Notice ID: 36C24E21Q0042
This requirement is for a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services.
This requirement is a follow-on to a current contract for like services.
The Contractor shall provide services under an IDIQ contract for Clinical Research Quality Associate (CRQA) services to the Site Monitoring, Auditing and Resource Team (SMART). The tasks include performing on- and off-site visits, providing post-visit reports, and providing GCP Program Quality Support (PQS) following SMART guidelines. Additionally, if requested, the contractor will identify to SMART, a monitor to fulfill the role of a Lead CRQA for a specific study. This Lead will coordinate the overall study monitoring plan and associated activities under the direction and supervision of the VA Employed Chief of SMART Monitoring. Specific Tasks:
The contractor shall provide Clinical Research Quality Associate (CRAQ) visits and associated services as requested by the VA SMART Program. The contractor shall inspect a clinical trial site using a clinical trial specific monitoring plan developed and provided to the contract monitor by the Chief of SMART Monitoring or designee. These inspections can be off-site (remote review of key critical data) or on-site (in-person or virtual equivalent).
