Clinical Data Specialist Resume Samples

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G Corwin

Gracie

Corwin

83733 Leif Street

Phoenix

+1 (555) 708 9256

83733 Leif Street

Phoenix

Phone

p +1 (555) 708 9256

Experience Experience

San Francisco, CA

Clinical Data Specialist

San Francisco, CA

Stoltenberg-Lockman

San Francisco, CA

Clinical Data Specialist

Provide problem solving assistance to clinics regarding VitalSign6 software application, clinic workflow integration, and patient tracking surrounding MBC
Provides status updates to management on a regular basis
Work closely with clinical staff to provide on-going data support for both internal and external reporting and data transfer
Prepares materials to assist more senior clinical data staff with reporting all out-of-range laboratory results to health care providers
Works with project managers to resolve data quality or noncompliance issues
Assist research coordinator in research collaborations with academic investigators for product development
Identifies opportunities to increase efficiency of data collection and management activities

Los Angeles, CA

Clinical Data Specialist Supv

Los Angeles, CA

Christiansen Group

Los Angeles, CA

Clinical Data Specialist Supv

Monitor staff performance, perform evaluations and make recommendations regarding disciplinary action
Work with Coding Manager to establish coding compliance standards, procedures and policies
With the HIM Manager and Department Director, establish a plan to ensure data quality, security and ongoing monitoring of data access
Perform the work of Clinical Data Specialists
Supervises daily initial and concurrent coding to assure turnaround time goals are met providing a seamless workflow at the facility level
Ensures quality account services to patients by working with team members to execute process flow and achieve quality objectives
Responsible for coordinating and administering professional development for all coders within the company/facility

present

New York, NY

Senior Clinical Data Specialist

New York, NY

Gibson-Beahan

present

New York, NY

Senior Clinical Data Specialist

present

Significantly participates in development of a new process/revision of an existing data management process
Provide1:1 training to new or junior staff in clinical data management tasks and SYK processes
Train internal and clinical colleagues in clinical data management role by serving as an expert in a specified area in both informal and formal classroom setting
Provide input into clinical data management training curriculum
Sit on a Clinical Core Team and actively participate in team meetings. Obtain input from Manager for clinical data management issues
Train the CDM and/or Clinical Core Team in the study specific clinical data management processes
Transfer coding file to database development/biostatistics

Education Education

Associate’s Degree in Related Field

Liberty University

Associate’s Degree in Related Field

Skills Skills

Ability to exercise judgment and employ basic reasoning skills
Ability to adhere to detailed instructions
Knowledge of regulations relating to clinical data management and Good Clinical Practices (GCP)
Ability to exercise independent judgment in doing medical summaries with strong analytical capabilities
Strong attention to detail
Ability to work effectively within a team configuration
Strong clerical, interpersonal, and organizational skills
Excellent computer skills
Perform functional and/or User Acceptance Testing of Study Management Reports and other deliverables
Flexibility and adaptability to change

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Clinical Data Specialist Resume Examples & Samples

Bachelor’s degree with 2+ years of clinical research experience OR Master’s degree with no required experience
Working knowledge of good data management and clinical practices, Food and Drug Administration 21 CFR Part 11 regulation, and Health Insurance Portability and Accountability Act
Experience working with clinical data management applications and report tools

Clinical Data Specialist Resume Examples & Samples

Work with the clinical operations team to facilitate project implementation onsite at participating clinics
Conduct training on screening and follow-up assessment procedures to clinic staff
Educate clinic staff on the importance of screening for depression
Provide problem solving assistance to clinics regarding VitalSign6 software application, clinic workflow integration, and patient tracking surrounding MBC
Ensure patients are monitored (in-person, via telephone, or through communication with clinical staff) for changes in depression severity and medication side effects
Document depression assessment, treatment, and outcome measurements, according to policies and procedures for project outcomes tracking purposes
Report to clinic staff on patient outcomes, including overall clinic screening, response and remission rates
Facilitate regular provider rounds with the consulting psychiatrist on patients enrolled in MBC to ensure that appropriate care is being provided
Model patient education for depression and non-medication treatments as directed by the consulting clinical psychologist
Facilitate specialty treatment referrals, as needed
Attend weekly VitalSign6 team meetings and perform other duties as needed
Facilitate and coordinate the daily clinical trial activities and play a critical role in the conduct of the study
Participate in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment
Complete documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a weekly and/or monthly basis
Bachelor’s degree in nursing, social work, psychology, health psychology, healthcare administration or related field
Demonstrated ability to establish rapport quickly with a wide range of people
Minimum 2 years clinical experience in a relevant setting OR minimum 2 years research experience in a relevant setting (Preferred combination of clinical and research experience)
Bilingual in Spanish is preferred but not required
Knowledge of depression and depression treatment
Knowledge of community resources for depression
Experience working with electronic health records and web-based software systems
Experience with low income, medically under-served populations

