Clinical Data Coordinator I
Caris Life Sciences
4 months ago
On-site
Phoenix, AZ
Clinical Research and Development
Position Summary
The Clinical Data Coordinator ensures accurate clinical data entry and integrity for Caris Medical Affairs protocols/projects at Precision Oncology Alliance sites. Collects and reviews clinical protocol research data; interprets data with source documentation for entry into computerized databases; applies data definitions and case report form requirements; responds to data queries; schedules on-site visits for data review and EDC data entry.
Job Responsibilities
- Abstract clinical data from subject source documentation.
- Enter data into study-specific EDC case report forms.
- Clean/verify clinical data accuracy.
- Update EDC after verification and resolve data queries.
- Track site goals and case report form completion; prioritize cases for analysis.
- Maintain study-specific documentation.
- Perform QC audits of the clinical database.
- Follow GCP, FDA, IRB, and HIPAA regulations; site operating procedures and ethical standards.
- Confirm consenting is performed/documented prior to data abstraction.
- Maintain source document management and request-for-information requirements.
- Act as site designated entry person.
- Travel to multiple investigative sites as required.
- Communicate with research team, investigators, CRAs, study sponsor, and ancillary staff.
Required Qualifications
- 3–5 years of data collection experience in a GCP/clinical research regulatory environment.
- Knowledge of GCP, ICH, and Code of Federal Regulations.
- Oncology clinical study experience; strong medical terminology.
- Experience with project planning/reporting; strong communication/presentation.
- Training/mentorship experience.
- EDC systems experience.
- Proficient in Microsoft Office (Word, Excel, Outlook) and basic business Internet use.
Other
- Ability to sit and/or stand for long periods.
- Occasional evenings and overtime may be required.
The Clinical Data Coordinator ensures accurate clinical data entry and integrity for Caris Medical Affairs protocols/projects at Precision Oncology Alliance sites. Collects and reviews clinical protocol research data; interprets data with source documentation for entry into computerized databases; applies data definitions and case report form requirements; responds to data queries; schedules on-site visits for data review and EDC data entry.
Job Responsibilities
- Abstract clinical data from subject source documentation.
- Enter data into study-specific EDC case report forms.
- Clean/verify clinical data accuracy.
- Update EDC after verification and resolve data queries.
- Track site goals and case report form completion; prioritize cases for analysis.
- Maintain study-specific documentation.
- Perform QC audits of the clinical database.
- Follow GCP, FDA, IRB, and HIPAA regulations; site operating procedures and ethical standards.
- Confirm consenting is performed/documented prior to data abstraction.
- Maintain source document management and request-for-information requirements.
- Act as site designated entry person.
- Travel to multiple investigative sites as required.
- Communicate with research team, investigators, CRAs, study sponsor, and ancillary staff.
Required Qualifications
- 3–5 years of data collection experience in a GCP/clinical research regulatory environment.
- Knowledge of GCP, ICH, and Code of Federal Regulations.
- Oncology clinical study experience; strong medical terminology.
- Experience with project planning/reporting; strong communication/presentation.
- Training/mentorship experience.
- EDC systems experience.
- Proficient in Microsoft Office (Word, Excel, Outlook) and basic business Internet use.
Other
- Ability to sit and/or stand for long periods.
- Occasional evenings and overtime may be required.