Clinical Research Resume Samples

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E Howe

Elissa

Howe

11976 Dangelo Haven

Houston

+1 (555) 491 1941

11976 Dangelo Haven

Houston

Phone

p +1 (555) 491 1941

Experience Experience

San Francisco, CA

Clinical Research Psychologist

San Francisco, CA

Jones, Bechtelar and Nicolas

San Francisco, CA

Clinical Research Psychologist

Prepare budgets for research protocols and obtain research grants by preparing and writing protocol applications
Collect and maintain data for ongoing research and academic protocols in the DMH
Medical discharge planning
Major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy
Provides diagnostic and therapeutic procedures (including but not limited to)
Psychosocial history taking
Retrieve, sort and collect data from hard copy and electronic databases. Collect and maintain data for ongoing research and academic protocols

Phoenix, AZ

Manager, Clinical Research

Phoenix, AZ

Frami Group

Phoenix, AZ

Manager, Clinical Research

Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans
Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director
Plans and manages study site activities and provides ongoing updates of site status to management
Oversee, develop, and manage CDM staff with the goal of maintaining quality processes and practices in the management of clinical research information
Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
Oversees all aspects of human resource management including recruitment and retention of assigned staff and ongoing staff performance evaluations
Responsible for managing the development, initiation, functionality, progress and completion of clinical databases used in clinical studies managed in the DCC

present

Los Angeles, CA

Senior Site Clinical Research Associate

Los Angeles, CA

Dickinson, Johnston and Kuhlman

present

Los Angeles, CA

Senior Site Clinical Research Associate

present

Provides leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US)/ region (US) of responsibility
In the country/region based, manages activities of clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol
May conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCP’s), ICH Guidelines, and AbbVie Standard Operating Procedures (SOP’s) and business processes
Conducts all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives
In the country/region based, manages the SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies
Builds and maintains a high performance team of monitoring staff
In country based, may provide administrative management oversight to up to 8 Study Leads responsible for conduct of study at local level

Education Education

Bachelor’s Degree in Clinical

University of South Florida

Bachelor’s Degree in Clinical

Skills Skills

Excellent knowledge of regulations that apply to clinical studies
Able to maintain good relationships with physician and other medical providers
Strong negotiating skills
Strong leadership skills essential
Mentor team members to encourage personal and professional growth
Ability to prioritize and manage time efficiently
Working knowledge of SOPs/regulations relevant to clinical research
Ability to exercise independent judgment
Relevant therapeutic area experience desirable
Good written and oral communication, interpersonal, analytical, conflict resolution, and problem-solving skills

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Clinical Research Data Specialist Lead Resume Examples & Samples

Able to practically apply strong knowledge of the federal regulations governing the protection of human subjects e.g. FDA, GCP/ICH guidelines, OHRP and HIPAA regulations
Attends and actively participates in all internal and external protocol start up orientations
Acts as the primary site contact for the sponsor’s CRA for assigned industry trials
Able to practically apply knowledge in research regulations, including the reporting of Serious Adverse Events (SAE) and protocol violations
Ensures that collection of clinical data is available to the PI, Sponsor and CRO in a timely manner
For in house, NCI sponsored and Cooperative Group studies, interacts with QA Team to ensure accuracy of CRFs prior to submission
If required by protocol, contacts patient or family for survival status after patient is taken off treatment; ensures that the Café database status fields are updated until patient death. If delegates to Data Specialist I, will orient to process and oversee
Participates in QAMC audits by thoroughly reviewing assigned patient chart and reporting on results
Independently prepares for and participates in NCI, FDA, pharmaceutical and other audits for assigned trials, as well as any other trials assigned to the CISO CRA’s Team
Has necessary experience and knowledge to assist Study Coordinator with patient work ups
Provides assistance and input to the PI for publishing study results when requested
When requested, assists with orienting, training and mentoring newly hired Data Specialists I
Provides assistance and guidance to Data Specialists I and II in identifying and assessing protocol violations
Provides assistance and guidance to Data Specialists I and II in completing protocol required SAE reports
Follows CISO SOPs in conduct of work
Knowledgeable about and complies with hospital regulations
Follows Medical Records rules for using and returning charts and accessing EPF and Affinity (LAC)
Attends and participates in required internal and external meetings and conference calls with sponsors
Ensures work environment is organized to function efficiently
Observes office etiquette, by acting courteously and professionally with fellow staff members
Reports off to assigned Data Specialists and Study Coordinator when away from office for reporting SAEs and other duties for coverage

Regional Clinical Research Associate Resume Examples & Samples

2+ years of relevant experience
Bachelor's Degree in a related field or BSN
Previous experience in the Pharmaceutical industry
Basic medical and business knowledge
Competency in Clinical Research or having demonstrated adequate level of proficiency within the CRA II competency profile
Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations
Degree in a Scientific or Healthcare discipline

Clinical Research Document Specialist Resume Examples & Samples

Comfortable working in a fast-paced environment
Knowledge of the HIPAA Privacy Rule $
Experience negotiating ICF language with research centers and IRBs

Clinical Research Data Specialist Resume Examples & Samples

BA/BS or similar preferred
1-3 years minimum experience in data collection / management
Self-directed, resourceful, highly motivated, and energetic
Mission driven, goal-oriented with commitment and passion to emerging field of AYA oncology
Ability to work with and influence peers, project teams and management
Must be able to work independently and with direction from the Director(s) and Program Managers
Basic analytical skills with data analysis, data interpretation, problem solving and recommendations for action
Excellent written and verbal communication as well as interpersonal skills
Excellent judgment and ability to interpret information
Excellent organizational skills and the ability to prioritize critical tasks
Ability to convey information to and manage staff with different backgrounds, abilities and communication skill

Clinical Research Associate, Taiwan Resume Examples & Samples

Location: Taiwan
Arranges for the appropriate destruction of clinical supplies
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
Maintains complete, accurate and timely data and essential documents in systems utilized fortrial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints
Follows the corresponding Monitoring Guidelines for each assigned trial
Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times
Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
May participate in the HA and IEC/IRB submission and notification processes as required/appropriate
Act as an point of contact in site management practices
May be assigned as a coach and mentor to a less experienced site manager
May contribute to process improvement and training

Clinical Research Associate, Lead Resume Examples & Samples

Provide leadership for the Clinical Operations project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work
Define, assign, coordinate, oversee and assess utilization and productivity of the monitoring team
Coordinate and supervise site monitoring assignments and activities
Direct and prioritize team efforts and assess overall team progress against study timelines and metrics
Develop performance standards for project team
Identify and notify appropriate parties of emerging out of scope activities
Evaluate impact on resource needs, study processes and related documents
Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance
Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance
Coordinate the development, use and maintenance of study-specific processes, related documents, templates, monitoring and regulatory tools
Define site selection and activation
Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes
Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives
Serve as key site management trial-team member to internal and external partners
Collaborate with internal and external partners to develop trial-specific tools and processes
Provide input regarding the development of the CRF design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports
Review and analyze site payments and associated site status against Clinical Operations budget
Identify and oversee trial-related training and performance concerns of monitoring team; maintain awareness of level of performance and training needs; provide ongoing input for development of individual training plan
Coordinate and oversee trial-specific training for CRAs which may include therapeutic in-service, reference materials, investigator meeting, team monitor training, on-site co-monitoring and training visits
Assist with all aspects of performance management including compiling and providing feedback for team members' annual performance evaluations
Supervise and manage monitoring trial-team members' adherence to DCRI and sponsor- specific administrative policies with guidance
Review and approve trial-related expense reports, timesheets, and time-off requests
Assist in the development, implementation and revision of processes, SOPs and standard forms
Support the DCRI's mission, department goals and organizational activities
Required:4-5 years related clinical research experience, including 3 years directly related CRA experience or clinical trial management experience
Prior experience directly managing local and remote team of monitors ***
Significant experience being a lead and mentor ***
Experience with streamline monitoring on large trials or experience with managing monitoring across multiple projects
ID knowledge and/or international experience a plus
Experience working on a network of trials a plus (including Device, Drug, Data Mining, Biomarker Discovery, etc...) ***
Strong protocol development experience including the ability to provide operational feedback ***
Experience working with large budgets and aggressive timelines
Excellent writing and speaking skills
Strong multitasking skills and managing priorities across changing situations
Ability to think "outside the box" is critical ***
Track record of setting up efficient operations for monitoring (i.e. trip report review, trip scheduling , etc)
Experience developing action plans, identifying, communicating and resolving issues identified during visits
Experience resolving performance issues with staff ***
Political "saviness" and maturity -experience working with more than 2 sponsors/multi partners
Analytical, creative, methodical, and strong data skills
Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or
Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research
State of North Carolina license may be required.**

Clinical Research Operations Specialist Resume Examples & Samples

Bachelor’s degree in Clinical Research/Public Health/ Business or related field
2 years’ experience in project management and clinical research projects
Experience supervising, training, and/or mentoring new staff or students
Strong leadership skills necessary for determining, recommending, and implementing improvements to policies/processes and best practices
Familiarity with clinical terminologies
Familiarity with FDA regulatory requirements

Cancer Clinical Research Business Manager Resume Examples & Samples

Master's degree and six years relevant experience or combination of education and relevant experience
User knowledge of Microsoft Office Suite
Advanced understanding of financial principles
Strong analytical skills to review and analyze complex financial information
Demonstrated success in performing meticulous, high quality and compliant work
Direct experience managing clinical trial budgets and financial activities of a Clinical Trials Office. Experience working in or with industry, and in cancer research is also desired

Breast Oncology Clinical Research Associate Resume Examples & Samples

Knowledge of the principles of clinical research and federal regulations
Familiarity with IRB guidelines and regulations
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred

Clinical Research Supervisor Resume Examples & Samples

Excellent written and verbal communication skills; excellent interpersonal skills
Good leadership, diplomacy, judgment, and decision-making skills
Ability to manage multiple priorities in a fast-paced, deadline-driven environment
Advanced education Ph.D., Masters, or related training in a related field
Three to five years of clinical research experience; preferably managing clinical research involving academic and external/private sector stakeholders
A demonstrated history of supervising research staff
Experience in Expertise with Project Management software and creating Gantt charts Excellent analytical and problem-solving skills
Working knowledge of FDA and NIH regulatory requirements
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals

Director of Clinical Research Operations Resume Examples & Samples

Ten years related research experience
Five years of supervisory experience
Strong organizational, analytical, and problem-solving abilities
Ability to work on matters of high sensitivity and confidentiality with both diplomacy and discretion

Clinical Research Technician Resume Examples & Samples

Maintain inventory of supplies and equipment
Ensure specimens are properly logged, handled and stored
Operate standard laboratory and research study equipment
Follow direction of research staff or others involved in the clinical research project work
Strong communication and computer skills

Clinical Research Admin / Director Resume Examples & Samples

Collaborate with the PPI, NCC, NDMC and performance site trial team members to ensure successful conduct of clinical trials by managing daily study activities
Interact with clinical site personnel about matters concerning compliance and verification of the trial, FDA and CIRB regulatory requirements, contractual requirements, and shipment and receipt of investigational products
Track progress and provide authorization to begin site enrollment based on the predefined criteria for each required component of a trial
Maintain database/tracking tools which track site and subject enrollment as well as other elements pertinent to the trial execution
Serve as a liaison between performance site personnel, the PPI, the NCC, and the NDMC trial management teams to enforce adherence to study protocol, the trial MOPP, and SAE reporting
Assist in the development and maintenance of the trial MOPP
Attend and assist in preparation of DSMB and Trial Investigator meetings
Prepare monthly study update newsletters for participating sites
Coordinate regular conference calls of steering, executive, and scientific advisory committees and face-to-face AHA Conference investigator meetings or other national meetings
Interface with CIRB liaison regarding site CRIB approvals, annual renewals, and reporting of SAEs
Interface with NDMC data manager regarding site and data quality issues
Participate in site initiation visits and staff training as deemed necessary for the trial
RCC responsibilities include acute care stroke call availability after normal business hours as required
Ability to assist with the coordination of research studies in a particular discipline
Ability to make independent contributions to projects and studies based on professional training or functional experience
Must be able to interact with study sites in a professional manner
Can accomplish work under general direction
Capable of advising and explaining information to others
Ability to manage moderately complex projects
Ability to work with the NCC leadership to accomplish the necessary NCC tasks, in addition to short- and long-term goals
Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence
Graduate degree in natural sciences or an equivalent combination education/experience
At least ten (10) years of work experience, with a Minimum of three (3) years of experience directly involved with clinical research or similar experience in medical field preferred
Proficiency with regulatory guidelines for clinical trials preferred
Proven organizational ability and strong attention to detail
Demonstrates decision-making and problem-solving skills
Excellent time-management skills, communication and interpersonal skills (written and oral), and computer skills including word processing, spreadsheet, and PowerPoint are required

Otolaryngology Clinical Research Coordinator Resume Examples & Samples

Flexibility and ability to adapt to various situations
Possess a level of comfort working with patients and clinicians
Develops knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research
Develops knowledge of University of Colorado Denver, UCH, and CHCO Policy and Procedures in relation to conducting multiple clinical research trials
Develops a working knowledge of study regulations, budgets, and billing processes
Knowledge of basic human anatomy, physiology, and medical terminology
A bachelor's degree is required
Minimum of 1 year clinical research experience
Experience with both sponsor and PI initiated studies
Strong regulatory knowledge
Experience submitting to the Institutional Review Board
Familiar with COMIRB policies
Experience with data management, queries and reports
Experience with statistical analysis

Clinical Research Data Coordinator Resume Examples & Samples

Associate’s Degree in a related field or two years’ experience in a medical or clinical environment
Knowledge of and experience with basic human anatomy, physiology, and medical terminology
Experience using Microsoft Office products
Research experience, oncology is a plus

Clinical Research RN Resume Examples & Samples

Collaborates with 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, toxicity checks, and protocol specific tests and procedures
May be called upon to perform the following specific tests and procedures: (1) electrocardiogram; (2) blood pressure, pulse, height, weight, and temperature measurements; (3) phlebotomy and specimen processing and shipping; and (4) pulse oximetry
Bachelor’s degree in Nursing
One (1) or more years of RN experience in a research and/or oncology

Senior Associate, Clinical Research Resume Examples & Samples

Ensures that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met
Collaborates in the conduct of clinical studies from protocol feasibility through study report generation and sign-off; Ensures that protocol as well as protocol amendments (if applicable) are prepared
Coordinates the review of applicable study-specific essential documents including informed consent documents, case report forms (CRFs), subject directed recruitment materials, etc
Writes Clinical Study Reports (CSRs), if needed; Ensures review and approval of CSRs ; Ensures that the monitoring plan is prepared, reviewed and approved
Ensures timely review and approval of monitoring visit reports (May perform site (co)-monitoring when needed)
Serves as the primary point of contact with Investigators and J&J Study Team
Manages study timelines including key milestones
Coordinates the processes of Due diligence, site contracting and purchase order preparation as well as invoice tracking
Coordinates product and label requests for clinical studies
Coordinates the collection of all the essential documents needed for the investigator initiation package (IIP); Approves the IIP prior to authorizing the initial product shipment
Ensures investigational product has been approved, labelled, shipped, accepted and returned appropriately; Ensures accountability of Investigational Product at sites
Ensures management of retain samples; Ensures set-up and maintenance of electronic trial master files including periodic reviews
Ensures input and updating of study status into the global tracking system
Participates in the generation of corrective and preventative action plans to address issues and deviations
Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately
A minimum of a Bachelors’ degree is required, preferably in science, engineering, medicine or related field
A minimum of 4 years of experience in the conduct of clinical studies or equivalent is required
Previous experience with clinical study management is preferred
Experience with ICH/GCP guidelines is required
This position may require up to 10% of domestic and international travel.Clinical Data Management

Clinical Research Financial Analyst Resume Examples & Samples

Prepare a comprehensive quarterly clinical trial financial report and present the report to disease center leaders and administrators
Review and develop new financial reporting metrics
Assist in all new clinical research staffing decisions based upon financial analysis review
Maintain a database of existing clinical trials with payment schedules, dollars received and dollars outstanding
Prepare invoices as required by various study sponsors and manage collection of all outstanding receivables including milestone grid management
Work with and assist Principal Investigators, administrators, and study teams with the allocation of personnel costs during the quarterly clinical trial offset process
Work closely with Research Accounting to maintain and enhance clinical trial accounting policies and procedures
Work with Research Accounting and study teams to review and monitor appropriate expenses against budget
Serve as a resource to study teams, investigators, and institute departments in clinical research financial matters
Bachelor's Degree in Business or related field
0-3 years direct experience or equivalent work experience. Previous clinical research experience preferred
Excellent communication skills and organizational abilities are essential
Knowledge of computer applications (Excel, Word, Access) is essential
Visa sponsorship is not available for this position

Clinical Research Auditor Resume Examples & Samples

Perform a minimum of 24 audits of DF/HCC clinical trials annually
Schedule approximately 2 audits a month with the appropriate research study teams at DFCI, MGH, BWH, BIDMC, BCH, their Affiliates and at external sites engaged in multi-center research
Prepare for scheduled audit by thoroughly reading and understanding selected protocol requirements, federal regulations, Good Clinical Practice guidelines and DF/HCC policies
Conduct pharmacy and regulatory reviews for the selected protocol
Conduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc
Summarize and present audit findings to the Overall Principle Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities during an exit interview
Train investigators and study staff in documentation of clinical trial activity, protocol compliance and regulatory requirements
Analyze audit findings to appropriately assign major or minor violations, rating the audit and drafting a Final Audit Report for review and approval by the Data & Safety Monitoring Manager
Present audit findings to the Audit Committee for final evaluation
Document audit findings and outcomes in appropriate repositories
May perform special audits upon request (mock audits, Office for Humans Research Studies (OHRS) file reviews, IRB, Affiliate site audits, etc.) or may perform special projects at the request of the ODQ Director or Data & Safety Monitoring Manager
Compose “Audit Alerts” to disseminate trends in audit findings across DF/HCC institutions via the research listserv (CRA II)
Participate in training sessions regarding the DF/HCC Audit Program (preparing and/or presenting) (CRA II)
Provide support for the maintenance of the DF/HCC Clinical Trial Audit Manual, DF/HCC Standard Operating Procedures (SOPs) pertinent to clinical trial auditing and the audit database (CRA III)
Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encountered by the clinical research auditors across the DF/HCC institutions (CRA III)
Identify needed DF/HCC system changes within DF/HCC through the extrapolation of the audit findings (CRA III)
Provide guidance and mentoring to junior staff through co-auditing during initial training of new hires and act as a subject area expert to junior peers (CRA III)
Bachelor’s degree in a scientific field is required at all CRA levels
1-2 years clinical research auditing or monitoring experience, oncology research preferred (CRA II)
3-5 years clinical research auditing or monitoring experience, oncology research preferred (CRA III)
Certified Clinical Research Profession (CCRP) from an approved accrediting organization (CRA III)

Ubc-lead Clinical Research Associate Resume Examples & Samples

Thorough knowledge of sponsor specific project requirements, protocol and timelines
Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines
Maintains at least one active site per study assignment
Assists with project specific training
Ensures appropriate CRA visit scheduling per protocol; tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks
Maintains Q&A log for site and monitoring issues
Maintains and tracks Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines
Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
Attends client and project team meetings – assists with preparation, content and leading of meetings as required
Assists with reporting on monitoring activity to include status report, co-monitoring and trip report metrics
Acts as back-up for Project Manager and may be primary contact for UBC/Sponsor interaction
Coordinates EDC data entry, if applicable, and DCF resolution
Coordinates site assignments in conjunction with Project Manager and Functional Manager; assists with other project specific tasks as delegated by Project Manager
Consistently completes on site monitoring in accordance with project specific timelines
Attends project team meetings, departmental meetings and 1:1 with manager a minimum of monthly; responsible for content discussed during these meetings
Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File with minimal corrections required
Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
Consistently completes Call Log or Telephone Contact Report detailing communication with sites in a timely manner
Maintains regular contact with assigned sites per protocol
Consistently completes expense reports within UBC timelines and guidelines
Assists PM and management team by being an AIM leader
A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
I = Instruct how to conduct visit, report/letter writing and manage issues and actions
M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
Creates and maintains clinical project documents with Project Manager oversight and finalizes with appropriate team review (PM, Sponsor, etc.)
Includes: Clinical Management Plan, Trip Report and Letter Templates, CRF Transmittal Form, Monitoring Worksheet, input for Monitoring Plan
Bachelor’s degree – Life Science preferred or equivalent industry and monitoring. Must have Complex Cardiovascular experience
Displays leadership, organizational and interpersonal skills
Proven skills with CTMS, EDC, Outlook, Excel and other basic computer software and client specific systems (if applicable)
Up to 50% travel

Clinical Research Associate Administrator Resume Examples & Samples

Manage data according to prescribed standards and transcribe data in case report or data forms
Prepare documents for statistical analysis and descriptive data
Follow-up with study subjects in accordance with research protocol(s)
Ensure compliance with subject consenting and reporting of adverse events and side effects
Adhere to legal, professional, and ethical codes of conduct with respect to confidentiality and privacy
Ensure that all research efforts are in compliance with Federal, agency, and IRB-specific requirements and regulations
Schedule and maintain calendar of data collections, appointments, and updates

Clinical Research Associate Positions Resume Examples & Samples

A minimum of two years’ experience coordinating research protocols (four years preferred) as a certified research coordinator
A minimum of two years’ experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification will be given preference
Understanding of AAALAC and USDA regulations regarding animal subjects research
A minimum of two years’ experience coordinating research protocols
Clinical competence in application of professional nursing theory, practice, and skills for the care of patients

Clinical Research & Data Quality Coordinator Resume Examples & Samples

Design and develop complex models used for health care data analysis and data mining and for complex health care data relationships to improve data collection activities, data analysis, monitor contractor performance, and member health care outcomes as they relate to Quality Improvement
Support the E.H.R. Incentive Program with complex data analyses, including risk assessment and random audit selections, data analysis for federal report purposes and validation of provider and program data
Assist internal and external customers with data analysis and data relationships
Communicate among AHCCCS divisions and health plan administration for the purpose of identifying, resolving and monitoring data anomalies and general data relationship issues
Attend internal and external meetings to answer questions, provide recommendations and participate in problem solving and decision making related to encounter data submissions, processing, analysis and health outcomes
Interpret various administrative rules, policies and procedures pertaining to encounter and CQM data
Significant experience in PC programming and common software tool usage including but not limited to SPSS, Microsoft Access and Excel, within the context of health care industry
Demonstrated experience in statistical or analytical theories and techniques and data-mining skills; superior mathematical skills
Proficient understanding of methodology requirements including but limited to HEDIS and CMS Core Measurement sets, as well as extensive understanding of data validation methods
Strong ability to effectively lead and/or facilitate a team of professionals from within and/or outside the agency
Demonstrated knowledge of State and Federal Policies and Procedures governing Title XIX, Title XXI, Managed Care, Long Term Care, Individuals with Special Health Care Needs, Behavioral Health and Tribal health care entities
Advanced degree in biostatistics, statistics, epidemiology, business, health administration or related field

Clinical Research Associate, West Coast Resume Examples & Samples

Moderate clinical research and independent field monitoring experience
Thorough understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines and an intermediate understanding and application of applicable therapeutic standards
Strong organizational, documentation, presentation, and interpersonal skills as well as a willingness to work within a team-oriented environment
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail
Effective command of written and spoken local language, if not English, as well as English
Must have valid, current driver's license and ability to secure corporate credit card
ACRP CCRA or equivalent certification/credentials strongly preferred

Senior Specialist, Clinical Research Resume Examples & Samples

Able to function as a subject matter expert (SME) on medical device products
Assist in the preparation of study start up activities with a high degree of skill and knowledge. Collaborate with monitoring team to coordinate on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled
Assist in the preparation of and critically review relevant portions of regulatory submissions for local and government regulatory bodies
Participate as a key member to provide analysis in internal protocol compliance meetings, and independent safety review meetings (e.g., DSMB, Medical Monitor, and Clinical Events Committee and protocol deviation meetings)
Collaborate with other Clinical Research Associates and project teams to ensure that trials are conducted and maintained in a standardized way
Extensive site management experience
Ability to communicate and relate well with key opinion leaders and clinical personnel
Effective written, verbal and presentation skills
Able to build constructive and effective relationships using diplomacy and tact
Able to identify problems and root causes while proposing potential solutions
Strongly motivated, is able to achieve work goals, and executes through appropriate channels

