assist with the development of, documents related to safety and security. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
- Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to datacapture,collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to securityof data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol#s data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
- Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants, study, and institution
- Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. May make recommendations to investigators and oversight organization(s). Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
- Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors. Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team. Knowledge, Skills and Abilities Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers)
117
Clinical Research Coordinator Resume Examples & Samples
- Plans and coordinates assigned research studies, serves as principle liaison for the project, interfaces with research subjects and collects research data, oversees administrative support, develops appropriate tools needed to conduct the research, and maintains record keeping systems and procedures
- Ensures all research activities occur in compliance with guidelines for human subject protection research. Ensures all key personnel engaged in the research study have met training requirements. Serves as a resource to other research staff members regarding assigned clinical protocols
- Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding source
- Provides regulatory oversight for the conduct of assigned clinical trials. Prepares and oversees LG Hospital IRB submissions and continuing reviews, maintains regulatory and legal documents per IRB, FDA, DOH and other applicable regulatory agencies when required
- Develops and implements recruitment strategies in accordance with sponsor requirements. Oversees and conducts informed consent process under direction of Primary Investigator and maintains appropriate documentation according to GCP, FDA, and IRB guidelines
- Maintains adequate inventory of study supplies. Oversees and maintains drug and medical device accountability according to regulatory guidelines for receipt, storage, dispensation, and return of investigational product according to SOPs policy on Investigational Drug/Device Accountability
- Collaborates with other Research Coordinators, particularly in areas where clinical and non-clinical research areas interface. Contributes to the mentoring of new research staff. Functions as a resource for physicians, other health care providers, and ancillary support staff regarding care of the research participant as it relates to any given clinical research protocol; conducts staff in-services as appropriate
- Coordinates and manages the patient assessments according to protocol standards at LGHealth locations, in a clinically safe and regulatory compliant manner. Utilizes clinical knowledge and assessment skills necessary to evaluate, report, and record accurate medical information including response to therapy according to approved research protocol
- Develops and maintains rapport with patients to promote adherence to treatment and data collection protocols. Coordinates participant tests and procedures and maintains study timelines in data collection and completion of case report forms
- Assures collected data for any approved research protocol is correct, sufficient, all inclusive, regulatory compliant and the integrity is intact. Maintains study files in accordance with sponsor requirements and LGH SOP Policies, including consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
- Assures the source documentation of all research activities is completed and accessible for CRF completion, reporting purposes, and for site visits by Sponsors and other regulatory agencies. Facilitates, conducts and oversees monitoring visits with Sponsors and other related agencies for the purpose of evaluating the accuracy and quality of the collected data
- Maintains effective and ongoing communication with Sponsor, research participants and PI during the course of the study
- Performs rotating evening and weekend On Call coverage for active research trials if required
- Travels to various LGHealth facilities as required to execute trials. Travels to investigator and clinical research coordinator meetings
- Attends and participates in research team meetings; educational research and clinically relevant workshops; and sessions provided by LGH to maintain skill sets, knowledge base, and continuing educational credits for both licensure and research certification renewals
- Bachelor’s degree in a health science or related field (eg, biology, public health, healthcare administration)
- Two (2) years’ experience in a research or clinical environment
- Working knowledge of medical and research terminology
- Comprehension of Federal Regulations for Human Subjects in research
- Comprehension and certification in Good Clinical Practices (ICH/GCP) for human research
- Computer Competency including proficiency in Microsoft Outlook, Word, Excel, electronic data capture and electronic health records (EHR) navigation
- Research professional certification (CCRP) or willingness to pursue certification
118
Clinical Research Coordinator Resume Examples & Samples
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensureethical conduct and protect vulnerable populations. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
- Data management and informatics. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
- Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
- Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors. Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team
119
Clinical Research Coordinator Resume Examples & Samples
- Associates degree and three (3) years direct clinical research experience; OR
- Medical Assistant/Lab Technician certification and (3) years direct clinical research experience; OR
- RN, LPN, LVN and two (2) years of direct clinical or medical laboratory experience; OR
- Bachelor’s degree and one (1) year direct clinical research experience; OR
- CRA, CCRA Certification
- Previous experience with electronic medical records
- Previous experience managing, organizing and entering patient data in various databases
- Willing to be trained in phlebotomy
- Must possess a valid Arizona driver’s license with two years of driving experience and reliable transportation with proper Arizona registration and vehicle insurance
- Six (6) years’ experience in clinical research and training; OR
- Bachelor’s degree in a field appropriate to the area of assignment and two years related research experience (Health or biological sciences related field)
- Demonstrated experience in Phlebotomy and/or certified Phlebotomist
120
Clinical Research Coordinator Resume Examples & Samples
- Document research participants who are lost to follow-up or who have dropped out (e.g., causes, contact efforts)
- Coordinate protocol related research procedures, study visits and follow-up care
- With oversight from the clinical research team, educate research participants and family on protocol and study intervention
- Facilitate site qualification, study initiation and monitoring visits
- Work effectively with multidisciplinary, ancillary and inter-professional research teams
- Possess a basic understanding of scientific center goals and the importance of serving our customers
121
Clinical Research Coordinator Resume Examples & Samples
- Ensure the research participant has sufficient time and opportunity to ask the investigator medical questions
- Document the informed consent process in the source document and provide the research participant with a copy of the informed consent
- Oversee the development of advertising materials
- Participate in teleconferences and/or meetings to review study progress and conduct
- Assess and ensure research participant safety throughout study participation
- Maintain close communication with investigator
- Attend investigator meetings as appropriate and communicate relevant information to the research team
- Understand and proficiently communicate all components of research documents, such as protocol, investigator brochure and research instructions
- Ensure long term storage of study documents
- Submit IRB closing report (i.e, termination) after sponsor has closed study site
- Act as liaison with research participants, investigators, sponsors and healthcare professionals
- Prepare for site qualification, study initiation, monitoring and close-out visits
- Ensure all research participant encounters are updated as appropriate and within 24 hours in a recognized electronic system/database (e.g., CTMS)
- Must possess basic understanding of Good Clinical Practices (GCPs) provided by the International Conference on Harmonization (ICH)
- Required MedStar Health Research Institute trainings include: a) Collaborative Institutional Training Initiative (CITI), b) Conflict of Interest (COI), c) annual MedStar Health mandatory's
122
Clinical Research Coordinator Resume Examples & Samples
- Participate in protocol review, evaluations, study design and risk assessments to subject population; Prepare, amend and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, Amendments, Continuing Reviews, and study close out); Develop informational materials for recruitment; Create and maintain ordersets within the hospital electronic medical records systems; Organize and distribute regulatory documents; Assess study population/availability; Provide/secure source documentation tools for subject’s charts/records; Communicate with PI and sub-investigators about changes in trial; Provide training to nurses, technicians, and other medical and non-medical staff. Prepare reports for Data Safety Monitoring Board, provide and interpret original data, including data field queries to and from study statistician. Stay abreast of changes to institutional and federal regulatory policies and laws. Individual capable of communication/interaction with the public, patients and medical staff
- Identify potential subjects from review of existing protected health information based on inclusion/exclusion criteria; Interact efficiently with PI to choose data for rapid risk statification of patients (for example, choosing proper CT scan images); Identify, schedule screening procedures and review results; Recruit subjects and keep accurate records; Obtain patient consent including discussion of treatment/intervention alternatives and signature on Informed Consent forms; Respond to questions from nurses, technicians, and medical and nonmedical staff, per protocol; Serve as an advocate for the subjects and their family; Prepare for and be present at monitor visits; Record, document and report adverse events and protocol deviations to maintain compliance; Facilitate and participate in pre-study visits with sponsor and research personnel. Occasionally travel (out-of-state) to other institutions to initiate multicenter studies or to train and maintain training
- Utilize REDCAP database to create forms for physician data capture; Extract data from source documents and complete Case Report Forms (CRF) or database entries; Order and receive drug/device supplies as directed; Capture and record adverse event data; Manage handling of laboratory specimens; Maintaining sample/specimen tracking and inventory; Order and receive drug/device supplies; Prepare and present study protocol reviews at meetings; Review on-going study subjects on a daily basis. Maintain oversight and quality assurance of all standard operating procedures specific to study lead responsibilities. Maintain training logs
- Aid with administrative duties for the clinical program including but not limited to; entering study data into study databases, filing, photocopying, arranging meetings, and data entry; Assist with study related patient care budgets, purchase orders, and reconciling study related patient care expenses. Work in a team environment with a professional and positive attitude; Attend, present and reside over informative conferences to better understand signs/symptoms and diagnosis for current patients; Able and willingness to take call when needed as a shared responsibility within the team
123
Clinical Research Coordinator Resume Examples & Samples
- Managing one or more clinical trial and formulating and recommending policies and procedures to effectively administer such programs. Responsibilities may include, but are not limited to: ensuring fidelity of the research protocol (e.g. following randomization schedule or ensuring all study assessments are completed for a given day)
- Coordinating screening eligibility and subject recruitment for participation in various research projects at the Clinical and Translational Research Building
- Scheduling of appointments within our department and other departments within the University. These responsibilities include attending study related meetings to work with the investigator team on developing recruitment and retention strategies
- Acting as a liaison between the University of Florida, various Industry Sponsors regarding studies, and subjects. Candidates should be comfortable initiating correspondence with the subject's family, the research team and Industry Sponsors
- Assisting university administrators and interinstitutional groups in solving specific client care and treatment problems and in disseminating information in regard to university regulations, policies, and contracts
- Designing, developing, and conducting special studies in the assigned area of client care and treatment. Collecting and analyzing data as appropriate
- Performing tasks related to the maintenance of a database including communication with research group, data verification, and data entry. For these responsibilities, candidates will need to be proficient using MS Office Programs; MS Word, MS Excel, MS PowerPoint and Adobe Software
124
Clinical Research Coordinator Resume Examples & Samples
- Demonstrated computer and data entry skills, and proficiency with MS Office Suite software programs
- Demonstrated knowledge of IRB protocols and processes
- Demonstrated strong attention to detail and ability to adhere to project deadlines
- Ability to travel to off-site locations that may not be accessible via public transportation
- Ability to work evenings/weekends hours as needed
125
Clinical Research Coordinator Resume Examples & Samples
- Baccalaureate degree and 2-3 years of research work experience, -or-
- Associate's degree or equivalent experience with 4 years of research work experience or equivalent
- ACRP or SOCRA certification or equivalent
- 2 years of experience as a Clinical Research professional, supporting all aspects of clinical research
- Strong experience with audit facilitation
- Knowledge of research methods, good clinical practice (GCP), biostatistics and scientific publication processes
- Excellent computer skills, including word processing, and spreadsheet analysis
- Familiarity with HIPAA, Human Subjects Protections regulations and GCP/ICH guidelines
- Demonstrated effectiveness in resolving research issues of varying complexity
126
Clinical Research Coordinator Resume Examples & Samples
- Screening for patients and coordinating real-time patient
- Facilitating trial participation for all recruited patients
- Filling out case report forms and enter data into electronic database
- Responsible for daily functions of clinical trial
- Provide assistance to physicians analyzing images in the clinical trials (imaging data transfer and upload, preparation of image reading sessions, collection of data forms, transfer of data into electronic database)
- Initiate contact with and provide technical support for investigator sites
- Coordinate and participate in internal and external meetings including logistics and preparation of required material
- Clinical or basic science research background preferred
- Outstanding communication and organization skills
127
Clinical Research Coordinator Resume Examples & Samples
- Assist with data abstraction from a variety of sources including patient medical records, hospital clinical information systems, and questionnaire database
- Assist with data collection, data analysis and system evaluation, may administer and score questionaire
- Verifies accuracy of study forms, updates study forms per protocol
- Assists with regulatory binders and QA/QC procedures
- Responsible for screening applicants over the phone, and assessing them to see if they meet appropriate criteria
- Collects computerized questionnaire data from research participants
- Organizes, and/or maintains study databases. Responsible for data entry and quality control of data
- In conjunction with the PI, develops, writes, and implements new research protocols including design, data collection systems and institutional review board approval (IRB). May recommend changes to research protocols
- Performs literature searches as appropriate
- Ability to work independently and effectively as a member of the team
- Strong analytical skills and the ability to resolve technical or research problems and issues, and to interpret the acceptability of data results
- At least one year of work experience in a research setting preferred. Sound independent judgment and competence in research methodologies. Previous experience working with patients or in a healthcare setting strongly preferred
128
Clinical Research Coordinator Resume Examples & Samples
- Facilitate the needs of an interdisciplinary research team to manage the storage, organization, and retrieval of multiple data sources, including task-related fMRI, functional connectivity MRI, sensitive genetic data, and behavioral research data
- Facilitate Institutional Review Board submission process by preparing protocol applications, protocol amendments, safety reports, adverse event reports and other required documents. Manage and maintain regulatory documents
- Perform vitals and phlebotomy on subjects; process and ship specimens
- Interact with both clinical and non-clinical human populations in a research context
- Act as the primary liaison for study subjects to communicate about the study. Arrange and conduct initial interviews of study subjects, including discussing symptom onset and family history, and evaluate criteria for inclusion/exclusion per study protocol; coordinate subsequent assessments of subjects as outlined in study protocol
