Human Research Protection Regulatory Manager - TBI
Summary: The Human Protections Regulatory Manager is responsible for the direction, operation, and management of the Regulatory Affairs and Research Compliance program. S/he will ensure compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).
- Under government guidance, the contractor is responsible for the operation and management of the Regulatory Affairs and Research Compliance program.
- Ensures compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).
- Assists in the development and updating of the DVBIC regulatory compliance policies, standard operating procedures, requirements and related matters.
- Establishes training programs in human subject protection and HIPAA compliance.
- Conducts research compliance monitoring.
- Obtains Scientific review of proposals and protocols.
- Facilitate information flow and acts as liaison between agencies such as USUHS, Federal and Contractor Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs) Institutional Bio-safety Committees (IBCs), research administration offices, Food and Drug Administration (FDA), Office of Human ResearchProtections (OHRP).
- May conduct site monitoring visits to ensure compliance with regulations and human subjects protection.
- May encounter patients who are confused, agitated, or abusive
- Master’s Degree required.
- Must have Human Subjects training completed. Training in human subjects’ research protection, animal use, bioethics, and HIPAA required.
- Certified as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA).
- Must be a U.S. citizen.
- Minimum 5 years related experience in clinical program management and 10 years’ experience in clinical research and/or regulatory affairs arena required.
- Prior experience within the DoD/VA systems of care strongly preferred.
- The contractor will normally work up to 40 hours a week, 0800 to 1630, Monday through Friday (hours may vary).
- Must be available to travel locally, regionally and nationally.