Clinical Research Monitor Report Reviewer Resume Examples & Samples

Bachelor’s Degree with 2+ years clinical research experience required
Advanced Degree with 0+ years clinical research experience required
Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel) required
Previous experience in clinical monitoring preferred
Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, etc.) preferred

Clinical Research Monitor Resume Examples & Samples

Bachelor’s Degree in life sciences, health related disciplines or nursing
2-3 years Clinical Research experience (preferably with Clinical Monitoring experience)
Expertise in GCP, ISO 14155 (preferably) and regulatory requirements in Greece
Experience with Ethic Submissions & coordination
Flexibility in terms of (inter)national travel (up to 80%)
Possess a working knowledge of disease state and investigational product

Prin Clinical Research Program Resume Examples & Samples

Bachelor’s degree and 7+ years of project management experience OR
Master's degree and 5+ years of project management experience OR
Doctorate and 3+ years of project management experience OR
M.D., *D.V.M. (*Board Certified)
Expert in MS Project (or similar scheduling software) and Excel skills
Medical device or regulated industry experience
PMP certification
Perform work without appreciable direction. Exercises considerable latitude in determining objectives and approaches to

Cra-senior Site Clinical Research Associate Resume Examples & Samples

Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol in an off-site and affiliate based capacity
Conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes
May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues)
May train and provide guidance to junior staff. Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
Reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/ COM/ Sr. COM as appropriate, as defined in the study monitoring plan
Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline by enhancing the enrollment schedule of clinical investigative sites
May act as back-up or secondary reviewer for other countries as required
Participates in field training and mentoring of new/junior SCRAs as well as insourced SCRAs
Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up
Employs good financial management to conserve costs of departmental operation and controls travel expenses, with guidance from Senior ACOM/ COM/ Sr. COM as appropriate
Identifies, evaluates and recommends new/potential investigators/sites on an on-going basis.( Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.)
Participates in special projects/work groups

Senior Site Clinical Research Associate Resume Examples & Samples

Builds and maintains a high performance team of monitoring staff
Provides input to forcast resource requirements for assigned clinical studies in the country(ies) responsible for
Advises on pre-audit activities for btoh PV and GCP requirements
Ensures audit and inspection readiness in clinical sites within country(ies)/region(s) of responsibility
Ensures study-related parameters are tracked as appropriate
In country based, might administer budget for salary and operating expenses and might review and approve expenditures to achieve cost effective operations
Candidate should be located in Phoenix, AZ
Minimum of 6 years clinical research experience, at least 3 years of experience in clinical site monitoring
Experience monitoring Immunology

Site Clinical Research Associate Resume Examples & Samples

Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity
The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites
Bachelor’s Degree required; medical/science/nursing background is preferred

Senior Site Clinical Research Associate Resume Examples & Samples

Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to: Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to SCRAs. Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
Facilitates Quality Assurance Audit processes as indicated
Reviews monitoring visit reports for assigned CRA’s
Reports monitoring activities and study site conduct accurately and completely
May provide input relative to performance review and development opportunities
Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable
May coordinate local SCRA team working on the same projects, when applicable
Manages investigator payments as per executed contract obligations
Negotiates investigator/ hospital agreements with stakeholders
Participates in and/or presents at departmental and other functional meetings as needed, including Site Management & Monitoring meetings
Maintains appropriate communication with relevant functional areas

Clinical Research Medical Director Neuroscience Resume Examples & Samples

Three (3) or more years of clinical research experience
Strong background in neurodegeneration/neurobehavior
Experience on partnered programs
Experience and knowledge in designing, conducting and analyzing Phase 2 and/or 3 clinical trials in AD
Familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements, particularly for AD
Demonstrated ability as a medical expert in a complex matrix environment

Head Clinical Research IT Resume Examples & Samples

Ability to build strong strategic relationships with key scientific leaders of clinical research
Demonstrated ability to get things done in a highly matrixed IT organization
Domain expertise in clinical research, including a working knowledge of the scientific disciplines of clinical science, clinical biomarkers, pharmacology, biostatistics and bioinformatics, and how they combine to drive clinical research
PhD/ MS in Life Sciences or a related discipline preferred
Strong domain expertise in the application of IT to Clinical Research is essential, including a deep understanding of clinical development scientific processes and how they are supported by IT tools and systems
10+ years experience in leadership roles in pharmaceutical R&D IT, and/or clinical development and/or Bioinformatics
Ability to lead the analysis of complex and ambiguous business needs, and integrate those into compelling and actionable strategic plans
Demonstrated track record of delivering high-value capability projects in an R&D environment
Seasoned line management skills, with a particular emphasis on energizing and developing the existing team of effective and experienced technical specialists
Ability to create and support a dynamic culture of innovation and continuous improvement in line reports and in the matrix
Excellent collaboration and communication skills, with the versatility to build strong partnerships with technical leaders and also become trusted advisers to senior executives
This individual will be recognized across BMS R&D as the key leader for Clinical Research IT, and recognized internally and externally as a thought-leader in this field
1601817

Clinical Research Associate, Anemia Resume Examples & Samples

Assist with clinical data review
Interact with CRO and monitor trip report review
Assists in tracking and updating study timelines

Director of Clinical Research Resume Examples & Samples

The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide
The successful candidate will have oversight for ongoing and planned product trials within the oncology therapeutic area
The Clinical Research MD will report to a more senior member of the oncology clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials
Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans
Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
Coordinates the collection and analysis of clinical data for internal analysis and review
Develops manuscripts for publication in peer-reviewed journals
Will be part of a team responsible for defending the clinical development program before regulatory authorities
Serves as a scientific and clinical resource within Gilead Clinical Research

Clinical Research Associate, Novosibirsk Resume Examples & Samples

You hold a Medical Academy degree, nature science or any relevant education
2 years of experience as a CRA in international pharmaceutical company or Clinical Research Organisation
You have the ability to analyze data; good presentation, communication skills
You are mobile, flexible and result-oriented with a ‘can-do’ attitude
Good command of Russian and English oral and written would be a great advantage

Clinical Research Psychologist Resume Examples & Samples

Execute all appropriate Investigator responsibilities on assigned projects
Serve as a Primary and Sub-Investigator on research protocols
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure efficient and compliant clinical operation
Assist with the psychological and clinical oversight of all aspects of function and work performed
Assist with training and input on performance assessments for clinical operations personnel
Work directly with clinical operations personnel in diagnostic assessment of trial subjects, psychiatric histories, and evaluation of inclusion/exclusion criteria for study participants
Participate in on-call and general psychiatric coverage schedules
Liaise with sponsors on study conduct and study progression as requested
Provide psychological consultation as required or requested by the client/sponsor or the clinical staff
Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested
Establish working relationships with client representatives, promoting confidence and reliability regarding the clinical operations
Represent California Clinical Trials Medical to clients in a positive and professional manner
Provide support for marketing activities as requested
Liaise with physician staff of Glendale Adventist, Brotman MC and local/regional medical consultants as necessary
Participate in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies
Participate in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed
Ensure that all established timelines relating to areas of responsibility and assigned projects are met
Ensure that the quality standard of clinical work product is met
Perform other duties as assigned by immediate supervisor
Detailed oriented with the ability to work in a fast paced environment
English
Clinical practice experience of at least two years is preferred
Clinical or pharmaceutical research experience desirable
Ability to obtain and maintain an unrestricted license to practice psychological services in the state of California
Knowledge of the FDA regulated drug development process is helpful

Field Clinical Research Associate Resume Examples & Samples

Act as the liaison between the in house Seattle Genetics team, the CRO, vendors, and multiple clinical sites. Maintain close contact with sites by telephone, correspondence, and on-site visits
Apply the applicable SOPs, Clinical Monitoring Plan, Research Specimen Manual and CRF Completion Guidelines as indicated
Identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with and track start up activities including essential document review and collection, and facilitating Ethics Committee, other committee, and budget/contract review and approval process
Perform Site Initiation Visits. Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures and CFR, and GCP/ICH Guidelines
Perform Interim Monitoring Visits
Perform drug accountability and ensure adequate drug supply
Review and authorize research specimen sample shipments to central lab, as applicable
Collaborate with Drug Safety Group to ensure that study staff complies with the serious adverse event reporting requirements
Coordinate supply of clinical supplies to the site
Ensure site regulatory file is complete and accurate
Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance
Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan
Ensure clinical trial site training records are current and maintained as required
May assist in the preparation and follow-up of on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
Assist Data Management as required
Complete routine administrative tasks in a timely manner
Attend staff meetings and trainings as required
Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable
BA/BS or equivalent or any relevant and qualifying training with a minimum of 3 years of relevant clinical monitoring experience
Excellent organizational, interpersonal, verbal, and written communication skills, (including experience in making presentations),
Demonstrate ability to discuss scientific, medical and therapeutic area information
Strong working knowledge of CFR and GCP/ICH requirements
Flexibility towards work assignments, new learning and travel. Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
IT literate with a strong working knowledge of PC functions and recent experience with Microsoft based applications, Electronic Data Capture Systems, and CTMS, Impact or like system. Experience in oncology preferred, and monitoring complicated trials

Lead Clinical Research Associate Temp Resume Examples & Samples

Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned
Responsible for the oversight and management of the assigned CRA team
Act as a mentor to CRAs and provides on-site training as necessary
As defined by the study project needs, recruits, qualifies, initiates, monitors, and manages clinical trial centers through all phases of clinical development (Phase I – IV)
Serves as liaison between project management team, field sites, investigators, study coordinators, pharmacists, and staff members
Develop and participate in CRA project-specific training
Contributes to the preparation of IND and other regulatory documents and submissions
Conducts trip report review for assigned projects as well as tracks visit/trip report metrics and summarize/report to teams
Tracks utilization of visits against the budget in conjunction with the study Project Manager
Manages data collection process and responds to questions received from clinical site regarding the protocol and any other study related issues
As defined by the study project needs, monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation. Ensures resolution of data queries
Assists with the development and negotiation of study budgets for clinical trial centers
Assists in the development of clinical protocols, amendments, informed consents, CRF/ source document design, monitoring plan, site instruction manuals, protocol specific training documentation, administrative letters, and other project related documents
Assists with the overall management of the project Trial Master File
Tracks study enrollment, data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites
Assists in providing data to prepare sections of the annual and final clinical study reports and clinical sections of regulatory filings
A Bachelor’s degree in clinical development, life science or a related field is required
Approximately 5-7 years of combined Lead CRA and site monitoring experience in the pharmaceutical or biotech industry required
Knowledge of regulatory guidelines including GCP, ICH, CFR etc
Excellent prior experience in all aspects of the clinical trial process
Must be Proficient in MS Office
Prior experience with MS Project desired
Experience in CTMS
Excellent organizational and communication skills are required
Must have the ability to prioritize multiple tasks and complete projects within established deadlines

Senior Representative, Clinical Research Resume Examples & Samples

Assess informed consent form (ICF) and collaborate with site (e.g., study coordinator) to ensure ICF includes all Code of Federal Regulations (CFR) and Edwards requirements
Assist with query management and resolution as needed
Maintain effective relationships with external advisors, clinical investigators, vendors, and applicable research staff
Participate in work streams and or process improvement initiatives (e.g., RACI)
Bachelor’s degree in a related field is preferred
Minimum of 1 year of previous work experience working with regulatory documentation for clinical studies is required
Proven expertise in MS Office, Adobe, and ability to operate general office machinery
Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master file) preferred
Excellent written and verbal communication skills and interpersonal relationship skills
Strong problem-solving and critical thinking skills
Knowledge and understanding of international and domestic medical device regulatory guidelines relevant to clinical protocols
Ability to manage confidential information with discretion
Ability to interact professionally with all levels of the organization
Must be able to work in a team environment

Manager, Clinical Research Resume Examples & Samples

1) Collaborate with Global Study Teams and CRO partners to ensure timely, accurate feedback throughout the conduct of the trial
Primary point of contact to support planning and execution of Celgene-sponsored clinical trials (phase’s I-IV)
Responsible for project leadership and site relationship management of pre-defined Clinical Trial Partner sites to support optimization of key processes and to ensure critical trial milestones/timelines are being met
Have a comprehensive overview of all Celgene sponsored clinical study activities in Canada
Support the Feasibility process of clinical programs and studies in collaboration with Global Clinical Research Development Operations and CRO partners, as appropriate
Scientific/healthcare related degree
Relevant therapeutic area experience desirable
Excellent knowledge of regulations that apply to clinical studies
Strong leadership skills essential
Ability to prioritize and manage time efficiently
Financial and business awareness

Clinical Research Admin Resume Examples & Samples

Ensuring successful startup of the study at all clinical sites under the leadership of the principal investigator
Managing, coordinating, planning and evaluating research projects or a multi-site research program for the University of Cincinnati, College of Medicine, Department of Psychiatry and Behavioral Neurosciences
Managing and mentoring Clinical Research staff positions
Ability to serve as a PI on own research project
10 years of relevant experience
Graduate degree in health related field or equivalent experience

Oncology Clinical Research Associate Resume Examples & Samples

Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
Educated to degree level (biological science, pharmacy or other health related discipline)
Strong working knowledge of EDC systems, IVRS and CTMS

Lead Marketing Coordinator Clinical Research Resume Examples & Samples

Develop long-term marketing and recruitment strategies to meet ambitious enrollment goals; strategies should include mass marketing, community outreach and engagement, and social media
Establish connections both within and outside the University to build collaborative recruitment relationships
Manage vendor connections and financial planning for strategies
Ad design
Manage a team of community engagement specialists/recruiters to ensure the successful enrollment in the project
Hiring and supervising staff, conducting performance reviews, and ensuring staff are appropriately trained
Assigns studies and tasks to staff. Ensure staff workloads are appropriate and being performed accurately
Manage personnel and performance problems appropriately and swiftly
Clinical Research recruitment experience, and/or experience working in an academic medical center or large health system strongly
Experience with marketing, advertising, and/or recruitment for clinical trials
One year of prior experience supervising, or as a manager of direct reports responsible for hiring decisions and performance reviews
Experience in a leadership role, as well as experience mentoring and training junior staff
Excellent public relations skills
Ability to navigate complex systems and organizational structures
Demonstrated understanding of program recruitment and/or ability to be resourceful and tactical in solving recruitment challenges
The ability to work effectively with a wide range of individuals and groups at all levels of authority
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 is also required
Knowledge of IRB requirements for recruitment desirable
Demonstrated excellent organizational skills
Ability to direct the work of others, for jobs requiring supervision

Clinical Research Associate HVT Germany Resume Examples & Samples

Medical field degree in nursing
Good English and German (written & spoken)
Computer skills – Microsoft Office (Word, Excel, Access, Powerpoint), Internet
Familiarity with hospital environment
Good communication and organizational skills
Detail and results oriented working style
Experience with clinical studies in European Union (medical device trials preferred )
Detailed knowledge of European and international regulations of Good Clinical Practice (GCP), Experience with Class II & III medical devices preferred, experience with cardiovascular clinical studies preferred, documented basic education/training in clinical research

Experienced Clinical Research Associate Resume Examples & Samples

Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job (comparable to one year) or completion of PPD Drug Development Fellowship
Customer focus
Good English language and grammar skills required; French language skills would be a plus

Experienced Clinical Research Associate Resume Examples & Samples

1+ years experience as a field clinical research monitor (CRA) that provides the knowledge, skills, and abilities to perform the job (or completion of PPD Drug Development Fellowship)
Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment
Frequently drives to site locations. Frequently travels (60-80% of time) domestically with extended overnight stays
Exposure to biological fluids with potential exposure to infectious organisms
Personal protective equipment required such as protective eyewear, garments and gloves
Exposure to fluctuating and/or extreme temperatures on rare occasions
Ability to work in an upright and /or stationary position for 6-8 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Frequent mobility required
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
Regular and consistent attendance
LI-CW1

Clinical Research Associates Resume Examples & Samples

Excellent understanding and demonstrated application of GCPs and applicable SOPs
Development and preparation of the local informed consent form
Management of the delivery of study supplies
Strong customer focus
Effective interpersonal skills

Clinical Research Associate, Belgrade Resume Examples & Samples

Previous experience as a clinical research monitor (comparable to 2+ years) that provides the required knowledge, skills and abilities
Effective organizational and time management skills
Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software

Trainee Clinical Research Associates Resume Examples & Samples

University degree in a science related field or are a certified health professionalMinimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job OR equivalent combination of education, training, & experience
Knowledge of ICH-GCP, EU and FDA requirements
Excellent English and German skills

Experienced Clinical Research Associate Resume Examples & Samples

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
May provide assistance to less experienced clinical staff
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Good therapeutic and protocol knowledge as provided in company training
Good organizational and problem-solving skills
Effective time management skills

Clinical Research Associate, Romania Resume Examples & Samples

University degree in a science related field
At least 1 year independent monitoring experience in clinical development phase II-IV
Fluency in English and in Romanian
Good organizational and time management skills

Senior Manager, Clinical Research Projects Resume Examples & Samples

Direct the creation and execution of clinical trial activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection
Lead cross functional clinical study team to achieve study milestones
Interact with internal and external groups to achieve study milestones
Determine study requirements, define specifications, and initiate and lead the selection of third party
Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and
Manage clinical study budgets within agreed variance
Communicate clinical studies performance data to other members of the management and medical affairs team
Prepare and maintain and/or oversee the preparation and maintenance of required study and regulatory documentation, including but not limited to: study status reports, reports for Competent Authority submissions, informed consent form (ICF), Monitoring Plan, Pharmacy Manual, investigator contracts and budgets
Key contributor to the development and/or review and approval of study documents including, but not limited to: protocol, case report forms (CRFs), study procedural documents, ICF, statistical analysis plan, and clinical study
May provide input into the clinical development strategy for assigned study including but not limited to operational feasibility, budget and timeline estimates
May participate in and/or lead department initiatives
Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices
Develop standard operating procedure (SOPs), as required
A solid clinical operations professional with at least 5 years’ experience in clinical research
Must have proven technical leadership skills
Individual must have cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes the oversight of internal and/or external stakeholders involved in the following activities: site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, legal review and regulatory affairs
Effective verbal and written communication and presentation skills are required in relating to relevant stakeholders both inside and outside the organization
Knowledge of team development principles and successful implementation of the same is desirable
Track record of effective management and oversight of CROs plus ensuring ICH/GCP compliance and risk management of clinical studies is expected
Excellent interpersonal and influencing skills
Ability to effectively lead a cross-functional team in a matrix environment
Experiencing writing protocols, CRFs and other study-related
Proven problem solving and timely decision making skills
Excellent leadership, risk management, planning and project management skills
Ability to effectively interact with all levels of professionals and support staff
Participate in continuous improvement initiatives in the department
Thorough knowledge of global regulatory requirements and ICH/GCP guidelines essential

PRN Clinical Research Technician Resume Examples & Samples

Collect, record, and maintain volunteer screening, check-in and study data according to study-specific protocol and SOPs, ensuring quality control for content, accuracy and completeness. Record, report and interpret findings appropriately to develop study-specific database
Prepare for clinical trials by organizing and labeling specimen collection tubes and containers, setting up equipment and documents and planning logistical activity for procedures as per study protocol
Perform a variety of medical procedures such as venipuncture, collection of vital signs, height and weight measurements, EKGs and stool and urine collections on study volunteers according to study-specific protocols
Monitor volunteer safety and report adverse reactions to appropriate medical personnel
Maintain and restock medical supplies as needed. Upon conclusion of study, clean clinical areas and equipment; store equipment as necessary
Recruit and screen volunteers for clinical trials and maintain volunteer database
Bachelor's Degree in Life Sciences preferred
Good skill in using MS Windows and Office applications such as Access, Power Point, Outlook and Word
Ability to pay close attention to detail

Rn-research Clinical Research Department Days CHI Health St Francis Resume Examples & Samples

Interpersonal skills necessary to gather and exchange information with physicians, patients, families, visitors and other hospital personnel
Analytical skills necessary to develop and implement the coordination, collection, evaluation, and processing of clinical trial data, interpret medical documentation and lab results,
Ability to concentrate and pay attention to detail for up to 80% of work time when charting lab work, taking physician orders, scheduling patients and so forth

RN Clinical Research Resume Examples & Samples

Primary responsibility for this candidate is to manage research protocols by identifying study related elements, evaluating patient eligibility, development of study tools, data collection, data entry and reporting on study participants within study timelines
Ability to manage multiple projects and report data on a regular basis while maintaining credibility and confidentiality of all patients. Keeps Physicians, Research Director informed concurrently of study enrollment, adverse events, protocol deviations, protocol violations, study progress, patient visit issues, monitoring visits, updated study requirements
Develops and composes professional correspondence to the Institutional Review Board by accurately developing protocol specific informed consents, protocol applications and serious adverse event reporting through the Principal Investigator
Ability to resolve queries through accurate supportive documentation. Coordinates and directs both internal and external monitoring visits and audits
Responsible for completing Case Report Forms and databases and IRB updates in a timely manner, as well as, resolve all queries generated by the Registry
Ability to coordinate protocols and patient visits with all sponsors and provide each sponsor with its protocol data. Obtains necessary follow in adherence with protocols

Coord Clinical Research Resume Examples & Samples

Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
Assists sponsor and US FDA audit teams
Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
Maintains patient confidentiality according to ethical and legal requirements
Assists in providing coverage for satellite clinic sites as necessary
Responsible for coverage after hours and on weekends as necessary
Medical and research terminology
Knowledge of federal regulations, good clinical practices (GCP)
Computer skills including use of clinical trial database, electronic data capture, and MS Word or
Communicate and work effectively with a diverse team of professionals
Organizational and prioritizing capabilities
Work independently in a fast pace environment with minimal supervision at off-site facilities
Clinical experience- 1+ yrs
Clinical research experience- 3 years

Coord Clinical Research Resume Examples & Samples

Interviews prospective subjects and assure qualifications for participation in clinical trials and obtains informed consent
Participates in all assigned study related visits/meetings(investigator meetings may require travel) and implements the assigned clinical trials according to mutually agreed upon timelines by PI and Sponsor
Educates subjects for elective participation in our clinical trials
Educates clinic/hospital personnel on assigned clinical trials in protocol conduct, data collection process and related issues as applicable
Ensures all study related personnel have completed required training and training is documented, before conducting any protocol related activities
Actively recruits and exceeds enrollment goals in assigned clinical trials and provides monthly, written documentation of screening/enrollment/follow-up activities
Coordinates the collection of data according to the research protocol, operation manual and case report form guidelines within the budgetary guidelines established by the Director
Draws, prepares and ships laboratory samples for clinical trials
Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines
Instructs Principal Investigator on procedures and tests that need to be performed in compliance with the study protocol and advises PI on the results of procedures and testing; calling to attention findings of clinical importance in a timely manner
Documents phone conversations with sponsors, study subjects, physicians, coordinating organizations, and any other pertinent resources and place in appropriate source
Schedules follow-up visits/procedures for study subjects and provides source documentation for activities conducted during these visits
Completes accurate and complete data entry into case report forms or pre-established computer programmed formats in a timely manner
Coordinates, schedules and is made available for assigned study monitor visits, quality assurance audits, and query resolution of collected data in a timely manner
Identifies strategies for patient enrollment in research studies in collaboration with the PI
Report all serious or unexpected adverse events immediately to PI and Research Director
Assists in maintenance of research related logs and contact data base
Maintains up to date research knowledge through continuing education
Actively promotes an open line of communication and a professional relationship with all members of the organization
Utilizes appropriate resources to resolve problems. Report any unresolved issues to Director
Possess the ability to prioritize and organize high volume workload and flexible with changing priorities to fit the daily needs of the department, patients and customers we serve
Knowledgeable of, and adheres to all local, state, and federal research regulations and guidelines
Performs any other duties as assigned

