Clinical Regulatory and Operations Specialist
Office of Clinical Research Policy and Regulatory Operations (OCRPRO)
Division of Clinical Research (DCR)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
U.S. Department of Health and Human Services (HHS)
NIAID, one of the largest Institutes of the NIH, is seeking a Clinical Regulatory and Operations Specialist with a number of regulatory responsibilities, including clinical trial safety management, oversight of Data and Safety Monitoring Boards (DSMBs), clinical trial management/monitoring, investigational new drug (IND) and investigational device exemption (IDE) management, including safety related input for Food and Drug Administration (FDA) communications, oversight of the protocol development program, management of clinical quality management systems, liaison activities with the NIH intramural Institutional Review Board, and trans-NIAID clinical trial policy development.
These roles also extend to DCR’s clinical trials management and oversight involving public health emergency response and on-going clinical research activities. The incumbent provides technical direction and expertise in the development, conduct, and oversight of DCR’s clinical research programs of national and international scope. These situations require immediate, diplomatic, technically accurate, mission-aligned decisions and actions for rapidly responding and deploying lifesaving resources during an infectious disease outbreak.
The Clinical Regulatory and Operations Specialist will be assigned responsibility for various clinical research activities pertaining to FDA-regulated (IND and IDE) studies within the DCR’s clinical research portfolio. The incumbent’s primary responsibilities will be safety oversight of clinical studies as outlined below.
Safety Oversight of Clinical Studies / Pharmacovigilance
The incumbent is responsible for the safety oversight of assigned clinical studies, specifically:
• Ensures compliance with adverse event (AE), serious adverse event (SAE), suspected unexpected serious adverse reaction (SUSAR), and unanticipated problem (UP) reporting regulations (domestic and international) and provides scientific and technical leadership to DCR staff and contractors regarding the reporting of these events.
• Applies knowledge of applicable federal and HHS regulations and guidance, NIH policies, and NIAID policies to develop and maintain DCR policies or guidance related to the Independent Safety Monitor (ISM), Safety Monitoring Committee (SMC), and Data and Safety Monitoring Boards (DSMB); and manages all ISM, SMC, and DSMB activities.
• Develops and presents safety training materials to colleagues and clinical site staff.
• Drafts site-specific safety SOPs and/or assists sites in development of SOPs.
• Collaborates with IND/IDE regulatory and Clinical Monitoring staff to ensure a comprehensive and cohesive approach to the overall safety oversight of each assigned clinical study; and collaborates with the Technology Transfer and Intellectual Property Office (NIAID/OD/OSMO/TTIPO) to ensure accurate representation of safety office involvement on applicable agreements.
• Serves as liaison to pharmaceutical companies on safety-related issues.
• Represents NIAID at meetings, conferences, and symposia and participates as an authority on matters relating to pharmacovigilance.
• Bachelor's degree, or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained).
• Bachelor's or higher degree in major study in biology, nursing, or another field related to the health sciences as well as 5 years clinical research experience
• Experience in pharmacovigilance or primarily in safety oversight of FDA regulated research and PV, RAC, or other clinical research specialty certification
Visit www.USAJobs.govand access the detailed vacancy announcement NIH-NIAID-DE-21-11031630 (U.S. citizens) and #NIH-NIAID-MP-21-11047572 (status candidates) beginning March 15, 2021. Applications must be submitted online by 11:59 p.m. on March 19, 2021.
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HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, and inclusion.