Clinical Data Coordinator I (Hybrid role - 3 days in office)
About The Position
The Clinical Data Coordinator I performs clinical data entry activities for Caris Medical Affairs protocols and projects at Caris Precision Oncology Alliance sites. The role supports research efforts aimed at improving treatment and medical outcomes for oncology patients by maintaining high standards of clinical data integrity and quality. Responsibilities include collecting and reviewing protocol research data, interpreting source documentation for entry into computerized databases, and applying an understanding of data definitions, case report forms, and other clinical research data-collection information. The coordinator responds to queries in a timely manner and schedules on-site visits for data review and EDC entry. The position works with onsite research teams to support appropriate consenting and documentation before data abstraction, and communicates with investigators, clinical research associates, study sponsors, and ancillary staff. The role may involve travel to multiple investigative sites, occasional evenings, and overtime. The position requires the ability to sit and/or stand for extended periods.
Requirements
- 3–5 years of experience in data collection activities within a GCP/clinical research regulatory environment.
- Knowledge of critical elements for success in clinical trials, including GCP, ICH, and the Code of Federal Regulations.
- Clinical study experience in oncology.
- Strong understanding of medical terminology.
- Experience in small- and large-scale project planning and reporting, with strong communication and presentation skills.
- Experience providing training to internal and external staff, using a mentorship approach for less experienced colleagues.
- Experience with EDC systems.
- Proficiency in Microsoft Office Suite, specifically Word, Excel, and Outlook, and general working knowledge of the Internet for business use.
- Ability to sit and/or stand for long periods of time.
- Successful completion of the pre-employment process, which includes criminal background check, drug screening, credit check where applicable, and reference verification.
Responsibilities
- Abstract clinical data from subject source documentation.
- Enter clinical data into study-specific EDC case report forms.
- Clean clinical data to verify accuracy.
- Update the EDC after subject data verification, including resolving data queries.
- Track site goals and case report form completion.
- Prioritize site cases for analysis.
- Maintain study-specific documentation.
- Perform quality control audits of the clinical database.
- Support and adhere to Good Clinical Practices, FDA, Institutional Review Board, and HIPAA regulations, Site Operating Procedures, and ethical standards for clinical research.
- Work with the onsite team to confirm appropriate consenting is performed and documented before data abstraction.
- Follow Caris and site requirements for source document management and requests for information.
- Act as the site-designated data entry person.
- Travel to multiple investigative sites if required.
- Communicate effectively with the research team, investigators, Clinical Research Associates, study sponsors, and ancillary staff.
- Schedule on-site visits to perform data review and EDC data entry.
- Respond to data queries in a timely fashion.
Benefits
- Medical, dental, and vision coverage options
- Health Savings Account for medical expenses and dependent care expenses
- Flexible Spending Account for certain out-of-pocket expenses
- Paid time off, including vacation, sick time, and holidays
- 401(k) match and financial planning tools
- Long-term and short-term disability insurance coverage
- Voluntary benefit options
- Employee Assistance Program
- Pet insurance
- Legal assistance
- Tuition assistance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