- Evaluate neuropsychological testing, medical records, and laboratory results for study relevant clinical data. Coordinate subject care by scheduling follow-up assessments and communicating concerns about the subject with the study investigator and the subject’s primary care provider, including writing neuropsychological testing reports
- Previous neuroimaging research experience (at least one year)
- BA/BS degree in psychology, biology,neuroscience, orequivalent scientific or clinical discipline or relevant work experience
- Working knowledge of issues involved in clinical research (e.g., following protocol, IRB, study participant communication)
- Ability to handle sensitive clinical and genetic information
- Proficiency with Microsoft Excel
- Strong written and spoken English language skills
- Experience with any of the following: Freesurfer, SPSS, Microsoft Access/SQL database, LAVA
- Previous clinical research experience with patient populations
- A basic understanding of neuroanatomy, neuropsychological testing, and data management
129
Clinical Research Coordinator Resume Examples & Samples
- Retrieving data and generating reports from the database as requested by PI and fellows. For example, site specific reports for upcoming study subject follow up visits; reports on follow up completion rate or past due study follow up visits
- Ensure accuracy and completeness of data files and subject research files and provide support documents detailing file organization
- Assist with all multi-site study data collection
- Running queries to verify data quality on regular basis
- Assist fellows with system-related questions or problems
- Preparing reports on the quantity and quality of data in the data management system
- Developing simple user interfaces for data entry, workflow management and querying
- Maintain user authentication systems to ensure database security and limit user access
- Edit manuscripts for non native English speaking fellows
- Maintain IRB files and communication with IRB for specific studies
- Maintains research data, patient files, regulatory binders and study databases per FDA standards
- Acts as a liaison between Sponsor, Sponsor Representatives and PI
- May develop systems for QA/QC
- Documenting before, during, and after cardiac procedures for clinics or outpatient visits
- Act as a study resource for patient and family
- May monitor and evaluate lab and procedure data
- Responsible for the administration and oversight of all study questionnaires
- Acts as a liaison between Research Affairs and Unit
- Prepare documents and study binders for FDA audits (if needed)
- Recommends protocol changes and may assist with writing protocols and manuscripts
- Monitors and manages study funds; prepares invoices; identifies and verifies patient care charges as appropriate
- Orients and trains junior team members on the study protocols as appropriate
- Assists in the coverage of other research studies when necessary
- Experience with MS Office products including MS Access. Additional experience working with databases, such as REDCap preferred
- A basic understanding of biology
- The ability to work well with a diverse group of individuals is also crucial to the role
- Previous experience with clinical research and electronic data management systems required
- Responsible for monitoring and managing study funds with the assistance of the grant manager
- Responsible for preparing orders for general office supplies, preparing invoices, and for directing, verifying, and correcting patient care charges as appropriate
130
Clinical Research Coordinator Resume Examples & Samples
- Actively participates in the department's quality improvement efforts. Identifies opportunity for quality improvement to colleagues and management. Takes personal responsibility in improving patient satisfaction with the quality of care and service provided
- Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing informed consent discussions. Demonstrates leadership in ensuring adherence to ethical practices during the conduct of research in order to protect the rights and well-being of patients and the collection of quality data. Utilizes multiple communication methods to facilitate the effective conduct of research. Supports the development of new staff and colleagues, may serve as a preceptor
- Develops and maintains productive working relationships internally and externally by demonstrating accountability for actions, enthusiasm, motivation and commitment to patients and colleagues. Demonstrates an understanding of cultural differences and holds peers accountable for healthy relationships. Maintains a conscious balance between work and personal life. Models safe work hours, time management and healthy lifestyle. Communicates with peers and management any safety hazards identified in the workplace. AGE SPECIFIC COMPETENCY: The individual must be able to identify the patient's particular needs regarding age, education level, literacy and the presence of any language barriers so that all clinical research related instructions can be adapted to the patient's needs. This is particularly important regarding the informed consent process. Must also be aware of the various institutional resources to facilitate this process. Note: The above statements are intended to describe the general nature and level of work being performed by people assigned this job. They are not exhaustive lists of all duties, responsibilities, knowledge, skills, abilities and working conditions associated with the job
- Identifies the financial variables that affect research. Uses a variety of resources and strategies to manage the care of patients participating in research, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms. Utilizes a variety of strategies to enhance recruitment while being mindful of the needs of diverse patient populations. Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of the diverse patient population. Provides leadership to the research team in ensuring collection of source data and completion of documentation that validated the integrity of the research
- Takes responsibilities for identifying his or her ongoing professional development needs and seeks resources and opportunities to meet those needs, such as through membership in nursing or research organizations. Provides detailed and appropriate teaching to patients and families to effectively guide them through the research study. Supports the development of others. Creates an open environment of open dialogue, inquiry and continuous development by asking for feedback and improving practice
- Minimum 2 years nursing experience
- Oncology experience preferred
- Special Skills and Abilities Required
- Rating of solid/Strong/Good or higher on most recent performance evaluation
- May supervise nonprofessional staff
131
Clinical Research Coordinator Resume Examples & Samples
- Adheres to IRB-approved protocols and serves as advocate for the proper conduct of research and compliance with the protocol requirements
- Responsible for participant recruitment, screening for eligibility, and registration to studies across our center
- Presents trial concepts and details to patients and their families and actively participates in the informed consent process according to institutional and federal regulatory guidelines
- Coordinates all aspects of patient care/treatment in compliance with protocol requirements (clinical treatment, study visit timing, and follow-up care) for assigned study participants
- Schedules/requests required tests; collects and processes specimens; and monitors and reports patient response according to protocol requirements
- Oversees the preparation and sign-off of drug orders by physicians and communicates with the medical team regarding study requirements, need for dose modification, and adverse event reporting to ensure protocol compliance is maintained
- Disburses investigational drug and provide patient teaching regarding administration as well as maintenance of drug accountability documentation
- Provides patient education and emotional support to patients and their family members throughout study participation
- Maintains up-to-date and accurate source documents in the patient study file and collaborates with physicians and data coordinators for submission of accurate comprehensive data
- Responsible for the accurate and timely reporting of adverse events (side effects) and unanticipated problems posing risks to subjects according to protocol, institutional, and governmental requirements
- Coordinates study implementation activities as well as audits/monitoring visits conducted by study sponsors
- Responsible for the collection, processing and shipping of laboratory specimens for assigned protocols
- Demonstrates fiscal accountability by tracking research charges and monitoring protocol budget/contract and billing procedures/insurance implications of study participation
132
Clinical Research Coordinator Resume Examples & Samples
- Interest in learning the skills necessary for the administering and scoring standardized psychological tests, including intelligence measures, and measures of specific cognitive abilities, including memory, attention, language and visual-spatial processing
- Ability to interact with diverse staff and patient populations, including adults and children
- Basic computer skills for data entry and management of data base
- Ability to organize and obtain scientific literature pertinent to clinical populations
- May perform other duties to support clinical and administrative team
- Minimum of B.A. in Psychology or related field required
- Excel programming experience
133
Clinical Research Coordinator Resume Examples & Samples
- Professional knowledge of a wide range of nursing concepts, principles, and practices for specialized nursing assignments in clinical research studies and with humanitarian use devices
- Apply research regulations to all duties. Ensure research quality by practicing in compliance with all Presence Health standards, IRB policies, and federal, state, and local regulations, including adherence to the principles of Good Clinical Practice (GCP)
- Protect the rights of human subjects by obtaining proper informed consent and adhering to consent and protocol guidelines. Maintain a safe environment for subjects, their families, and staff through compliance with all federal, state, local, and standards and maintain strict patient confidentiality according to HIPAA regulations and applicable law
- Prepare and submit documents (protocols, amendments, clinical data, etc.) to sponsors, IRB, and regulatory entities in a timely manner, maintaining documents in accordance with applicable regulations and Presence Health standards. Assist investigators and Director of Clinical Research Operations develop plans for research projects. Collaborate on the preparation of manuscripts for publication, including assistance with study design, preparation for IRB submission, study implementation, data analysis and publication (internal or external)
- Submit Serious Adverse Event reports (SAEs/SUAs/SAERs, etc.) and protocol deviations to the Director of Clinical Research Operations, IRB, sponsors, and other regulatory entities as appropriate per FDA regulations and guidelines
- Bachelor’s degree in business, or related field required
- RN/Bachelor in nursing preferred
- Master’s level education preferred
- 3 years experience working with regulatory and legal matters concerning clinical research and clinical trials preferred
- 3 years experience working with study documents and trial applications preferred
- 2 years experience gathering and preparing preliminary research information for writing teams (i.e. regulatory reports, study reports, safety narratives, etc.) preferred; provide some preliminary technical report writing
- Proficient in Microsoft Office (especially Word and Excel)
- Proficient with Outlook
- Ability to obtain data, enter it into a database, correct and clean the data, assist with data accuracy verify action, and conduct preliminary analysis of data
134
Clinical Research Coordinator Resume Examples & Samples
- Theoretical knowledge of biology, microbiology, social sciences, or related field
- Experience completing clinical trials case report forms via hard copy and online
- Experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians
- Experience in medical assessment and patient interviewing to determine toxicities related to protocol management
- Experience interpreting medical charts and abstracting data from medical records
- Experience working with investigational drug authorization criteria
- Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as CREDIT, Access, Excel and MS Word
- Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities
- Experience with medical and clinical management systems EPIC and VELOS
- Experience working with x-rays, scans, and other diagnostic procedures
- Knowledge of hematology/oncology. Ability to differentiate various cancers by stage, histology, and site to determine patient eligibility for protocols and assure accurate randomization
- Experience administering psychosocial tests
135
Clinical Research Coordinator Resume Examples & Samples
- Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience
- Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens
- Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills
- Certification as a clinical research associate or coordinator
136
Clinical Research Coordinator Resume Examples & Samples
- Oversees compliance with study protocols; manages quality control, completion and submission of study related documents
- Monitors study enrollment goals and promotes enrollment and participant compliance. Develops informed consent and screening materials, screens and recruits subjects, schedules visits, obtains informed consent, answers participant questions, oversees study visits including the collection and shipment of study samples, and acts as a liaison between participants and other study-related parties
- Prepares, submits and maintains IRB, FDA, and/or other regulatory applications, documents and research correspondence. Recognizes, tracks and reports adverse events and deviations per protocol requirements, and institutional and federal guidelines
- Prepares for and coordinates sponsor site visits. Works with the sponsor representative/ monitor to make corrections, resolve issues, implement process improvement, etc
- Develops and maintains patient databases, investigational logs and records of study treatment administered, and/or procedures followed
- With assistance from other IM Research Administration staff, develops study budgets and negotiates payment schedules with sponsors. Monitors budget expenses and billing for related services
137
Clinical Research Coordinator Resume Examples & Samples
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
- Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Scoretests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Map protocol data flow. Predict areas of vulnerability for a protocol#s data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
- Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statisticalelements needed for conduct of clinical and translational studies
- Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. May make recommendations to investigators and oversight organization(s). Maintain compliancewith institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
- Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors. Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team. Can easily use computing software and web-based applications(e.g., Microsoft Office products and internet browsers)
138
Clinical Research Coordinator Resume Examples & Samples
- Six years of relevant research experience in a clinical setting OR three years of research experience in a clinical setting with a Bachelor of Science degree
- Must have computer skills and dexterity required for data entry and retrieval of patient information
- Must be proficient with Windows-style applications and keyboard
- Critical thinking skills to apply to the process of trial evaluation and submission, particularly the development of study related budgets, contracts and patient consent documents
- Experience in clinical research
- Experience with data entry and data base management
139
Clinical Research Coordinator Resume Examples & Samples
- Responsible for the sound conduct of clinical trials within clinical discipline
- Maintains accurate and complete documentation
- Organizes the management of all aspects of a clinical trial
- Promotes a high level of communication and professionalism among research team members
- Processes specimens according to protocol and IATA Guidelines
- Contributes to the maintenance and integrity of the clinical trials database
- Participates in protocol assessment and planning activities
- Adheres to screening and enrollment procedures
- Implements subject follow-up procedures
- Follows procedures for case report form (CRF) preparation and completion
- Complies with Sponsor, FDA, and/or internal audit processes
- Ensures positive relations with study sponsors
140
Clinical Research Coordinator Resume Examples & Samples
- Coordinate research activities
- Act as liaison between investigator, agencies, sponsoring companies, and other participants
- Supervise and coordinate the collection and dissemination of subject/patient study data
- Serve as key study personnel
- Implement research protocols
- Assist in the development of research designs, diagnostic and treatment protocols
- Research and analyze project components
- Conduct data analysis and provide written analysis
- Provide instruction on research protocols including interpretation of test results, observations, and related study data to physicians, nurses, professors, teachers, and technician involved
- Instruction provided in an understandable manner
- Supervise research staff, students and others involved with research protocols
- Coordinate, assign and review work of others as it relates to research studies
141
Clinical Research Coordinator Resume Examples & Samples
- Associate’s degree and/or 4 years’ experience in Health Sciences
- Strong knowledge of clinical research study design
- Computer, telephone, and fax machine utilization skills
- Ability to interact effectively as a member of a team and work collaboratively with others
- Effective time management and organizational skills
142
Clinical Research Coordinator Resume Examples & Samples
- Bachelor's degree strongly preferred
- Prior experience with Clinical Trials