Clinical Research Associate, Work From Home Resume Examples & Samples

Detail-oriented with knowledge of scientific, medical, and regulatory terms
Knowledge of ICH Guidelines, GCP, and FDA regulations
Understanding of the drug/device development process
Computer skills, including MS Word, Excel, Outlook, and PowerPoint; ability to learn new
Professional writing and communication skills
Ability to multi-task in fast paced environment is essential
Ability to function in a team environment under time and resource pressures
Ability to manage, organize, and make decisions
Three years direct monitoring experience or equivalent; combination of monitoring experience
Three years direct oncology monitoring experience
Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and closeout)

Clinical Research & Medical Affairs Resume Examples & Samples

2 years of degree level study completed
A minimum of 2:1 achieved in first year of study
Bio science degree types only
High level of accuracy and attention to detail
Passion for working in the pharmaceutical/medical industry
Highly analytical
High level of scientific understanding and intellectual capacity
Adaptable and able to work with a wide range of different personalities
Excellent communication skills both written and oral
Seeks opportunities to learn and grow professionally
Able to prioritise and manage own workload autonomously
Flexible and adaptable team player
Self-motivatedClinical Research MD

Senior Assoc Clinical Research Resume Examples & Samples

Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study
Prepares design validation plans that meet product design goals; intended use; regulatory requirements; divisional operating procedures; and Clinical Research work instructions
Prepares clinical protocol; clinical brochure; case report forms; informed consents; and other required documents for clinical studies
Identifies and qualifies clinical investigators and clinical sites
Proposes and negotiates budgets for clinical studies. Initiates payments to sites
Initiates clinical studies and provides for investigator and staff training
Arranges for and assists Statistical Support with the collection and statistical analyses of clinical data
Monitors clinical studies; ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights; safety; and welfare are protected; ensures data integrity through completeness; accuracy; and legibility
Reviews data; prepares and presents clinical data reviews and data summaries
Responds to audits and data queries representing a project or team
Assists in presentation of clinical information to the FDA
Initiates standard publication or presentation of clinical data in professional journals or meetings
Functions independently in the field and interacts with all levels of medical and scientific professionals
Assumes responsibility for attending training sessions; presentations; and continuing education sessions to expand professional expertise via professional and educational opportunities
Serves as a resource person for most technical questions or directs inquiries to appropriate references
Accepts and completes all management-directed work assignments such as clinical assignments; travel; and other tasks

Clinical Research Operations Specialist Resume Examples & Samples

The minimum of a Bachelor’s degree and three to five years experience in clinical/translational research operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) or an equivalent combination of education and experience is required. Master’s degree preferred
Direct experience in the following areas
Development of protocols, consent forms, and case report forms
Operational involvement in multi-site clinical trials
Working knowledge of GCP regulations
Working knowledge of CMS/GCP/ OHRP/FDA/HIPAA regulations

VP, Clinical Research Resume Examples & Samples

Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across neurology and pain
Direct authorship contributions in protocols and clinical study reports
Lead and motivate clinical development medical staff
Oversee hiring additional staff as needed
Interact with senior management and serve as a standing member of various leadership meetings and Monthly Project Review forum
Serve as a primary internal and external spokesperson for Alkermes neurology and pain clinical development programs
Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations
Generate yearly strategic goals and objectives for the group
In collaboration with the clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required
Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards
Identify and develop collaborative relationships with key investigators and key opinion leaders globally. Attend and oversee neurology and pain clinical advisory boards and investigator meetings
Critically review regulatory submissions (such as INDs and NDAs)
Requires a Medical Degree and clinical training in Neurology
Strong leadership and collaborative interpersonal skills
10 + years of experience in the pharmaceuticals. Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired
Knowledge of safety reporting principles, including global safety reporting regulations
Able to perform thorough reviews of various medical and legal documents in a timely manner

Clinical Research Associate, Budapest Resume Examples & Samples

Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service
Conduct monitoring activities independently
Ideally 2 or more years of monitoring experience in interventional studies with a CRO, pharmaceutical or biotech company

Executive Director of Clinical Research Resume Examples & Samples

Play a leadership role in managing multiples of Phase I through Phase IV clinical research trials across all functional areas of the drug development process
Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectation are met
Guide clinical operations in outlining standard operating procedures (SOP) for Clinical Development that facilitate the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards
Lead and motivate clinical staff
Develop and review protocols and interact with key external opinion leaders regarding protocol development
Collaborate with investigators and study site team members
Conduct investigator meetings and site visits
Implement and supervise clinical trials, including requests for eligibility and other waivers
Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations. Prepare SAE narratives for submission to regulatory affairs, reconciling SAE database, MedDRA and WHO coding
Advise and troubleshoot any medical problems arising at clinical sites
Interact with data management to support data entry including assistance with edits
Demonstrate leadership and interpersonal skills
Support commercial and marketing team for life-cycle management of approved products
Participate in data analysis, publication preparation, and conference presentation
Represent clinical development function for other teams’ need including business development and legal related projects
Interact with senior management and product team regarding drug development strategy and plan
Interact with investigators and key opinion leaders regarding protocol development
Write protocols, IB and annual reports
Contribute to Clinical Study Reports
Write safety section of IND and NDA submissions
Help prepare for budgets and progress reports; complete other administrative tasks as required
Represent clinical development to support regulatory, safety, manufacture, data analysis and other business need
Requires a Medical Degree with clinical experience
Requires Hematology or Oncology experience and knowledge
Three to 5 years’ experience in the pharmaceutical or contract research industries, or academic clinical research
Knowledge of safety reporting principles, including FDA safety reporting regulations
Skill in writing narratives
Experience with safety database coding
Able to work independently, prioritize tasks efficiently and meet expected time frames
Able to perform thorough reviews of various medical and legal records in a timely manner
Able to interact and collaborate professionally with various departments, regulatory agencies and investigators

Manager, Clinical Research Resume Examples & Samples

Forecasts, develops and implements policies and procedures in the areas of research compliance, human resources and budgetary goals and objectives that are consistent with University of Utah’s policies
Develops and promotes new and existing policies, procedures and programs to internal and external functional groups
Participates in oversight committees to establish compliance standards and administrative plans and policies
Assures institutional clinical trials are conducted according to University and federal regulations as well as the NCI-approved Data and Safety Monitoring Plan through auditing and oversight of HCI’s Research Compliance Office
Develops departmental strategies consistent with the department’s continuous quality improvement program
Oversees all aspects of human resource management including recruitment and retention of assigned staff and ongoing staff performance evaluations
Ensures competency of clinical research staff working in a complex and regulatory-rich environment through the development and/or presentation of educational programs

Manager Medical Writing, Clinical Research Resume Examples & Samples

At least 5 years of experience writing clinical research documents
May consider less experience with advanced degree
Adept in Microsoft WORD

Clinical Research Associate, Greece Resume Examples & Samples

Excellent standard of verbal and written communication skills in English language
Highly organized with strong attention to detail and deadlines
Advanced skills across all of the MS Office packages

Manager, Clinical Research Administration Resume Examples & Samples

Set up and maintenance of program files for internal and external constituents
Track third party Clinical Operations vendor agreements with respect to scope, quality, budgets, deadlines/milestones, communication, documentation/administration, and employee resources
Assure departmental and corporate compliance with clinical operations SOPs; liaise with Quality Department to document adherence
Prepare and support Committee Meetings as defined in the Sponsor and vendor contracts
Work with the Finance Department to assure timely invoice processing support for external Clinical Operations vendors and consultants
Prepare updates for Donor Development, Marketing and other LLS departments as directed
Minimum of 5 years of project administration, management, or process improvement experience
Bachelor's Degree required; Master’s Degree preferred with a focus in Project Management, Process Improvement, Business, and/or Operations or in a scientific field
Laboratory experience in an academic or biotechnology setting preferred
Experience with project management tools and software or ability to learn the software as needed
Demonstrated organizational aptitude
Proficient in Microsoft Applications; Excel, PowerPoint, Word

Clinical Research Data Associate Resume Examples & Samples

Bachelor's Degree or equivalent work and/or life experience
Proficiency in database and word processing skills, and MS Office
Strong customer service skills and an ability to interact cordially with others
Knowledge/experience with electronic data submission

Manager, Clinical Research Resume Examples & Samples

Provide direct oversight for all activities relating to the daily operation of the CDM team in the DCC including making project assignments and setting dates for completion with staff input
Responsible for managing the development, initiation, functionality, progress and completion of clinical databases used in clinical studies managed in the DCC
Oversee, develop, and manage CDM staff with the goal of maintaining quality processes and practices in the management of clinical research information
Hire and directly supervise CDM I-IV staff members. Approve time and attendance
Support staff in decision making, project planning and goal setting
Communicate regularly with team; share information, provide relevant updates
Complete evaluations and promote staff development and education opportunities as appropriate
Develop and maintain high quality standards using documented processes and guidelines
Function as a lead clinical data manager on cross-functional project team. The lead CDM is responsible for configuration of electronic data capture system, creation of data validation processes and checks, creating reports, and maintaining change control process
Oversee initial design and implementation phase for unique network research projects
Develop, evaluate and implement new systems and processes used in the management of clinical research information, e.g. medical imaging management systems, and processes for the management and validation of external data sources
Act as internal resource for network directors and the director of the DCC to operationalize far reaching research goals and find realistic solutions to unique problems
Implement creative solutions and innovative practices as applicable regarding data management practices

Clinical Research Technician Resume Examples & Samples

Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set
In the course of biospecimen handling, follow Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Clinical Laboratory Improvement Amendments (CLIA) processes, UAHS and Banner procedures and/or other applicable policies as necessary
Follow direction of research staff, investigators, or others involved in the clinical research project work

Experienced Clinical Research Associate Resume Examples & Samples

Oversight of all sites for a study/ies they are responsible for at a country level
Clinical research monitoring experience (minimum 2+ years) that provides the required knowledge, skills and abilities and experience mentoring or training others
Effective clinical monitoring skills

Regional Clinical Research Associate Resume Examples & Samples

Good quality background and experience with healthcare or pharmaceutical development is required
Must be driven to deliver quality results on time and in a highly ethical and professional manner
Candidate must be willing to travel (up to 25-50%, potential more depending on enrollment). International travel may be required
Great organizational and communication skills
Proficient in use of Microsoft Office applications
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and/or correspondence
Ability to speak effectively before groups of customers or employees of organization and in a high pressure environment
Track study timelines
Review and track study budgets
Provide periodic updates on Clinical Development
Provide monitoring support, in some cases functioning as the primary site monitor
Assist in writing and review of protocols, amendments, and informed consent forms
Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.)
Perform investigative site training
Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams
Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed
Ensure compliance with study-specific procedures
3-5 years of investigative site monitoring or study coordinator/study nurse experience

Manager, Clinical Research Resume Examples & Samples

Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials
Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards
Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions
Manage standing team meetings to discuss issues related to the CRC/RDC team and clinical trial needs
Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight
Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans
Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency
Coordinate with MDG and PIs to provide information on available or competing protocols, workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA, Feasibility, MDG scoring and navigation of review committees required for activation, etc.)
Prepare clinical research reports for PIs, MDGs, HCI Leadership and sponsors
Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director
Provides transparent clear directives and constructive, professional communication with fellow Program Managers to promote uniformity across MDGs and within the CTO
Actively attend and participate in representation of the Clinical Trials Office at MDG and RIP meetings for primary teams and as needed for other Clinical Program Managers
Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB
Facilitate cooperative and collaborative institutional relationships
Ensures PI and MDG satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through
OTHER: Assume responsibility for additional assignments as directed by the CTO Associate Director

Clinical Research Associate, Italy Resume Examples & Samples

Qualified as per the Ministerial Decree dated 15/11/2011
Ideally 2 years’ monitoring experience in clinical development phase II-IV
Fluency in English and in Italian

Clinical Research Associate Senior Clinical Site Monitor Resume Examples & Samples

10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV)
At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution
Thorough technical working knowledge of Remote Data Capture, EMR and computer based systems
Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills
Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time
Ability to successfully manage the designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
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Clinical Research Coor Resume Examples & Samples

Coordinates daily operations of clinical research studies in Neurology to include assisting Chair & PI(s) with maintaining performance reports, bio-sketches, statistics, analyzing grant development & submission
Recruit, enroll, assess, and track participants as they complete protocols for various Neurology studies. Assist Chair & PI in coordinating and performing a wide variety of research related functions including assessments data collection, data entry, interpretation of data and data analysis, collecting blood and biological samples. Must be proactive and timely in all areas of trails; including developing marketing materials for new clinical studies, preparation of study initiations, screening and scheduling study subjects, getting subject consents, and teaching subjects about protocol expectations
Facilitates IRB applications for submission and review
Assist in pre-award budgets for all faculty related research projects. Assist in monitoring and management of budgets for all research projects to include completing all associated forms
Must maintain accurate records and relevant collection of data to assigned patient to include communication, correspondences, and maintenance of pertinent documents related to research
Other duties as assigned to include any research trainings

Clinical Research Associate, MDS Anemia Resume Examples & Samples

With oversight, assist in the management of a region for a study or studies
Assist in the preparation of investigator meetings
Assist in meetings or conference calls with CROs and multi-disciplinary study team
Assist in some aspects of vendor oversight (CRO, Central Lab, Central IRB, IWRS)

Clinical Research Coordinator Associate Resume Examples & Samples

Some knowledge of psychopathology and psychiatric terms is desired
The candidate must possess the necessary patience and resourcefulness to interact well with psychiatric patients, especially children, and their families
Basic statistical skills

Lymphoma Clinical Research Liaison A Resume Examples & Samples

Provide clinical support by quickly and accurately transcribing essential clinic or patient information onto electronic reports as the PI speaks with patients in real-time; check reports for correct punctuation and grammar errors, if any
Manage the PI’s calendar, including facilitation of appointments, meetings and conference calls, as well as assistance booking traveling, creating trip itineraries, processing of reimbursement, and attendance of meetings and conferences as requested
Prepare/format written correspondence on behalf of the PI, ensuring that all correspondence and other written materials and presentations are accurate and prepared in a timely manner
Act as a liaison with various external and internal constituencies on behalf of the PI keeping him apprised of issues and action items on his agenda; establish good working relationships with research partners, research sites, and affiliated organizations
Perform comprehensive literature, database and web-based searches with writing of summaries of findings as requested
Assist with development and preparation of project-related reports, manuscripts, clinical concepts, research study protocols, and presentations
Assist with any relevant submissions to ensure timely adherence to important deadlines, collection, processing and assistance in the compilation and verification of research data, create graphs/figures for data presentations and publications
Other duties will be performed for the PI, PM or LCRN as deemed necessary and important

Associate Director of Clinical Research Operations Resume Examples & Samples

Bachelor’s degree in a field appropriate to the area of assignment
Eight or more years of related research experience implementing clinical research protocols including clinical trials and/or cohort studies
Three or more years of supervisory experience
Master’s degree in a field appropriate to the area of assignment
Desire to serve a lively and diverse research community
Strong organizational, analytical, and problem-solving abilities
Demonstrated skills in leadership and team-building

Manager, Clinical Research Resume Examples & Samples

Bachelor’s Degree or equivalent in a scientific field of study and four (4) years related research experience
Knowledge of Good Clinical Practice (GCP)
Valid Driver’s License and acceptable driving record at the time of hire
Two (2) years previous supervisory experience
Research Nurse certification and at least two years of prior clinical research experience are required
Six (6) years of prior research experience
Master’s degree in Public Health or Healthcare Management is desired
Proficiency with information systems and experience investigating costs related to clinical research trials
Knowledge of IRB and policies and procedures
Strong ability to organize, prioritize, and coordinate multiple activities to meet deadlines

Clinical Research Rn-targeted Therapeutics Team Resume Examples & Samples

Collaborates with the clinical team in developing all aspects of patient care
Assesses patient’s pertinent health history
Experience: R.N. with a minimum of 1 year of RN experience
Bachelors of Science in nursing (BSN)
Knowledge of common pharmaceutical terminology

Medical Director, Oncology Clinical Research Resume Examples & Samples

Clinical Development team participation and leadership
MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions
NDA/MAA/Submission experience preferred
Superior communication, strategic, interpersonal and negotiating skills
Ability to proactively predict issues and solve problems
Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
Diplomacy and positive influencing abilities
Therapeutic area knowledge relevant to mechanism of action
Regional/global Regulatory requirements
GCP/ICH
Emerging research in designated therapeutic area

Associate Director of Clinical Research Resume Examples & Samples

The successful candidate will have oversight for ongoing and planned product trials within the Inflammation therapeutic area
The Clinical Research MD will report to a more senior member of the Inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections
Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff
Assists in the clinical evaluation of business development opportunities

Director of Clinical Research Resume Examples & Samples

The successful candidate will have oversight for ongoing and planned product trials within the Liver Disease therapeutic area
The Clinical Research MD will report to a more senior member of the Liver Disease clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
Three (3) to five (5) years experience with a proven success record in clinical research studies and trial design is required
Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices
Experience in Liver Disease drug development
Ability to think analytically and strategically to formulate, develop, and execute clinical plans
Strong leadership skills with an ability to set vision, lead change, and mentor others
Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
Excellent scientific written and oral communication skills
Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected)

Site Clinical Research Associate Study Start Resume Examples & Samples

Assist with the start-up activities of new clinical trials across Australia and New Zealand
Assist in CSMS activities and/or reporting of study information and metrics
Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Assist in completion of activities required for planning and execution of a clinical study
Assist in the planning and submission strategies to ensure sites can open our clinical studies as soon as possible
Assist in study activities such as preparation of protocol and informed consent, investigator/site selection, investigator meeting and contract preparation, and other activities to ensure on time completion of studies
Assist in negotiation and execution of study budgets and contracts with study sites
Participate in all study activation activities
Assist in driving efficiencies within the start-up function
Prioritize activities to ensure study timelines are met
Study Contributor
Assist in development of study/site budgets and vendor contracts
Requires moderate level of oversight and guidance

Prin Clinical Research Spec Resume Examples & Samples

Experience working with Health Authorities around the world, specifically PMDA
Ability to supervise others over the execution of a trial
Customer focusedComputer skills (MS Office products, word processing, spreadsheets, etc.)
Ability to independently lead a study team and trial with little supervision
Excellent understanding of biostatistics and trial design
Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011

Clinical Research Medical Director Resume Examples & Samples

Provide medical expertise specific to US
Provide consolidated feasibility and site selection input to global and US teams
Perform local AE review and provide general medical support for safety issues
Be aware of clinical trial SAEs on a country level
Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials
Support ICRO/ and Global teams in interaction with regional regulatory agencies
Provide assistance to ICRO and site for IEC/IRB Interactions
Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care
Demonstrates a high level of understanding of the protocol to train others on the protocol including site personnel where applicable
Demonstrates understanding of the protocol to evaluate investigator / site patient protocol compliance and patient safety
Ability to manage a study from the medical perspective, and a demonstrated capability to problem-solve and mediate complex medical / operational issues within the regional and therapeutic area context
A minimum of two years pharmaceutical industry or clinical trial management experience required

Clinical Research Technician Resume Examples & Samples

Manage clinical trial documentation such as CRFs (case report forms) and DCFs (data clarification files) within Data Management. This activity includes distributing DCFs, tracking and filing of DM project documentation
Interact with CDM staff, management, and other project team members to resolve issues and provide status information
Assist Data Operations Coordinator/Data Team Lead in the creation and maintenance of the Data Management Study File and Data Management Plan (Data Tracking Guidelines) and other project files

Clinical Research Application Specialist Resume Examples & Samples

Bachelor’s degree in Clinical Research, Science, Health Sciences, Information Technology, Business or related field
One year experience working with web-based applications/information systems in a healthcare, finance, or other highly-regulated environment
Prior experience in building calendars with OnCore at an academic medical center is preferred
Experience with other CTMS or financial data systems in support of clinical research is desirable
Experience providing technical support to customers
Demonstrated knowledge of study design criteria, randomization processes, clinical and bio-specimen terms used in research studies, and scientific and medical concepts and terminology
Knowledge of Federal and Institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research
Knowledge of medical billing terms and research billing operations for industry, institutional and national group -sponsored research
Diplomatic disposition and customer service orientation with excellent written and verbal communication skills
Detail-oriented self-starter with outstanding interpersonal skills, and a reputation for establishing and maintaining good customer and end-user relations
Comfortable asking questions, working with minimal supervision, and collaborating with coworkers in a team environment on complex projects
Quick and agile learner, able to adapt to changes in technology and its intended use
Able to synthesize complex clinical trial information in order to facilitate decision making
Proficiency in Microsoft Windows and Office, including advanced skills in Excel
Familiarity with terminology and processes associated with all phases of clinical research

Group Head, Clinical Research Resume Examples & Samples

Lead or oversee the creation of clinical strategies and clinical development plans for assigned programs across development phases, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
Manage, oversee and develop Clinical Research direct reports, building the group’s capabilities in support of the needs of our evolving development portfolio. Coach, train, and/or mentor employees to optimize their performance
Identify program issues and develop sound strategic solutions with clinical teams to ensure their timely resolution
Be the recognized clinical expert for assigned development program/s both within and external to Ironwood
Provide medical input into the design of clinical trials for these development programs. The Clinical Research group will design scientifically rigorous and cost-effective clinical protocols that are aligned with the clinical development plan, are suitable to test the trial's hypothesis, and likely to meet the objectives of the trial while also ensuring study design elements that are ethical and consistent with standard of care and local practices
On assigned programs, serve as a medical monitor for clinical studies (provide medical oversight of the study; address eligibility questions; review safety and adverse event information), working closely with cross-functional team members, including external partners, to ensure planning and execution of high quality clinical trials that meet key milestones, maintain timelines and keep within budget
Assist in the preparation of clinical protocols and Regulatory documents (eg., INDs, annual reports, FDA/EMA meeting requests, briefing books, and NDAs) and other relevant clinical documents
Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities
Contribute actively to the Clinical Affairs leadership team, relevant governance bodies, and process improvement initiatives
Collaborate effectively with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
Provide clinical, scientific and development expertise to business development projects and diligence
An MD or DO degree, with internal medicine expertise
Eight or more years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3, through registration, and post-approval
Strong strategic thinker who can provide vision and purpose for teams and a drive for results
Possesses thorough understanding of operational aspects of clinical research and development
Strong general knowledge of regulatory requirements, including principles of GCP, ICH and CFR, that apply to clinical development, with significant experience interacting directly with Health Authorities
Three or more years of people management experience, with demonstrated ability to motivate, mentor, develop and lead other physicians in clinical research
Able to set priorities for team, establish clear direction and objectives and maintain accountability
Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment
Persuasive, effective and flexible in interpersonal interactions at all levels, with outstanding oral and written communication capabilities
Effective relationship management skills with internal and external partners
Strong analytical, decision-making, project management and problem-solving skills
Specialty training and board certification, or expertise in gastroenterology, rheumatology or nephrology would be ideal, but is not required

Clinical Research Coordinator Pediatric Anesthesia Resume Examples & Samples

Demonstrated clinical and/or research experience in Anesthesia and/or Pediatrics
Knowledge of EPIC based electronic medical record systems
Experience in clinical trials management, including writing and submitting IRB applications, protocol revisions and consent

Clinical Research Operations Manager Resume Examples & Samples

Extensive experience in clinical research as a coordinator, research nurse, data manager or clinical project manager
CCRC certification, excellent knowledge of Good Clinical Practices and Regulatory requirements for clinical research studies
Demonstrated leadership and supervisory skills including conflict resolution
Strong financial expertise in accounting, budget planning and financial forecasting
Strong expertise in grants and contract administration
Strong negotiation and interpersonal skills
Strong knowledge of industry standards and/or regulatory requirements

Non-clinical Research Protocol Manager Resume Examples & Samples

Minimum of 7 years work experience within the pharmaceutical industry
Knowledge of preclinical/nonclinical research
Demonstrated Excel and analytical skills
BA/BS degree in a life science field
US military experience will be considered towards industry experience requirements

Clinical Research Associate Trainee Resume Examples & Samples

Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as data management and pharmacovigilance
Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices
Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to CTL and/or line manager
Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution
Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Strong written and verbal communication skills including good command of English language
Excellent organizational and problem-solving skills
Ability to manage competing priorities