Clinical Data Specialist Resume Examples & Samples

Identifies inclusion/exclusion criteria, reads medical charts and enters data on new subjects; if they meet registration requirements in research study, enrolls subjects and instructs them in protocol procedures. Submits confidential records and research materials to study group reviewers at other institutions when applicable
Prepares statistical information for each subject entered in or removed from research study
Assesses and documents subjects' response to treatment through physical assessment and/or data analysis; reports any evidence of toxicity to drugs or chemicals used in treatment of subjects
Reviews data to determine treatment modifications and alterations between research study plan and actual subject care
Confers with physicians and nurses to obtain statistical informa- tion concerning subjects when they have tests performed or receive treatment elsewhere
May assist with preparation of annual or terminal summary for each research study as well as other required information for Institutional Review Board
Prepares data of any new research study for Institutional Review Board and informed consent for subjects' families
Purchases office equipment and laboratory supplies maintaining inventory and expense records

Clinical Data Specialist Resume Examples & Samples

Perform clinical data entry and validation to ensure completeness and accuracy of data
Recognize inconsistencies and initiate resolution of data problems
Contact health care providers to clarify and resolve issues
Review scientific literature in regards to mutations
Assist research coordinator in research collaborations with academic investigators for product development
Bachelors degree, preferably in Biology related field
Professional and detail oriented
Proficient with Windows, Word and Excel

Clinical Data Specialist Resume Examples & Samples

Responsible for all activities of clinical trial data management including CRF design, database and edit check development, query generation/processing, reconciliation of CRF and electronic data, and database cleaning activities
Assist in the planning and implementation of the data management portions of clinical research projects. Develops systems for organizing data to analyze, identify and report trends
Work with CRAs and statistical department to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams
Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
Bachelors degree is required. Bachelor in a Scientific Displine is highly preferred
Minimum 3 to 5 years clinical data management experience supporting clinical trials in a pharmaceutical, medical device, or biotech company
Proficient with Microsoft Access
Adept at learning new databases
Experience with web-based Electronic Data Capture (EDC) systems
Good understanding of medical terminology, human physiology and laboratory testing preferred

Clinical Data Specialist Resume Examples & Samples

Develops systems for organizing data to analyze, identify and report trends
Analyzes the interrelationships of data and defines logical aspects of data sets
Prepares reports of clinical trial studies for internal validation and cross validation studies
May evaluate and resolve issues regarding contents of reports
Critically reviews and cleans electronic case report forms/data sets for completeness, accuracy, and quality
Generates, tracks and resolves data queries using existing data validity checks
Retroactively applies new data quality requirements to previously collected data when new validity parameters are established
Works with project managers to resolve data quality or noncompliance issues
Performs analysis and calculations using curated data
Prepares spreadsheets or other informatics consumable formats of the case data at the direction of project leads
Prepares reports for the Leidos team and external entities
Generates tables, figures and listings in support of project presentations
Evaluates and resolves issues regarding content of reports
Develops user requirements documentation, Standard Operating Procedures (SOPs), and training materials relating to data management processes
Identifies opportunities to increase efficiency of data collection and management activities
Provides status updates to management on a regular basis
Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in the Life or Biological Sciences, Biomedical Sciences, Bioinformatics, or equivalent
A minimum of five (5) years of progressively responsible clinical data management experience
Must be able to obtain and maintain a Public Trust Clearance
Experience with at least ONE of the following clinical data management systems: Electronic Data Capture, Remote Data Capture, Clinical Data Management System
Familiarity with interactive databases and data validation
Proficiency in Microsoft Office (Word, Excel, Access, and PowerPoint)
Knowledge of regulations relating to clinical data management and Good Clinical Practices (GCP)
Must be detail oriented with strong analytical skills and the ability to prioritize multiple tasks/projects
Ability to communicate effectively orally, as demonstrated via telephone/web conferences/team interactions, and in writing, with non-technical and technical staff at various levels of the organization
Strong problem solving, planning, and organizational skills
Ability to work effectively within a team configuration
Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Experience with data modeling and data representation
Knowledge of statistical methods and analysis
Basic familiarity with scripting languages, SAS, and/or HTML