- Experience working with children
- Ability to work independently, coupled with the knowledge of when to seek advice
- Able to manage day to day activities while juggling other responsibilities
143
Clinical Research Coordinator Resume Examples & Samples
- Prior experience with clinical trials
- The following characteristics: Honest, trustworthy, able to think strategically
- Ability to manage day to day activities while juggling other responsibilities
- A clear understanding of the importance of confidentiality
144
Clinical Research Coordinator Resume Examples & Samples
- Collaborates with division manager to monitor study expenditures, order supplies, assists with budget / funding updates and analysis of appropriate expenditure of funds
- Attends and participates in division Career Development meetings
- Demonstrates initiative, enthusiasm, positive attitude, teamwork, integrity and commitment to the research mission of the Division of Pediatric Emergency Medicine by providing assistance with special projects and working as directed and where needed
145
Clinical Research Coordinator Resume Examples & Samples
- Develops and maintains basic competencies required to conduct clinical research
- Enrolls and manages study patient follow-up; to include identifying an appropriate licensed research staff member to enter all protocol required labs, tests, procedures and medication orders in the electronic medical record system timely and accurately
- Manages monitoring visits
146
Clinical Research Coordinator Resume Examples & Samples
- Interfaces with clinical staff to identify patients eligible for clinical trials
- Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (30%)
- Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent
- Completes required follow-up and active patient monitoring per study protocol. (30%)
- Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (15%)
- Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies. (15%)
- Performs other duties as assigned or required. (10%)
147
Clinical Research Coordinator Resume Examples & Samples
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research.Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.May develop, or assist with the development of, documents related to safety and security. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
- Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture,collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
- Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop,proposals or protocols; identify shortcomings of proposals and protocols.Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies
- Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. Assign, review, and train others in various work responsibilities.Serve as a mentor to junior staff,including other CRCs. Employ escalation and performance plans as needed.Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants, study, and institution
- Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies.Develop protocol-specific systems and documents including process flows, training manuals,SOPs, and CRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial study milestones and report appropriately. Coordinate with financial teams,PRMO, etc. Assist with study budgets.Prepare for, take part in, and potentially lead site initiation,monitoring, closeout visits, and document storage activities.Collect information to determine feasibility, recruitment and retention strategies. May make recommendations to investigators and oversight organization(s). Maintain compliance with institutional requirements and policies.Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
- Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making,and escalate issues appropriately.Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors.Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements.Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.Knowledge, Skills and Abilities Can easily use computing software and web-based applications (e.g.,Microsoft Office products and internet browsers)
148
Clinical Research Coordinator Resume Examples & Samples
- Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures and all research related policies and procedures of the North Florida/South Georgia Veterans Health System , Shipping and Transport of Biologic Materials policies and procedures as well as other regulatory policies and procedures regarding human subject research. Assists in prioritizing and overseeing the work of Clinical Research Assistants to ensure all aspects of the clinical trial process are accurately completed
- Independently coordinates and oversees all aspects of clinical research trials by (1) identifying possible clinical trial candidates by attending rounds, patient care conferences, interviewing patients and/or reviewing medical records, (2) interpreting medical information and other source documentation to confirm subject eligibility for clinical trial participation, (3) understanding protocols and educating subjects, caregivers and/or legally authorized representatives about the purpose of the pertinent clinical trial, testing procedures, visit schedule, completion of study required documents, potential side effects and potential economic impact, (4) reviewing informed consent documents and answering questions about informed consent content with subjects, caregivers and/or legally authorized representatives, (5) confirming proper execution of informed consent documents including documentation of the informed consent process, (6) randomizing or registering subjects on clinical research trials, (7) following subject's clinical course including inpatient hospitalizations, clinic or office visits and administered treatments and tests, (8) accurately communicating all protocol-specific requirements and protocol-required modifications with key personnel such as Physicians, Physician Assistants, Pharmacists and Nurses, both inpatient and outpatient as well as collaborative departments, (9) confirming that all protocol-specific tests and procedures are completed within study timelines, (10) interpreting test results and accurately communicating these to subjects and staff, (11) evaluating and grading toxicities, (12) extracting protocol-required data from medical records, including medical history, diagnosis, pathology, laboratory, radiology, specialty test results, progress notes and reported side effects or adverse reactions, (13) reviewing protocol and subject data with Principal Investigators and sub-investigators as needed, (14) accurately entering data on paper case report forms and into a computerized database, (15) submitting accurate and complete data to study sponsors according to protocol timelines, (16) maintaining complete case report forms and/or research charts in compliance with privacy laws, (17) collaborating with investigators and monitors to resolve case report form discrepancies or queries and (18) updating and maintaining trial and subject related data in the OnCore Clinical Trials Management System
- Collaborating with Research Regulatory Specialists to submit accurate Institutional Review Board documents such as continuing review/study closure reports, serious adverse event reports, protocol addenda and other documents by (1) reviewing documents to determine appropriate reporting requirements, (2) completing required forms and attaching appropriate documentation such as cumulative adverse event tables, de-identified signed informed consent form, data safety monitoring board reports and/or audit reports, (3) forwarding documents to CTO regulatory staff within appropriate timelines to prevent project expiration or sponsor deficiencies, (4) reviewing IRB submission packets for accuracy and completeness, (5) tracking regulatory paperwork from initial submission to CTO IRB staff to receipt of final approval documents, (6) reviewing approval documents for accuracy and completeness, (7) entering updated approval information in database, (8) filing approval documents in regulatory and/or study binders, (9) distributing new documents to patient care units and (10) alerting ancillary staff of new documents
- Collaborates with Managers, Research Administrators and UF Health Shands billing staff to ensure proper billing compliance for subjects consented to research studies by (1) reviewing the study billing plan, (2) ensuring study funded tests are ordered properly per UF Health guidelines, (3) completing billing tracking documents, (4) reviewing all UF Health billing for subjects on clinical trials in a timely fashion and (5) updating study billing plans and related compliance documentation as necessary throughout the course of a study
- Plans and conducts in-services on assigned clinical trials to disseminate protocol information. Prepares pre-printed study orders and study information sheets and secures appropriate approvals as indicated. Attends Institutional Review Board meetings and professionally responds to questions from the Board or IRB staff. Attends University of Florida Shands Cancer Center and Hematology/Oncology meetings and prepares and/or presents requested information. Attends Investigator meetings and represents the University of Florida professionally. Collaborates with Program Assistants to maintain up-to-date comprehensive regulatory and/or study binders. Provides sponsors with updated regulatory documents. Collaborates with Program Assistants to coordinate the procurement of research samples to include whole blood, serum, urine and pathology slides and tumor blocks by (1) communicating sample requirements with key personnel, (2) confirming samples are appropriately labeled, (3) processing samples according to sponsor requirements, (4) storing samples appropriately until shipment, (5) preparing human blood, serum, urine and pathology samples for shipment as required by the protocol, (6) preparing differential and/or pathology, (7) collecting radiological films and/or CDs and (8) shipping protocol required samples and/or radiological films/CDs in accordance with protocol, local, state and federal requirements
149
Clinical Research Coordinator Resume Examples & Samples
- Proficiency with Microsoft Office and electronic medical record (EPIC)
- Excellent interpersonal skills, both verbal and written, as well as creative problem solving capability
- Ability to multi-task, prioritize appropriately, and work well both in a team and individually
- Enthusiast and self-motivated, with passion and interest in translational medical research
150
Clinical Research Coordinator Resume Examples & Samples
- Prepares, submits and maintains IRB, FDA, and/or other regulatory documents and research correspondence. Recognizes, tracks and reports adverse events and protocol deviations per institutional and federal guidelines
- Prepares for and coordinates sponsor site visits
- Develops and maintains patient databases, investigational logs and records of drugs administered, and/or procedures followed
- Reports to research manager and principle investigators
151
Clinical Research Coordinator Resume Examples & Samples
- Under direct supervision of a physician and nurse (if applicable), is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials
- Collaborates with physician in determining eligibility of patients for clinical trials
- Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations
- Maintains regulatory documents in accordance with SOPs and applicable regulations
- Additional responsibilities may include working directly with other research bases and/or sponsors
- Bachelor's degree in a clinical or scientific related discipline is strongly preferred
- Minimum one year of experience in clinical or scientific related discipline is required, preferably in oncology
- ACRP or SoCRA certification preferred or willing to obtain within one year
152
Clinical Research Coordinator Resume Examples & Samples
- Screens potential patients for protocol eligibility
- Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol
- Coordinates patient care in compliance with protocol requirements
- May disburse investigational drug and provide patient teaching regarding administration
- Responsible for accurate and timely data collection, documentation, entry, and reporting
- Responsible for education of clinic staff regarding clinical research
- Associate's degree in a clinical or scientific related discipline desired, Bachelor's degree preferred
- Healthcare professional preferred: RN, LPN
- RN License in OR or WA
- Oncology research experience preferred
- EMR experience preferred
- SoCRA or ACRP certification preferred
- Computer Skills: data entry, online data capture software, scanning
- Detailed
153
Clinical Research Coordinator Resume Examples & Samples
- Working with research team
- Assisting PI with study visits
- Assessing and reporting AEs/SAEs
- Patient data entry
- Source documentation
- Other administrative duties as assigned and other possible trial related duties
- Research Coordinator or Nurse (LPN or RN)
- Clinical trial experience required
- Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services
154
Clinical Research Coordinator Resume Examples & Samples
- Completes required follow-up and active patient monitoring per study protocol
- Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies
- Associate's degree, RN, or equivalent research experience. Bachelor's degree preferred
- Generally has at least 2 years of experience
- Current research-related certification from accredited program (e.g. CIRA, CCRP) and/or willing to obtain
- Has mastered the components of clinical research operations and is primarily responsible for independent interactions with patients and sponsors (e.g. study accruals, protocol adherence, regular communication with clinic staff); has frequent and direct line of communication to PIs
155
Clinical Research Coordinator Resume Examples & Samples
- Fluent (speaking and writing) in Spanish and English required
- Research experience working with Latino adult populations in northern California and in Latin American countries
- Research experience working directly in community settings with older adults, including underrepresented adults (e.g., lower income, ethnically diverse)
- Experience in delivering standardized health-related behavior change protocols in the areas of physical activity and nutrition
- Knowledge and experience in delivering functional fitness testing for older adults
- Experience supervising ethnically diverse groups of employees
- Willingness and ability to travel to designated Latin American countries required
- Knowledge and experience using an array of information technology tools for health behavior change (e.g., embodied conversational agents, interactive voice response systems, mobile health and SMS applications) required
- Knowledge and experience using RedCAP, Microsoft Office (including Excel, PowerPoint, and Word) and FileMaker Pro highly desired
156
Clinical Research Coordinator Resume Examples & Samples
- Assists the PIs to refine the specific aim, questions, hypotheses, and/or objectives of the research protocols. Assists in ordering study materials, equipment, and/or research animals as specified in the research protocol and in accordance with Clinical Research Division policies
- Conducts the study in accordance with the approved protocol
- Designs a randomization scheme if required for the study. Designs recruitment materials, advertises the study, and recruits participants. Designs measurement schedule and maintains a master calendar for the study and serves as a point of contact for research subjects
- Meets with potential research subjects to explain the research project in detail and enroll eligible subjects into the study by obtaining written informed consent
- Schedules subjects for a research appointment(s) or schedules operating room time as determined by the protocol. Screens patients, patient records, and databases to determine study eligibility and participation using advanced professional skills acquired through nursing training and experience. Coordinates patient treatment and monitors’ patient response to protocol treatment in clinical trials and communicates results to the PI appropriately. Collects lab samples including blood draws and performs preparation of specimens as required by the protocol
- Administers surveys or questionnaires as specified by the protocol
- Abstracts required research data elements from paper, electronic patient records or other existing documents, clinical computer databases such as the Armed Forces Longitudinal Technology Application (AHLTA), Composite Health Care System (CHCS) or Joint Patient Tracking Application (JPTA), and/or electronic diagnostic reports in accordance with the research protocol and enter these data into spreadsheets, databases, and/or statistic software
- Delivers specimens to internal laboratory and/or ship specimens to a referral laboratory as specified by the protocol
- Works with the designated statistician to clean and prepare data sets for analyses
- Collects, sorts, files, and maintains all paper and electronic documents related to the protocol as required by the IRB, IACUC and principle investigator. Submits protocol amendments of the study protocol to IRB and IACUC. Backs up all electronic files regularly. Immediately reports any adverse events to the Medical Monitor or Data Safety Monitoring Board, sponsor, and IRB or IACUC. Assists the PI to write the final report and submit it to the IRB, IACUC, and study sponsor
- Submits progress reports to study sponsors and appropriate compliance committees as required by local policies and the protocol. Identifies delays and other shortcomings in meeting objective and develop a contingency plan as required
- Maintains complete and accurate drug and equipment accountability at all times for the study
- Communicates and provides information during any sponsor COR site visit related to the study
- Tracks animal use according to protocol requirements
- Prepares documentation for the acquisition of equipment and supplies to meet clinical investigation protocol requirements
- Ensures all members engage and supporting research have adequate safety and regulatory training to meet protocol requirements
157
Clinical Research Coordinator Resume Examples & Samples
- Creating and maintaining research protocols
- Upkeep of regulatory materials for all studies
- Ensuring adherence to IRB regulations
- Recruiting, consenting and enrolling participants for studies and clinical trials