Clinical Research Associate, Oncology Resume Examples & Samples

You will be responsible for ensuring that, at the site level, the Clinical Monitoring Plan is implemented
Excellent knowledge of Good Clinical Practice (GCP) and also good working knowledge of conducting clinical trials in general
Experience of performing site start up procedures, routine monitoring and site closure

100

Manager of Clinical Research Resume Examples & Samples

Education: Bachelor's degree required. Degree in health sciences or business preferred
Experience: Minimum of five years’ experience in clinical research required. Customer service experience in a medical office or hospital setting preferred
Licensure/certification/registration: National Research Organization required

101

Director, Regional Clinical Research 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
Attends educational workshops
Review professional publications
Participates in professional societies
Proficient in Microsoft applications
Contacts with pharmaceutical companies and clinical research organizations

102

Manager of Cardiology Clinical Research Sites Resume Examples & Samples

Knowledge of organizational policies, standard operating procedures and systems
Public presentation skills
Interpersonal skills
Cardiology experience
Management experience

103

Clinical Research Medical Director Resume Examples & Samples

Supporting the development, execution and communication of the global scientific/medical evidence plan
Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
Supporting the development of key scientific external relationships with opinion leaders
Participating and providing clinical input into safety and regulatory interactions
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
Familiarity with concepts of clinical research and clinical trial design, including biostatistics
Sound scientific and clinical judgment
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Two (2) or more years of clinical research experience and/or basic science research
MD plus accredited residency in relevant sub-specialty, board certified or equivalent
Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

104

Clinical Research Study Leader Resume Examples & Samples

Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality
Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders
Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle
Assures consistency and standards across a study or studies for all investigational sites and in line with project standards

105

Clinical Research Coordinator Ophthalmic Resume Examples & Samples

Ideal candidate will have prior working in clinical research, with a specific emphasis on project management, either as a clinical research coordinator or regulatory coordinator
Professional clinical research certification (ACRA or SoCRA) is desirable but not required
Prior experience within ophthalmology, or prior ophthalmic technician training / certification is NOT required

106

Senior Director of Clinical Research Resume Examples & Samples

A minimum of a Bachelor’s degree in Biological Science or related discipline, with a minimum of 10 years related scientific / technical experience, including leadership / management role within Clinical Research for at least 8 years
With a PhD or Masters, these requirements would be a minimum of 8 years related scientific / technical experience, with at least 6 years of management within a Clinical Research role
People management experience is required
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required
Ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across NPD and LCM projects is required
Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is preferred
Comprehensive understanding of clinical trial regulations across multiple regions is required
Ability to lead teams to deliver critical milestones is preferred
Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives is preferred
Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is preferred
Experience in effective management of platform budget processes is preferred
Neurovascular experience is preferred.Clinical Research non-MD

107

Site Clinical Research Associate Resume Examples & Samples

Clinical Project& QualityManagement
Conduct site qualification including analysis and recommendation, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes
Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
Minimum of 1 year of clinically-related experience, of which 6 months must be in clinical research monitoring [R1]
Demonstrated strong site management and monitoring skills
Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
Good written and verbal communication skills both in English and in the local language
Exhibit high degree of flexibility when facing changes in the work environment
Previous experience with electronic data capture systems desirable
Strong ability to work independently with minimal supervision

108

Clinical Research Medical Director Resume Examples & Samples

Supporting the development, execution and communication of the global scientific evidence plan
MD plus accredited residency in inflammation or oncology, board certified or equivalent
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
In-depth understanding of clinical development and concepts of clinical research and clinical trial design, including biostatistics

109

Clinical Research Study Leader Resume Examples & Samples

Leads the cross-functional Study Management Team (SMT). In the SMTL role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting
With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives
Conducts protocol and site feasibility assessments to ensure optimal site selection
Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
Proactive management of all aspects of the study
Manages both internal and external partners
Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality
Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs
Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
CRSL may provide support and mentoring to other CRSLs
Where appropriate, accountable to DBPT for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team

110

Clinical Research Coordinator Associate Resume Examples & Samples

Familiarity with Breast Cancer resources in the Bay Area is a plus
Experience with recruitment of research participants for clinical studies
Familiarity with EPIC is a plus

111

Clinical Research Coordinator Associate Resume Examples & Samples

Advanced Degree
Board Certified Behavior Analyst
Experience in working with children with intellectual disabilities and teaching social skills

112

Clinical Research Coordinator Healthcare Resume Examples & Samples

To serve as coordinator for both single and multi-center, investigator initiated and industry sponsored, clinical studies, with responsibilities to include participant recruitment and retention efforts, medical record data extraction, data entry, and management of IRB and other regulatory matters related to clinical research under the instruction and direction of investigators
Requires Bachelor degree in a science or health-related field or equivalent education and experience
Extensive experience with successful submissions to IRB

113

Clinical Research Finance Manager Resume Examples & Samples

BA/BS degree with a major in a health or business related field and 5 years of applicable experience or an equivalent combination of education and experience required
Strong, proven experience as a supervisor required
Strong working knowledge of CPT coding and medical terminology required
Basic understanding of third party payor and sponsor reimbursement policies and standards of practice
Computer proficient – must have strong Excel, Word, presentation, and database skills
Ability to effectively collaborate with multiple departments and a strong team work ethic
Ability to work independently with self-motivation and initiative
Strong organizational and analytical skills and attention to detail

114

Clinical Research Analyst Resume Examples & Samples

2+ years of clinical coding experience
3+ years of relevant analytics experience
3+ years of healthcare or pharmaceutical industry experience
Knowledge of health care claims, products, data and systems
Preferred experience in working in a data warehouse environment as well as the ability to work with large data sets from multiple data sources
Experience of project work, specification and testing
SQL/SAS programming skills (e.g., SAS Base, SAS STAT, SAS Macros)
Knowledge of analytic programming tools and methods (SAS, SQL, OLAP, Business Objects, Crystal)

115

Clinical Research Associates Resume Examples & Samples

Two up to four years of clinical monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)
Oncology experience would be a plus
Good communication, planning, organization and problem solving skills

116

Clinical Research Associates Resume Examples & Samples

Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Completing Serious Adverse Event (SAE) reporting, processing production of reports
Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned
Assist with training, mentoring, and development of junior employees, e.g. co-monitoring (for CRAs II and SCRAs)
Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II and SCRAs)
Fluency in Czech and English language

117

Clinical Research Associates Resume Examples & Samples

Recruiting potential investigators, working with start-up department for EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor
Minimum 1 year of monitoring experience in pharmaceutical or CRO industries
Fluency in local and English language

118

Clinical Research Resume Examples & Samples

Directs and oversees Clinical Development/Operations and Regulatory Affairs process for a research and development services provider conducting clinical trials of experimental vaccines and biologics
Develops study protocols and creates standards and guidelines for clinical research services and programs
Ensures adherence to standard operating procedures, good clinical practice and FDA regulations
Coordinates inspection of the organization and contract facilities, and coordinates regulatory submissions and Agency interactions
Active/current Secret clearance is required (interim Secret is also acceptable)
Master’s Degree with at least 12+ years of experience in the field is required
Familiarity with a variety of the field's concepts, practices, and procedures
Must rely on extensive experience and judgment to plan and accomplish goals
Must have a wide degree of creativity and latitude
Must be willing to travel occasionally
PhD with 9+ years of relevant experience

119

Clinical Research Administrative Director Resume Examples & Samples

Maintains investigational drug and drug accountability adhering to all NIH, NIAID, NINDS and other applicable federal pharmacy guidelines
Maintains copies of each protocol that is IRB approved including all subsequent amendments and versions while adhering to all institutional and federal guidelines
Maintains copies of the first and last pages of signed current informed consents that have been approved by the IRB for each protocol
Maintains all current FDA form 1572s and Investigator of Record (IoR) forms and signature pages
Ensures that outpatient dispensing is done according to guidelines in the most current IRB approved version of all protocols
Liaises with protocol principal investigators to establish pharmacy’s role in the trial for study drug compounding, packaging, and dispensing
Liaises with external agencies/organizations, as required
Monitors pharmacy activities to ensure adherence to study protocols and dispensing procedures
Communicates with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial
Maintains a pharmacy binder (paper or electronic) which contains a study summary, protocol, dispensing procedures, dispensing checklist, and any other relevant materials for each investigational trial
Available by prior scheduling request to dispense medications if needed for after-hours
Maintains investigational drug inventory
Performs an ongoing perpetual inventory and a monthly total inventory of all investigational products
Responsible for correct ordering, storage, dispensing and return of investigational agents according to IRB, state and federal (NIH, FDA) requirements
Maintains investigational research database for assisting with drug accountability, dispensing and return of investigational products
Attends bi-weekly staff meetings
Participates in all new study start-up meetings
Serves as an educational resource to study participants and other staff regarding drug dispensing, dosing allowed concomitant medications, and drug interactions with non-study medications, other dosing requirements (food effects, etc)
For each research study, correctly stores, dispenses, and records investigational product according to sponsor’s instructions, participant’s randomization; maintains study blinding where appropriate
Orders new study-specific inventory in a timely fashion so that study drug administration is uninterrupted
Returns unused study drug to sponsor according to study-specific requirements
Cooperates with study monitors during site visits to facilitate oversight on study drug storage, dispensing and accountability
Constructs and maintains Pharmacy Plan and all standard operating procedures as needed for the investigational pharmacy
Completes all required research training and maintains certificates of Good Clinical Practice and Human Subjects Protection as required by institution, State and Federal Agencies (e.g., NIH, FDA, OHRP)
Maintains Ohio Pharmacist license in accordance with Ohio State Board of Pharmacy
Maintains Ohio Pharmacy License for the Clinical Trials Research Pharmacy in accordance with the Ohio State Board of Pharmacy, including required text books
Supervises research pharmacy technician as required. Delegates work assignments and checks work orders filled by technicians
Fulfills all requirements to serve as StrokeNet National Coordinating Center Central Pharmacist
Coordinates time off with back up pharmacist
Attends annual ACTG, HPTN, StrokeNet and other Network meetings as required
Ohio License from State Board of Pharmacy
RPh or PharmD
Ability to Obtain Independent Pharmacy Licensure from State Board of Pharmacy
Eligibility to apply for an institutional DEA license
Eligibility to apply for a wholesale license
Meticulous documentation skills
Previous experience with investigational drug management preferred but not required

120

Clinical Research Monitor Based Inspain Resume Examples & Samples

Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
Excellent problem solving skillS
Experience of conducting clinical research activities in a regulated environment

121

Clinical Research Senior Program Resume Examples & Samples

Bachelor's Degree, preferably in a Business, health-related, scientific or engineering field
Minimum 4 years of experience within a Business Analyst and/or project management role (2+ years with Masters or Doctorate degree)
Project Management Certification (preferably PMI) - preferred
Green Belt Certification – Ongoing use of Six Sigma tools (Process map, C & E, FMEA’s, Risk Analysis, etc.) - preferred
Able to clearly communicate with all levels of management while collecting business needs and requirements
Proficient in MS Office Suite of Products; Word, Powerpoint, Visio, Project (ex: customization of fields, tables, views; modifying reports; analysis of critical path.) and Excel (ex: pivot charts, vlookups, graphs, truncating text, etc.)
Applied knowledge of project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk, procurement, and stakeholders as defined by Project Management Body of Knowledge)
Enthusiasm towards process improvements and change management
Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership
Strong problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team
Excellent self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback
Flexibility to adjust quickly and effectively to frequent change and altered priorities
Candidates with work experiences in pharmaceutical, medical devlice and/or CRO industries are preferred
Practical experience performing project management for a cross-functional project
Critical chain project management certification or experience with application of critical chain project management principles

122

Clinical Research Associate, Dcri-outcomes Resume Examples & Samples

Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2.Completion of a master's degree in Public Health,., Health Administration or a related area with. two years directly related clinical trials research experience; or
Completion of a bachelor's degree plus a Minimum of three years directly related experience in clinical trials research; or
Completion of a bachelor's degree plus a minimum of four years closely related research experience

123

Clinical Research Coor-clinical Research Institute Resume Examples & Samples

Develop and maintain relationships with faculty members interested in or currently conducting clinical research
Develop and maintain relationships with assigned pharmaceutical, medical device, and other medical manufacturers considering clinical trials
Actively market the Clinical Research Institute
Facilitate IRB application and submission via iRIS system
Facilitate ongoing and timely communication with the IRB via iRIS system
Recruit and enroll human subjects while protecting subjects and subjects’ rights
Maintain Study files/documents on all assigned studies
Facilitates data quality and integrity
Assist with development and management of research study budget
Assist faculty/staff with development of research protocols
Assist with clinical research education and training of volunteers, students, new employees
Attend affiliated clinical research meetings and professional meetings where research and compliance training may occur
Obtain SoCRA (CCRP) or ACRP (CCRC) certification when eligible
Maintain CPR certification
Maintain IATA training/certification
Maintain required institutional training to be able to participate in Clinical Research activities (i.e. CITI and HIPAA research training)
Obtain/Maintain ACLS certification
Participate in the Clinical Research call schedule rotation as needed
Obtain and maintain appropriate credentialing approval from University Medical Center's Medical Staff office
Healthcare related training with current licensure/certification in their field. OR
Bachelor's degree from an accredited university with a major in the area of research being conducted

124

Specialist Clinical Research Resume Examples & Samples

Reviews protocol and Case Report Forms (CRFs) during the development process and contributes to enrollment /randomization/blinding procedures
Serves as a Clinical Trial Systems Administrator for related system functions including study configuration and assures appropriate study integration
Responsible for initiating timely payments to the sites and communicating with Clinical Planning/Finance
Monitors study progress and routinely interacts with study team members and management to inform them of PSM issues that may impact study milestones
Works closely with study site personnel to resolve issues, e.g. payments, supplies, enrollment/randomizations, product accountability
Performs randomization, product accountability and supply reconciliation for assigned studies
Manage research supplies and related study needs including permission of tools/questionnaires, clinical file archiving
Assure management and control of product throughout lifecycle
Responsible for conducting assigned responsibilities in compliance with applicable Abbott Policies and regulations
Participates in various organizational committees and develops work flow process improvements for department procedures
Plays an active role as trainer for purposes of cross-training or for educating new PSM employees; often assists with formal or informal training of study personnel and study team members outside of PSM regarding roles and responsibilities
Serves as a PSM subject matter expert for study teams and cross functional stakeholders understanding of research processes
Flexible, well organized, and strong communication and interpersonal skills
Works well under pressure, with initiative to take on unfamiliar tasks
Basic and some advanced computer skills (includes word processing, spreadsheets, instrumentation related to Abbott network systems and advanced technical software)
Team oriented, with high energy and desire to achieve results. Ability to work in multidisciplinary teams and meet business goals
BA in health profession or scientific related field preferred
0-5 years’ experience in the clinical research industry preferred
Knowledge of Good Clinical Practice and research industry standards preferred
Proficiency with clinical systems and/or experience with clinical trial management systems preferred

125

Clinical Research Medical Director Resume Examples & Samples

MD plus accredited residency in relevant sub-specialty
Board certified or equivalent
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in Neuroscience
Strong background in neurodegenerative diseases with expertise in AD highly preferred

126

Clinical Research Quality Auditor Resume Examples & Samples

A Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
At least 3 years in clinical research in industry or academia
Proven auditing ability
Demonstrated ability to prioritize own work and multi-task
Ability to routinely and independently exercise sound judgment in making decisions
Relevant subject matter knowledge

127

Rwlpr Clinical Research Associate Resume Examples & Samples

Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements
This includes pre-award activities, oversight of the scope of work, budget and resources
Developing and implementing the RSU Management Plan
Ensuring collaboration across RSU, including communication with regions and countries
Assisting with the creation and review of core scientific, technical and administrative documentation
Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
Ensuring overall project efficiency and adherence to project timelines and financial goals

128

Clinical Research Coordinator Associate Resume Examples & Samples

BA/BS or MA/MS
Experience with social science research and/or clinical trials
Knowledge of eating disorders

129

Clinical Research Coordinator Healthcare Resume Examples & Samples

MRI/fMRI collection, processing and analysis, and interpretation
Maintain research appointments calendar
Writing programing scripts to streamline data processing and analysis
Assist in making appointment reminder calls to research participants
Cancel and reschedule appointments as needed
Place research notes in MiChart as needed
Perform general office and administrative duties as assigned
Other duties as directed by the Principal Investigator
Bachelor’s degree in Neuroscience
Computer proficiency (e.g. Microsoft Word, Excel, Power Point and EndNote), including programming languages (i.e., Python, FreeSurfer, R, Matlab, Swift, C & Git)
Extensive experience (5+ years) with processing and imaging analysis platforms such as Freesurfer, FSL, and SPM
Confident and highly motivated with excellent multi-tasking ability and record-keeping skills
Previous experience working on fMRI analysis
Outstanding organizational skills with meticulous attention to detail
Proven ability to work independently with minimal supervision
Ability to problem-solve and establish timelines and priorities
Available to work some evenings and weekends as necessary
Ph.D. degree in Neuroscience with post-doctoral training on brain imaging and biomarkers
Experience working with older adults and veterans
Experience working and interacting with research participants
Experience with Electronic Data Capture
Proficiency in using statistical analysis packages such as SAS and SPSS or other research laboratory programs
A working knowledge of medical terminology and assessment of laboratory values
Additional Information

130

Clinical Research Assoicate Resume Examples & Samples

Must possess 2+ years of oncology experience
Experience in monitoring clinical trials required
Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
Ability to reason independently and recommend specific solutions in clinical settings
Understand current GCP/ICH guidelines applicable to the conduct of clinical research
Valid driver’s license; ability to rent automobile

131

Field Clinical Research Associate, Senior Resume Examples & Samples

Strong preference for prior clinical monitoring experience
A general familiarity with cardiac, vascular, and/or neuromodulation technologies Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment
Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution

132

Clinical Research Coordinator Healthcare Resume Examples & Samples

Management of clinical research studies including patient screening and enrollment; study medication accountability; database management; coordination of study visits, labs and procedures; documentation and communication with physicians, study coordinators and sponsors
Coordinates the submission of clinical study materials to IRB and other regulatory agencies for approval
Collects specimens and monitors subjects. Assists in the reporting of tests results
Attend investigator and coordinator meetings
Serve as a resource and contact person for active protocols
Critique study protocols and assist with budget
Bachelor’s degree or equivalent professional degree and documented 5 years’ clinical research experience
Ability to communicate effectively and follow written and verbal instructions
Demonstrate strong analytical and organizational skills, including high level accuracy and attention to detail while exercising good judgment
Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects and meet/negotiate deadlines
Ability to effectively work with diverse teams as well as independently
Demonstrate efficient organizational skills and ability to effectively problems solve and implement solutions to improve processes
Excellent interpersonal and conflict resolution skills
Takes initiative in process improvement and functions in self-directed manner and demonstrated willingness to be flexible where needed
Understanding of IRB and applicable regulatory guidelines
Proficient use of computers and applications including Microsoft Word, Excel, PowerPoint, EndNote, Microsoft Access and SPSS
SOCRA certification
Knowledge of and experience with UMHS basic research, ULAM and UCUCA policies and procedures
Prior experience with laboratory administration and finance

133

Assistant, Clinical Research Resume Examples & Samples

A minimum of an Associate Degree with minimum 2 years of industry experience is required or H.S. diploma with a minimum of 8 years of industry experience required
Previous experience with study coordination is preferred
This position may require up to 10% domestic travel
This position is required to be based in Skillman, NJ.Clinical Trial Coordination

134

Site Clinical Research Associate Resume Examples & Samples

Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas
Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline
Report monitoring activities and study site conduct accurately and completely
Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues
Supports remote monitoring, if and as applicable
Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
Candidate should be located in Missouri
Exhibits high degree of flexibility when facing changes in the work environment. Attention to detail and strong interpersonal skills
Previous experience with electronic data capture systems is desirable

135

Clinical Research Asssociate Trainee Resume Examples & Samples

Complete appropriate therapeutic, protocol and clinical research training to perform job duties
Gain experience in study procedures by working with experienced clinical staff
Under close supervision, perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices
Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Bachelor's degree, preferred in health care or other scientific discipline; or equivalent combination of education, training and experience

136

Neuroimaging Clinical Research Coordinator Associate Resume Examples & Samples

2-3 years of related experience in subject recruitment, assessment, and analysis related to brain imaging research
Technical experience in running MRI scans
Proficiency with basic programming and scripts
Desired experience in
Neuroimaging analysis with extensive experience with analysis toolkits and frameworks: SPM, FSL, AFNI, Nipype, Freesurfer, Murfi (Multivariate and Univariate Realtime-fMRI imaging), open fMRI
Experience in Cognitive experiment stimulus creation: E-Prime
RedCap experience desired

137

Clinical Research Associate, Device Resume Examples & Samples

Assists in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC
Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required
May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA
Attends study-related, company, departmental, and external meetings, as required
Ability to handle several priorities within multiple, complex trials

138

Clinical Research RN Phase Resume Examples & Samples

May be called upon to perform the following specific tests and procedures specifically related to the research study: a) electrocardiogram, b) blood pressure, pulse, height, weight, and temperature measurements, c) phlebotomy and specimen processing and shipping, d) pulse oximetry
Bachelor’s degree in Nursing or other related field
Excellent interpersonal, communication, organizational skills, and ability to problem solve and multi-task
Ability to perform common RN duties such as: drug administration, infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures

139

Clinical Research Clinical Associate Resume Examples & Samples

Prior research experience required
Experience with statistics and big data highly recommended
Biology or health sciences background preferred
Interest in authoring publications preferred
Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience

140

Technician, Acpru Clinical Research Resume Examples & Samples

Communicates and interacts in a professional manner with AbbVie Clinical Pharmacology Research Unit (ACPRU) personnel, study projects, and other internal/external departments
Maintains accurate and complete source data in PIMS and/or the source documents and communicates source discrepancies or issues, as appropriate
Performs study-related protocol activities, i-e., ECGs, blood draws, meals, etc…as assigned
Maintains safety and confidentiality of study subjects throughout the study and communicates safety related information in an appropriate manner
Assists with the training of entry level Research Technicians and provides feedback of trainees progress on a regular basis
Participates in quality and compliance improvement projects
Understands and complies with SOPs, FDA regulations, basic GCP requirements and identifies potential risk of compliance deficiencies
Maintains volunteer database with prompt and timely updates and informs the R&S Clinical Research Nurse of progress
Performs phone interviews regarding the volunteers eligibility based on the inclusion/exclusion criteria and refers issues to the R&S Clinical Research Nurse as appropriate
Performs pre-study R&S setup i-e. R&S calls, document preparation, laboratory set-up, label preparation, lab ordering, performance of QC checks, and inclusion/exclusion sign-off and obtains confirmation from the R&S Clinical Research Nurse as appropriate

141

VP, Clinical Research & Medical Affairs Resume Examples & Samples

Interact with Cerus management to define and develop clinical strategies consistent with business objectives and regulatory requirements
Direct activities related to phase 1-4 clinical trials (e.g., protocol development, design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, and study analysis and reporting)
Provides clinical input into target product profile and commercial planning activities
Ensure CRMA adherence to national and international regulations and standards (GCP, MDD, ICH)
Lead interactions with Steering Committees and Data Monitoring Committees
Oversight of adherence to protocols and regulatory requirements, assuring safety of study subjects
Write medical monitoring plans. Review adverse events, monitor safety and prepare analysis and regulatory submission
Participate in the review and editing of regulatory submissions and quality documentation
Interact with Marketing, Product Development, Medical Science Liaisons, Hospital Implementation and Global Scientific Affairs for strategic positioning and support of clinical trials and needed medical data
Interact with Regulatory Affairs for positioning regulatory strategy
Cultivate and maintain key relationships with outside business partners, scientific and clinical advisors, and therapeutic thought-leaders
Oversee operational activities and CRMA personnel including clinical research, drug safety and biostatistics
Manage and participate in human resources/organizational development activities including; recruitment of key CRMA personnel, performance management, employee development and training
Draft annual clinical budgets and ensure budgets and schedules are met
Participate in scientific publications and presentations; and review of publications to insure consistency with corporate objectives
Provide clinical trials result data in medical journals and present results at conferences and symposiums
Ensure quality system compliance as it relates to area of responsibility
MD degree: Prefer Board Certification (or Eligible) in related field (e.g., Hematology, Transfusion Medicine, Internal Medicine, Pediatrics and Infectious Diseases)
Minimum of 10 years clinical trial experience; includes 5 years management background and 5 years clinical/drug/medical device development experience in the biotechnology or pharmaceutical industry
Demonstrated significant, successful ability to conduct clinical development in an industry setting, including IND, NDA, PMA or BLA filing experience
Thorough understanding of regulatory requirements
Strong negotiation skills to influence policy making bodies both internally and externally
Ability to integrate clinical expertise with Cerus business objectives; strong sense of Company with ability to translate corporate goals into project plan
Recognized as an effective leader; strong leadership, management and mentoring skills; team oriented
Ability to effectively communicate (encompasses verbal, written, interpersonal, listening); ability to communicate across multiple disciplines successfully (internally and externally)
Needs to be comfortable, and indeed thrive in a flexible, dynamically changing and challenging environment
Willing and able to travel up to 30% of the time

