Description
The Department of Veterans Affairs is seeking sources for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services. The contractor will provide CRQA monitoring services to the Site Monitoring, Auditing and Resource Team (SMART) to ensure compliance with GCP regulations and guidelines. Services include conducting site initiation visits, routine monitoring visits, and providing GCP training and support. The contractor will also be responsible for preparing site visit reports and summary letters, and providing feedback to the SMART Program Manager.
Key aspects of the job include:
* Conducting site visits to inspect clinical trial sites for compliance with GCP and VA research policies
* Reviewing subject and investigator study records for compliance with GCP and VA research policies
* Providing GCP training and support to site staff
* Preparing site visit reports and summary letters
* Providing feedback to the SMART Program Manager
The ideal contractor will have experience in clinical research monitoring, GCP training, and VA research policies. They will also have excellent communication and organizational skills, and be able to work independently and as part of a team.