Regulatory Compliance and IRB Documentation Management

The contract pertains to regulatory compliance and IRB documentation management for NHLBI-sponsored clinical trials, requiring comprehensive support in preparing and submitting required regulatory documents to institutional review boards, maintaining complete and audit-ready trial master files, and promptly reporting adverse events in accordance with federal and institutional guidelines. The selected contractor will ensure ongoing adherence to regulatory standards throughout the trial lifecycle, providing diligent oversight and documentation practices that support institutional and federal audit readiness. Work will be performed primarily in Bethesda, Maryland, and the contract is structured as a subcontract under the National Institutes of Health, part of the Department of Health and Human Services, with NAICS code 541611 indicating management consulting services. Interested parties must submit responses by July 30, 2026, and the opportunity is open to eligible subcontractors seeking to provide technical and administrative support for NIH-funded research activities. The contractor must demonstrate proven experience in clinical trial regulatory workflows, IRB communications, and maintaining compliant documentation systems under strict federal oversight.