142

Clinical Research Medical Director Resume Examples & Samples

Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy
Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
Supporting clinical trial conduct
Participating in engagement of external key stakeholders (often in partnership with other functions)
Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
Supports implementation of Medical governance for respective product, which includes
2+ years of Clinical, Research or Medical Affairs experience
Accredited fellowship in Rheumatology
Board certified or board eligible
Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
Experience with clinical study management and conduct
Familiarity with US health care compliance considerations
Experience with opinion leader interactions
Experience with integrated delivery networks, accountable care organizations, and payers
Broad and formal leadership experience

143

Clinical Research Dev Lead, Early Development Resume Examples & Samples

MD/DO with experience in vaccinology / immunology
Minimum 3 years industry experience or
10 years experience working in a scientific or medical institution
Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP
Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape
Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum
MD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology
Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks
Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making
Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences
License to practice medicine and board and/ or professional certification is an asset

144

Clinical Research Psychologist Resume Examples & Samples

Provide consultation, differential diagnosis, and treatment planning for all disorders defined by the Diagnostic and Statistical Manual for Mental Disorders to adults (including, but not limited to)
Retrieve, sort and collects data from hard copy and electronic database
Manage data processing applications, maintain hard copy and electronic files and is accountable for accurate and timely processing of all research data
Use advanced and varied functions of several software programs like Microsoft Excel, graphics programs such as Microsoft Power Point, and statistical software such as SPSS in order to analyze data and produce reports
Perform a variety of duties concerned with the collection, analysis, evaluation and dissemination of DMH-related research
Serve as an investigator on protocols related to human research
Provide technical support for these studies to include investigator training, procedural assistance, data collection, presentation preparation, scientific writing, and publication
Collect and maintain data for ongoing research and academic protocols in the DMH
Establish and maintain electronic records of current and past research, academic activities such as lectures and training courses, and publications, including original research, case reports, text books, letters to the editor, book chapters, etc
Assist investigators with protocol design, to include research questions, background, literature searches, experimental procedures and data sheet design
Maintain research packets for use by investigators in the DMH
Contact study enrolled patients via telephone, email, or in person as needed for data collection for research protocols
Alert investigators to Institutional Review Board (IRB) deadlines, by serving as liaison between the Clinical Investigation Department and the DMH
Assist investigators with or independently create and prepare materials for initial reviews, continuing reviews, and terminations of research protocols as required by the IRB or IACUC
Establish schedules to meet required protocol timeframes, facility availability, and investigator work schedules
Receive individual assignments from Staff and Residents which involve specialized and/or short-term studies; identifies information sources, collects, researches and assembles background data; creates special study reports, which may also include other departments within the command or BUMED. These reports may require in-depth analysis
Prepare budgets for research protocols and obtain research grants by preparing and writing protocol applications
Function as the administrator for all research assistants and research coordinators, temporary or permanent, when working on DMH projects
Provide oversight to DMH residents or Psychology Trainees in the conduct of research, data collection and data compilation. This oversight will ensure adherence to government and institutionally-mandated rules and regulations, the protection of human and animal subjects, and the maintenance of patient confidentiality
Provide other duties that are within the scope of work

145

Clinical Research Parasitologist Resume Examples & Samples

Designs, implements and reports parasitology studies on ecto- and endo-parasites in both companion and food-producing animals
Serves as investigator as in-house parasitology studies for development drug candidates and label extensions of approved products
Ensures compliance with Good Clinical Practices (GCP) and occasionally Good Laboratory Practice (GLP)
Supports external parasitology studies, as needed
Maintains contact with the all stakeholders (project leader, RA, Quality Assurance (QA) etc. and keeps them informed of the study progress
Implements and manages a parasitology laboratory, including rearing and maintaining colonies of ectoparasites and gastrointestinal nematodes
Trains and manages laboratory technician(s)
Defines objectives, budgets, resources, timelines associated with the parasitology laboratory
Supports pre-development activities as required, including implementation of sensitivity assays, evaluation of formulations and dose characterization studies
Supports biological activities related to parasitology
Participates, as required, in meetings with management and/or regulatory agencies to present parasitology topics
Develops and maintains a network of clinical parasitology and scientific contacts
Minimum of (3) years of experience parasitology research, which may include graduate study in a relevant scientific field
Familiarity with MS Office programs
Familiarity with the principles of Good Clinical Practice and Good Laboratory Practice

146

Clinical Research Representative Resume Examples & Samples

Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes. Identifies and communicates important protocol and data management issues to appropriate sponsors
Recruits participants for research studies. Determines participant eligibility based on study specific criteria. Verifies that patients have completed appropriate registration materials and maintains related records and information. Obtains and reviews relevant medical history with participants
May serve as a backup, collecting and processing phlebotomy specimens for analysis using appropriate or specified equipment. Ensures proper labeling and obtains pertinent clinical and protocol information on request forms. Performs vital signs and EKG as appropriate
Trains other Research Assistants in scheduling and data entry systems and in clinical procedures such as EKG, vital signs and phlebotomy

147

Clinical Research Psychologist Resume Examples & Samples

Provide consultation, differential diagnosis, and treatment planning for all disorders defined by the Diagnostic and Statistical Manual for Mental Disorders to adults (including, but not limited to): organic mental disorders; psychotic disorders; schizophrenia; delusional disorders; mood disorders; anxiety disorders; somatoform disorders; psychoactive substance use disorders; sleep disorders; factitious disorders; impulse control disorders; psychological factors affecting physical condition; disorders usually first evident in infancy, childhood, or adolescence that manifest in an adult patient such as, eating disorders and gender-identity disorders; conditions not attributable to a mental disorder that are a focus of attention or treatment; sexual disorders; adjustment disorders; personality disorders; dissociative disorders; post-traumatic stress syndrome; etc
Provides diagnostic and therapeutic procedures (including but not limited to): interviewing; major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy; community outreach (e.g., health promotion and command consultation); mental status examination; crisis intervention; case management; medical discharge planning; psychosocial history taking; psychological test administration and interpretation; etc
Serve as an investigator on protocols related to human research. Responsible for the conduct of research, the collection, accuracy, and analysis of research data, and reporting of said data
Write and prepare research applications, conduct literature searches for background information, conduct research, collect and analyze data, perform statistical analyses, perform scientific writing and manuscript preparation, and submit completed manuscripts to academic journals or other sources as appropriate
Retrieve, sort and collect data from hard copy and electronic databases. Collect and maintain data for ongoing research and academic protocols
Manage data processing applications, maintain hard copy and electronic files and be accountable for accurate and timely processing of all research data
Use advanced and varied functions of several software programs like Microsoft Excel, graphics programs such as Microsoft PowerPoint, and statistical software such as SPSS in order to analyze data and produce reports
Provide technical support for research studies to include investigator training, procedural assistance, data collection, presentation preparation, scientific writing, and publication
Assist investigators with protocol design, to include research questions, background, literature searches, experimental procedures and data sheet design. Maintain research packets for use by investigators
Receive and complete individual assignments from Staff and Residents, which involve specialized and/or short-term studies; identify information sources; collect, research and assemble background data; create special study reports, which may also include other departments within the command or BUMED. These reports may require in-depth analysis
Function as the administrator for all research assistants and research coordinators, temporary or permanent
Provide oversight to Residents or Psychology Trainees in the conduct of research, data collection and data compilation. This oversight will ensure adherence to government and institutionally-mandated rules and regulations, the protection of human and animal subjects, and the maintenance of patient confidentiality
Experience with Trauma Management Therapy similar to the therapy discussed in the following reference is preferred
Beidel, D. C., Frueh, B. C., Uhde, T. W., Wong, N., & Mentrikoski, J. M. (2011). Multicomponent behavioral treatment for chronic combat-related posttraumatic stress disorder: A randomized controlled trial. Journal of Anxiety Disorders, 25(2), 224-31. doi:10.1016/j.janxdis.2010.09.006
Knowledge of U.S. Navy; Naval Medical Center, Portsmouth; and/or Directorate of Mental Health policies and procedures is preferable, but not required
Knowledge of the Directorate of Mental Health functions in order to comprehend the scope of care and interactions of this directorate is preferable, but not required

148

Clinical Research RN Resume Examples & Samples

Education: Graduation from an accredited school of nursing
Experience: A minimum of 1 year of RN experience
1 year of RN experience in research and/or oncology
Bachelor of Science in Nursing (BSN)

149

Associate Clinical Research Resume Examples & Samples

Ensures validity of study by identifying/resolving
A University degree is preferred or equivalent experience
Three to six years of related work experience is required
Strong verbal communication and interpersonal skills
A mechanical aptitude and good organizational skills
A keen interest in continuous learning
Experience running cartridges and dealing with blood is preferred
Science/Chemistry/Biochemistry and/or phlebotomy experience would be considered an asset
Personal attributes: professionalism , adaptability, approachability, enthusiasm, excellent attention to detail, self-motivated, shows initiative and can work effectively as part of a team
You must be a self-starter and have the ability to follow instructions and use good judgment. The individual must be flexible and be able to work in a fast paced environment with changing priorities
This position requires someone who can work Monday through Friday from 8:00 a.m. to 5:00 p.m

150

Clinical Research Coordinator, Certified Resume Examples & Samples

Recognizes, tracks and reports adverse events and protocol deviations
Represents the research program at meetings, national and international research consortia
Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis

151

Experienced Clinical Research Associate Resume Examples & Samples

Note: The ideal candidate will reside within the region
Minimum of 1 year monitoring experience with a pharmaceutical company and/or CRO
Minimum of 1 year experience of monitoring complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Transplant, etc in the U.S.A
Proficient in the use of core trial management systems

152

Clinical Research Associate Trainee Resume Examples & Samples

If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA in tracking subject site recruitment progress
Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Under close supervision may support start-up phase
Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
Convey features and opportunities of study to site
Collaborate and liaise with study team members for project execution support as appropriate
Good written and verbal communication skills including good command of English language

153

Specialist, Clinical Research Resume Examples & Samples

Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
Edit/amend informed consent documents
Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery

154

Clinical Research Operations Manager Resume Examples & Samples

Provide leadership and oversight for clinical study operations world-wide
Establish mechanisms to track and report 3M’s global clinical research activities and impact
Ensure that OUS clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
Collaborate with division clinical managers to develop clinical studies to support division’s priorities and businesses
Bachelor's degree or higher from an accredited institution
Minimum of ten (10) years of pharmaceutical, medical device and/or academic health care experience
Minimum of ten (10) years pre-clinical and/or clinical research experience
Master’s degree or higher in a Science discipline from an accredited institution
Minimum of five (5) years of medical device experience
Experience with new product development programs
Proven process improvement experience such as Six Sigma
Strong communication skills and a demonstrated ability to work collaboratively with multiple functions and organizations
3M experience working across multiple disciplines, businesses and/or departments (applies to internal applicants only)

155

Clinical Research Supervisor Resume Examples & Samples

Manage and develop a team of Clinical Research Professionals
Collaborate with the division and Clinical Managers to develop clinical studies to support division’s priorities and businesses
Establish mechanisms to track and report clinical research activities and impact
Ensure that clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
Propagate necessary policies and procedures to ensure compliance
Provide and facilitate clinical planning in support of business initiatives
Bachelor’s degree or higher from an accredited institution
Minimum of five (5) years combined experience working in a clinical research and/or technical environment
Bachelor’s degree or higher in Science, another health care discipline (e.g. MD/DO, RN, PharmD, MPH) or related discipline from an accredited institution
Minimum of five (5) years clinical trial management experience
Minimum of two (2) years supervisory experience
Certification, or willingness to obtain Association of Clinical Research Professionals (ACRP) Certified Clinical Research Accreditation (CCRA®)
Experience working with health economics studies
Demonstrated understanding of Good Clinical Practices (GCPs) and clinical trial regulations
Previous experience leading cross functional teams
Ability to influence across the Health Care Business

156

Clinical Research Associates Resume Examples & Samples

Unlike some CRA roles you will not be pushed to satisfy
All aspects of site management as prescribed in the project
Negotiation of study budgets with potential investigators and

157

Clinical Research Coordinator Associate Resume Examples & Samples

Excellent verbal and written communication skills in English and Spanish
Prior experience with patients or research subjects is desired. Preference given to applicants with previous experience, particularly clinical research experience, with older adults who may have neurological impairment (e.g., Parkinson’s disease) or cognitive impairment (e.g., Alzheimer’s disease)
Ability to communicate clearly and empathetically with research participants and their families
Strong interpersonal skills, including the ability to work easily with research participants and research team members
Strong general computer skills and ability to quickly learn and master computer programs
Proficiency with Microsoft Office and Excel

158

Clinical Research Protocol Analyst Resume Examples & Samples

Bachelor’s degree in relevant field such as biology, biomedical engineering, psychology, nursing, or public health
Advanced degree (PhD, PharmD, MPH) and/or clinical background (nursing or MD) preferred
Minimum 4 years experience in clinical research and/or patient recruitment
Experience interacting directly with patients in a research setting is a plus
Ability to analyze with strong attention to details
Persuasive writing skills and the ability to simplify complex medical concepts
Strong organizational skills and ability to perform multiple tasks
Ability to work independently, function effectively as a member of a team and adhere to strict deadlines
Ability and willingness to work collaboratively across multiple teams (Sales, Analytics, Proposals, Project management, IT, Media, etc.)
Strong working knowledge of (Word, Excel, PowerPoint) in a PC environment
Demonstrated comprehensive understanding of clinical research patient recruitment across multiple therapeutic areas

159

Assistant Site Clinical Research Associate Resume Examples & Samples

Supports the (Associate)/(Senior) ClinicalOperations Manager, Site Clinical Research Associates and any other clinicalresearch personnel involved, in the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operation Procedures and applicable global, local and regulatory requirements and companyobjectives
The AssistantClinical Research Associate is key participant in the study startup activities and site openingactivities as well as study conduct and site closure tasks
May managethe activities of clinical Investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This positionmay assume independent site management responsibility in accordance with experience and performance
Supports and/or conducts (accompanied) site qualification, initiation, interim monitoring and study closeout visitsfor Phase 1-4 studies in accordance with local regulations, Good Clinical Practices(GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and businessprocesses, if applicable
Conducts assigned clinical site activities and/or supports the (Sr.) SCRA in those according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision
Manages the overallactivities of site personnel and motivate/influence them to meet study objectives, with appropriate supervision
Ensures qualityof data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
Ensures safety and protectionof study subjectsaccording to the monitoring plan, AbbVie SOPs, ICH Guidelines, and federal regulations
Appropriately escalates serious or outstanding issues to (Sr)/ (Associate) Clinical Operations Manager or the appropriate project team member(s)as defined in the study monitoring plan
Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites.Reports monitoring activities and study site conductaccurately and completely. Prepare and submit written reports,both monitoring and administrative, with appropriate supervision. Keep management informedof study progress through periodic updates
Supports SCRAs with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required
Assists to conserve costs of departmental operation and control of travel expenses, with guidance from (Sr) Clinical Operations Manager
Assists in study budget preparation and clinical study agreement execution, including ensuring necessary payments are made according to executed agreements
Negotiates investigator/ hospital agreements with stakeholders. Maintainsand completes own expensereports as per local and applicable guidelines
Participates in departmental meetings
Supports new and innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs
Gains knowledge and expertise acrossmulti-therapeutic areas throughclinical and scientificliterature review, ongoingawareness of industry practices and participation in professional activities
Undergoes and maintainstraining as requiredby Global ClinicalOperations and otherrelevant company procedures, to ensure adherenceto federal regulations, Good Clinical Practices (GCPs),ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
Appropriate life-science or healthcare-related qualification or experienceor equivalent work experience
Appropriate tertiary qualification, health related(e.g., Medical, Scientific, Nursing) preferred
One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trialsis preferred
Knowledge of conducting industry-sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelinesand applicable local regulations is preferred
Good planningand organizational skillsand the ability to work effectively and efficiently in a dynamicenvironment with competingprojects and deadlines
Good written and verbal communication skills.Written and verbal fluency in English and local language (if not English).Good observational skills,analytical and conceptual capabilities. Attention to detailand strong interpersonal skills
Ability to work, understand and follow work processes within the assigned function

160

Data Analyst, Clinical Research Resume Examples & Samples

Performs all data management activities for assigned studies, as appropriate
Protocol and Statistical Analysis Plan (SAP) review and input
Case Report Form (CRF) development and maintenance
Edit Check specifications development and maintenance
Data Management Plan development and maintenance
Data Quality Checks and discrepancy management
Analyzes data, identifies trends; prepares data tables for reports
Database setup testing and Edit Check programming testing
External data handling
Device reconciliation and tracking for investigational product
Participate in Post Market Surveillance reporting as appropriate
Additional study specific activities
Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate
Communicates well with peers, study teams and management as appropriate to support studies and goals
Participates in efforts to improve Data Management processes, as needed/assigned
Represents the Data Management group at study team meetings
May represent the Data Management group on cross-functional task forces
May train and mentor other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs) on certain tasks
Applies best practices and established standards
Serves as a liaison between the study team and clinical data operations
Is a Subject Matter Expert (SME) in one or more areas within Data Management
Has a general understanding of the clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies
Communicates and collaborates with all levels of employees, customers, contractors, and vendors
Provides input to departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procedures and processes
Performs other related duties and responsibilities, on occasion, as assigned
Typically a minimum of four plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data management processes
Good organizational and project management skills, as well as attention to detail
Highly skilled with MS Office, especially Excel, Word, Publisher and Powerpoint
Strong ability to work with Clinical Data Management Systems
Understands databases; good technical skills in querying and analyzing data (SQL, Oracle, SAS or equivalent)
Certified Clinical Data Manager (CCDM) preferred
Ability to work in a highly matrixed and geographically diverse business environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written
Multitasks, prioritizes and meets deadlines in timely manner
Ability to travel approximately 10%
Ability to maintain regular and predictable attendance
Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent

161

MCI Clinical Research Coordinator Resume Examples & Samples

In lieu of degree, 7 years of oncology research or 9 years of research experience required
CITI Certification required
Must have broad experience in clinical trials
Clinical Research Coordinator Certification preferred
Computer literacy in Microsoft Office (MS Access, MS Word, and MS Excel) and Electronic Capture Platforms
Ability to manage multiple projects/protocols systematically and strong proofreading skills
Excellent interpersonal, collaborative, and team-building skills are required
Must be able to work in high-stress, high volume area and multi-task to ensure enrollment of patients in research protocols according to regulatory requirements

162

Clinical Research Coop Resume Examples & Samples

The general task and duties for this job is to collaborate with management, scientists, engineers, technicians, and test participants in order to design, execute, and complete projects
Work individually and in a team environment, includes cross-functional teams
Apply problem-solving skills to resolve scientific issues
Develop testing protocols; administer testing, analyzing and reporting the data
Ability to take initiative, think and work independently, problem-solve, work in teams and multitask; a solution orientated professional
This position actively participates in the execution and collection of research data of clinical investigations on Edgewell Personal Care products
The primary locations of this research will be at 50 & 60 Commerce Park, both in Milford CT
This position will help in designing, executing, analyzing and reporting the results of clinical investigations on Edgewell Personal Care products
This position executes clinical investigations of personal products, which may include direct contact with study participants to obtain measurements of skin properties
Facilitates clinical studies execution including preparing study documentation, supplies, labeling and dispensing test product, recruiting/scheduling/reporting panelist participation, and other study related responsibilities as needed
Supports other functions of The Institute of Evaluation Sciences or other Edgewell facilities as necessary
Junior or Senior studying Biology or Psychology with effective verbal and written communication skills
Ability to conduct statistical data analysis and its interpretation
Past work experience in industry
Experience with automated data collection systems
Owns a valid driver’s license

163

Clinical Research Financial Manager Resume Examples & Samples

Provides collaborative leadership and management oversight and coordination of special research projects for the NIAID, Division of Clinical Research (DCR), Office of Planning and Operations Support (OPOS)
Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate budget objectives
Serves as the primary interface for the budget management and planning of clinical research projects and other associated activities
Provides collaborative financial leadership and coordination of all budget components
Develops, maintains and tracks detailed site management budgets identifying applicable clinical research activities, tests, and other associated activities (e.g., subcontracts) to be performed during the conduct of a clinical research protocol
Ensures coordination and dissemination of information that would financially impact the clinical research projects by facilitating and maintaining strong communication channels among the many entities participating such as: NIH teams, investigators/colleagues, Leidos Biomed staff, subcontractors, etc
Works independently to assess complex financial requirements
Communicates with the CMRP Director, senior management, program staff and NIAID DCR project officials to provide consistent and accurate information
Participates in the financial execution of projects and provides technical guidance in the development of operational, technical and budget processes, templates, procedure manuals, and other documents
Prepares, monitors and analyzes financial forecasting, cost proposals, and reports
Monitors budget progress against complex project plans/key deliverables and provides monthly expense analyses
Manages budget risks by proactively anticipating issues and develops contingency plans and solutions
Conducts financial meetings and assists in the development of meeting agendas and summary reports as requested
Supervises staff
Possession of a Master’s degree from an accredited college/university in a field related to biomedical research/clinical trials/health or six (6) years related experience in lieu of degree
A minimum of ten (10) years of progressively responsible, relevant experience in clinical research, including a minimum of six (6) years directly managing financial activities for protocols, site management and/or clinical research activities
In-depth knowledge of study design, clinical and bio-specimen terms used in research studies and scientific and medical concepts and terminology
Comprehensive knowledge of accounting theories, principles, procedures and methods, report analysis, contracting principles, provisions, reporting requirements and cash flow requirements
Excellent research and investigative skills with a high degree of accuracy and attention to detail
Extensive budgetary and strategic planning experience as it relates to clinical research
Ability to review complex documents independently and/or in collaboration with various stakeholders, and determine sufficiency of financial documentation
Experience in leading and developing team members
Must be detail-oriented, creative and flexible
Advance proficiency in Microsoft Excel, Word, and PowerPoint
Clinical Research or Project Management Professional with infectious disease experience
Experience in human subjects protection and clinical research activities
Familiarity with Federal Acquisition Regulations (FARs)

164

Clinical Research Coordinator Healthcare Resume Examples & Samples

Highly professional demeanor and positive attitude
Bachelor’s degree in related field required
1 to 3 years of clinical research experience involving human subjects, IRB methodology, and working with a clinical research team
Must be able to multitask and prioritize effectively
Ability to work as part of a team or individually while meeting deadlines in a multitasking environment
Comfort with and proficiency in software applications used to support research processes (eResearch, etc)
Previous experience with MiChart, RedCap
Background in a medical field and knowledge of medical terminology
Flexible schedule is required, as some weekend (day) coverage may occasionally be required

165

Clinical Research Associate, Senior Resume Examples & Samples

Responsible for overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems / risks, creating mitigation plans, taking actions or corrective actions using timely communication
Contribute to protocol development and study related documents such as informed consent related to monitoring activities
Develop the monitoring plan for clinical studies
Ensure compliance to ICH/GCP/local regulations
Confirm and track that all key site personnel have project specific training
Responsible for study status reports, essential documents, and accurate study files
Assist with resolution of investigational site/data queries
Liaise with project team members regarding study site issues
Travel to study sites for meetings and monitoring visits upon request (ca. 40% travel of which 10% international)
Experience as a clinical research associate minimum of three years, five years preferred
Bachelor’s degree, in biological sciences or healthcare
Excellent interpersonal and organizational skills
A pro-active, committed and motivated attitude
Ability to work very accurate and thorough
Ability to work well in a team environment but also independently without significant oversight
Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines

166

Clinical Research Associate Respiratory Therapy Resume Examples & Samples

Work closely with R&D Engineers and Product Managers to provide in-depth clinical respiratory therapy knowledge in support of product development
Respond to questions from engineering regarding metrics, etc. pertaining to respiratory therapy guidelines
Perform research as needed to provide applicable information
Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
Identify issues that need resolution to ensure safety and effectiveness of the products
Participate in cross-functional meetings to provide clinical perspective and knowledge
Knowledge of how to, or a willingness to learn to, write protocols, reports, and other forms of research projects for various studies that Clinical Affairs is engaged in

167

Clinical Research Technician Resume Examples & Samples

Perform medical diagnostic tests such as electrocardiograms, blood pressure checks, glucose measurements, etc
Collect and process blood and urine samples per protocol requirements
Professionally interact with subjects, visitors, staff, and other healthcare professionals
Maintain nurse’s station inventory
Sanitize and stock treatment rooms and subject bedrooms
Dispose of and replace biohazard waste in lab and exam rooms per OSHA requirements
Perform administrative tasks as needed
Troubleshoot any study issues
Order and prepare lunch for subjects as needed
Other duties and responsibilities as assigned or directed
Ability to communicate in a clear and professional manner
Adhere to Good Clinical Practices (GCP)
Attention to detail and accuracy in completing tasks
EMT and BLS certification required
Paramedic and ACLS certification required
Registered Nurse degree required

168

Senior Associate, Clinical Research Resume Examples & Samples

Serve as a central contact for communications/correspondence between the Generic Product Development, Biopharmaceutics Group, and CROs and other vendors
Review the study protocols and if needed help to design data collection from known case report forms (CFRs)
Identify and assess the suitability of clinical and bioanalytical facilities for bioequivalence studies. Conducting general GCP and GLP audits
Maintain study schedules, request proposals/contracts from CROs, compare competiveness and work quality of the CROs, maintain study budgets, initiates CDAs with different vendors, process vendor contracts and ensures payments are sent on time to vendors
Monitor trials throughout their duration, which involves visiting the trial sites on a regular basis
Verify that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
Write visit and audit reports
Analyze and interpret scientific data using Phoenix WinNonlin and other databases
Generate and track drug shipments and ensure timely delivery of final clinical and bioanalytical reports for regulatory submissions
Ensure all unused trial supplies are accounted for and stored properly
Perform duties such as bulk copying and faxing, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents
Assist coordination of study logistics, documents, drug shipments, enrollment and safety 5%
Collect regulatory documents required for study initiation
Maintain central study files in a state of audit-readiness
Maintain reference products inventory list and order products when needed. Maintain reference products inventory list and order products when needed
Communicate regularly with Generic Products Development teams: provide information, track study randomization codes, reports, may follow up on problems identified during the study
Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, appropriate industry and Good Clinical Practices, Good Laboratory Practice and Applicable Regulatory Guidance standards
8 years of experience with medical terminology, GCP, GLP and Pharmaceutical Industry Regulatory guidelines is required
5+ years of demonstrated proficient with MS Office (Word, Excel, Access, and PowerPoint), email, internet, required
2+ year of experience using computerized systems i.e., Phoenix WinNonlin, SAS, and other databases required
2+ years of experience analyzing and interpreting scientific data and skilled use of computerized systems and databases required
8 years work experience in clinical and bioanalytical science environment required

169

Clinical Research Coordinator Associate Resume Examples & Samples

BA/BS in Psychology, Public Health, Social Work or related social science field
Experience with social science research, ideally with children
Knowledge of University administrative systems

170

Clinical Research Coordinator Trauma & Critical Care 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
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
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. 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. 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

171

Clinical Research Associate, Temporary Resume Examples & Samples

Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
Actively participate in the implementation and execution of clinical trial activities from study planning through closure
May perform site qualification, initiation, monitoring, and/or close out site visits
Develop and maintain tracking tools to support management of clinical studies
Participate in site budget negotiations
Assist in developing and managing study timelines
Plan and participate in Investigator meetings and CRA trainings
Assure regulatory compliance of investigational sites with SOP’s and FDA and ICH guidelines
Minimum of 3+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc
Experience in protocol development/writing is preferred
Experience in international or global clinical trials is preferred
Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU directive, and other relevant, local regulatory requirements
Good knowledge of concepts of clinical research and drug development
Ability to travel up to 25% travel including ground and air required

172

Clinical Research Psychologist Resume Examples & Samples

Organic mental disorders
Psychotic disorders
Schizophrenia
Delusional disorders
Mood disorders
Anxiety disorders
Somatoform disorders
Psychoactive substance use disorders
Sleep disorders
Factitious disorders
Impulse control disorders
Psychological factors affecting physical condition
Disorders usually first evident in infancy, childhood, or adolescence that manifest in an adult patient such as, eating disorders and gender-identity disorders
Conditions not attributable to a mental disorder that are a focus of attention or treatment
Sexual disorders
Adjustment disorders
Personality disorders
Dissociative disorders
Post-traumatic stress syndrome
Provides diagnostic and therapeutic procedures (including but not limited to)
Interviewing
Major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy
Community outreach (e.g., health promotion and command consultation)
Mental status examination
Crisis intervention
Case management
Medical discharge planning
Psychosocial history taking
Psychological test administration and interpretation
Responsible for the conduct of research, the collection, accuracy, and analysis of research data, and reporting of said data in the DMH
Write and prepare research applications, conducts literature searches for background information, conducts research, collects and analyzes data, performs statistical analyses, performs scientific writing and manuscript preparation, and submit completed manuscripts to academic journals or other sources as appropriate
Possess a doctoral degree in clinical or counseling psychology
Possess a valid, unrestricted license or certification to practice as a psychologist in any one of the 50 States, the District of Columbia, the Commonwealth or Puerto Rico, Guam or the U.S. Virgin Islands
Experience with Trauma Management Therapy similar to the therapy discussed in the following reference preferred
Complete MTF provided human subject protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date
Knowledge of Federal regulations regarding the ethical conduct of research on humans
Knowledge of the data collection techniques to identify and analyze problems, apply solutions, identify trends, and prepare charts and graphs utilizing available software programs such as Microsoft Office Suite
Knowledge of Navy and Naval Medical Center Portsmouth and Directorate of Mental Health policies and procedures is preferable, but not required
Skill in scientific writing and ability to use literature search databases in order to prepare research proposals, applications, presentation preparation, and manuscripts evidenced by publication in peer-reviewed journals, completed thesis/dissertation work (or equivalent), or endorsement of strong formal writing skill by previous employers or academic advisors
Skill in using advanced and varied functions of several software programs such as Microsoft Excel, graphics programs such as Microsoft Power Point, and statistical software such as SPSS in order to organize and analyze data and produce reports
Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, often changing conditions and research workload
US citizenship and background investigations are required for this position

173

Clinical Research Evaluation Supervisor Resume Examples & Samples

Manage, coordinate and execute clinical testing of sexually transmitted infections, blood borne infections and transfusion transmissible infections in support of clinical laboratory mission and research studies
Oversight of US FDA Pre-Market Clinical Trials and other IRB approved clinical trials and non-clinical studies
Support IRB submissions
Support development of Cooperative Research and Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)
Provide support for internal, manufacturer (sponsor), CAP, and/or US FDA 483 regulatory audits
Serve as point of contact for manufacturer and sponsor study coordinators
Provide regular project updates to Principal Investigators
5 years of related experience including oversight of clinical trials

174

Clinical Research Data Manager Resume Examples & Samples

Work closely with the scientific team to determine deliverables and study expectations
Coordinate with our team of data analysts to establish all aspects of data collection, data transfers, data cleaning and reporting
Contribute to cross-functional collaboration, decision-making and goal-setting

175

Oncore Ctms Clinical Research Calendar Builder Resume Examples & Samples

Build and configure electronic study calendars with budget details for clinical trial data capture in accordance with the terms of the protocol
Update OnCore protocol information as amendments occur to the protocol calendar/ budget
Develop prioritization schema to aid in workload management for calendar and budget build tasks
Provide input to and implement processes to ensure calendar and budget build reflect accurate trial information
Perform system testing as directed and quality control of application functionality during application upgrades
Assist coverage analysts, budget specialists and cancer center employees who encounter technical issues problems or have questions relating to OnCore
Collaborate with direct supervisor, finance team, clinical research team, project manager, health system representatives, consultants and vendors to ensure overall completion of goals, schedules, and deadlines
Stay up to date on all new and evolving institutional changes as they relate to policy, pricing, budgeting, etc. for clinical trial data captured in OnCore
Provide ad hoc reporting to OnCore, Clinical Trials Office and Cancer Center leadership, as necessary
Assist the OnCore team in developing learning tools as they relate to calendar/ budget building tasks
Act as a resource to other calendar/ budget builders utilizing OnCore
Knowledge of cancer research, the oncology field, or related experience

176

Associate Specialist, Clinical Research Resume Examples & Samples

Assist in the preparation of study start up activities. Collaborate with monitoring team to coordinate on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled
Identify and investigate discrepancies in documentation by applying clinical protocol knowledge and develop processes to minimize possibility of recurrence
Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and FDA audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
Assist in the preparation of relevant portions of regulatory submissions for local and government regulatory bodies
Assess current processes, identify opportunities, and propose solutions to improve process efficiency within and across related functional areas
Site management experience
Site pre-qualification visits through close out visit experience
Substantial computer literacy
Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting is preferred
Able to apply appropriate clinical research SOPs, ISO guidelines, ICH/GCP guidelines, and FDA guidelines, as needed

177

Clinical Research Associate Finland Resume Examples & Samples

Experience as a CRA in clinical development phases II-IV
Capability to work in a team
LI-LS1

178

Manager, Clinical Research Services Resume Examples & Samples

Exceptional written and oral communication skills, to include presentation and report writing skills
Demonstrated interpersonal skills, along with the ability to interact effectively with a diverse constituent population
Demonstrated organizational and prioritization skills, along with the ability to meet deadline and focus on the completion of tasks
Ability to generate and implement successful approaches to addressing research study related issues

179

Clinical Research Associate Apprenticeship Resume Examples & Samples

Completes various training and related instruction and maintains detailed documentation of training completion
Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites
Performs PPD investigator file reviews and logs findings in CTMS
Maintains assigned data points within CTMS according to the established conventions within specified times
Remotely reviews EDC (with or without source verification, depending on local practice and regulations) and drug accountability log. Performs source data verification from web-based sources where possible, and in compliance with local laws
Writes, follows and resolves clinical queries and issues
Evaluates, conducts and documents site management contacts according to the monitoring plan and conducts remote study-level training as needed to improve site performance and study compliance
Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study
Reviews and appropriately escalates site key risk/performance/quality indicators (SRAP, KRI, KPI, KQI [e.g., early termination and screen-fail rates, average number of open findings, etc.]) , ad-hoc clinical listings review, tracks and trends violations and deviations, ensures visits occurred per the MP, site status, enrollment, CRF status and SAE follow up
Provides trial status tracking and progress update reports to CTM as required and ensures study systems are updated per agreed study conventions (e.g., CTMS)
Liaises with CRA to promptly collect documents, review data points, findings from EDC and file reviews, etc
Previous experience in a medical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered
Prefer individuals with leadership experience and training, such as Lean Six Sigma or equivalent
Proven success in deadline driven environment a plus
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

180

Advanced Practice Provider Head & Neck Medicine Clinical Research Resume Examples & Samples

Capable of anticipating and balancing the needs to multiple stakeholders
Resourceful, securing and deploying resources effectively and efficiently
An effective communicator
Openly relatable and comfortable with diverse groups of people
Adaptable in approach and demeanor in real time to match the shifting demands of different situations
Current New York State (NYS) RN and NP licenses/registrations
Master’s degree in nursing, prescriptive privileges (or eligibility)
3+ years of related clinical experience
Related National NP certification
BLS certification
Graduate from an accredited PA program
NCCPA certification
Active NYS license or be qualified for state licensure
A minimum of 2 years of related experience as a PA is preferred

181

Lead Assistant Clinical Research Coordinator Resume Examples & Samples

Strong clerical, interpersonal, and organizational skills
Ability to exercise judgment and employ basic reasoning skills
Clinical research experience

182

Intern Clinical Research Resume Examples & Samples

Shadows and learns functions and or projects under the close supervision of a department employee
Assignments are assigned to enhance and build upon the academic experience and the Intern is the primary beneficiary of this job. This job is designed to offer a professional work environment experience, two-way communication tactics, and exposure to the Quintiles organizational structure
Assignments will reflect the work being accomplished within the business department and may include working on independent projects or as a member of a project team
Performs other duties /learning activities as directed
Appropriate verbal and written communication skills to function within a professional work environment
Working knowledge of MS –Office suite of applications
Pursuing BS/BA or a community college /vocational certification course
Prefer junior or senior (i.e. in the last 1 or 2 years of the program), but will consider other class levels, as appropriate. Regional/country variations may apply

183

RN Clinical Research Resume Examples & Samples

Graduate of an accredited/approved school of Nursing
Licensed as a Registered Nurse in the State of Alaska at time of hire
Demonstrated ability to work as a team
Bachelor’s Degree in Nursing (BSN) preferred
Certification within area of expertise or practice preferred (OCN, CCRP)
Two years of oncology nursing experience preferred

184

Bft-mgh Neurology Department Seeking Clinical Research Coordinator Resume Examples & Samples

Recruit and schedule study participants
Coordinate scheduling with other research coordinators and investigators
Maintain documentation of recruitment activities
Enter data into an electronic data capture system
Monitor and reports adverse events as required by study protocol and institutional/federal regulations
Resolve data discrepancies as requested by Sponsors

185

Emergency Medicine Clinical Research Coordinator Resume Examples & Samples

Able to work as independently and as a team player
Very good communication skills
Ability to juggle multiple tasks, people and schedules
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Comfort with computers, specifically the Windows operating system, is essential
Comfortable searching the Internet, as well as performing literature searches using Medline
Proficiency in Microsoft Office, as well as the ability to learn how to use new software
Staff member will be trained in phlebotomy and collection of vital signs

186

Clinical Research / RN Coordinator Resume Examples & Samples

Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research
Clinical competence in application of professional nursing theory, practice, and skills for the care of pediatric and adult patients
Complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and integrity training within one month from start date

187

Clinical Research Coverage & Budget Analyst Resume Examples & Samples

Comprehensive knowledge of medical terminology, pharmacology, disease processes, surgical and medical procedures
Minimum of 3 years experience in a research setting, preferably in billing, coverage determinations and budgeting and/or understanding of research billing regulations
Demonstrated understanding of ICD-9, ICD-10, CPT-4, HCPSC, coding protocols and CMS regulations
Knowledge of clinical trial federal, state and local regulations preferred
Experience with EPIC preferred
Must have strong MSOffice computer skills, and ability to conduct Internet searches
Strong project management, analytical, organizational, and problem solving skills
Demonstrated ability to work on deadlines, set priorities and juggle multiple projects without compromising quality

188

Director, Global Clinical Research Resume Examples & Samples

Manage and enhance a global portfolio of performance and especially clinical outcomes studies, and conduct such studies as appropriate, with an emphasis on microbiology and biomarkers
Coordinate global performance and clinical outcomes projects
Masters or higher in in a relevant field
4 years of relevant experience in the independent scientific and administrative conduct of clinical research studies
Familiarity with a wide range of a empirical research techniques and basic statistical methods
Additional languages, particularly Spanish, are a plus
Adaptable and flexible to adjust to changing demands, timelines and deliverables
Ability to exercise independent judgment, prioritize and take action as needed to drive own and other’s research to conclusion and publication
Appropriate computer skills
Strong team orientation to work with peers, Key Opinion Leaders, investigators, funders, and other players important to the success of the program and company

189

Head & Neck Clinical Research Liasion Resume Examples & Samples

Theoretical knowledge and/or Bachelor’s Degree in a social science or basic science such as Biology, Microbiology or a related field and/or relevant related work experience
Strong experience in research protocol start-up procedures, including study feasibility, study activation and IRB processes and qualification procedures
Advanced knowledge of investigational protocol data management, query resolution, protocol design and protocol implementation
Strong experience in clinical trials budget negotiations, including development, preparation and monitoring of clinical trials budgets, to reach agreement on payment, deliverables, and other issues to ensure the smooth and efficient execution of contractual obligations
Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions
Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team
Demonstrated knowledge of medical billing and collections guidelines and procedures. Experience in analyzing protocols to assist in determining standard of care versus research-related cost, and in monitoring financial activity on research accounts to verify accuracy of charges to the study account
Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet
Possess a Clinical Research Coordinator Certificate or Master’s Degree

190

Clinical Research Associate, / Senior Cra-uk Resume Examples & Samples

General Medicine (Infectious Diseases, Immunology, Gastrointestinal, Vaccines, Respiratory, Cardiovascular and Endocrinology)
Oncology
CNS
Previous nominal practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company or CRO
Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines
Good command of written and spoken English language

191

Clinical Research Pre-award Professional Resume Examples & Samples

Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
One (1) year of budget development, grant and/or contract experience
Two (2) years of clinical research coordination experience
Experience working as part of a multidisciplinary team
Experience working with human subject research regulations
Experience coordinating clinical research studies and reading clinical trial protocols
Previous clinical trial budgeting, grant and/or contract experience
Thorough understanding of UCD fiscal policy and the regulations set forth by sponsoring agencies
Ability to change and/or develop departmental policies to ensure the department(s) is within compliance
Independent judgment as well as self-directed work capabilities
Ability to learn the University’s InfoEd system and procurement related functions
Ability to interact with faculty, sponsors, PRAs, trainees, and the administrators on a regular basis. Communication will be across departmental and central administration lines
Professional business conduct and an ability to maintain effective lines of communication are required
Ability to prioritize and handle multiple competing deadlines is a must
Proficient knowledge of Microsoft Excel and Word
Individual must be very well organized, detail oriented, and able to work independently
Working knowledge of human subject research regulations and experience coordinating clinical research studies and reading clinical trial protocols

192

Clinical Research Coordinator Associate Resume Examples & Samples

Experience with social science research
Proficiency in positron emission tomography imaging software such as PMOD
Proficiency with database management including REDCap
Eagerness to learn image analysis techniques such as FreeSurfer, DtiStudio

193

Clinical Research Coordinator Associate Resume Examples & Samples

Strong knowledge of basic concepts in family planning, such as major contraceptive methods and clinical abortion methods
Direct experience in a clinical setting where abortion is provided
Experience in health education and/or counseling to family planning patients
At least two years of direct clinical research experience

194

Specialist Clinical Research Monitor Resume Examples & Samples

Conduct site qualification, initiation, remote and interim monitoring and study closeout visits under the guidance of the manager
Be responsible for monitoring and reporting the progress of the trial and for verification of data
Bachelor’s Degree, preferably in a clinical science/nutrition/nursing field or Associate's Degree/RN with relevant clinical experience is required
One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company
Good planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
Good written and verbal communication skills; attention to detail and strong interpersonal skills
Good observational skills, analytical and conceptual capabilities
Strong ability to work independently or with a team with minimal supervision
The Monitor is accountable to Clinical Project Manager. The Monitor conducts clinical site monitoring visits according to the monitoring plan, ensuring Abbott studies are conducted according to all applicable regulations and business processes

195

Clinical Research Associate, Oncology Resume Examples & Samples

To work as part of an international clinical team which is led by the Clinical Trial Manager
To be responsible for ensuring that, at the site level, the Clinical Monitoring Plan is implemented
Ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework
Excellent knowledge of Good Clinical Practice (GCP)
A good working knowledge of conducting clinical trials in general and specifically in oncology, ideally including haematological oncology (ie. Lymphomas, leukemias etc)
Fluency in both Italian and English (spoken and written) is essential
Valid drivers’ licence and ability to travel throughout Czech Republic

196

Clinical Research Associate, Oncology Resume Examples & Samples

Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
Gains an in-depth understanding of the study protocol and related procedures
Experience monitoring complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Transplant, etc
Valid driver's license
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information effectively
Proven Skills in Site Management including management of site performance and patient recruitment
Demonstrated high level of monitoring skill with independent professional judgment
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
Able to work highly independently across multiple protocols, sites and therapy areas

197

Manager, Clinical Research Resume Examples & Samples

Leads and coordinates research activities administered by OneFlorida Clinical Research Consortium. Meets with investigators and reviews potential protocols for fit, feasibility, and implementation for the consortium. Serves as the point person for the protocols and their development. Executes community-based pragmatic and implementation science research throughout the State of Florida. Directs the research and evaluation work conducted by the OneFlorida CRC team, both at the University of Florida and with teams housed in the OneFlorida CRC's academic, health system, and health payer partners throughout Florida. Ensures that systems are in place for the effective, efficient, and accurate conduct of funded studies and clinical trials
Responsible for the ongoing workload assessment and reassignment of work as needed Manages resolution of problem solving for issues arising from the conduct of research activities and directly supervises day-to-day activities of the OneFlorida Integrated Clinical Research Program (ICRP) to include
Work with the Maintenance of Certification coordinator to develop, implement and track research-based educational programs for community clinicians linked to OneFlorida--supported research projects and best practices. Assist with Maintenance of Certification and Continuing Medical Education program development
Work with the ICRP Coordinator whom directly supervise the Practice Research Facilitation team and whom facilitates the Clinical Champions and Health System Engagement
Supervise the OneFlorida IRB coordinator including: helping to develop workflow processes, track practice involvement in ICRP studies and monitor ICRP studies as they move through the OneFlorida IRB
Works with the OneFlorida Leadership to develop research proposals and grant applications. Leads development of research proposals that will use the OneFlorida CRC infrastructure to conduct research with internal and external investigators. Works in conjunction with the PIs to develop research proposals that are scientifically rigorous, logistically feasible, and important to the OneFlorida CRC mission and membership. Works with the PIs and the OneFlorida Chief Operating Officer (COO) to create and execute budgets appropriately for the work proposed
Facilitates coordination across projects and project partners to support statewide initiatives and research programs, including activities related to the CTSI and the OneFlorida CRC. Ensures that relationships with entities involved in the programs lead to appropriate levels of commitment and use of resources to achieve programmatic goals, performance metrics, and service delivery. Ensures the research team adheres to policies and procedures, meets compliance guidelines and goals are met within specified timelines
Advises and coordinates with Program Directors and PIs regarding financial and operational planning, strategic planning, budgeting, auditing, program direction, project management, contract review, and supervision of associated administrative activities
Acts as liaison for OneFlorida with partner, investigator, sponsor, and internal/external stakeholders. This includes but is not limited to conference exposition, presentations, and meetings as requested
Responsible for understanding policies and procedures related to the programs, and developing and implementing procedures for the programs/service area
Master's degree preferred in Social/Behavioral Sciences, Public Health, Health Services Research, Economics, or a related field
Two years' experience in working within and/or conducting pragmatic, observational, and community-based health care projects
Attention to detail, particularly with regard to implementing project protocols and in terms of collecting data to ensure data accuracy and integrity
Ability to work independently and to collaborate with a variety of community leaders and members, health care providers, faculty and staff

198

Commercial Product Manager Life Sciences & Clinical Research Resume Examples & Samples

Develop and implement business plans with specific regard to the category (e.g. Life Science) to ensure that European Product Management strategy is delivered at a local country level in an effective and appropriate manner. This includes language, pricing, sales force communication, supplier and marketing liaison. Processes should enable two-way communication, so that central strategies can be delivered locally, but also local market input can be fed back to the centre to ensure that strategies are executed in the most effective manner
Candidates must have a bachelor’s degree in business, operations, or a scientific field. An advanced degree in business or science is preferred
Candidates must have 3 - 5 years of progressive commercial experience and ideally experience in working in a customer facing environment for a similar time
Potential candidates should have relevant experience in at least two (and preferably more) of the following areas

199

Clinical Research Study Specialist Resume Examples & Samples

Proactive in identifying issues/project risks
Strong communicator, written and verbal both internally, and externally (clinical sites and vendors)
Scientifically minded; prior experience in protocol design and submission