Clinical Data Specialist Resume Examples & Samples

Generate, process, track and resolve queries
Prepare Data Management Plans
Perform SAE reconciliation between the clinical database and the Drug Safety database
Perform external data reconciliation
Close study database based on pre-defined criteria as per timelines
Assist in defining and the follow-up of milestones and timelines
Lead various data management meetings for CRF development, e-Help, edit checks with study team
Train sites at investigator meetings and data management staff on study database
Provide support to data management staff over the course of the study
Represent Data Management as the lead contact and liaison on the clinical study team
3-5 years' Clinical Data Study experience

Clinical Data Specialist Resume Examples & Samples

Interprets data using a variety of techniques, ranging from simple data aggregation via statistical analysis to complex data mining
Identifies project/initiative requirements by working directly with Operations and Clinical leaders; analyzing operations; identifying analytical requirements; and documenting results
Design, develop, and implement a variety of reports, graphs, summaries, presentations and other business solutions that convey analytic results and align with business needs
Prepares executive level reports and presentations by collecting, analyzing, and summarizing information
Develops data models, reports, and summary analytics across a variety of subject matters, including medical practice financial management and clinical outcomes reporting and other physician, practice and healthcare group data-driven initiatives
Utilizes data from EHR and EMR systems, Claims, Lab, Professional Billing and other sources to resolve complex healthcare related issues
Work closely with clinical staff to provide on-going data support for both internal and external reporting and data transfer

Senior Clinical Data Specialist Resume Examples & Samples

Team player with ability to work well with technical and clinical team members
Ability to collaborate with entire clinical team (CRAs, Safety, Bios, etc.)
Excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (RECIST, CDISC/CDASH, Labs, Adjudication, etc.)
Ability to adhere to and create detailed DM study instructions and documents (CRF guidelines, Trial Design Document, edit check specifications, etc.)
Ability to perform research for data collection and protocol specific topics
Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)
Organized and thorough with attention to details
Effective Interpersonal skills and excellent communications skills, verbal, written and listening
Ability to learn new things, teach others, and accept constructive criticism
Effective logical thinking ability in regards to Problem-solving skills
Proficiency in computer applications (Windows, Excel, Word, Outlook etc.)
Travel, occasional as required for bid defenses, Investigator Meetings, or other meetings as requested, not anticipated to exceed 40hr per year

Clinical Data Specialist Supv Resume Examples & Samples

Responsible for coordinating and administering professional development for all coders within the company/facility
Provides opportunities for all coders to develop additional skills across multiple medical specialties
Promotes cross training of coders throughout company/facility
Ensures quality account services to patients by working with team members to execute process flow and achieve quality objectives
Monitors daily coding volumes, high dollar accounts, productivity and turnaround times
Supervises daily initial and concurrent coding to assure turnaround time goals are met providing a seamless workflow at the facility level
Supervises final coding turnaround times to assure timely claims processing
Provides second reviews and responses to queries from the coders on complex records
Run daily, monthly and periodic reports on account volumes, productivity, turnaround times, and quality measures for management staff
Participate in the interviewing, reference checks and hiring of new staff
Monitor staff performance, perform evaluations and make recommendations regarding disciplinary action
Plan and coordinate monthly team section meetings and education, track programs for staff, including coding verification, coding problem identification/review, and staff development
Work with Coding Manager to establish coding compliance standards, procedures and policies
With the HIM Manager and Department Director, establish a plan to ensure data quality, security and ongoing monitoring of data access
Attend various planning meetings as needed
Perform the work of Clinical Data Specialists

