Clinical Research Regulatory and sIRB Consulting

This subcontract for Clinical Research Regulatory and sIRB Consulting supports prime contractors on NIH/NIMHD research network projects by facilitating regulatory approval for multi-site studies. The scope of work includes drafting reliance agreements, managing single Institutional Review Board submissions, and coordinating protocol amendments through the use of regulatory tracking software. The successful provider must possess specialized expertise in Good Clinical Practice and NIH sIRB Policy to ensure the delivery of executed reliance agreements and formal IRB approval letters. The opportunity is associated with the National Institutes of Health and is performed in Bethesda. Interested parties should note the response deadline of November 23, 2026. The project falls under NAICS code 541611, focusing on administrative and regulatory consulting to maintain compliance across complex clinical research networks.