200

Clinical Research Associates Resume Examples & Samples

Join a stable team of 90 CRAs across Russia and benefit from outstanding training and development, both initially and throughout your career
ONCOLOGY Focussed
Minimum of one year of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)

201

RN Clinical Research Coordinator Resume Examples & Samples

Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability
In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and thoroughly documents all findings
May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians
Attention to details and accuracy

202

Clinical Research Enrollment Assistant Resume Examples & Samples

Clinical Research Coordinator, or RN/LPN with research/Data entry experience
Proficient with computers including data entry, MS Office, and email
Cardiology experience Required

203

Clinical Research Coordinator Associate Resume Examples & Samples

Experience with database, data management, FDA regulations, IRB requirements and the Stanford clinical research environment highly desirable
Ability to determine workload priorities in an appropriate way to accomplish tasks and goals, meet deadlines and anticipate and solve potential problems
Experience with patients or research subjects
Experience with basic statistics
Good oral and written communication skills to effectively work with physicians, clinical staff and other health care professionals
Proficiency with Microsoft Office, Word, Excel and various industry-oriented electronic data capture programs
Excellent organizational skills and attention to detail in maintaining accurate, retrievable records

204

Clinical Research Coordinator Associate Resume Examples & Samples

Strong computer programming skills (especially Matlab)
Strong data analysis skills
Experience with signal processing and statistics
Experience with server maintenance

205

Clinical Research Coordinator Associate Resume Examples & Samples

2 years of prior work experience
Experience working on study protocol submissions and modifications
Experience obtaining bio specimens and archiving samples
Excellent oral communication skills to effectively work with other research and administrative support staff
Ability to work well and communicate effectively with subjects and families

206

Clinical Research Data Specialist Resume Examples & Samples

Reads and understands clinical data from medical records. Extracts and enters required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs)
Maintains currency of research regulations including rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback
Interfaces with sponsors of externally sponsored trials. Provides timely data entry, plans and organizes monitoring visits and responds to inquiries
Performs follow up for study patient survival by reviewing medical records. Contacts other institutions for data on patients hospitalized at other institutions
Interacts closely with quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in-house, National Cancer Institute (NCI) sponsored and Cooperative Group studies. Discerns basic data discrepancies/protocol violations. Assists in obtaining outside documents and study specimen procurement and handling
Attends new protocol start-up orientations. Completes required protocol specific training
Assists in preparation of audits of assigned studies such as National Cancer Institute (NCI), Food and Drug Administration (FDA) and pharmaceutical audits
Completes spreadsheets for industry studies in real time to ensure sponsor is invoiced appropriately and timely
Ensures confidentiality, accuracy, security and appropriate access of all data and records

207

Clinical Research Monitor Resume Examples & Samples

Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies
Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
Communicate visit findings with site personnel, ensure relevant follow-up
Identify site needs, provide solutions to facilitate the clinical trial process
Act as a primary point of contact for study sites as requested
Assist in initial and ongoing site personnel training as required
Attend Investigator and/or Coordinator meetings
Lead all relevant monitor responsibilities

208

Rtg-clinical Research & Medical Evidence Specialist Resume Examples & Samples

Bachelor’s degree in life sciences or other technical discipline
Experience in clinical research, specifically in clinical project management and governance
Knowledge of local evidence needs, laws & regulations, including Good Clinical Practice, NHMRC, MTAA and TGA guidelines
Knowledge of clinical monitoring functions, scientific or clinical research and the scientific method, including study design and implementation
Masters or PhD preferred
Strategically and clinically minded with an eye on the bigger picture
Driven, reliable and resilient with a “can do” attitude
Ability to understand mindsets of other stakeholders in commercial and functional roles and speak their language
Customer-focused with a clear record that demonstrates the ability to build solid relationships with external and internal stakeholders at all levels
Team-oriented, outgoing, collaborative and friendly
Strong judgment and interpersonal skills
Ability to work effectively whether independently/ unsupervised or in cross-functional teams and in a matrix organisation
Able to prioritise, handle multiple tasks and work under pressure
Strong communication and presentation skills. Ability to understand and communicate complex concepts and ideas in a way that connects and engages the audience
Personal passion for sharing knowledge and facilitating the development of others
Excellent organizational and project management skills
Attention to detail
Model Medtronic Leadership Expectations & Behaviours
Shape: Committed to being experts in what we do, with a clear vision of where we are going and the plan to get there - Thinks critically and makes sound decisions by engraining “patients, people and profits” as the way we prioritize & drive decision making
Engage: Partner with others knowing that diverse talent, skills & perspectives lead to better outcomes – foster an environment of diversity, inclusion and engagement
Innovate: Bold thinker who creates new ideas and bring out best solutions forward to benefit out patients, and customers – generate breakthrough ideas by creating an environment that supports experimentation, and responsible risk taking
Achieve: We do what we say we are going to do, delivering results with the highest standards – drive accountability, start by establishing your personal brand, for delivering results

209

MC Clinical Research Monitor SH Resume Examples & Samples

Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. Masters degree will substitute for 1 year of experience. A PhD or MD will substitute for 2 years of experience
8+ years’ experience in device, biotechnical and/or pharmaceutical industry clinical trials
Familiar with Medical Device and/or combination product trials and regulations
Expertise with GCPs and regulatory and compliance guidelines for clinical trials
Significant knowledge of clinical and outcomes research study design
Demonstrated ability to work effectively on cross-functional teams
Local language and English skills
Experience working with customers
Ability to deal with complexity and ambiguity even in the face of adversity
DESIRED/PREFERRED QUALIFICATIONS
Advanced Degree MS or PhD or MD
Experience in conducting clinical trials in cardiovascular therapeutic indications

210

Clinical Research Prin Program Resume Examples & Samples

10+years project/program management in a high tech or medical industry
10+ years experience successfully implementing substantial projects
5 years progressive leadership experience
MBA or masters degreeIT/ BioMedical / Project Management
Expertise with MS Office (particulary Excel, Word, Powerpoint)
Experience developing end user programs (training, communications, technology initiatives)
Fiscal management, budget tracking, and reporting skills
Previous experience succeeding in a global organization
Global Mindset
Change Management experience

211

Clinical Research Monitor Germany Resume Examples & Samples

Two years Clinical Research experience (one year of Clinical Monitoring preferred)
Expertise in GCP, ISO 14155 (preferably) and regulatory requirements in Germany/Austria
Business knowledge or experience within the medical/healthcare industry

212

Analyst, Clinical Research Resume Examples & Samples

Works with Director of Country Operations to design and operationalize a strategy for data analysis and visualization supporting the region
Assess data coming into and exiting the country and presented to project teams, headquarters or other interested parties for appropriate accuracy, fit, impact analysis, and presentation
Supports country leadership team with data analysis and presentation for reporting and infrastructure measures to operationalize country strategy including: problem assessment, project planning, project implementation and assurance of ongoing project maintenance and monitoring
Works closely with CRDs, Head of Site Account Managers and Head of COMs in the provision of metrics and measurements that monitor country performance or specific country/project initiatives
Runs alternative scenarios/Impact analysis when supporting managers for country manpower/human resources assessments or determining individual trial human resource needs
Conducts all analysis/assessments/reports utilizing appropriate fiduciary principles supported by company and country leadership team
Works cooperatively with all headquarters based colleagues collecting and tracking country and global performance
Maintains knowledge and awareness of all new Merck systems for understanding reporting and analytical capabilities
Fluency in Microsoft Excel
Fluency in presentation/analytics Business Intelligence (BI) software packages (may include SpotFire, Clik, Tableau, or other similar tools)
Proven track record in supporting data/metric collections, data organization, data cleaning, data analysis, data visualization and presentation
Knowledge, awareness, and experience in clinical trial operations in a pharmaceutical company

213

Clinical Research Coordinator Healthcare Resume Examples & Samples

Oversee participant recruitment activities and maintain participant tracking systems
Oversee data collection, analysis, and presentation
Assist PIs in planning and preparation of presentations of research findings, including writing and editing reports and articles for publication
Assist PIs in development of grant proposals and manuscripts, including proposals for new and/or continued research activities
Hire, train, and supervise project personnel; develop and manage project teams and team meetings
Develop timelines and project schedules; develop process documentation; ensure that all human subject protections are in place; oversee and monitor project budget
A bachelor’s degree in health related field, preferably in nursing or public health is required; Master’s degree preferred
One (1) to three (3) years of demonstrated work experience on research projects with vulnerable subjects and project administration and the ability to manage research protocols and data
Is or has the ability to become PEERRS certified
Experience with reporting software and interpreting analysis
Candidate must have excellent oral and written communication skills, attention to detail, strong interpersonal skills, and organizational skills
Demonstrated proficiency with Microsoft Office products (including Outlook, Word, Excel, and PowerPoint); expertise with reporting software and interpreting analysis

214

Research Assistant Clinical Research Resume Examples & Samples

Administer questionnaires, and assists with procedures for obtaining patient screening and recruitment as well as obtaining research specimens
Assist in obtaining educational resources necessary to perform and interpret research and to remain abreast in research area of function
Maintain a safe clean laboratory-working environment including appropriate equipment maintenance and usage, by conforming to laboratory and hospital policies and standards
Maintain laboratory inventory, including timely ordering and receipt of required supplies and their proper storage
Perform approved research projects according to defined protocols and procedures including appropriate collection, recording, storage and analysis of data and reporting of results
Prepare, label, store and disposesof reagents, and calibrates equipment for research projects
When position is required to work within the outpatient clinic, assist with patient care activities to ensure efficient and appropriate service
Bachelor of Science degree in chemistry, biology or other basic science or Bachelor of Arts degree in a science or health related field with a minimum of 15 credit hours in related science courses
Interest in clinical research and women's health issues is strongly preferred
Manual dexterity and visual acuity necessary for handling and processing specimens for testing, including preparation of specimens, operation of laboratory equipment, microscopic examination, etc
Demonstrated ability to accurately collect, store and interpret research data
Demonstrated ability to communicate with patients, staff and investigators

215

Certified Clinical Research Coordinator Resume Examples & Samples

Interprets complex clinical research data
May prepare and ensure grant applications, IRB / GCO documents are submitted
May obtain informed consent under general supervision of the Investigator(s) and educate participants regarding study requirements

216

Medical Assistant, Clinical Research Center Resume Examples & Samples

Checking schedules and organizing patient flow; accompanying patients to exam/procedure room, assisting patients as needed with walking, transferring, dressing, collecting processing specimens and point of care testing, preparing for exam, etc
Assists physicians with various procedures, takes vital signs, relays instructions to patients and or families; answers calls and provides pertinent information
Fulfills clerical responsibilities as assigned which may include sending and receiving patient medical records, obtaining lab or x-ray reports, hospital notes, referral information, etc. Completing forms and requisitions as needed, managing charts to ensure information is completed and filed appropriately
These responsibilities may be carried out using the electronic medical record (EMR) system or manually as necessary
Enters orders into the electronic medical record (EMR) system or prepares prescription refill requests on behalf of the physician for the review and approval by the ordering physician
Inventories, orders or re-stocks medical supplies as applicable
Provides set-up of examination room and instruments in accordance with proper sterilization techniques established by hospital and infection control policies
Maintains logging system as required for refrigeration of medications, point of care testing, sterilization process, crash cart or others as needed
Checks expiration dates on all medications and medical supplies disposing appropriately as per institution policy
Maintains a safe, secure, and healthy work environment by following standards and procedures and in compliance with legal regulations
Complies with established personal protective equipment requirements necessary for protection against exposure to blood and other potentially infections body fluids, chemical disinfectants, radiation and other hazardous substances
Assists in the maintenance of medical charts (filing, Op Reports, test results, home care forms)
May schedule surgeries/procedures or work in conjunction with Surgical Coordinator verifying times with patients; preparing charts, pre-admissions and consent forms as necessary
May be required to perform proficient phlebotomy duties
May perform appointment scheduling and registration for patients as well as updating patient demographic and insurance information
May maintain, adjust and confirm patient office schedule
May check and verify & update insurance information utilizing internal or web sources
May perform and verify pre-certification for procedures as necessary
Provides training and mentoring to Level I MA staff
Directs and assigns MA schedules and work flow to meet the needs of the practice and applicable to patient volumes
Oversee the successful delivery of clinical office support to meet the needs of each physician
Performs other duties and tasks as required

217

Associate Clinical Research Coordinator Resume Examples & Samples

Assists with the collection, maintenance, and storage of relevant clinical data including electronic data entry, case report forms, patient follow-up and regulatory binders in accordance with the study sponsor and all regulatory bodies
Assists with the planning and coordination of regulatory activities pertinent to clinical trial operations, including but not limited to: interfacing with local and central IRBs, assuring patient safety and organizational compliance with institutional, local, state and Federal policies/procedures, regulations, guidelines, and laws
Assists senior-level research coordinator staff with patient screening, education, consenting, monitoring, and evaluation for protocol accrual

218

Clinical Research Coordinator Pediatrics Resume Examples & Samples

Ethical and participant safety considerations. Maintainfamiliarity with the ethical conduct of research and safeguards neededwhen conducting research.Train junior staff in the ethical conduct of research. May help in thedesign of studies so theyinclude specific safeguards to ensure ethical conduct and protectvulnerable populations.May develop, or assist with the development of, documents related tosafety and security.Communicate to research participants the difference between clinicalactivities and researchactivities, and the risks and benefits of study participation
Data management and informatics. Use and train others inElectronic Data Capture (EDC) systems, technologies, and softwarenecessary for studyoperations.Score tests, enter data, and complete Case Report Forms accurately andaccording to protocol.Assistwith the development of, or develop, data collection documents andinstruments. Detect issuesrelated to data capture, collection or management; suggest solutions.Investigate incomplete, inaccurate, or missing data/documents to ensureaccuracy andcompleteness ofdata; follow and develop, or assist with development of, SOPs for dataquality assurance. Adheretoprocesses and run queries, summaries, and reports to monitor thequality of data. May develop QAprocesses and oversee the creation and use of queries, summaries, andreports for qualityassurancepurposes. May be responsible for recognizing trends related to dataquality and escalating asappropriate.Map protocol data flow. Predict areas of vulnerability for a protocoldata flow plan. Determineareas where data provenance may be compromised and develop solutions.Recognize when data agreements or special regulatory requirements arenecessary; mayassemble thenecessary parties to ensure that all agreements are in place
Scientific concepts and research design. Understand and train othersin the basic concepts ofstudy design. Independently conduct literature reviews. Assist with thedevelopment of, or develop,proposals or protocols; identify shortcomings of proposals andprotocols.Identify various stakeholders (statistical, operational, etc.) toensure adequate design,implementation, and testing of study aims. May determineoperational/statistical elements neededforconduct of clinical and translational studies
Leadership and professionalism. Assist research colleagues inidentifying efficiencies andimproving process. Successfully take part in or lead a committee ortask force. Actively seek outcontinuing education opportunities for self and study team members.Participate in or leadscientific presentations and publications.Assign, review, and train others in various work responsibilities.Serve as a mentor to juniorstaff, including other CRCs. Employ escalation and performance plans asneeded.Recognize and employ the professional guidelines and code of ethicsrelated to the conduct ofclinical research; summarize and clarify for study teams. May beresponsible for identifyingpotential problems and risks to the participants, study, and institution
Study and site management. Participate in sponsor-requiredtraining. Obtain information for or coordinate operational plans formultiple research studies. Develop protocol-specific systems and documents including processflows, training manuals,SOPs, andCRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial studymilestones and report appropriately. Coordinate with financial teams,PRMO, etc. Assist withstudybudgets.Prepare for, take part in, and potentially lead site initiation,monitoring, closeout visits, anddocument storage activities.Collect information to determine feasibility, recruitment and retentionstrategies. May makerecommendations to investigators and oversightorganization(s).Maintain compliance with institutional requirements and policies.Oversee maintenance ofDelegationof Authority Logs and training of KP on study specific duties
Communication and team science. Prepare for and lead teammeetings. Take an active role in including others in decision-making,and escalate issuesappropriately.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

219

Clinical Research Team Manager Resume Examples & Samples

Actively involved in the recruitment, hiring, orientation, ongoing training, and retention of CRSO staff. Supervise and guide a team of clinical research coordinators through established problem solving process for setting up and maintaining clinical research projects. Monitor outcomes and suggest departmental changes to make training and management process more effective and/or efficient. Identify areas for improvement and make recommendations for re-allotment of resources, as needed
Performs ongoing performance management activities including the ImPACT evaluation. Ensures staff is appropriately trained to perform the tasks delegated to them, and ensures staff have appropriate required skills, e.g., CPR, to perform job responsibilities
Assist CRSO leadership in evaluating new study protocols and current staff workloads to assist in determining the distribution of new projects/workloads
Develop and maintain tools, processes, programs, and standard operating procedures (SOPs) designed to support the conduct of clinical research
Quality Assurance: Work with Principal Investigators to ensure Regulatory and Institutional Compliance for all study protocols supported by direct reports
Assure appropriate regulatory compliance, IRB approval and renewal, and appropriate training of all research personnel
Ensure coordinators are adhering to best practices including confirmation of subject eligibility, proper informed consent process & documentation, and protocol adherence
Conduct quality assurance reviews/audits on CRSO-supported projects to ensure protocol compliance, accuracy of data collection, adherence to regulations and applicable good clinical practice guidelines. Audit reports will be created and submitted to Associate Director and Director
PI satisfaction: Ensure team coordinators meet with and maintain weekly communication with all study PIs regarding study progress, status, enrollment and other pertinent issues, as necessary. Team Manager should attend these meetings as needed
Clinical Research Budgets and Billing Compliance: In collaboration with the Associate Director CRSO and Clinical Trials Financial Management (CTFM), assist in the development of staffing budgets that appropriately cover costs of study implementation. Also monitors to ensure billing compliance through adherence to CHOP research billing processes
Trial Enrollment: Work with coordinators and PIs to strategize recruitment methods for studies to ensure accrual objectives are met
Quality Improvement Initiatives: Work with CRSO management team to identify, develop, and implement quality improvement initiatives
As a member of the CRSO management team, provide administrative leadership and oversight to coordinators, , including guidance on GCP, protocol conduct, etc. and provide pertinent updates to Associate Director and Director in a timely manner
Demonstrate an ability to lead and motivate team members with vision, integrity, and flexibility
Work with Director and Associate Director to develop, organize, maintain, and manage the infrastructure and resources necessary for supporting quality clinical research
Participate in Research Institute-sponsored education and training activities as requested
Bachelor’s Degree with minimum 7-9 years clinical research experience or a Masters Degree in Public Health (or related field) with at least 5-7 years clinical research experience
Experience with IND or IDE clinical trials
Demonstrated ability to work independently and drive processes
Demonstrated ability to manage projects and/or teams
Registered Nurse (RN) in the state of Pennsylvania preferred
Pediatric experience preferred

220

Field Clinical Research Associate Resume Examples & Samples

Ensuring adverse events and protocol deviations are reported in an efficient manner
Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
Coordinates with study teams, field clinical engineers or designee to: Enroll sites into new and ongoing clinical studies - Facilitate enrollment of study subjects via site coordinators - Facilitate resolution of data queries and action items at clinical sites - Promptly reports the findings of monitoring visits according to SJM processes
Participates in conference calls and training sessions
Mentors less experienced clinical team members as requested
A Bachelor’s degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field
Minimum two years clinical research monitoring experience
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees
Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment

221

Clinical Research Analyst Resume Examples & Samples

Minimum of five (5) years broad scope clinical experience required
Certification in Healthcare Quality, Managed Care, HIAA, Credential, Risk Management or Legal Nurse Consultant preferred
Demonstrate familiarity with applicable regulatory guidelines and requirements (URAC, EQRO), with at least two years managed care experience, experience with regulatory or accrediting body requirements and Clinical Quality Improvement experience preferred
Prior experience with Home Health, Quality Improvement, Health Risk Management or Legal Nurse Consulting preferred
Possess an understanding of broad range of business needs, goals and objectives and the potential impacts of each, including but not limited to Contracts and Network Management, Legal, Member Services, Complaints and Grievances, Utilization Management, Population Health, CHOICES and Credentialing
Demonstrate effective written and verbal communication skills
Must be self-motivated and able to manage multiple task and priorities within specified timeframes
Proven PC skills with Microsoft Office, specifically Word and Excel
Strong analytical skills with understanding of basic statistics required
Demonstrate proficiency in medical record review and creation of medical chronologies for case review
The ability to analyze and interpret data for standard of care with presentation to a varied audience
Demonstrate excellent logic, systematic and critical problem solving skills
Demonstrate proficiency with computers and diverse software packages

222

Clinical Research Prog Lead Resume Examples & Samples

Bachelor's or advanced degree preferred in nursing, biology or other health science field, operations research, or other related field, or equivalency
Minimum five (5) years' experience and demonstrated skills to successfully perform the assigned duties and responsibilities, i.e. coordinating research projects under specific guidance, training and/or experience in research methodology/research study design, hypothesis testing; OR experience in clinical trials protocols involving research methodology/research study design, and hypothesis testing
Five (5) years of progressive leadership experience preferably in the clinical research industry
Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations
Ability to assess functional processes, workflow and develop documented improvement plans for efficiency and quality output
Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities; (i.e., complex trial designs, data standards, data reviews, etc.)
Clinical Trial Management Software experience (i.e., Clinical Conductor, OnCore, Velos)
Demonstrated ability to positively influence others in a team environment
Proactive and critical evaluation of multiple aspects of clinical trial execution Background knowledge of assigned department's area of specialization
Attention to detail; strong interpersonal and collaborative skills; excellent, effective verbal and written communication skills and the ability to multi-task in a fast-paced environment while working with a diverse subject population
Proficient in Excel, PowerPoint, and graphics programs
Health Information and Accountability Act (HIPAA)
CHR regulations for recruitment and consent of research subjects

223

Manager, Clinical Research Resume Examples & Samples

Accountable for the management of the Clinical Research Department and all direct reports
Conducts interviews, makes hiring decisions in conjunction with senior management, ensures adequate staffing, and conducts training, orientation, and mentoring of new employees
Assists in the development of the team’s goals and performance metrics and the analysis of established objectives
Effectively communicates performance metrics to the clinical research team and ensures training needs are met
Conducts the performance evaluations of direct reports, addresses noncompliance, and recommends corrective measures through progressive performance management
Collaborates with planning and scheduling teams to ensure effective utilization of study resources
Participates in study initiation and audit meetings for project team assignments
Establishes quality standards for the department, identifies opportunities for improvement, and recommends updated standards
Responsible for the development, maintenance, and revision of Standard Operating Procedures and study specific procedures
Works closely with other departments to maintain project progress and issue resolution through weekly meetings and tracking tools
Reviews upcoming projects for feasibility and assists with resource planning to meet study requirements
Participates in the review of pre-study documents as necessary to ensure protocol compliance and quality
Closely monitors the progress of each clinical study team to ensure consistency and quality in performance
Acts as a liaison with the sponsor as necessary
Represents the organization, both internally and externally, as a source of consultation, information, and expertise
Provides input and ensures compliance to department budget requirements, including budgeted study hours

224

Principal Clinical Research Associate Resume Examples & Samples

Provides leadership in complex clinical research activities including: reaching agreement on study goals with other functional areas, coordinating and overseeing study monitors and investigators to ensure compliance, monitoring, analyzing and interpreting study data, and preparing reports
May contribute to the design of clinical studies. Independently plans and implements complex or significant clinical research studies and projects
Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organization
Plans own work assignments; may plan and/or delegate work to others
Assumes responsibility for coordinating the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific objectives
Maintains a high level of professional expertise through familiarity with scientific literature, RMS product portfolio and competitive environment
Travels to field sites to monitor studies or coach and train co-workers at the CRA level and below
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
May recruit, train, and manage co-workers and contract workers for specific projects
Collects and maintains legal and regulatory documentation, as applicable
Coordinates or conducts reference material testing in-house
Organizes investigators meetings, as necessary
May represent the Company as primary contact on projects
Interacts with senior management from other RMD departments or Roche companies on significant matters often requiring coordination between departments/organizations
May lead project teams to solve business problems of moderate size risk and complexity
Assists investigators with publication activities

