Clinical Data Coordinator I (Hybrid role - 3 days in office)
About The Position
The Clinical Data Coordinator is responsible for clinical data entry activities for Caris Medical Affairs protocols and projects at Caris Precision Oncology Alliance sites. The role supports research efforts to improve treatment, health, and medical outcomes for oncology patients by maintaining high standards of clinical data integrity and quality. It involves collecting and reviewing clinical protocol research data, interpreting source documentation for entry into computerized databases, understanding data definitions and case report forms, and responding to queries in a timely manner. The coordinator schedules on-site visits to review data and perform EDC data entry. The role is hybrid, with three days in the office.
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.
- Knowledge of GCPs, ICH, and the Code of Federal Regulations.
- Clinical study experience in oncology.
- Strong understanding of medical terminology.
- Experience with 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.
- Must successfully complete the pre-employment process, which may include a 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 following verification of subject data, 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 (GCP) guidelines, FDA, Institutional Review Board (IRB), and HIPAA regulations, Site Operating Procedures, and ethical standards for clinical research trials.
- Work with the onsite team to confirm appropriate consenting is performed and documented before data abstraction.
- Maintain source document management and requests for information according to Caris and site requirements.
- Act as the site-designated entry person.
- Travel to multiple investigative sites if required.
- Communicate effectively with the research team, investigators, Clinical Research Associates, study sponsors, and ancillary staff.
Benefits
- Medical, dental, and vision coverage options
- Health Savings Account for medical and dependent care expenses
- Flexible Spending Account for certain out-of-pocket expenses
- Paid time off, including vacation, sick time, and holidays
- 401k match
- 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