- Carrying out protocols activities (scheduling patient appointments, processing blood, administering surveys, collecting study data and specimens in clinics and the OR ect)
- Organize research group activities
- Assisting PI and Co-investigators with additional tasks as needed
- Bachelor’s degree is required; premedical coursework preferred
- Experience with Microsoft Office (statistical programming a plus)
158
Clinical Research Coordinator Resume Examples & Samples
- Assists with screening, informed consent, and enrollment of patients
- Administers standardized testing tools to subjects
- Coordinates and/or performs study procedures including interviews, vital signs, blood draws and sample processing
- Conducts subject interviews and assessments of subjects’ well-being and cognitive function, both in-person and by telephone, and maintains the data
- Creates and executes training sessions for new and ongoing studies
- Trains and orients coordinators and fellows
- Completes and maintains study screening logs, IRB documentation, regulatory files, source documentation, and case report forms
- Collects and enters data as specified by protocols
- Meets regularly with study PIs to review subject and study data and assists with the monitoring for and reporting of adverse events and protocol deviations
- Assists with writing and altering protocols, informed consents and other study documents. Drafts and submits applications to the IRB, including initial submissions, amendments, and continuing reviews
- Works with Program Manager and PI to prepare study reports and assists with drafting grant applications
- Creates standard operating procedures to standardize trial activities at the site
- Searches medical literature and retrieves journal articles and other references
- Acts as a study resource for patients, families and staff
- Schedules and performs study follow-up visits including neuropsychological testing batteries, MRIs/PET imaging, blood draws and sample processing
- Maintains inventory, stocks and orders supplies. Calibrates or updates study equipment
- Actively participates in meetings and teleconferences with other research colleagues by organizing and presenting study screening and enrollment results, sharing best practices, and troubleshooting challenges
- Takes call one weekend per month and 5 weeknights per month to help cover off hour study enrollments and procedures
- Collects and prepares data for monitoring, audits, and analysis by following Quality Assurance and Quality Control procedures, and participates in data monitoring/audits
159
Clinical Research Coordinator Resume Examples & Samples
- Conduct validation studies of data entered into multiple registries associated with local and multicenter studies
- Analyze, summarize, and present clinical and radiographic data collected from international multicenter outcome research collaborations
- Communicate and assist site coordinators at collaborating centers in multicenter research projects with data collection and interpretations
- Perform measurements on clinical radiographs of various implant parameters to feed back to the surgical teams using various software packages
- Prepare PowerPoint presentations of work for research meetings, scientific forums, multicenter investigator update meetings, etc
- Train students on clinical analytic techniques
- Develop, write and maintain laboratory protocols and standard operating procedures
- Collaborate with supervisors in writing and editing material for publication; may present papers or appear as principal or secondary author in publications
- Prepare written and/or verbal status reports
- Provide assistance to lower technical and support personnel as assigned. Orient new Research Technicians and Fellows to the lab
- Independently modify techniques as necessary to meet research and/or experimental needs
- Attend scientific conferences such a as the annual Orthopaedic Research Society and American Academy of Orthopaedic Surgeon meetings
- The ability to learn specific software and statistical tools for clinical outcome evaluation
- Excellent verbal and written communication skills for writing protocols, reporting research results, and generating scientific publications
- The ability to interact professionally with all levels of staff and faculty
- Excellent critical thinking skills and the ability to work independently are essential
- Must be self-motivated
- Proficiency in Word, Power point, Excel, and literature searches essential
- Strong organizational skills are necessary
- Demonstrates analytical skills to problem solve effectively
- Minimum of 1 – 2 years of related experience required
- Incumbent should have experience working with the public as certain aspects of the job require patient interaction. Strong statistical background preferred
160
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s Degree in a social science or related field required
- Equivalent experience, education and or training may be substituted for the degree requirements
- Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) certification required
- The ideal candidate will be detail oriented, have excellent organizational skills, computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, Oncore™ and PowerPoint
- Possesses excellent communication and interpersonal skills, be able to maximize resources and be resourceful
- Three (3) to five (5) years of oncology research preferred
- One (1) year of supervisory experience in a clinical research environment preferred
- Supervision in a unionized environment preferred
- Bilingual skills preferred
161
Clinical Research Coordinator Resume Examples & Samples
- Theoretical knowledge of a biological science such as Biology, Microbiology or a related field as typically attained by a Bachelor's degree, or an equivalent combination of education and experience
- Bilingual: Spanish-English
- Demonstrated experience working in a clinical setting
- Ability to administer and instruct patients to self-administer medications related to respiratory conditions
- Ability to coordinate travel arrangements, prepare travel vouchers and expense reimbursement forms. Familiarity with university travel and reimbursement policies
- Experience and familiarity with the Institutional Review Board; experience preparing and submitting continuing review materials, amendments, and other regulatory documents to an IRB
- Familiarity with cooperative group agencies and trials including experience preparing and submitting a variety of forms related to research protocols in compliance with federal policies and other agencies with ability to pay conscientious attention to detail
- Must be familiar with clinical medical problems and terminology
- Demonstrated experience recruiting study participants and knowledge of human subjects guidelines
- Proven ability in working with individuals and groups from diverse cultural, ethnic, socio-economic and social backgrounds
- Experience with statistical software (SPSS or JMP) preferred
- Certification in Respiratory Therapy
162
Clinical Research Coordinator Resume Examples & Samples
- Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel and PowerPoint is required
- The ideal candidate will have a clear understanding of Food & Drug Administration (FDA), Office of Human Research Protection (OHRP), and Health Insurance Portability & Accountability Act (HIPPA) regulations and possess a considerable understanding of Good Clinical Practice (GCP) guidelines
- Must be capable of independent decision-making, and multitasking. To be successful, the candidate must have excellent organization, communication and interpersonal skills
- Two (2) years of experience in Clinical research regulatory affairs preferred
- Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) preferred
163
Clinical Research Coordinator Resume Examples & Samples
- Provides consolidated comments from the clinical site on the draft study protocol to the PM, taking into account operational and subject safety issues
- Perform all aspects of the clinical process to include the development and approval of study schedules, study specific documentation, clinical set-up, resourcing, clinical conduct, delegating tasks as appropriate
- Monitors/maintains participant safety, dignity and compliance, including coordination of appropriate medical consultation/treatment as appropriate. Provides updates regarding participants wellbeing to the investigators and PM
- Work closely and proactively with operational teams to ensure laboratory, equipment and all operational requirements are fulfilled, study is adequately resourced and all personnel are trained and competent on all study procedures. Leads operational team members to ensure staff, supplies and equipment are appropriate
- Keeps the PM and site management aware of deficiencies or potential problems and assists in taking appropriate action in response to issues
- Is fully aware of all regulatory submissions, timelines and approvals and coordinates and ensures submission of documents to the IRB/IEC as appropriate for timely review
- Works with recruiting and screening staff to define a recruiting plan for the trial and to ensure the study is recruited on schedule. Update PM regularly with recruiting and screening information, question and concerns. Reviews participant eligibility information to determine if protocol criterions are met. Communicates with Investigators and PM regarding participant eligibility
- Coordinates CRF activities as appropriate; i.e.: Oversees completion of case report forms, CRF documentation and data queries. Works with key staff to ensure these items are completed in a timely manner. Oversees transfer of CRF information to appropriate data management individuals
- Ensures biological samples are shipped as appropriate and as directed by the client, in a timely manner
- Knowledge of drug development process, ICH Guidelines and GCP
164
Clinical Research Coordinator Resume Examples & Samples
- Recruit and schedule eligible participants for research studies via telephone, email, and mailings
- Maintain participation of study subjects
- Assist with treatment assessments of patients through phone and/or on-site questionnaires
- Create and implement recruitment strategies to identify eligible participants and inform potential participants about the research and eligibility criteria
- Perform protocol specific interviews and maintain study regulatory documentation
- Prepare for and attend audits/monitoring visits. Aid in resolution of queries
- Prepare IRB applications, protocols, progress reports, and informed consent forms
- Follow established guidelines in the collection of clinical data and administration of clinical studies
- Collection, compilation, documentation, and analysis of clinical research data and results
- Assist principal investigator in developing plans for research projects and discuss results
- Generate follow up reports & clinical study follow up documentation
- Assist with collecting lab results and medical clearances as needed
- Assist in developing plans for research projects and analyzing results
- When needed assist with on-site patient support. (Some travel may be required)
- Coordinate the patient history review process
- Act as a Liaison between the patient advocates and clinical team
- Ensure safety of sensitive information for the entirety of the review process
165
Clinical Research Coordinator Resume Examples & Samples
- Create various weekly and monthly reports to track Biologics Delivery Systems (BDS) sales, inventory and product shipments worldwide
- Create and manage all BDS product invoicing and orders for 50+ sites
- Manage regulatory holds on product orders
- Responsible for developing relationships with site project coordinators and continual liaising with same regarding questions or discrepancies about products inventory
- Create and manage tracking systems for product shipments to all 50+ sites
- Manually prepare pre-clinical shipments for sites
- Manage and track in-house product inventory levels
- Manage BDS Contract processing for physicians and hospitals/universities
- Work closely with Legal and HCC to initiate, proofread, revise and facilitate approval of all BDS contracts
- Be the liaison for all the contract partners
- Manage compliance training for BDS; prepare training materials for physician training
- Expense Report processing for physician training
- Management of office supply inventory
- High school diploma required; Bachelor s Degree preferred
- Must have strong critical thinking and problem solving ability
- Proven success as a liaison working with various personalities and cultures exhibiting strong communication ability
- Must be able to trouble shoot, prioritize, and make fast decisions
- Ability to work under deadlines and in a fast paced work environment
- Computer literacy and proficiency in Microsoft Office Products such as Word, Excel, and Outlook
166
Clinical Research Coordinator Resume Examples & Samples
- Screening, enrolling, and following patients on clinical trials while ensuring protocol compliance
- Collaborating with supervisor and physicians in determining eligibility of patients for clinical trials and coordinating patient care
- Additional responsibilities include documentation, data collection, and data entry
167
Clinical Research Coordinator Resume Examples & Samples
- Minimum of Associate's degree in a clinical or scientific related discipline desired, Bachelor's degree preferred and 1 year of experience in a clinical or scientific related discipline, preferably in oncology. An equivalent combination of education and experience, which provides proficiency in the areas of responsibility, may be substituted for the education and experience requirements
- Proficient in Microsoft Office including MS Word, Excel, Access and PowerPoint; MS Outlook and Internet Explorer
- Must possess effective analytical, technical, and problem solving skills
168
Clinical Research Coordinator Resume Examples & Samples
- Computer skills related to data management required
- Data analysis skills and basic understanding of statistics
- Ability to work independently and collaborate with a team
- Three years of relevant work experience in clinical trials management or research experience in clinical trial setting
169
Clinical Research Coordinator Resume Examples & Samples
- Prior research experience in Ophthalmology is desired but not required
- Advanced degree: Master’s, PhD, MD, MBBS, or a degree recognized by the International Medical Education Directory (IMED) is desired
- Experience working at Stanford University and understanding Stanford Protocols
- Experience managing and developing a junior level clinical research staff
170
Clinical Research Coordinator Resume Examples & Samples
- Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines
- Under the supervision of the Principal Investigator (PI) and appropriate management prepares and submits regulatory documents in an accurate and timely manner
- Schedules subject visits
- Prepares labs/tests per protocol
- Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsor requirements
- Administers the investigational product according to the parameters of the study protocol and under the direction of the physician. LVNs/LPNs may administer medications under their state licensure and under the order of the PI. Non-LVNs may administer oral and subcutaneous drugs with appropriate training and under the license of the PI
- Monitors and evaluates patients’ condition with regard to the investigational product
- Conducts routine assessments to evaluate the subject’s response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate
- Educates the subject about the applicable study particulars
- Informs/updates the subject about pertinent study details as needed
- Documents subject information as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
- Reviews all lab/tests with the physician in a timely manner
- Reports subject’s progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner
- Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed
- Notifies appropriate management and external parties of serious adverse events according to protocol
- Collects pre-study essential documentsssential to protocolRB as neededccording tot he according to GCP and files appropriately in the study record
- Maintains the study file record according to GCP
- Maintains subject participant records according to GCP
- Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget
- Documents investigational product received dispensed, and returned to study sponsor according to GCP
- Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
- Attends Investigator Meetings as necessary
- 2 to 5 years’ healthcare experience with Dialysis experience preferred
- Willing to pursue CCRC or SoCRA certification when eligible
- Current appropriate state licensure if applicable
- Proficient with PCs and Microsoft Office applications
171
Clinical Research Coordinator Resume Examples & Samples
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May develop, or assist with the development of, documents related to safety and security. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
- Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
- Scientific concepts and research design. Understand and train other sin the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design,implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies
- Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications.Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants, study, and institution
- Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams,PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. May make recommendations to investigators and oversight organization(s).Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
172
Clinical Research Coordinator Resume Examples & Samples
- Theoretical knowledge of biology, molecular biology, or related field
- Knowledge of and adherence to federal and university research guidelines
- Knowledge of IRB functions and responsibilities as they relate to clinical research. Ability to train and educate researchers in the areas of IRB and federal research guidelines, protocol design and implementation, and proper documentation
- Knowledge of experimental protocols and protocol design
- Knowledge in data collection and data form completion. Ability to utilize data collection tools
- Demonstrated understanding of the informed consent process
- Familiarity with the preparation of specimens for basic laboratory analysis (i.e. centrifugation, peripheral smears, etc.)
