Clinical Data Specialist Job Description
Clinical data specialist
provides training on patient physiology, anatomy, and disease state as well as use of products to staff.
Clinical Data Specialist Duties & Responsibilities
To write an effective clinical data specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical data specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Coordinates and manages the clinical data for various phases of clinical study
Acts as primary site contact with sponsor’s Clinical Research Associate (CRA) for externally sponsored trials
Maintains currency of federal regulations governing the protection of human subjects such as Food and Drug Administration (FDA), Good Clinical Practice/International Conference on Harmonisation (GCP/ICH) guidelines, Office of Human Research Protections (OHRP), Health Insurance Portability and Accountability Act (HIPAA), rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback
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
Assists with study specimen procurement and handling
Participates and attends internal and external new protocol start-up orientations and completes required protocol specific training
Prepares and participates in audits of assigned studies such as National Cancer Institute (NCI), Food and Drug Administration (FDA) and pharmaceutical audits
Participates in Quality Assurance Monitoring Committee (QAMC) in-house audits by reviewing assigned patient chart and reporting on findings as relates to protocol/patient compliance
Maintain existing databases and develop guidelines to ensure data integrity
Work with data providers to discuss and clarify data ambiguities, inconsistencies
Clinical Data Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Data Specialist
List any licenses or certifications required by the position: CCS, CTR, AAPC, RHIA, RHIT, EDC, CCDM
Education for Clinical Data Specialist
Typically a job would require a certain level of education.
Employers hiring for the clinical data specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Education, Nursing, Management, Healthcare, Medical, Science, Computer Science, Biology, Life Sciences, Medical Terminology
Skills for Clinical Data Specialist
Desired skills for clinical data specialist include:
Medical terminology
FDA regulations
Blood and marrow transplantation
Field of oncology
Anatomy
Physiology and medical terminology
Physiology
Word
Medicine and related fields
Windows
Desired experience for clinical data specialist includes:
VitalSign6 is an evidenced-based model of care that helps primary care physicians effectively identify and treat patients with depression
The clinical coordinator is not directly involved in patient care
Assesses appropriate inclusion/exclusion of data based on defined data dictionary
Maintains confidentiality of patient/members and staff information
Maintains required credentials
Performs assignments that need to be completed, even when outside the scope of routine responsibilities
Clinical Data Specialist Examples
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Clinical Data Specialist Job Description
Job Description Example
Our company is looking to fill the role of clinical data specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical data specialist
- Perform clinical review of a medical record and summarize the findings to facilitate additional review
- Conducts analysis of data in cooperation with the medical staff to assist in identification of improvement activities
- Understands current issues, practices and trends in healthcare
- Provides documented reports of findings from data collection as requested
- Attend education classes to build and maintain knowledge of the expections of this positions
- Assist in the planning and implementation of the data management portions of clinical research projects
- Support clinical programming/analytics
- Work with Database Programmer Analysts to develop edit checks
- Prepare and present CRF and CRF completion guidelines at investigator meetings
- Ensure quality data management activities – , data review, query generation and resolution, generate status reports to clinical staff and management
Qualifications for clinical data specialist
- Support analysis of clinical study data
- Basic knowledge of SAS or R is preferred
- Minimum 3 years experience in acute care
- Current Basic Life Support for Healthcare Provider card from the American Heart Association or American Red Cross
- Independently create CRFs (Case Report Forms) in electronic database systems to collect data from all clinical trials
- Continually evaluate the CRFs for required modification due to the dynamic nature of this research
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Clinical Data Specialist Job Description
Job Description Example
Our company is looking to fill the role of clinical data specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical data specialist
- Provide training and education for stakeholders
- Identifies inclusion/exclusion criteria, reads medical charts and enters data on new subjects
- Analyze medical records, extracting clinical, pathological, therapeutic and epidemiologic data in accordance with established ICD-10 CM and CPT-4 AMA coding principles and guidelines
- Ensure that data is optimally coded for research purposes, financial reimbursement, planning, statistics and regulatory reporting
- Communicate directly with physicians to ensure that clinical documentation is coded timely, accurately and in compliance with CMS guidelines and national correct coding initiatives
- Extraction and entry of required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs)
- Maintaining and developing databases and spreadsheets used for clinical trials and research data collection and operations
- Maintaining currency of research regulations including rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback
- Interact closely with regulatory and quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in-house, sponsored and Cooperative Group studies
- Assist in design of case report forms (CRFs) for clinical studies
Qualifications for clinical data specialist