Senior Clinical Data Specialist Resume Examples & Samples

Review data. Identify data trends on a project level
Query/DCF generation. Begin to identify appropriate standard query/DCF (Data Clarification Form) text
Integrate or close queries/DCFs for all categories on a project or program. Perform quality control of queries/DCFs for rest of team
Perform UAT (User Acceptance Testing), design and oversee UAT for a specific study
Write or review a DMP (Data Management Plan) for a specific project or program
Develop complex status reports and utilize status reports to determine follow-up action
Work with various vendors to obtain expected deliverables in a timely manner
Code verbatim terms & perform consistency review of coded terms
Collaborate with Medical Sciences for coding review and approval
Transfer coding file to database development/biostatistics
Write study specific coding guidelines
Identify processes for improvement related to department process
Significantly participates in development of a new process/revision of an existing data management process
Review draft of new/revised data management WI/SOP
Complete study start up activities such as CRF (Case Report Form) design and Database Specifications/Edit Check Specifications
Review and provide feedback to Clinical core team documents
Sit on a Clinical Core Team and actively participate in team meetings. Obtain input from Manager for clinical data management issues
Train internal and clinical colleagues in clinical data management role by serving as an expert in a specified area in both informal and formal classroom setting
Provide input into clinical data management training curriculum
Train the CDM and/or Clinical Core Team in the study specific clinical data management processes
Train Investigators and Coordinators at Investigator Meeting in the CRF, the EDC system, and the completion guidelines
Provide1:1 training to new or junior staff in clinical data management tasks and SYK processes
Mentor junior staff within department

Clinical Data Specialist Resume Examples & Samples

An understanding of the products offered at Myriad and the clinical histories that are appropriate for each product
Ensure that the appropriate testing was performed as requested by the health care provider
Contact health care providers to clarify any concerns and resolve any issues prior to test release
Detailed review of all elements of a laboratory report. This requires understanding of the current processes at Myriad that may contributes to a patient’s result and being able to trouble shoot effectively
Confirm that the best possible patient care was given to each and every patient prior to sending out a report to their health care provider
Bachelors degree, preferably in Biology or a related field

Clinical Data Specialist Resume Examples & Samples

A demonstrated ability to establish rapport quickly with a wide range of people
A Bachelor’s or Master’s degree in social work, psychology, healthcare administration, nursing, biology, or related field
A minimum of 2 years’ combined clinical and research experience in a relevant setting
Prior experience working in a research setting
Bilingual in Spanish/English
Experience with diverse groups

Clinical Data Specialist Resume Examples & Samples

Clinical Data and Query Review
Ability to interact with entire clinical team (CRAs, Safety, Biostatisticians, etc.) and answer questions related to specific data collection concerns
Knowledge of clinical trials data processing concepts
Ability to create DM study documents (CRF guidelines, trial design document, edit checks, etc.)
Knowledge of unique data collection concepts (RECIST, CDASH, Local Labs, Adjudication, etc.)
Good knowledge of data management processing systems (preferred systems are InForm, Rave, and Oracle Clinical)
Effective Interpersonal skills and good communications skills, verbal, written and listening
Willingness to learn new things and teach others
Travel, as required for office visits, bid defenses, Investigator Meetings, or other meetings as requested, not expected to exceed 40hrs per year

Clinical Data Specialist Resume Examples & Samples

2 years of experience in PICU or NICU area with knowledge of terminology and flow sheets
Experience related to research and project management with knowledge of research principles, methodologies, and study design
Experience and comfortability with Excel required
Experience working with EPIC required
Collaborative Institutional Training Initiative (CITI)
Familiarity working in a pediatric ICU department is highly required
Experience with Microsoft Excel
Good interpersonal, communication, and conflict resolution skills
Adept at problem-solving
Flexibility and adaptability to change
Collects and maintains clinical data primarily by review of medical records, discussion with physicians, nurses, families, and other personnel responsible for patient care and prognostic outcomes
Maintains extensive records as regards patient stays, outcomes, and disease process
Utilizes interactive skills with other hospital staff and/or departments for purpose of requesting and collecting data as applies to stated requirements
Collects necessary data as needed for review by physicians pertaining to issues occurring for physician quality assurance
Retrieves and tabulates necessary data regarding monthly patient activity, e.g., admissions, discharges, patient days, percent of occupancy, traumas, deaths, and transports
Adheres to Health Insurance Portability and Accountability Act requirements pertaining to strict confidentiality regarding patient data, quality assurance indicators, and results of information collected
Participates in reviewing necessary outcome trends, analysis, and opportunities
May update training and maintain certification requirements
Performs other department-specific responsibilities related to database maintenance and/or data collection
Supports and participates in continuous assessment and improvement of quality data entry and analysis
Meets regularly with physicians responsible for database oversight