- Proficiency with the operation of a personal computer and software applications, such as MS Word, Outlook, PowerPoint and Excel
- Bachelor’s degree in biology, molecular biology, or related field
- Knowledge of anatomy, physiology, and pathophysiology of pulmonary and critically ill patients
173
Clinical Research Coordinator Resume Examples & Samples
- Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP, and protocol guidelines
- Identify potential problems or inconsistencies and take action as appropriate
- Articulate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator, and other members of the study team
- Collect initial subject health and demographic information by interviewing subjects and by accessing other appropriate sources
- Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator
- Ensure a flow of communication including telephone conferences between subject, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
- Perform clinical tasks including, but not limited to; vital signs, height and weight, ECG, phlebotomy, and specimen packaging
- Maintain timely internal source documentation as well as sponsor-required information
- Dispense and maintain accurate records of investigational and study product
- Educate subject and family members regarding specific studies and clinical drug trials in general
- Provide educational in-services for third party vendors providing protocol specific care to subjects
- Maintain reasonably regular, punctual attendance consistent with company policy, the ADA, FMLA, and other federal, state, and local standards
- Provide appropriate community resource referrals to subjects, caretakers, and family members at conclusion of subject’s participation in study, as appropriate
- Maintain compliance with all company policies and procedures
- Strong ability to multi-task
- Strong computer skills
- Ability to support and demonstrate the mission and goals of the company
- Ability to communicate clearly and effectively (written and oral)
- Excellent interpersonal and customer service skills
- Bachelor’s degree in a health-related field required
- At least one year experience in clinical research or a relevant clinical role
- Knowledge of medical terminology and clinical practices
- BLS Healthcare Provider required
174
Clinical Research Coordinator Resume Examples & Samples
- Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol#s data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
- Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed forconduct of clinical and translational studies
- Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potentialproblems and risks to the participants, study, and institution
175
Clinical Research Coordinator Resume Examples & Samples
- Mentors, trains and reviews the work of less experienced clinical research staff
- Develops work flow policies and procedures, prepares manuals and documents related to operations of the function
- Oversees the clinical assessments of the study subjects including but not limited to screening, evaluation and testing of the subjects
- Oversees data collection, processing, storage, inventory and quality control for clinical research studies
- Independently obtains informed consent for all types of clinical studies and educates participants regarding study requirements
- 5 years of clinical research
176
Clinical Research Coordinator Resume Examples & Samples
- Review and abstract data from electronic medical records
- Recruit and enroll research participants
- Conduct research interviews using a structured instrument
- Enter, clean and manage research data
- Develop and manage research databases
- Special projects and other duties as assigned
177
Clinical Research Coordinator Resume Examples & Samples
- Assist the Principal Investigator in the conduct of clinical studies including preparing IRB/GCO submissions, doing regulatory filing, psychometric testing, collecting data and Laboratory specimen, recruiting patients, reporting Adverse Events and Serious Adverse Events
- Accountable for management of case report forms and subject and regulatory binders for industry / sponsor / IRB audits
- Obtain informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests
- Independently obtain informed consent for other clinical studies
- Screen and coordinate; including documentation of the consent process, and scheduling of subjects and necessary personnel and administration of all patient visits
178
Clinical Research Coordinator Resume Examples & Samples
- Maintain Research charts which contain a copy of all source documents
- With input from PIs and Research RNs, create and maintain Standard Operating Procedures (SOPs) specific for each study
- Be familiar with the “study calendar” (developed by Research RN) for each patient so that the
179
Clinical Research Coordinator Resume Examples & Samples
- Engaging in outreach efforts to contact participants by postal mail, email, and telephone
- Assigning participants to study therapists and ensuring that the treatment schedule is maintained
- Conducting physical and mental health screens over the phone to potential participants to determine their eligibility for the study
- Maintaining all related study databases
- Instructing participants on the study processes and answering any questions regarding study procedures and details
- Monitoring progress of participant’s genetic sample processing
- Managing participant compensation
- Compiling IRB and GCO related submissions
- Assisting in the preparation of conference presentations and manuscripts
- Related administrative tasks
- In addition, psychology students who voluntarily participate in research internships at the WTC
- Program at Mt. Sinai will assist the study coordinator in completing study tasks under the supervision of the coordinator and Dr. Feder
180
Clinical Research Coordinator Resume Examples & Samples
- Maintains source documents and subject files in accordance with Mount Sinai policies and procedures
- Bachelor’s Degree
- 0-1 years of clinical or laboratory research experience
181
Clinical Research Coordinator Resume Examples & Samples
- Bachelor's degree in nursing and Florida Licensed with two years of experience, including one year of research experience or a master's degree in an appropriate area of specialization
- Clinical Research Certification or able to acquire within two years of hire
- Two years of experience with clinical trials, including HIV/AIDS
- Working knowledge of computers and computer software such as MS Word, Excel, and Outlook
- Excellent verbal and written English skills
182
Clinical Research Coordinator Resume Examples & Samples
- Participates in hiring and training Clinical Research Assistants. Monitors performance of staff. Contributes to annual performance evaluations of staff. Ensures that schedules, follow up and completion of research protocols progress as planned. Works with staff to resolve day-to-day problems
- Assists in the execution of new IRB applications and processes annual reviews for the IRB committees with regard to consents. May attend IRB meetings as required or address IRB questions regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and terminations to the IRB for review and approval
- Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients. Revises protocol consent form to comply with federal, state and IRB guidelines
- Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with clinical research nurse and/or principal investigator. May enroll patients onto clinical trials
- Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors and/or pharmaceutical company representatives. May prepare reports for pharmaceutical company monitors as well as routine audits for the FDA, if applicable
- Bachelor's degree required. Bachelor's degree in scientific discipline preferred
- Bachelors degree and two years experience in a medical setting and/or clinical research or a Master's Degree and one year experience
- Knowledge:Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations
183
Clinical Research Coordinator Resume Examples & Samples
- Responsible for administrative functions of multi-site research studies
- Develops and maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements
- Works with PIs and Research Nurses to ensure the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to FDA, HSPC, HIPAA and other agency guidelines
- Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring
- Responsible for assisting with IRB applications for the department for both study initiation and renewal
- Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety
- Acts as liaison with Principal Investigators, pharmaceutical company representatives or other project funding organizations to monitor and update project progress
- Facilitates patient screening, recruitment and scheduling, initiating research patient records, administration of questionnaires, maintaining database Excel spreadsheets, completion of case report forms, performing data edits with P.I.’s research staff, pharmaceutical company monitors, etc
- Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care
- Participates in the conceptualization and design of future projects, including drafting concept sheets, protocols and research proposals
- Provides research project management expertise for entire project lifecycle, including process design, proposal development, oversight of contracting, and study implementation in compliance with regulatory and HIPAA guidelines
- Maintains system for monitoring and maintenance of patient data records
- May provide technical support for the preparation of grant proposals, publications, presentations and special projects
- Participates in weekly research staff meetings
- Protects rights and research data of research volunteers, including medical records, data, etc. Obtain necessary consent forms, or HIPAA information forms as needed, in research process
- Performs other related duties as assigned or required
184
Clinical Research Coordinator Resume Examples & Samples
- Works with PIs and Research Nurses to ensure the completion and maintenance of consent forms, case report forms, and source documents to ensure that research is being conducted according to GCP, FDA, HSPC, HIPAA and other agency guidelines
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines
- Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and research participant safety
- Notifies direct supervisor about concerns regarding data quality and study conduct
- Facilitates research participant screening, recruitment and scheduling, initiating research participant records, administration of questionnaires, maintaining database Excel spreadsheets, completion of case report forms, performing data edits with P.I.’s research staff, pharmaceutical company monitors, etc
- Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care. Provides assistance with research participant research billing and reconciliation
- Maintains system for monitoring and maintenance of research participant data records
- Coordinates training and education of other personnel
- Participates in centralized activities such as auditing, Standard Operating Procedure development, etc
- Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency
- May identify new research opportunities and present to investigators
185
Clinical Research Coordinator Resume Examples & Samples
- Personnel Supervision. Assumes lead role to ensure adherence by program personnel to abide by all operations and protocol. Works closely with medical director to direct and evaluate the work of research personnel. Trains and schedules workloads for Clinical Research Coordinators
- Clinical Resource. Acts as the immediate clinical resource and the liaison between physicians, nurses, laboratory personnel, etc
- Patient Identification, Recruitment and Scheduling. Develops strategies to build clinical trials participant registry used to identify, recruit, and schedule patients who may be eligible to participate in the research program; and oversee staff in executing those functions
- Financial Reporting. Works with existing clinical trials personnel and the business office to ensure proper fiscal oversight and management of the clinical trials program
- Meeting Attendance. Attends and presents clinical trial information at various meetings, which may require out-of-state travel
- Assessment. Oversees or performs the initial assessment of potential patients and takes clinical history. Ensures staff correctly identifies patients who may be eligible to participate in the clinical trial and the initial assessment of potential patients is completed, including patient’s clinical history, the patient data form is correct, and a consent form from each patient is received. Responsible for conducting ongoing assessments of outreach and recruitment strategy to determine needed services, funds, and volunteers
- Testing and Training. Oversees personnel or performs conduction of research tests and supervises exercise training sessions. Overseeing site visits by monitors; oversees proper reporting
- Information Distribution. Oversees personnel or provides potential patients with study information. Obtains informed consent forms
- Data Management. Performs or assists in data entry, management, and data analysis
- Follow-Up. Responsible for overseeing or performing the initiation, organization, and carrying out of patient follow-up. Oversees the conduct of home-based patient training programs through periodic telephone calls. Assesses patients and analyzes patient monitor data at all follow-up visits
- As Needed. Performs various duties as needed to successfully fulfill the function of the position
186
Clinical Research Coordinator Resume Examples & Samples
- Theoretical knowledge or Bachelor’s degree in a biological life science or related discipline or equivalent education and experience
- Demonstrated experience in the clinical research setting, including protocols, principles, and standards. Demonstrated experience planning and performing clinical research studies, particularly trials involving patients with HIV, HCV or TB
- Ability and willingness to maintain subjects’ absolute confidentiality
- Knowledge of signs, symptoms, pathology of HIV infection, Hepatitis C infection and/or Tuberculosis
- Demonstrated experience administering study related questionnaires and assessments
- Demonstrated experience interpreting laboratory values to determine subject’s eligibility and potential toxicities and insight to know when abnormalities should be reported to a clinical nurse or Physician
- Demonstrated experience in interpreting medical charts and extracting accurate data from medical records
- Demonstrated experience handling laboratory samples and knowledge of shipping procedures for dangerous goods. Ability and willingness to obtain IATA certification within 6 months of hire
- Bilingual; fluent in Spanish
187
Clinical Research Coordinator Resume Examples & Samples
- Associate's degree or LPN or equivalent education with work experience will be considered
- 3 years of experience in clinical research or equivalent experience
- 2 years of experience with FDA requirements or equivalent experience
- 1 year of experience with protocols and contracts or equivalent experience
188
Clinical Research Coordinator Resume Examples & Samples
- Clinical trials experience preferred, especially from Emory
- Strong attention to detail and ability to effectively organize multiple complex projects
- Collaborative, team-player mindset
- Phlebotomy and venipuncture training/certification a plus
- Prior experience with IRB and/or WIRB submissions a plus
- Proficient in Microsoft Suite (Outlook, PowerPoint, Word, Excel…)
189
Clinical Research Coordinator Resume Examples & Samples
- Prepares study start-up templates and documentation including eligibility checklists, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
- Serves as main point of contact with sponsors and keeps investigators informed about enrollment opportunities
- Screens and registers patients; ensures eligibility requirements are met
- Assures consent forms are completed correctly and in entirety and that the consent process is appropriately documented
- Proposes orders for study related clinic procedures such as blood draws, exams, infusions and other procedures according to protocol requirements; coordinates with clinic, and pharmacy staff to ensure proper documentation and timing of research-related procedures
- Attends clinic visits as time permits and when appropriate to update concomitant medications and adverse events and assure subject understanding of study requirements
- Responsible for the abstraction of data and CRF interpretation with data coordinator assistance
- Identifies procedural problems, communicates to the PI and research manager, and completes patient safety net reporting
- Manages Serious Adverse Event reporting to study sponsors and the IRB
- Screens third party safety reports per institutional procedures
- Assures adherence to research protocols and maintains protocol deviation documentation
- Requests insurance authorization and assures the process is complete prior to initiation of study procedures
- Collaborates with study monitors and responds to findings
- Creates and maintains patient tracking tools; communicates status to sponsors, investigators, management and relevant departments
- Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
- Maintains Patient Tracking System (PATS) and provides information for center-wide accrual reporting
- Maintains study financial trackers
- Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant brown bags, faculty and administrative presentations, and other opportunities of interest
- Associate degree required, with Bachelor’s degree preferred
- Applicant must have a minimum of two to three years of clinical research or related experience
- Previous experience in oncology research and clinical data collection is preferred
- This position requires excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment
- Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills
190
Clinical Research Coordinator Resume Examples & Samples
- Prepares study start-up documentation including IRB documents, eligibility checklists, study-specific clinic orders and study calendars
- Assures consent forms are completed correctly and in entirety
- Schedules study related clinic procedures such as biopsies, blood draws, and imaging according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
- Abstracts data from medical records to complete study-specific CRFs (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents
- Collects and transports specimens from the UW to Fred Hutch, as needed
- Collaborates with study sponsor/consortium delegate to assist with study monitoring visits and responds to findings
- Creates and maintains patient tracking tools, communicates status to investigators
- Manages study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts, and regulatory binder
- Liaises with study sponsor, investigator(s), and members of study team to communicate timelines, expectations, and study status
- Prepares quarterly reports regarding collected data and samples for distribution to PIs
- Creates and maintains quality metrics for the studies
- Acts as a resource to physicians, investigators, other staff members, other study sites, and other organizations regarding protocol procedures, data collection requirements, and other study related operations
- This position requires excellent organizational skills and attention to detail
