Clinical Research Support and Collaboration for NHGRI Protocols

The National Human Genome Research Institute (NHGRI) seeks a small‑business contractor to provide a full suite of clinical‑research support services for NHGRI protocols over a three‑year ID/IQ period. The contractor will deliver protocol monitoring, data‑management, regulatory (IND/IDE) support, Data Safety Monitoring Board (DSMB) coordination, and advanced statistical consulting, primarily from its own facilities with occasional travel to the NIH campus in Bethesda, MD. Work will be ordered via task orders that may be time‑and‑materials or fixed‑price, with a total contract ceiling of up to $4 million and a minimum guaranteed value of $50 k. The effort requires expertise in rare‑disease, genetic, and gene‑therapy studies, as well as compliance with NIH IT security, privacy, and Section 508 accessibility requirements. • Provide end‑to‑end clinical‑research management (monitoring, data handling, regulatory filings). • Support IND/IDE submissions, annual reports, FDA meetings, and safety reporting. • Administer DSMB meetings, prepare statistical analyses, and deliver reports for genetics and rare‑disease studies. • Maintain full compliance with HHS security/privacy clauses, Section 508 accessibility, and NIH data‑handling policies.