Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services
DEPARTMENT OF VETERANS AFFAIRS
Original Solicitation Links
Contact
Submission Instructions
Description
The Department of Veterans Affairs, RPO-E Research and Development has a requirement for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services. This is a Sources Sought Notice only, and no quotes are being requested at this time. Responses should include company information, capabilities, socioeconomic status, and any existing contract vehicles. The services involve monitoring clinical trials conducted by or requested by the VA's Cooperative Studies Program (CSP). This includes performing on-site and remote monitoring visits, reviewing study protocols, subject consent processes, investigational product accountability, adverse event reporting, source document verification, and ensuring regulatory compliance. The contractor will be responsible for preparing site visit reports and providing corrective action support. Travel will be required for on-site visits, and expenses will be reimbursed according to Federal Travel Regulations. Personnel performing these services must meet specific qualifications, including a Bachelor's degree or equivalent, completed GCP training, and a minimum of ten years of experience in clinical trial monitoring, with additional consideration for federally funded research and VA-funded trials. A background investigation will be required for personnel accessing VA computer systems.
Classification Codes
Smart Codes
Specifications
Requirements
- Minimum 3 references
Documents
| Title | Date Posted |
|---|---|
| PWS GCP Monitoring6-15-2026rlk.docx | Jun 15, 2026 12:00 PM |
| 36C24E26Q0050.docx | Jun 15, 2026 12:00 PM |
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