- This position requires the ability to self-motivate, problem solve, and prioritize multiple competing tasks in a dynamic environment
- Receives general instructions for new and non-routine assignments/projects
- May act as a resource for less experienced colleagues
- Provides solutions to unique and complex problems beyond established procedures
- Collaborative focus is essential
191
Clinical Research Coordinator Resume Examples & Samples
- Principal Investigator Support
- Associate degree required
- A minimum of three to five years of clinical research or related experience
192
Clinical Research Coordinator Resume Examples & Samples
- Serves as an intermediary between supervisor and other departmental staff by transmitting written and oral requests, messages and instructions
- Assists with budget preparation and is responsible for monitoring and maintaining records of expenses for variance reporting
- Assists in the planning and logistical coordination of meetings and office activities, forums and conferences
- May review and revise brochures, announcements or other informational items regarding program and/or departmental operations
- Drafts, edits and formats materials such as flyers, leaflets and letters. May prepare minutes of meetings, agendas, correspondence, statistical reports, tables and other documents and transcribes dictation as needed
- Prepares and follows up on purchase orders, change orders, check requests and petty cash vouchers
- Processes and follows up on reimbursement for staff expenses. Makes travel arrangements and accommodations
- Screens and prioritizes all incoming mail for needed action and follow up
- Responds to mail where appropriate or distributes mail requiring attention to appropriate individual(s)
- Screens telephone calls, answers routine inquiries or refers caller to the appropriate individual for response
- Vocational duties pertaining to research include: collecting, recording, and inputting data/information into database; preparing and editing grant applications, proposals, and IRB/GCO submissions and filings; maintaining, organizing, and collating sensitive digital and physical research related documents
193
Clinical Research Coordinator Resume Examples & Samples
- Theoretical background in clinical and social sciences, biology, microbiology or related field. Knowledge of clinical trials research
- Experience with research protocol (in order to follow protocols to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians). Must be able to maintain confidentiality
- Knowledge of laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities
- Ability to use statistical software applications. Knowledge of database, word processing and spreadsheet applications. Strong experience working with Excel in order to create reports
- Ability to follow FDA policies regulating clinical trials
- Experience maintaining files and keeping records
- Knowledge of x-rays, scans, and other diagnostic procedures
- Skill at interpreting medical charts, experience in abstracting data from medical records
- Experience handling biological specimens
194
Clinical Research Coordinator Resume Examples & Samples
- Participate in Feasibility and Site Selection Process as well as Site Initiation Visit
- Pre-Screening of patients
- For Collection (non-therapeutic) studies, may consent patient for the trial
- Completion of Registration Forms and timely entering of patient enrollment information into all required databases
- Be familiar with the “study calendar” (developed by Research RN) for each patient so that the appropriate data can be collected. Prompt PIs and Research RNs about protocol requirements for upcoming study visits
- Complete Case Report Forms. Includes collecting required data, completing forms and entering data into database
- Tracking of Adverse Events from source documents and other communications. Approach PI and RN about grade and attribute related to Adverse Event. Track and maintain IND Safety Reports
- Review and respond to data queries
- Process, package and ship specimens to labs/sponsors
195
Clinical Research Coordinator Resume Examples & Samples
- Assists in new and unexpected research experiments and techniques
- May train less-experienced research staff and postdoctoral fellows in research techniques and use of equipment
- 2 years in a research environment or 1 year plus Master’s Degree in sciences or related field
196
Clinical Research Coordinator Resume Examples & Samples
- Provide direct administrative support to Supervisor and Department. Ensure that department functions and responsibilities are executed promptly and with minimal obstacles
- Manage Department purchasing and accounting. Maintain equipment and supplies so that the department is well supplied in advance of needs
- Serve as training delegate and oversee Department training functions and records. Ensure that Department members are up to date on required training and that training is documented
- Create CRFs, regulatory binders and other documents for the clinical sites, create files for the CRFs at the Company, and provide support for other members of the department
- Support the Clinical Research Associates by providing administrative assistance for effective study initiation, progress, and closure. Track and monitor activity in support of all study sites
- Log in CRFs as they are retrieved from the clinical sites, perform data entry, data verification, generate data clarification forms for sites on data questions or clarification, and troubleshoot problems in the database. Data Management that assures complete and accurate data to support regulatory submissions
- Assist in the maintenance of clinical files, both hardcopy and in the database. Maintain proper files to ensure compliance with FDA regulations
- Assist the clinical sites and field operations by processing supply order forms and device requests. Maintain clinical supplies and devices to meet protocol and regulatory requirements
- Support travel functions and meeting arrangements for Clinical Research staff and study participants. Facilitate ability of Department staff to interact with study participants
- Perform job functions compliant with Quality System Regulations and Good Clinical Practices. To ensure compliance to appropriate standards
- Other functions within the Clinical Research Department as required. Support the ability of the Clinical Research Department to achieve it goals
- Bachelors Degree in a science field
- Excellent communication and written skills
197
Clinical Research Coordinator Resume Examples & Samples
- Bachelors Degree in related field
- Two years experience in managing all aspects of clinical research trials with in-depth knowledge of protocol requirements and Good Clinical Practice
- Intermediate computer and internet knowledge
- Excellent customer service and patient care skills
- Meticulous organizational skills
- Excellent demonstrated written and verbal communication abilities
- Three to Five years experience in clinical research trials
- ACRP or SOCRA certification
198
Clinical Research Coordinator Resume Examples & Samples
- Initiation, implementation, operation and coordination of two separate clinical programs designed to improve the life of people with diabetes. One program is focused on providing diabetes education and the second program is focused on prevention of diabetes complications. This coordination includes, but not limited to, patients, healthcare providers, billing, and data collection efforts
- Maintains REDCap database
- Prepares programmatic reports for medical directors, administrators, and funders
- Monitors budget expenses and billing
- Assists patients with billing and insurance related questions and directs patients appropriately
- Monitors enrollment goals and initiates strategies to promote enrollment
- Coordinates with healthcare providers and clinics to provide information about the program and maintain a strong referral basis
- Assists marketing department with information for marketing and outreach efforts
- Coordinate procedural matters regarding day-to-day operations of the programs including scheduling for the clinical programs
- Coordinates meetings with staff and outside entities
- Must be willing and able to work at different clinic sites as needed
- Demonstrates positive interpersonal and communication skills to achieve excellent results
- Monitor patients enrolled in the program and assess and assist with any patient related issues
- Supervises, mentors and trains techs or students who may assist with the clinical programs
199
Clinical Research Coordinator Resume Examples & Samples
- Assist the Principal Investigator (PI) with protocol development, revision, and study analysis
- Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects
- Ensure study drug self-administration and accountability with patients
- Perform non-clinical ECGs
- Administer study questionnaires
- Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies
- Maintain or assist in maintaining IRB correspondence and regulatory documentation. Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, and other study reports
- Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner
- Coordinate monitoring visits and respond to queries and other requests from study monitors
- Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
- Participate in the review of charges for patients on clinical trials to ensure billing compliance
- Travel for industry sponsored investigator meetings
- Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations
200
Clinical Research Coordinator Resume Examples & Samples
- Serve as a designee of the Principal Investigator, CRS Study Support Services team and the NTCN to manage the daily operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy as well NCTN guidelines
- Collaborate with clinic research teams to ensure all clinical procedures and other protocol specific activities are completed as per study expectation
- Review study candidates medical records for study eligibility
- Enrollment to NCTN studies
- Develop and maintain patient tracking tools; communicates status to investigators, management and relevant departments
- 2+ years coordinating clinical research, preferably oncology trials
- Reviewing and abstracting data from medical records
- Working in clinic setting preferred
- Bachelor’s Degree is preferred
- Clinical research related certification preferred
- Knowledge of regulations and guidelines that govern clinical research
201
Clinical Research Coordinator Resume Examples & Samples
- Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants
- Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate training for program participants
- Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators
- Assure compliance with all relevant IRB and other regulatory agency requirements
- Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program. Requires proficiency in the use of spreadsheets such as Microsoft Excel, and in the use of databases such as REDCapMaintain program timeline including tracking deadlines for program components
- Coordinate program outreach activities including acting as a liaison with community organizations
- Process and ship lab specimens as necessary
- Able to use, troubleshoot and interpret data acquired by software associated with various data collection devices such as Near Infrared Spectroscope, EKG, Labview, blood pressure recording devices and others as necessary
- Collaborate with engineers for the development and improvement of software for data acquisition and interpretation
- Participate in coordinating outpatient community outreach educational protocols
- Perform other duties for the FPAD team as assigned
202
Clinical Research Coordinator Resume Examples & Samples
- Identify and confirm patients’ eligibility for institutional and collaborative group studies and verify pre-treatment requirements are met. Ensure appropriately signed, witnessed and dated consent is obtained, obtain registration confirmation data from Children’s Oncology Group (COG) and medical staff and obtain all pre-treatment lab, pathology, radiology requirements, registration and place appropriate protocol sections in medical record
- Conduct and coordinate training for program participants
- Work closely with COG research nurses to ensure family and provider adherence to study protocol, and proper flow of information from care environment to COG database
- Work with Oncology team to develop, implement, and maintain comprehensive databases and files related to the program
- Assist in the tracking of study related budget and expenditures. As needed, participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities
- Assist the Clinical Research Coordinator III with training of program staff, and the scheduling of people and material resources, as needed
- Consent for non – therapeutics studies as needed
203
Clinical Research Coordinator Resume Examples & Samples
- Oversee the recruitment, screening, enrolling and obtaining of consent from program participants. Conduct or coordinate training for program participants
- Coordinate research protocols and ensuring accountability compliance, and accuracy in grant budgets, grant submissions in eBridge, and perform other related duties
- Oversee the collection, analysis, and dissemination of research data. Report program data and progress to study investigators. Develop, implement and maintain comprehensive databases and files related to the program
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols as well as problems related to the administration of the funding proposals/funded proposals and communicate to the study investigators
- Assure compliance with all relevant IRB and other regulatory agency requirements. Verify grant is in compliance with grant source requirements. Provide assistance and tracking of grant and contract mechanisms, including funding announcement, internal management of proposals, internal review and awarding functions
- Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with the study investigator
- Coordinate and manage program outreach activities including acting as a liaison with community organizations. Organize internal and external meetings, site visits, and special events
- Maintain program timeline including tracking deadlines for program and grant components such as submission deadlines, funding cycles, timelines for annual reports, etc
- Coordinate and manage grant proposal submissions
- Manage study related budgets and provide reports as required to department administration and funding agencies. Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities
204
Clinical Research Coordinator Resume Examples & Samples
- Performs all other duties that may be assigned in the best interest of the Shirley Ryan AbilityLab
- Bachelor’s degree or higher in a behavioral or biological science
- Completion of a Certified Clinical Research Coordinator (CCRC) training program or equivalent is highly desirable
- Five years’ experience working as a clinical research coordinator or similar clinical research role
- Strong working knowledge of good clinical practice (GCP)
- Must have excellent attention to detail and autonomous work habits. Strong interpersonal and organizational skills are essential to succeed as a member of a research team, to exchange ideas, to work closely with numerous professional organizations and facilities and to plan and coordinate project completions
- Strong written communication skills are vital to this role, with experience in technical and medical writing preferred
205
Clinical Research Coordinator Resume Examples & Samples
- Determine participant eligibility, and conduct in-clinic recruitment and consenting for several pulmonary genetics studies
- Oversee data management and electronic patient tracking systems, including administering baseline and follow-up surveys and other study-related materials
- Maintain study databases, including survey data entry and data quality control; create electronic forms, reports and other documents, as requested
- Assist with all aspects of upcoming clinical trial, including determining patient eligibility, oversee baseline and follow-up patient tracking requirements, maintain database and source documentation, case report forms, adverse events, and other clinical trial materials
- Maintain regulatory requirements, including preparing amendments and continuing reviews for IRB submissions. Maintain and organize study regulatory binders on an ongoing basis
- Assist with activities of multiple external and internal team players, including clinical staff, IRB committee, academic/industry collaborators, bioinformatics, and other organizations as-needed
- Provide ongoing administrative support with preparation of protocols, grants, manuscripts, and professional conferences
- Bachelor's degree required, with a focus in biological sciences, nursing, social sciences, or public health
- At least 1 year of clinical research experience required, preferably in an academic hospital environment
- Experience preparing IRB regulatory documents required
- Proficiency in Microsoft Word, Excel, and PowerPoint; Experience with Redcap preferred
- Strong verbal and written communication skills in English
- A 1-year commitment is preferred
- Excellent interpersonal skills in a clinical setting, and the ability to communicate and relate effectively with diverse groups of patients, clinical personnel, and research staff via in-person, phone, and email communications
- Extremely mature, dependable, and independent
- Highly self-motivated and proactive; Able to identify, track, and drive issue resolution with minimal supervision or prompting
- Able to take direction from a wide variety of individuals at all levels, including Principal Investigator, and other study collaborators and technical staff
- Motivated to learn new processes and procedures, as-needed
- Detail oriented with excellent organizational, communication, problem-solving and time management skills
206
Clinical Research Coordinator Resume Examples & Samples
- Experience working with transgender youth; and
- Experience conducting research activities
- An understanding of the psychosocial and medical needs of transgender youth
- Ability to listen to youth and their parent/legally authorized representative and respond appropriately to what was expressed
- Ability to provide a supportive environment for youth
- Ability to separate research from care activities
- Ability to coordinate a research protocol
- Detail oriented; and
- Internal motivation to accurately meet protocol requirements, including researching ambiguous data
- Knowledge of transgender healthcare
- Knowledge of how to conduct research with children and adolescents
- Human subjects protection
- Ethical requirements in research
- Regulatory requirements
- How to document study activities; and
- How to implement research activities while ensuring protocol fidelity
207
Clinical Research Coordinator Resume Examples & Samples
- Completion of a bachelor’s or associate degree from an accredited nursing program (RN) plus a minimum of two (2) years healthcare, clinical and/or research experience
- Demonstrates compliance with hospital standards, policies and procedures
- Demonstrates organizational and time management skills
- Must be detail oriented
208
Clinical Research Coordinator Resume Examples & Samples
- Experience with Excel and Word
- Experience with databases
- Ability to work independently, interact professionally and possess effective writing and organizational skills
