Regulatory and Compliance Support for Human Subjects and Animal Research

The contract seeks a subcontractor to provide comprehensive technical and administrative support for the development and management of IRB and IACUC protocols, ensuring full compliance with federal regulations governing human and animal research. This includes preparing and maintaining regulatory documentation, facilitating audit readiness, and offering guidance on evolving compliance requirements to support studies conducted under the Defense Health Agency. The subcontractor must possess demonstrated expertise in institutional review and animal care and use protocols, with an emphasis on accuracy, timeliness, and proactive risk mitigation to uphold the integrity of research operations. Support services must be delivered with a high degree of precision to meet the stringent standards of the Department of Defense, ensuring all documentation is current, complete, and aligned with applicable federal guidelines. The subcontractor will be expected to collaborate closely with research teams to streamline protocol submissions, respond to regulatory queries, and maintain robust tracking systems for approvals and renewals. The opportunity is open for proposals through September 22, 2026, under NAICS code 541611, and performance is expected to support operations under the Defense Health Agency Contracting Activity, with no specific geographic limitations identified for work location.