- Bachelor’s Degree in Nursing, Pharmacy, Healthcare Management, Allied Health, Information Systems or related field, required
- Current licensure as appropriate
- Maintains current knowledge of trends and advances in clinical practice and healthcare informatics, new developments and innovations in hardware and software technology
- Assist in the compilation of clinical data for reporting regulatory submissions
- Ability to collaborate with entire clinical team (CRAs, Safety, Bios)
- Excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (RECIST, CDISC/CDASH, Labs, Adjudication)
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Clinical Data Specialist Job Description
Job Description Example
Our company is hiring for a clinical data specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical data specialist
- Performs accurate data entry of a significant amount of information from electronic or hardcopy source materials such as patient demographics, clinical raw data and testing results into electronic databases and spreadsheets in accordance with project requirements
- Reviews and verifies source materials to determine accuracy and completeness of information
- Verifies data entered into the computer by checking printouts/reports for errors and corrects as required
- Assists with identification and correction of data errors in accordance with quality assurance procedures
- Adheres to standard operating procedures, protocols, and study specific guidelines
- Adheres to data security and confidentiality requirements when handling confidential data
- Assists in logging and monitoring of physical location of source documents
- Assists with data entry tasks for multiple clinical studies as necessary
- Assists with manual data entry review as necessary
- Communicates with data management staff, tech leads and project data coordinators regularly on data entry and data management issues
Qualifications for clinical data specialist
- Ability to adhere to and create detailed DM study instructions and documents (CRF guidelines, Trial Design Document, edit check specifications)
- 7+ years of clinical research experience, including a minimum of 2 years clinical data management experience
- 3+ years of relevant clinical or data management experience with increasing levels of responsibility, including two years of data management experience
- 5+ years EDC experience
- Technically proficient in ad hoc query tools and other tools such as MS Excel or Access
- Experience with Data Clarification Form (DCF) preferred
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Clinical Data Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical data specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical data specialist
- Performs tasks as assigned to assist with the smooth operation of the Clinical Data Management and Project Data Management groups
- May assist with completion of data transfer files for timely and accurate reporting
- Obtain consent and enrolling patients into clinical drug trial and performing regulatory duties for monitoring these patients
- Retrieves and tabulates necessary data regarding monthly patient activity, , admissions, discharges, patient days, percent of occupancy, traumas, deaths, and transports
- Ensure eCRF is built according to the latest standards and best practices, including edit checks and applicable integrations (IWRS, CTMS)
- Provide specifications for data models to be used for quality review and for final data model (SDTM or other)
- Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking)
- Program, or oversee programming of, quality review checks and reports for use by Global Data Managers and other team members
- Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined
- Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for-purpose data models and transfer intervals
Qualifications for clinical data specialist
- Ability to work independently, but also as a part of a portfolio
- Ability to lead projects including effective mentoring skills, and the ability to deal effectively with cross functional team members
- Minimum of 1 year Data Management experience in lieu of degree
- Preferred Knowledge of SOPs, GCP & GDP standards
- Flexibility and capability to multitask
- Ability to prioritize and work both independently and with a team
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Clinical Data Specialist Job Description
Job Description Example
Our company is looking for a clinical data specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical data specialist
- Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements
- Responsible for acquiring and maintaining expertise in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, DTAs, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml
- Support the development of standards and drive their implementation within the organization
- The position mentors and coaches and may delegate work
- Analyze and provide rationale to recommend decisions, keeps specific area leaders informed of decisions
- Interact with Data Delivery and Data Analysis clinical teams, Biostatisticians, Medical Writing and clinical solution vendors
- Provide direction to external vendors and contractors
- Provide guidance and expertise to the clinical business teams using data processing solutions
- Share expertise to support internal teams and external Clinical Research Organizations (CROs) by organizing trainings, Question and Answers sessions, and organizing direct support when needed
- Contribute to a continuous improvement and innovation culture with respect to the current and future solutions for the clinical teams
Qualifications for clinical data specialist
- The ideal candidate will have 1-3 years of experience in data analytics
- Proficient in Microsoft Office (preferably within the PC operating system)
- Familiarity with formatting documents
- Ability to interact with entire clinical team (CRAs, Safety, Biostatisticians, ) and answer questions related to specific data collection concerns
- Knowledge of unique data collection concepts (RECIST, CDASH, Local Labs, Adjudication)
- Minimum 5 years experience in Clinical Data Management, database design/development or related industry experience