209
Clinical Research Coordinator Resume Examples & Samples
- Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook
- Experience in research administration including complex budgets and contracts
- Experience in qualitative research, including code development and qualitative data analysis
- Proven talent at working with numerous teams and facilitating collaborations
- Ability to solve problems and present solutions effectively
- Cultural sensitivity and ability to work with individuals from a variety of different backgrounds and nationalities
- Excellent written and verbal communications skills for meeting notes, grant and report writing, technical writing and editing, presentations, and other materials
- Undergraduate degree with 2-4 years’ experience in public health, research administration, and/or study coordination
- Willingness and enthusiasm to travel internationally
- Training or experience relevant to international health or international health policy
- International work experience
- Master’s degree from an accredited institution in Business Administration, Public Administration, Public Health, Global Health Sciences, Healthcare or related area such as Nursing (May 2017 graduates will be considered)
210
Clinical Research Coordinator Resume Examples & Samples
- Theoretical knowledge of medical and pharmaceutical terminology and concepts, and/or biological science, with a Bachelor's degree in pharmacy, biology or hematology, sufficient to prepare, review and understand the contents of medical research protocols and amendments
- Demonstrated project management experience with the ability to successfully plan, organize, prioritize, develop, analyze, implement and manage multiple clinical Phase I and II research projects with complex logistics involving multi-sites and priorities. Ability to set short and long-term goals of projects and project objectives, and work with others in achieving organizational goals and deadlines
- Experience with clinical trials ranging from Phase I-Phase II
- Strong demonstrated experience working with clinical trials research activities, regulatory compliance, guidelines related to informed consent, ethical conduct, and protection of human subjects as well as interpreting and comprehending complex clinical research protocols, activities and guidelines
- Knowledge of neurological disease such as Parkinson’s disease, dementia, atypical parkinsonian disorders, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, Lewy body disease and other related disorders
- Experience creating or modifying Informed Consent documents that comply with HRPP, FDA and other governing agencies
- International Air Transportation Association (IATA) certification preferred to oversee shipping of biological substances
211
Clinical Research Coordinator Resume Examples & Samples
- Prepare and conduct study visits
- Participate actively in team meetings regarding protocol design and execution
- Assist with IRB/NIH/FDA communications
- Maintain research data, subject files, regulatory binders, and study databases
- Perform study recruitment
- Perform processing of human samples
- Learn Progeny database for queries
- Provide task lists showing progress of work
- Respond to urgent timelines per NIH or institutional requirements
- Minimum of a BA/BS
- Phlebotomy skills, or a willingness to perform phlebotomy (training will be provided)
- Efficient use of computer based software programs ( Excel, MS Office, and MS Word)
- 1) commitment to excellence
- 2) high energy and flexible
- 2) problem solving personality
- 3) articulate, strong interpersonal skills
- 4) accepts all challenges, whether big or small
212
Clinical Research Coordinator Resume Examples & Samples
- COMMUNICATIONS: The CRC is expected to facilitate communications between sponsors and contract research organizations, research volunteers, investigators, regulatory personnel, and other key contributors to individual studies. The communications will include, but are not limited to, scheduling appointments, interfacing with the regulatory and financial authorities, working closely with study monitors, and problem solving
- DATA: The CRC will help carry out data acquisition through various testing modalities (e.g. visual acuity, refractions, intraocular pressure, etc.), inputting data into case report forms (CRFs), and resolving queries
- REGULATORY COMPLIANCE: Employees of the KCRC follow all local and federal regulations regarding clinical research in addition to protocol specific guidelines. The CRC is expected to actively support an environment where strict regulatory compliance is enforced
- RECRUITMENT: The CRC will work with the investigators in the recruitment and retention of study participants
- PROTOCOL SPECIFIC NEEDS: In addition to the broad technical skills needed in nearly every ophthalmic clinical study (e.g. visual acuity, refraction, intraocular pressure, etc.), each study often has unique needs. The CRC is expected to possess a willingness to learn protocol specific testing requirements and become proficient with phlebotomy
- High School diploma
- Experience as an ophthalmic technician (at least 2 years, at least COA or equivalent) or willingness to participate in a formal training program
- Knowledge of general clinical research operations and regulations or a capacity to learn quickly
- Experience with the MiChart (Epic) electronic health record (EHR) system
- Computer keyboard proficiency
213
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s Degree or higher in Health Education, Ethnic Studies, Psychology, related health and social service disciplines and/or equivalent work experience
- Exceptional interpersonal, written and oral communication skills
- Community outreach experience particularly in minority communities and/or Brooklyn
- Have the ability to prioritize
- Be highly energetic and flexible
- Able to work evenings and weekends
- SPSS or SAS experience
- Bilingual in Creole
- Grant writing
214
Clinical Research Coordinator Resume Examples & Samples
- Knowledge and/or experience in diet/nutrition, weight loss, and/or physical activity is a plus
- Must be detail-oriented, extremely organized, and willing to work with tight timelines and high expectations
- Comfort with digital health technologies
- Strong interpersonal skills and comfort working with participants from sociodemographically-diverse backgrounds
215
Clinical Research Coordinator Resume Examples & Samples
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's in a social or health science + 2 years’ experience; or 4 years practical research study or related experience
- Successful completion of a full course of study in an accredited college or university leading to a master's in a social or health science + 1 year experience is required
- Excellent computer skills with the ability to learn online web-based data collection, database management, and data analysis techniques preferred
- Strong Organization Skills
- Good Oral and written Communication skills
- Experience in hospital or university environment
- Knowledge of Good Clinical Practices
216
Clinical Research Coordinator Resume Examples & Samples
- Community outreach to promote GHUCCTS research and activities. This outreach will include a strong focus on enhancing enrollment of underserved populations
- Networking with other Clinical & Translational Science Award Institutions and their Recruitment Centers (CT-RC) to develop best practice models in regard to community awareness and recruitment of underserved populations
- Maintaining information such as specified studies and publication lists relevant to GHUCCTS
- This position may also be called upon to participate in recruitment activity for external sites/investigators served by GHUCCTS
217
Clinical Research Coordinator Resume Examples & Samples
- Must complete NU's IRB CITI/ GCP training before interacting with any participants & must re-certify every 3 years
- Clear understanding of federal and local Biomedical Clinical Research Regulations
- Critical thinking, active listening, persuasion, ability to clearly communicate with other teams and sub-specialties
218
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s degree in basic science or health related field. Experience may substitute for degree on a year for year basis
- Computer skills: MS Office Suite
- Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, excellent interpersonal skills
- CCRP certification through Society of Clinical Research Associates (SoCRA) or CCRC certification through Academy of Clinical Research Professionals (ACRP)
- Prior health care and/or research experience
- Excellent communication, writing, organizational and presentation skills
- Ability to effectively interact with multidisciplinary teams including patients, families, physicians, and administrative staff
- Familiarity with electronic medical records and study databases
219
Clinical Research Coordinator Resume Examples & Samples
- Clinically manage multiple clinical trials
- Assist with administrative duties as experience warrants
- Adhere to Research SOP’s
- Adhere to Good Clinical Practices and study protocols
- Ensure scientific integrity of data and protect the rights, safety and well-being of patients enrolled in clinical trials
- Discuss study protocols with patients and verify the informed consent documentation
- Provide patient with written communication of their participation (i.e. copy of the signed informed consent)
- Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient
- Meet with patient for each study visit and maintain accessibility to discuss any questions/concerns regarding the study
- Collect, process and ship blood/urine specimens as scheduled patient study visits require
- Perform ECGs and obtain vital signs of patients
- Schedule all patient study visits and procedures consistent with protocol requirements
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
- Administer questionnaires/diaries per protocol
- Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder
- Submit patient reimbursement requests per protocol on quarterly basis
- Ensure the filing and maintenance of all regulatory documents
- Schedule monitor visits and set up for monitoring visits prior to monitor’s arrival
- Completion of 1) allied health degree or 2) accredited degree program in health sciences
- CRC accreditation is preferred
- IWRS, ECDF or ECRF computer experience desired
- One to Two years previous experience with clinical trials required
220
Clinical Research Coordinator Resume Examples & Samples
- Responsible for assisting with the coordination and management of the clinical research and care program for metastatic breast cancer patients using Good Clinical Practice under the auspices of the Principal Investigator
- In collaboration with a multidisciplinary team of providers and professional staff within/across DFCI departments, facilitates on-going communication between patients and providers and provides support and education related to issues facing those with metastatic disease
- Serve as a liaison with patients and providers as it relates to the care program for metastatic breast cancer to direct patient flow and communication
- Provide general administrative support around all aspects of patient care including specialized document preparation, such as patient/provider communication and treatment summaries
- Assist in the development and coordination of program-related events and workshops for patients with metastatic breast cancer
- Identify, consent, monitor and interact with eligible study participants as directed/required by the clinical research and care program
- Responsible for data reporting, management and maintenance, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries
- Provide oversight of the clinical trials start-up (e.g., receipt of protocols through the Scientific Review Committee and IRB submissions) and close-out
221
Clinical Research Coordinator Resume Examples & Samples
- 4 year college degree, in Sciences
- Must have excellent attention to detail in data collections, and strong written and oral communication skills
- Good clerical skills obtained through education and/or experience
- The ability to work independently on assignments
- The candidate must be proficient in all Microsoft Programs and must be comfortable working with complex spreadsheets for the purpose of project management, data tracking, and data analysis
222
Clinical Research Coordinator Resume Examples & Samples
- Independently coordinates all research activities under the guidance of the PI
- Defines study tasks and timeline by assigning and prioritizing work
- Responsible for quality control
- Reviews work of trainees and other research assistants
- Responsible for regulatory binders and QA/QC
- Performs data analysis and QA/QC checks when required
- Acts as liaison between Research Affairs and the PI
- Prepare all IRB applications in conjunction with the PI
- Prepare IRB and NIH progress reports, with supervision of PI
- Contribute to protocol recommendations
- Collaborate with PI on grant management and grant applications
- Assist PI to prepare complete study reports
- Will develop study budgets in conjunction with the PI
- Organize materials for the preparation of research papers, manuscripts and other documents for publication and presentation
- Maintains accurate and up-to-date Agendas and Minutes for all research meetings
- Maintain source documents
- Ability to design, prepare, deliver and evaluate clinical programs
- Administrative skills to meet regulatory requirements
- Knowledge of current and developing clinical research trends
- Ability to meet the requirements of varying funding sources
- High degree of computer literacy
223
Clinical Research Coordinator Resume Examples & Samples
- Maintain clinical database including obtaining subject consent, extracting data from medical records and querying database
- Coordinate research projects including preparing and maintaining IRB documents, subject consents and grant budgets
- Perform statistical analysis on data for research purposes
- Assist in preparation of grant proposals, manuscripts for publication, scientific presentations and annual reports
- Serve on the research team, screening subjects for participation, performing physical examinations and coordinating with all involved departments
- Where required, collect study data and/or provide study intervention as required by study proposal
- Minimum master’s prepared or Master’s degree in a related field
- Five years experience in clinical specialty of specified program
- One to two years experience in clinical research or doctoral prepared
- Must have excellent attention to detail and autonomous work habits
- Written communication skills vital to this role, with experience in technical and medical writing preferred
224
Clinical Research Coordinator Resume Examples & Samples
- Coordinates all activities of ongoing clinical trials
- Obtain informed consent under supervision of the study investigator(s) educate participants regarding study requirements
- Screen patients for eligibility and register subjects with sponsoring agency
- Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing
- Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol
- Act as liaison between investigator(s) and sponsoring agency
- Coordinate activities pertinent to the safeguarding of patients’ rights in research
- Manages study data of ongoing clinical trials, alone or in conjunction with non-nurse research coordinators
225
Clinical Research Coordinator Resume Examples & Samples
- Must have excellent organization and follow-up skills
- Must have excellent problem-solving skills; ability to organize and prioritize work assignments
- Ability to handle multiple priorities in a fast-paced environment
- Ability to analyze situations and respond in a timely manner
- Ability to participate in multi-functional teams
- Ability to establish and maintain effective working relationships within The West Clinic
- Must be proficient in computer applications including word processing and e-mail
- Ability to work near toxic or caustic chemicals
- Ability to read, analyze and interpret financial reports, government regulations, common scientific and technical journals and legal documents
- Ability to respond verbally and in writing to common inquiries or complaints from customers, regulatory agencies or members of the business community
- Ability to effectively present information to top management, large employee groups and/or public groups
- Ability to calculate figures and amounts such as discounts, interest, commissions, percentages, BSA, ANC, drug calculations, area, circumference, and volume Ability to apply concepts of basic algebra and geometry
- Ability to define problems, collect data, establish facts, draw valid conclusions. Ability to interpret an extensive variety of technical complex instructions and deal with several abstract and concrete variables
- Recruits subjects for clinical trials through a variety of methods
- Screens potential subjects for eligibility to clinical trials including a careful review of the patient’s past medical history and a review of current findings
- Ensures compliance with protocols and appropriate documentation and support of medical management for subjects on clinical studies. This includes, but is not limited to, confirmation of correct dosing, alerting clinical staff to adverse events occurring on study, and providing guidance on dose modifications mandated or suggested per protocol
- Educates staff nurses about proper administration and expected side effects of protocol therapy
- Educates patients about protocol therapy including when medications are to be taken, what side effects to look for and actions to take in event that side effects occur
- Serves as a liaison between the Research Team and the non-research members to ensure compliance with the clinical trial requirements
- Protects the rights, safety and welfare of the patients
- Strives to maintain harmonious relationships with clinic personnel, medical staff, patients/caregivers and the public
- Obtains and maintains informed consents of each patient for the duration of a study
- Reviews newly-activated protocols, amendments, notices, suspensions and terminations
- Responsible for maintaining a current knowledge of the Code of Federal Regulations
- Interfaces with Physicians, Physician Nurses, Chemotherapy Nurses, Radiology, Medical Records, Front Desk/Scheduling, Phlebotomy, Laboratory, Insurance and Pharmacy regarding research
- Interfaces with multiple drug/pharmaceutical companies and multiple contract research organizations for management of clinical trial
226
Clinical Research Coordinator Resume Examples & Samples
- HS graduation or General Education Diploma and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
- Fluency in the usage of Institutional Review Board (IRB) online iMEDris system for submission, renewal, and modification of protocols through this system
- Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
- Experience with Facebook, Twitter, and Drupal
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Qualtrics, SPSS, Access, Stata, SASS, and Teleform programming platforms
227
Clinical Research Coordinator Resume Examples & Samples
- Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
228
Clinical Research Coordinator Resume Examples & Samples
- Experience working with complicated patient populations (i.e. Veterans, patients with substance use disorder, etc.)
