Clinical Data Coordinator I

Position Summary
The Clinical Data Coordinator is responsible for clinical data entry activities for Caris Medical Affairs protocols and projects at Caris Precision Oncology Alliance sites, ensuring clinical data integrity and quality for oncology research.

Job 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 verification, including resolution of data queries.
- Track site goals and case report form completion; prioritize site cases for analysis.
- Maintain study-specific documentation.
- Perform QC audits of the clinical database.
- Support and adhere to GCP guidelines and FDA/IRB/HIPAA regulations, site operating procedures, and ethical standards.
- Confirm appropriate consenting is performed and documented prior to data abstraction.
- Maintain source document management and requests for information per Caris/Site requirements.
- Act as site designated entry person; communicate with research team, investigators, CRAs, sponsor, and ancillary staff.
- Schedule on-site visits for data review and EDC data entry; willingness to travel to multiple sites.

Required Qualifications
- 3–5 years of GCP/clinical research data collection experience.
- Knowledge of GCP, ICH, and CFR; oncology clinical study experience.
- Strong medical terminology understanding.
- Experience with small/large project planning and reporting; strong communication/presentation.
- Experience training internal/external staff (mentorship).
- Experience with EDC systems.
- Proficient in Microsoft Office (Word, Excel, Outlook) and general Internet use for business.

Other
- May require occasional evenings and overtime.

Conditions of Employment
- Complete pre-employment process: background check, drug screening, credit check (if applicable), and reference verification.