Job Posting: Clinical Regulatory and Operations Specialist

Summary

This position is located in the U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Operations (OCRPRO).

Duties

If selected for the position, you will perform the following duties: Serve as the NIAID in-country/on-the-ground lead and authority in managing, overseeing, and coordinating clinical research operations during public health emergencies caused by emerging and re-emerging infectious diseases, with an emphasis on international clinical research. Conduct frequent site visits to ensure continuity of operations and confirm sites are operating under all applicable regulations, guidelines, policies, and standards. Develop and assemble Investigational New Drug (IND) submissions in close coordination with various research offices and committees of the DCR, contractors and pharmaceutical companies responsible for pre-clinical screening, and administrative collaboration with principal investigators responsible for clinical trial protocols. Represent NIAID at meetings, conferences, and symposia and participate as an authority on matters relating Investigational New Drug (IND) and Investigational Device Exemption (IDE) development, oversight and evaluation, and FDA regulations. Develop and maintain DCR policies related to the Independent Safety Monitor (ISM), Safety Monitoring Committee (SMC), and DSMB.

Who Can Apply