- Familiar with IRB & CHR protocols
- Elementary programing language knowledge (Matlab, Python, or R)
- Previous neuroscience research experience (four or more years)
- MRI Scanner Operator
- Previous clinical research experience
- Able to work well with others
- Microsoft Office Skills (Word & Excel)
- Experiencing planning and organizing meetings
229
Clinical Research Coordinator Resume Examples & Samples
- Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
- Prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore
- Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting
- Familiarity with specimen processing
- Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
- Ability to apply relevant information to the assessment, interpretation, and processing of medical data
- Ability to work with a sensitive population of patients (oncology patients)
- Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team-oriented environment
- May need to travel between one or more campuses via UCSF shuttle
- Prior analytical and writing skills in a science/research environment
- Knowledge of clinical research in breast oncology
- Knowledge and experience in managing oncology clinical trials
- Membership in a clinical research professional society
230
Clinical Research Coordinator Resume Examples & Samples
- Fluent in Cantonese
- Knowledge or ability to learn in bibliographic literature searches, reference and library programs (computer skills), library collections, libraries, national and international
- Ability to assist in writing and editing manuscripts with PI
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
231
Clinical Research Coordinator Resume Examples & Samples
- Knowledge of clinical research in hematology
- Exceptional database management experience and prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore
- Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day
- Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting
- Familiarity with specimen processing, or demonstrated ability to learn specimen processing in a laboratory environment
- Working knowledge of, or demonstrated ability to learn federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
- Knowledge of medical terminology, and/or the ability to apply information to the assessment, interpretation, and processing of medical data
232
Clinical Research Coordinator Resume Examples & Samples
- Familiarity with data management/analysis programs, including some of the following: Microsoft Excel, Access, Stata, SASS/ SPSS, REDCap and Teleform programming platforms
- Fluency in the usage of Microsoft word
- Familiarity with grant preparation, protection of human subjects, creating tables and figures for publication, manuscript preparation and submission
- Obtaining research publications from library/online sources for literature searches
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances
233
Clinical Research Coordinator Resume Examples & Samples
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities Demonstrated knowledge and understanding of research
- Ability to apply information to the assessment, interpretation, and processing of medical data
- Fluency in the usage of Committee of Human Research (IRB) online iMEDris system for submission, renewal, and modification of protocols through this system
- Knowledge of clinical research in oncology, preferably thoracic oncology
- Demonstrated knowledge and understanding of research in biological sciences
- Knowledge and experience in managing oncology clinical trials and experience with Phase I-III trials
234
Clinical Research Coordinator Resume Examples & Samples
- Ability to abstract data from medical records and transfer it to data collection forms or directly into databases
- Excellent verbal and written communications and presentation skills; and excellent interpersonal skills to work effectively in a diverse team
- Well-developed organizational and documentation skills; ability to attend to details
- Ability to work effectively in team-based environment; ability to prioritize tasks and meet multiple deadlines on concurrent projects
- Creativity and self-directedness in assisting with study implementation and addressing obstacles as they emerge
- Bachelor of Arts or Bachelor of Science degree or the equivalent combination of education and experience
- Experience working with patients or study subjects
- Experience working on grants, including applications and progress reports
- Experience with Atlas.it or other qualitative research software
- Experience entering and manipulating data using Microsoft Access databases
- Training/experience in the conduct of clinical research trials in an academic research environment
- Familiarity with UCSF processes and systems; experience and knowledge of CHR/IRB policies and procedures
- Spanish bilingual and bicultural with ability to translate between English and Spanish
- Familiarity with managing a research library
- Knowledge of the San Francisco system of care (medical, mental health, social services) for pregnant and post-partum women and awareness of the work of partner agencies such as Homeless Prenatal Program and the Department of Public Health
235
Clinical Research Coordinator Resume Examples & Samples
- Demonstrated ability to exercise tact and discretion in sensitive communications with patients and others. Demonstrated ability in handling a variety of confidential information appropriately
- Demonstrated positive interpersonal skills and problem solving abilities
- Willing to travel (limited travel for investigator meetings)
- Experience in clinical cardiology and clinical/cardiovascular research
- Science, research, or medical background
- Proficiency in the use of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
- Understanding of patient population to create rapport, while also giving insight to what is realistic and appropriate for patient participation
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
236
Clinical Research Coordinator Resume Examples & Samples
- The CRC will help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols
- Implementing new studies including preparation for site visits as well as study close outs
- Coordinating research related services between departments while participating in data and specimen collection and management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports, including abstracting data from the UCSF EMR and transplant database (TITUS). The CRC will be responsible for data entry into study related databases and case report forms
- Supporting the management and coordinating the tasks of single or multiple clinical research studies within the kidney transplant unit, depending on their size and complexity
- Phlebotomy experience, including collection of blood samples from patients, practice proper patient identification, working in clinic and hospital setting, and label vials with patient names and dates
- Fluency in the usage of Committee of Human Research (CHR) online iMedRIS system for submission, renewal, and modification of protocols through this system
237
Clinical Research Coordinator Resume Examples & Samples
- Proficiency in MS Office Suite including Word, Excel, Power Point
- Experience conducting literature searches using various search engines (e.g. PubMed)
- Ability to analyze and summarize research findings
- BA/BS degree with a major in biology, public health, psychology, sociology, or related field and five years of experience in administrative analysis or operations research; or an equivalent combination of education and experience
- Fluency in the usage of Internal Review Board (IRB) online iRIS system for submission, renewal, and modification of protocols through this system
- Knowledge of medical terminology, research policies and guidelines, database building/analysis, and data management within some of the following: iRIS, REDCap, and FileMaker Pro
238
Clinical Research Coordinator Resume Examples & Samples
- High school graduation or General Education Diploma and six months to one year of related work experience; or an equivalent combination of education and experience
- PC computer, programs (Word, Excel, Adobe) and data entry proficient
- Experience working with regulatory documentation, quality assurance
- Compliance auditing
- Experience with IRB/CHR submissions
- Excellent verbal, written communications and organizational skills
- Ability to handle sensitive personal and patient clinical information
- Familiarity with medical technical language and study protocols
- BA/BS degree with a major in a related field and one year of experience in administrative analysis or operations research; or an equivalent combination of education and experience
- Experience with conducting clinical research trials
- Proficient in electronic medical records and databases – preferably APEX
239
Clinical Research Coordinator Resume Examples & Samples
- Comfortable working with female patients
- CITI Certification
- Fluency in written and spoken Spanish
- Experience using Redcap and Qualtrics for creating study data collection materials and integrating data into larger databases, and SPSS software for data management and simple analysis
- Minimum of one year Clinical Human Research Experience with direct subject contract
- Experience consenting and following Spanish speaking research subjects through participation in clinical research studies
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS, R programming platforms
240
Clinical Research Coordinator Resume Examples & Samples
- Knowledge of Microsoft Word, Excel, Outlook, and other basic software programs
- Experience working with individuals in a clinical or a clinical research setting (for example, explaining medical tests and procedures to patients, explaining research procedures and risk/benefit to potential research subjects) and knowledge with medical terminology, medical testing, and human subjects research
- Excellent Analytical and problem solving skills
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines and obtain reproducible results
- College graduate with a Bachelor’s degree, majoring in the biological sciences, and with the associated hands-on laboratory experience (for example, Chemistry lab, Organic Chemistry lab, Biology lab, etc.)
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platform
- A minimum of two years of employment experience working in a research laboratory, or volunteer experience working in a research laboratory, or an equivalent combination of educational courses/laboratory experience including the development of sterile technique and experience with advanced specimen processing protocols
- Experience with processing specimens such as PBMCs or experience with processing specimens using detailed and advanced protocols (i.e. familiarity with PBMCs or using specimen processing protocols to isolate and cryopreserve PBMCS); Experience with blood-borne pathogen specimen handling
- Experience working and collaborating with medical professionals or other healthcare workers in either a clinical or research environment
- Experience working with HIV-positive individuals and/or individuals with lung disease (e.g., pneumonia) in a clinical or a clinical research setting
- Experience with blood-borne pathogen specimen handling
- Experience with UCSF/ZFG electronic medical records
- Experience with developing and maintaining clinical databases using RedCAP and other types of software
- Prior database experience in a laboratory setting
241
Clinical Research Coordinator Resume Examples & Samples
- Experience with translational research trials, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies
- Experience working with culturally and linguistically diverse groups
- Knowledgeable in phlebotomy issues, including working knowledge of tubes and procedures required for blood draw of clinical laboratory tests, and sample processing for T-cell assays, flow cytometry, and other research assays; basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage and disposal of reagents)
- Proficient in Microsoft Office programs with emphasis on Excel, Access, Word, Publisher; Proficient with Teleforms. Savvy internet user
- Demonstrate excellent attendance and reliability. Work during some evening hours and/or early morning hours required
- BA/BS degree in related field and/or two years’ experience in clinical, community health setting and/or research setting
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); Thorough knowledge of antiretroviral medications; Familiarity with treatments for HIV-related infections and medical terminology, research policies and guidelines, guidelines for handling diagnostic specimans including packing/shipping infectious substances, Certified Safe Shipper - IATA certification, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
- Good Clinical Practice Guidelines
- The Protection of Human Research Subjects
- IRB regulations for recruitment and consent of research subjects
- Effective Cash Handling Procedures
- Environmental Health and Safety Training
- Fire Safety Training
- Conversational Spanish language skills with medical terminology
- Advertising/publishing experience a plus
242
Clinical Research Coordinator Resume Examples & Samples
- Active CA State license; current CPR/AED license
- Knowledge and two or more years’ experience with measurement of body composition, including use of multiple DEXA machine models (Lunar, Hologic)
- One year experience in a clinical research setting, including application and training of GCP, HIPAA, CHR principles
- Experience using BodPod, single and multiple-frequency bioimpedance analysis and interpretation of test results
- Knowledge of operation principles and expertise with measurement of oxygen consumption and carbon dioxide production by indirect calorimetry (resting and during exercise); ability to perform such measurements using Parvomedics system; interpret test results
- Exposure to pulmonary function testing by spirometry, interpret test results
- Ability to design testing protocols and prepare associated documentation; develop flowsheets and protocol orders; assist with manuscripts
- Demonstrated ability to multi-task and work independently; proven attention to detail
- Exceptional written/ verbal communication skills; proven diplomacy and tact
- BA/BS degree with a major in a related field and two years of experience in administrative analysis or operations research; or an equivalent combination of education and experience
- Master’s degree in exercise physiology or exercise science
- Certification as an exercise specialist, registered clinical exercise physiologist from American College of Sports Medicine or equivalent licensure in exercise science or conditioning
- Experience with exercise and body composition testing in a variety of patient populations, including pediatrics and patients with chronic diseases
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and TeleForm programming platforms
243
Clinical Research Coordinator Resume Examples & Samples
- Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team
- Ability to establish cooperative working relationships with research participants , co-workers, & the PI
- Experience working with patients or study subjects and interviewing study subjects
- Experience using an accelerometer(pedometer)
244
Clinical Research Coordinator Resume Examples & Samples
- A minimum of one month experience working in research or with patients in a healthcare setting including electronic medical records
- Basic computer skills including knowledge and experience in MS Excel, PowerPoint, and Word
- Excellent problem solving ability and attention to detail. Superior analytic and organizational skills. Able to propose solutions to difficult problems. High degree of innovation and motivation
- Excellent verbal, written, editing, communication and interpersonal skills. Ability to communicate both verbally and in writing with patients, faculty, staff at all levels, and non-university personnel. Proactive in communicating with many people at various levels of academic and industry environments
- Demonstrated ability to craft sophisticated written communication pieces regarding sensitive correspondence. Excellent presentation and project management skills
- Must have judgment and diplomacy when communicating to staff and faculty at different levels of an organization. Good customer service. Professional attitude
- Ability to work in a fast-paced, team-based, dynamic environment, yet able to work independently with minimal supervision, exercising judgment and initiative. Possess excellent interpersonal skills with the ability to collaborate and cooperate with research team in a diverse setting. Is a team-player
- Excellent time management skills. Proven ability to balance multiple projects and meet deadlines. Ability to coordinate multiple tasks and re-prioritize responsibilities as necessary. Demonstrated ability to organize and manage multiple and sometimes conflicting tasks, schedules, and work flow. High level of accuracy. Good follow-through skills in a multi-tasking environment
- Ability to handle blood and tissue specimens
- Demonstrated record of excellent attendance and performance
- BA/BS degree in a related science
- Masters’ or Ph.D. in public health, statistics, epidemiology, or other related field
- Prior experience with IRBs and in submitting IRB paperwork
- Fluency in the usage of Committee of Human Research (CHR) online iRIS system for submission, renewal, and modification of protocols through this system
- Prior experience in coordinating all aspects of clinical research studies, as a research assistant, clinical research coordinator, or clinical research associate
- Previous experience working in clinical research at UCSF or another academic medical center
- Familiar with regulatory affairs, FDA regulations, and Good Clinical Practice (GCP). Knowledge of research protocols, clinical research processes, including medical chart reviews, and regulations involving human subjects
- Experience with FileMaker, MS Access database, Adobe Acrobat Professional, and statistical analysis programs such as STATA, SAS, or R. Knowledge of programming languages Python and/or Matlab
- Working knowledge of basis statistics. Knowledge of statistical principles necessary to perform the appropriate statistical analysis and experience designing statistical models, analyzing complex datasets independently, etc
- Prior experience with various methods of data collection and methodology. Experience working with large, complex administrative datasets
- Familiarity with UCSF systems (e.g. EPIC, REDCap, iRIS, etc.)
- Experience with clinical patient management, including scheduling and insurance authorization
- Familiarity with Osirix
- Proficiency in a second language (Spanish or Cantonese preferred)
- Certification as a research professional. Other relevant certifications
- Knowledge of Code of Federal Regulations and Good Clinical Practice as it relates to clinical research and clinical trials
- Knowledge and understanding of or training in clinical human research, in an academic medical/research environment
- Knowledge of or training in clinical trial recruitment, eligibility verification, protocol adherence, quality data submission, and adverse event reporting
- Understanding of investigational drug and device development processes and the various phases of industry clinical trials
- Solid understanding of clinical trials policies, procedures, and regulatory issues
- Knowledge of sound research methods regarding study design, data collection, and data analysis
- Possess working knowledge of industry side of clinical research
- Knowledge of UCSF and departmental policies for dealing with reimbursement; guidelines for research; confidentiality and HIPPA regulations; following the UCSF mission statement and purpose for research; and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: SASS/SPSS, and TeleForm programming platforms
245
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s Degree and six or more years as a clinical research coordinator
- SOCRA or ACRP certification required
- Excellent reading comprehension
- Foster/promote a positive image and professional appearance
- Sensitivity to intercultural relations
- Sensitivity to the maintenance of confidentiality
- Knowledge of Microsoft Products
246
Clinical Research Coordinator Resume Examples & Samples
- Bachelor’s Degree and three or more years as a clinical research coordinator
- SOCRA or ACRP certification preferred
- Ability to use Microsoft products, access data in computer data bases, compile data, and research information
- Proofread documents
- Troubleshoot problems
247
Clinical Research Coordinator Resume Examples & Samples
- Ability to compile and access data in computer data bases
- Ability to proofread documents and research information
- Use computer packages and word-processing software
248
Clinical Research Coordinator Resume Examples & Samples
- Reads and understands all correspondence relating to each study assigned. Responsible for all written and verbal communication and the documentation thereof. This will include but not be limited to communications with study sponsors, monitors, study subjects/patients, physicians and laboratories or other study-specified service providers
- Responsible for all IP accountability specific to each subject and total protocol inventory. Role includes proper documentation of IP assignment, temperature and expiration date monitoring, return of used IP, and destruction or return to sponsor
- Works with subjects/patients to ensure study compliance and understanding of participation requirements (i.e., timeliness of visits, return of study-related materials and at-home documentation
- Complete, accurate and timely entry (within 7 days of visit) of visit data into study electronic data capture sites when applicable
- Recruits and retains study Participants
- Processes, packages, and ships biological samples as required by study or centralized laboratories
- Organizes and maintains study binders for each participant in a study. Ensures that filing is complete, accurate and consistent among study participants
- Attends investigators’ meetings as required
- Works with patients to ensure that study requirements are met including appointments, labs, etc
- Networks and researches potential new studies
- Performs regulatory functions for existing studies
- Maintains control over study medications/supplies
- High level of customer services skills with a genuine caring approach to helping people
- Maintain a positive attitude with changing conditions
- Requires strong written and verbal communications skills to communicate effectively with individuals at all levels of the organization
- Must be able to work under general supervision
- Must have a professional and mature demeanor
- Must be able to work in a fast-paced department and handle multiple tasks, work with interruptions, and deal effectively with confidential information
- Excellent interpersonal skills for effective interactions with patients and staff
249
Clinical Research Coordinator Resume Examples & Samples
- Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience. Supervisory or project management experience required
- Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a social or health science and 1 year of experience; OR appropriate combination of education and experience
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a social or health science and 2 years’ experience; OR appropriate combination of education and experience
- 4 years practical research study or related experience
250
Clinical Research Coordinator Resume Examples & Samples
- Must complete Northwestern's IRB CITI training before interacting with any participants and must re-certify every 3 years
- Must be certified as a Clinical Research Coordinator through an accredited organization such as the Association of Clinical Research Professionals (ACRP); the Society of Clinical Research Associates (SoCRA) or similar
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a social or health science + 2 years’ experience; OR; OR appropriate combination of education and experience. OR
- 4 years practical research study or related experience; OR
- Master's degree in a social or health science + 1 year experience
