Mount Sinai Health System - Miami Beach, FL
posted 3 months ago
As Mount Sinai grows, so does our legacy in high-quality health care. Since 1949, Mount Sinai Medical Center has remained committed to providing access to its diverse community. In delivering an unmatched level of clinical expertise, our medical center is committed to recruiting and training top healthcare workers from across the country. We offer the latest in advanced medicine, technology, and comfort in 12 facilities across Miami-Dade (including our 674-bed main campus facility) and Monroe Counties, with 38 medical services, including cancer care, 24/7 emergency care, orthopedics, cardiovascular care, and more. Mount Sinai takes pride in being South Florida's largest private independent not-for-profit hospital, dedicated to continuing the training of the next generation of medical pioneers. The Director of Research Compliance plays a crucial role in ensuring that all research activities comply with federal regulations and institutional policies. This position provides guidance to research investigators on the preparation of human research proposals, formulates and assists in the planning and preparation of such proposals in compliance with Federal regulations and MSMC policies. The Director conducts preliminary reviews of protocols submitted by residents and requests revisions prior to submission to the IRB Chairman for review. This role also involves reviewing all protocol submissions, including new submissions, renewals, revisions, and deviations, as well as revising all informed consent forms submitted prior to review by the IRB. In addition to overseeing the IRB database and ensuring compliance with federal regulations, the Director acts as a liaison between Mount Sinai and external IRBs. The position also requires serving as an IRB or ARC representative during audits conducted by regulatory agencies. The Director is responsible for assisting investigators in budget preparation for animal research proposals, ensuring semi-annual inspections are conducted, and preparing and maintaining the Institution's Federal-Wide Assurance with DHHS Office for Human Research Protections (OHRP). This role also includes developing and maintaining the IRB/ARC Policies and Procedures Manual and attending national conferences to stay updated on federal guidelines in research.