225

Site Clinical Research Associate Resume Examples & Samples

Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators
Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function
Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment
Demonstrated business ethics and integrity

226

Clinical Research & Laboratory Operation Manager Resume Examples & Samples

Apply project management best practices in the development, initiation, planning, execution, control and closing of project
Manage the research administration of the projects. Manage budget and maintain accounts
Oversee adherence to SOPs, Good Clinical Practice and FDA regulations
Assist the PI on the review of agreements, MTAs, DTAs, patents and other documents
Develop and maintain program timeline and actively manage project progress
Define problems, troubleshoot, and identify potential solutions
Problem solve at a strategic level and work well with others to reach solutions, careful planning to achieve accurate and timely results, and the ability to work independently and well under pressure to ensure tasks are prioritized to meet aggressive deadlines
The CIBS Brinton Laboratory and Clinical Research Operation Manager will work directly with the PI, Brinton research laboratory staff and Clinical Operations Director
Bachelor’s of Science degree
Five (5) years experience in clinical trial, research and grant proposal preparation and management
Two (2) years’ experience managing multidisciplinary projects
Five (5) years experience managing multidisciplinary projects
Excellent negotiating skills
Experience in laboratory equipment procurement
Demonstrated ability to analyze information, situations, problems, policies and procedures and adjust strategic decisions and course corrections as a result
Ability to work independently and under pressure in an innovative academic environment with minimal supervision
Ability to establish and maintain cooperative working relationships with vendors, staff, program leaders, and administrators
Track record of managing multiple concurrent tasks, responsibilities, and changing priorities, while maintaining personal momentum and effectiveness
Excellent organizational, critical thinking, and decision making skills
Track record of successfully executing multifaceted projects, hitting deadline

227

Clinical Research Medical Director Resume Examples & Samples

M.D. degree
Two or more years of clinical research experience and/or basic science research
Accredited fellowship in Cardiology, board certified or equivalent
5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in dyslipidemia, cardiology, or endocrinology

228

Director of Clinical Research Operations Resume Examples & Samples

Provides strategic direction for clinical research office, to include establishing short and long term goals and desired outcomes
Provides expertise in planning, analysis, and reporting key departmental metrics related to clinical trial performance
Provides leadership and guidance on clinical research grants/contracts management
Responsible for achieving financial objectives for the research office, including: preparation of annual budgets for clinical research needs, justification of and approval for research office expenditures, analysis of labor cost variances (budgeted vs. actual), and routine communication of findings to departmental leadership
Collaborate with department and campus entities in the negotiation, coordination, administration and clinical trial contracts; ensure review of clinical trial agreements and sponsor budgets to ensure language of exhibit agrees with the main body of the clinical trial agreement
Responsible for clinical trial tracking systems for management of clinical trials to ensure adequate and appropriate workflow assignments for clinical research office personnel and appropriate resource utilization
Responsible for the framework of the departments overall clinical research office infrastructure
Management and oversight of staff at multiple locations of geographically distributed locations, including hiring, training, managing, performance assessment, mentoring of supervisors, professional & support staff. Initiates, influences & creates developmental opportunities for staff. Oversee space utilization and allocation as needed
Prepare coordinate, and maintain program content and delivery methods for daily operations and events within the department’s clinical research operations
Ensure that all protocols and study budgets are reviewed for feasibility prior to their submission to the department Executive Research Council and campus entities
Examine and evaluate program effectiveness, and makes changes as necessary
Develop, maintain, and implement policies and/or services by establishing standards operating procedures compliant with federal and state regulations, measuring results against standards and making necessary adjustments. Regularly review and maintain familiarity with current policies and procedures
Critically analyze performance data (audit and monitor findings) to monitor and evaluate effectiveness of policies revising program operating policies and procedures as needed
Organize and/or participate in various committees and teams to consult with program heads and administrative officials on policy and program needs as well as various administrative issues
Coordinate the regular publication of summary reports and serve as an information resource to coworkers, the department, the university, and external figures

229

Manager, Clinical Research Resume Examples & Samples

Participate in the development and coordination of protocols, informed consent forms, investigator brochures, clinical study reports, IND annual reports, and other documents, to ensure a thorough understanding of the goals and objectives of the proposed study
Manage the conduct of single and multicenter studies, including site selection, development of monitoring plan, communication plan, site budgets, and investigator meeting. Present protocol at investigator meeting. Develop study-specific EDC system and manage timeline of creation of the database before study start
Effectively manage the clinical staff (e.g., clinical research associates, administrative assistants) assigned to the study in order to meet study objectives
Lead and direct the study team, which includes individuals from various clinical and functional departments. The number of team members varies dependent upon the phase and complexity of the study
Maintain relevant FIPCUS internal tracking systems, including all clinical study management systems, by communicating with and obtaining input from the individuals and departments involved
Review and approve all study expenditures and bills, coordinating with the accounting department. Ensure decisions are made according to plan
Maintain ongoing communication with FIPCUS management regarding study progress, enrollment, and any problems encountered during the study. Trouble-shoot throughout the course of the study to resolve any issues arising at study sites, or with monitors and CROs
Travel to sites and other Ferring facilities as required
Ensure that the conduct of all studies follow local or global Ferring SOPs and regulatory requirements
Develop, negotiate and track study budgets and contracts including those pertaining to: CRO, Lab vendor, Sites, other miscellaneous vendors

230

Senior Site Clinical Research Associate Resume Examples & Samples

Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements
If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials
If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors

231

In House CRA Needed for Clinical Research Site Resume Examples & Samples

Ensures adherence to Compass policies and SOP’s
Performs compliance reviews on informed consent process documentation
Performs compliance reviews to ensure accuracy of inclusion/exclusion criteria to confirm Subject’s eligibility for participation prior to randomization
Performs compliance reviews on staff performance as it relates to adherence to protocol screening and randomization requirements and associated documentation
Performs routine and/or random compliance checks on overall study performance as directed
Excellent interpersonal and communication skills (written and oral)
Knowledgeable with Microsoft Office
Strong planning and organizational skills
Takes initiative
Minimum HS Diploma and/or GED Transcript
Minimum of2 years clinical research experience required

232

Clinical Research Comm Specialist Resume Examples & Samples

Identify, plan, and develop a range of digital and printed materials to support trial and project engagement among key stakeholders
Review and provide input on patient recruitment and retention plans; suggest innovative strategies to meet recruitment and retention challenges; engage critical stakeholders in DCRI-led projects
Provide input on technologic applications to optimize participant recruitment and facilitate site study operations and performance
Research social media and other trending technologies and suggest appropriate tactics to improve stakeholder engagement
Manage the translation process of relevant materials to reach diverse populations
Act as the team liaison for developing and finalizing content and relaying input on design and formatting options
Manage timelines and ensure that all materials are completed to the satisfaction of the DCRI clinical operation teams, principal investigators, and clients and are in compliance with relevant regulations, standard processes, policies, and procedures
Review and provide input during case report form (CRF) development
Collaborate with Clinical Data Management, Statistics, and Clinical Operations to create CRF guidelines/instructions. Maintain and update project and CRF terms databases
Provide input for the development of proposals for new work and project budgets
Collaborate with other functional groups within the organization to support project goals
Track and report feedback received to identify areas of success and improvement
Knowledge and experience in the coordination, planning, and implementation of communication strategies and tactics
Comprehensive therapeutic knowledge, including medical terminology
Working knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to understand and interpret clinical protocols and associated study specifications
Expertise in translating scientific, medical and complex concepts into more easily understood terms for various audiences
Strong communication and interpersonal skills, including a good command of the English language
Demonstrated ability to deliver quality results
Good team leadership skills
Strong software and computer skills, including proficient use of MS Word, WordPress, and Adobe Acrobat; SnagIt experience preferred

233

Clinical Research Navigator Resume Examples & Samples

Ensure Investigators and study teams are able to identify and connect with required resources within UMMS or UMMHC to accomplish research goals
Facilitate the connection to core services and develop and maintain standardized processes and guidance information on resource navigation necessary for implementation and performance of clinical research
Develop resources for and assist in connection of industry initiated study opportunities to appropriate Principal Investigator and study teams
Be the principal point of contact for the NIH Trial Innovation Network, assisting investigators in the conduct of multi-site NIH sponsored clinical trials
Define key strategies for optimizing cross-system efficiencies and shared policy development priorities, including research billing compliance
Collaborate with Director on assessment of existing Standard Operating Procedures and development of needed SOPs, including Good Clinical Practice
Serve as key resource and subject matter expert on the clinical trial management system and electronic medical records systems as related to research
Represent UMMS clinical research initiatives in cross-team and cross-institution working groups related to clinical research implementation in the UMMHC environment and inform parties regarding standard research practices
Advise and consult with clinical investigators and clinical research staff on individual study projects, focusing on feasibility, initiation issues and best practices
Support education and awareness on clinical research billing requirements for appropriate research billing
Advise investigators on navigation of the Investigational New Drug/Investigational New Device application process
Serve as a resource for OCR staff and study teams related to assessment of clinical costs in clinical research budgets
Bachelor degree in a health-related field, or equivalent experience
5 years of clinical study coordination or study management experience (drugs, devices)
Understanding of federal, state regulations and guidance related to clinical research
Understanding of Good Clinical Practice guidelines
Understanding of Clinical Research Billing requirements
Ability to work independently on multiple projects and prioritize confidential issues
Superior communication, organizational and interpersonal skills, attention to detail and ability to facilitate cross-system decisions
Ability to problem-solve and work under pressure in a deadline-driven environment
RN or Master’s degree in health-related field
Experience in an academic health center or hospital
Understanding of the Investigational New Drug/Investigational New Device application process
Certification as research coordinator or in other research domain preferred (CCRA, CIP)

234

Coord, Clinical Research Resume Examples & Samples

Participate in the development of protocol specific tools, (e.g., treatment data and/or therapeutic checklists) to aid with data submission
Extract and transcribe treatment data from hospital and clinical records required to complete study patient’s record and sponsor’s case report forms. Monitors quality and timelines of data submissions
Monitor status of all studies in database and ensures that all patient data (on-study and follow-up) are submitted, and respond to data queries from sponsoring organization, in a timely manner
Track and maintain accurate data of studies, accrual, and patient status activity in database
Maintain effective working relationships with research nurses and investigators participating in the study
Monitor strict adherence to protocols. Assure that cases are being finalized and reviewed by appropriate clinician
Review protocol requirements with physicians and research nurses. Identify and resolve issues with protocol compliance. Keep principal investigator and research nurse aware of any issues on compliance
Ensure that protocol document has current amendments. Inform staff and updates database
Provide data to study investigators as requested and submits data for analysis. Run quality control checks on data prior to transfer
Serves as a resource to physician and nurses to locate information for special reports and treatment decisions
Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices
Participate in all office staff meetings. Present current status of studies assigned
Participate in regularly held Protocol Review Committee meetings
Participate in the documenting work procedures specific to new studies
Perform other duties as required
Bachelor’s degree in a scientific or health care field, or equivalent experience
1-3 years experience in on-study data management and data collection in a research organization
Ability to read and understand complex protocols
Excellent computer skills including: proficiency in word processing; proficiency in relational databases
High degree or organizational and analytical ability to manage data collection and protocol adherence
Excellent interpersonal and oral communication skills
Good writing skills with the ability to compose correspondence

235

Coord, Clinical Research Resume Examples & Samples

Provide support to project through implementation of work plans, and preparation of deliverables. Assist in the documentation of project writing and preparation of material for project meetings
Review treatment protocols as they are developed to ensure that the treatment guidelines are consistent throughout the document and the appropriate documentation for the central reviews of research intervention as specified
Develop protocol specific tools (e.g., treatment data and/or therapeutic checklists) to aid with data collection and submission
Set up the protocol treatment template in the department’s database by abstracting the details of the protocol to aid in on-study patient tracking
Monitors status of all studies in the database and ensures that all patient data (on-study and follow-up) are submitted, and responds to data queries from sponsoring organization, in a timely manner
Maintains effective working relationships with research nurses and investigators participating in the study
Monitors strict adherence to protocols. Assures that cases are being finalized and reviewed by appropriate clinician
Prepares regular reports reviewing the status of the study. Reviews protocol requirements with physicians and research nurses. Identifies and resolve issues with protocol compliance. Keeps principal investigator and research nurse aware of any issues on compliance
Monitors notices from the Cooperative Group to ensure that protocol document has current amendments. Informs staff and updates database
Provides data to study investigators as requested and submits data to the Cooperative Groups for analysis. Runs quality control checks on data prior to transfer
Participates in all office staff meetings. Presents current status of studies assigned
Participates in regularly held Protocol Review Committee meetings
Participates in the documenting work procedures specific to new studies
3-5 years experience in on-study data management and data collection in a research organization
Familiarity with clinical trials highly desirable
Professional certification in clinical research highly desirable; otherwise, attainment of certification required within two years of hire

236

Director, Regional Clinical Research Resume Examples & Samples

Selects principal investigator and sub-investigator staff with National Senior Director, Clinical Research Operations
Evaluates new protocols with selected principal investigator for potential new studies
Negotiates contracts and prepares budget for new studies
Oversees the preparation and maintenance of regulatory documents for new studies
Follows-up with sponsor/CRO grants and contracts office regarding clinical trial agreements and indemnification letters
Plans and designs new forms/source document tools to be used in protocol implementation
Coordinates activities for tracking financial with the Accounting department including A/P and A/R
Hires, trains and evaluates productivity and quality of work of clinical research staff using the annual performance appraisal
Develops a plan for resource allocation including budget preparation for program and staff needs
Assures that all aspects of the clinical research program is in compliance with current FDA regulations
Coordinates sponsor site visits with research staff
Complies with any and all reasonable requests in the event of a possible FDA audit and site visit
Maintains all clinical research records in a safe and permanent location to comply with FDA regulations
Generates reports for the National Senior Director, Clinical Research Operations
Preferred: Over 10 years of management experience
Working knowledge of Microsoft applications (Word, Excel, PowerPoint)
Knowledge of medical billing and office automation software

237

Werkstudent Clinical Research Resume Examples & Samples

Assistance in preparations for inspections and audits
Fee settlement for clinical trials
Scanning, archiving and delivery of study relevant original documents in the central
Review and updating of databases (Excel, Word, Access)
Document translations (German-English)
Planning and organizing meetings (external and internal)
Strong identification with the values of Celgene
Enjoy office work
Fluency in German and English
Good to excellent Microsoft Office skills, especially Excel
Thoroughness, attention to detail
Interest in clinical trials

238

Principal Clinical Research Associate Resume Examples & Samples

Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organizaiton
Plans owns work assignments; may plan and/or delegate work to others
Interacts with senior management from other RMD departments or Roche companies on significant matters often requiring coordination between departments/organziations

239

Clinical Research Finance Analyst Resume Examples & Samples

Minimum of 1-3 years relevant work experience (Medicare Coverage Analysis, clinical trial budgeting, healthcare billing) (Required)
Experience in an academic medical center, teaching hospital, or clinical research environment (Preferred)
Working knowledge of federal and state laws, rules, and regulations related to research and healthcare billing (Required)
Knowledge of FDA and Medicare regulations related to clinical trials (Required)
Ability to interpret clinical research contracts, budgets, protocols, and consent forms (Required)
Ability to effectively communicate at all levels (Required)
Possess customer service skills appropriate for a fast-paced, high-volume, dynamic work environment (Required)
Ability to prioritize a variety of diverse projects and their deadlines using exceptional time management skills (Required)
Ability to work in a team environment and motivate team members by example (Required)
Excellent verbal and written communications skills (Required)
Ability to identify routine and/or unique problems and implement appropriate solutions (Required)
Excellent interpersonal skills to effectively convey and explain information, influence outcomes and tactfully deal with diverse people, situations, and ideas (Required)
Maintain confidentiality (Required)
Operate with integrity and encourage trust (Required)
Self-motivated (Required)
Analytical (Required)
Proficient in an automated environment, including effective utilization of Microsoft Windows (Outlook, Word, Excel, Power Point)

240

RN Clinical Research Resume Examples & Samples

Bachelor's Degree in Nursing preferred
2 years of experience in Nursing is required
Previous experience in research nursing is required

241

Clinical Research Associates Resume Examples & Samples

Join a stable team of CRAs across France and benefit from outstanding training and development, both initially and throughout your career
Internal candidates
Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP

242

Clinical Research Resume Examples & Samples

Technical experience and knowledge of Customer Relationship Management (CRM) tools and technology to organize, automate, and synchronize marketing and customer service is highly preferred
Strong initiative and drive to develop and maintain innovative systems and techniques for participant recruitment
Warm, engaging personal style, able to evoke excitement in others with regard to the mission of the

243

Manager Clinical Research Resume Examples & Samples

6~8 years of relevant experience in the field of research as a manager, administrator and/or investigator
3~5 years management experience leading diverse teams
Oncology Research experience required
Oncology Clinical experience preferred
Knowledgeable of pertinent research federal and state regulatory guidelines
Experience in conducting individual and small group education and training
Experience in budgeting and negotiation and understanding of contracting language
Demonstrated track record in managing research projects and funds from foundations, corporations and government sources
Knowledge of Good Clinical Practices, International Conference on Harmonization Guidelines, FDA Guidance
Strong knowledge of clinical trials and other types of clinical and translational research
Travel to multiple Advocate Hospital sites and Corporate Headquarters for meetings required
Abiltity to exert up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects is required
Walking. Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another is required
Oversees day -to day operations and activities to support the start-up, conduct, and evaluation of clinical trial research activities of the center
Oversees the interface between research staff and the Institutional Review Board and other Advocate offices to facilitate the conduct and compliance of clinical research
Champions operational excellence by engaging in continuous improvement of processes, sharing of best practices, and participating in efforts to improve research within the center
Assesses and provides education and training of research staff and investigators
Partners to provide financial oversight related to research study project budgets
Ensures regulatory compliance of research center
Develops new business relationships to augment and advance the center and the Department of Research and Innovation
Manages center communications related to research study availability, enrollment, and performance

244

Clinical Research Enrollment Assistant Resume Examples & Samples

Electronic Chart Review
Pre-screening potential patients
Scheduling appointments
EDC Data entry of key information regarding each candidate screened
Community Outreach, visiting local businesses to raise awareness of study
RN or LPN or Clinical research coordinator

245

Manager, Clinical Research Operations Resume Examples & Samples

Establish, evaluate, and oversee clinical and administrative operations, regulatory compliance, policies and procedures training and education for the Office of Research Administration clinical operations division
Manages and provides direction and leadership to clinical operations team
Oversight and monitoring of all MHS clinical trials as it relates to the assigned campus
Identify and communicate study-related issues. Facilitate and implement solutions with the research team
Present significant research efforts, findings, outcomes, and approvals internally and to external audiences
Utilize critical insight to evaluate and select research studies in conjunction with the Director of Clinical Operations and the associated Principal Investigator
Lead new research initiatives by engaging other therapeutic area specialists to assess their areas of interest within clinical research
Identify targets of opportunity both within the health system and with outside partners by exploring ways to integrate research opportunity within their practice area
Provide general leadership in relation to each individual trial and effectively collaborate with other departments to meet all timelines and goals
Independently oversees the functionality of study related documents such as Source Document Worksheets, Informed Consent Checklists, Concomitant Medication page etc
Assure all aspects of research are compliant with regulatory and study standards
Ensures timely follow up of industry research contracting execution (including Clinical Disclosure Agreement and Clinical Trial Agreement and Letter of agreements)
Consideration of the financial integrity of all studies by overseeing the time and effort tracking for all staff involved in relation to each trial. Responsible for the oversight of clinical research billing. Conducts monthly study budget reviews with executive leadership, plans, and implements change
Oversee research laboratory/pharmacy support services for Research Studies
Fosters collaborative relationships with other departments, entities and community organizations to facilitate and support the mission, vision and goals of research
Identifies and directly confronts issues which affect quality of service; collaborates with staff, manager and physicians to resolve these issues
Utilizes collaborative communication techniques to achieve positive outcomes in all interactions
Prepares accurate and timely written reports, statistics and other documentation as necessary or as requested
Effectively manages change processes as they impact research operations and staff
Maintains ongoing analysis of research performance and financial trends and opportunities
Presents to work on time, follow organization rules, policies, procedures and directives
Effectively interacts with staff in a positive and constructive manner
Ability to make suggestions for enhancements throughout the department and continually seeks opportunities to improve current policies, procedures and practices while prioritizing the tasks assigned
The Research Clinical Operations Manager must possess deep content expertise in leveraging Good Clinical Practice Guidelines to support clinical research operations as well as a proven track record of excellent leadership required for fostering effective collaboration between MHS executive leadership and research operations leadership
5 years of experience in a Clinical Research Operations, preferred
Management and leadership experience in Clinical Research Operations, research or a related health care field
Knowledge of research design, research process, study budgets and study implementation
Strong leadership, planning and project management skills
Thorough understanding of FDA, GCP and ICH guidelines
Thorough understanding of research compliance requirements

246

Clinical Study Manager, Clinical Research Resume Examples & Samples

*REMOTE BASED POSITION***
Manage one or more clinical trials, including Investigational Device Exemption, post-approval, post-market surveillance, feasibility, and/or marketing studies
Develop clinical plan strategies and execute on clinical study protocols, timelines, and budget management
Collaborate with Clinical Operations Data Management on data collection, quality control and analysis of clinical trial patient data and radiographic results
Support Regulatory and Marketing functions in strategic clinical data needs
Communicate study results through annual reports, investigator meetings, and global clinical discussions; track study performance through metric-based results
Demonstrate leadership qualities and mentor members of the Clinical Operations team
Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures

247

Director, National Clinical Research Resume Examples & Samples

Consistently exhibits behavior and communication skills that demonstrate DaVita Medical Group's commitment to superior customer service, including quality, care and concern with each and every internal and external customer
Uses, protects, and discloses DaVita Medical Group patients’ protected health information (PHI) only in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards
Add Job Functions for this Director Role
Minimum: Over 7 years and up to including 10 years of management experience
Interviewing and interpersonal skills

248

Asst-clinical Research Resume Examples & Samples

Receives, answers and processes departmental communications, including mail, telephone calls, faxes and email
Prepares reports, correspondence, presentations and other written documents as directed
As directed, works with medical staff and residents in the collection of data for scholarly activity and quality control improvement. This may involve patient interviews, discussing projects with potential subjects and requesting consent, passing out and collecting surveys, chart review, and abstraction or participation in prospective research studies
Performs/assists in transporting, processing, and storage of blood and body fluid specimens; packages specimens for shipping
Uses the internet to search and obtain information as needed. Uses medical literature search engines to conduct literature reviews, and obtains requested journal articles. May read articles and write summaries
Performs all other duties and projects as assigned
1 year of research experience preferred

249

Associate Clinical Research Operation Manager Resume Examples & Samples

Accountable for all activities of site related study execution of assigned studies / Monitors involving start-up, execution, and close-out. Accountable for the on-time and within budget study execution of assigned projects, including but not limiting to country and site feasibility
Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country / district, and provide impact analysis of significant changes affecting conduct of Clinical studies
Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation
Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions
Responsible for the acquisition and retention, performance management, and growth and development of talent. May be responsible for being the country point of contact for CROs for an assigned study / studies. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager
If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc
If assigned; Global Representative for single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials
If assigned; Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies. Responsible for the direct/functional management, as applicable, of the assigned Remote Monitors including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development

250

Clinical Research LPN Translational Research Institute Orlando Resume Examples & Samples

Ability to perform clinical tasks including assisting physician, ARNP and CRN with minor procedures and other study requirements as needed
Ability to work independently and as a team under the direction of the Investigator, PM and Clinical Operations Manager
Graduate of a nursing program
One year of clinical or research experience
Experience in the clinical/translational research environment (preferred)
Computer skills, particularly Microsoft Outlook, Word, Excel, Publisher, PowerPoint, Cerner, use of internet and other research tools (preferred)
Knowledge of clinical/translational research and research regulatory environment (preferred)
Current active State of Florida license as an LPN or RN
IV Certification, if LPN
Current Basic Life Support (BLS) certification
Current Advanced Cardiac Life Support (ACLS) certification (preferred)

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