Clinical Data Specialist Resume Examples & Samples

Receives and reviews patient lists for compliance with OCM quality measures
Conducts chart reviews to determine if patients meet denominator and/or numerator criteria
Assists with chart reviews related to compliance with the various requirements of the Oncology Care Model
Tracks referrals for OCM patients and monitors the receipt of outside reports
Monitors and enters treatment plans into the EHR
Runs patient reports through Informatics and Practice Insights as requested
Drafts correspondence and documents within the time-frame requested
Maintains files and office equipment
Additional tasks as assigned
Coursework in anatomy, physiology and medical terminology preferred
Minimum six months experience in a medical office or hospital setting with Electronic Health Record required
Experience as a Medical Scribe or similar experience preferred
Must be proficient with Microsoft Excel

Clinical Data Specialist Resume Examples & Samples

Acts as an integral member of the team in communicating and documenting lab results of infants with regard to newborn screening disorders
Communicates routine, non-urgent newborn screening results to healthcare providers
Documents all relevant information in the infant’s medical records
Prepares materials to assist more senior clinical data staff with reporting all out-of-range laboratory results to health care providers
Updates the program’s electronic tracking system to maintain accurate records for all infants under established procedures and processes
Utilizes the Program’s electronic tracking system to assist with
High School diploma; or equivalent
Two years of relevant office experience
A basic understanding of clinical information
Skilled in electronic file management and general software usage
A solid respect for the use of Standard Operating Procedures as they relate to the Clinical Public Health Lab
Flexibility in work schedule as required by laboratory section (i.e., weekend and holiday rotations)
Previous experience in newborn screening
Associate’s Degree in relevant discipline
Familiarity with Microsoft Office software including Access

Clinical Data Specialist Resume Examples & Samples

Travel as required to fulfill duties
Deliver mental health education and resilience training programs in partnering middle schools and high schools
Work with schools for logistics of program implementation
Prep materials for program implementation
Document notes on program implementation, protocol deviations, and other relevant information
Maintain relationships with community partners
Develop strategies for recruitment into research studies
Attend events in the community to promote and recruit for research studies
Attend weekly meetings
Administer clinical assessments for longitudinal studies on resilience and depression
Ensure safety of study participants
Assist in EEG, MRI, clinician assessments as needed

Clinical Data Specialist Resume Examples & Samples

2 years of experience in clinical specialty area with knowledge of terminology and flow sheets
Experience related to research with knowledge of research principles, methodologies, and study design
Knowledge of information systems, Microsoft Excel and Access, and database development

Clinical Data Specialist Resume Examples & Samples

Successful completion of education program as defined by the National Cancer Registrars’ Association
Knowledge of medicine and related fields, including anatomy, physiology, and medical terminology
Familiar with computer data entry
Working knowledge of Windows, Word, and Excel and must be able to learn electronic documentation systems
Excellent oral and written communication and organization skills. Requires great attention to detail
Ability to meet deadlines for abstracting and data requests
Ability to work effectively within role independently and with other team members
Ability to effectively communicate with physicians, as well as the ability to tactfully communicate with patients when necessary
Ability to prioritize work and manage time
Ability to conduct and manage multiple tasks simultaneously
Ability to accurately and efficiently enter cancer-related data into Metriq
Certification as a Certified Tumor Registrar (CTR) from the National Cancer Registrars’ Association or CTR eligible
CTR certification required within two years of hire
Three years of experience working with a cancer registry in an approved CoC cancer program

Clinical Data Specialist Resume Examples & Samples

Epic Certification and working experience in a similar role with Epic
Experience working with RedCap
Enters collected inpatient clinical data accurately and timely
Coordinates and monitors acquisition of clinical data and data entry for process efficiency and accuracy into registry repository system and retrieval of aggregate data
Adheres to data definitions provided by database’s governing body and remains aware of nationally recommended changes
Participates in annual review of data fields for relevance to current treatment methodologies and process improvement indicators
Assists in development and implementation of process to ensure data validation and integrity and capture of 100% appropriate patient population
Maintains competency and compliance of database requirements, e.g., inter-reliability audits as required
Participates in providing statistical support and analysis for all projects
Exports, validates, analyzes, and summarizes data for parties with the need to know
Facilitates provision of data needed for research
Provides data analysis and summary for internal and external projects, including institutional ad hoc Reports and requests for proposals
Identifies and communicates report limitations
Designs and develops data collection tools and readable reports appropriate for target audience
Attends offsite related educational seminars and conferences as required