Clinical Regulatory and Operations Specialist

Division of Clinical Research

Office of Clinical Research Policy and Regulatory Operations

The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes at the National Institutes of Health (NIH) and part of the Department of Health and Human Services (HHS), conducts and supports a global program of research to better understand treat, and ultimately prevent infectious, immunologic, and allergic diseases.

NIAID seeks a highly motivated and exceptional candidate for a clinical regulatory and operations specialist position in the Office of Clinical Research Policy and Regulatory Operations (OCRPRO), Division of Clinical Research (DCR), NIAID.

The OCRPRO mission is to facilitate the clinical research enterprise by providing protocol development, regulatory clinical trials management, and safety oversight for NIAID intramural and DCR programs.

The responsibilities of the clinical regulatory and operations specialist include the following:

•    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 DCR, contractors and pharmaceutical companies responsible for preclinical 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 to IND and investigational device exemption (IDE) development, oversight and evaluation, and FDA regulations

•    Develop and maintain DCR policies related to the independent safety monitor, the safety monitoring committee, and the data and safety monitoring board (DSMB)

Qualifications

Required

•    U.S. citizenship or certificate of U.S. naturalization

•    Bachelor's degree, or graduate/higher level degree with a major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of this position

•    Experience coordinating clinical research operations in response to emerging and re-emerging infectious diseases; supporting the development, technical management, and evaluation of clinical research programs; providing guidance on matters relating to IND and IDE development, oversight, and evaluations; and overseeing clinical studies to ensure procedures and policies are within safety protocols

Preferred

•    Previous experience submitting documents to the FDA or in regulatory affairs

•    Previous safety oversight and/or experience in DSMB operations

•    Ability to work well in a fast-paced environment

•    Ability to work with several different teams and stakeholders

•    Ability to handle multiple assignments with competing deadlines

To Apply

Visit the clinical regulatory and operations specialist vacancy announcement numbers NIH-NIAID-DE-24-12157967 (U.S. citizens) and/or NIH-NIAID-MP-24-12157966 (status candidates) to submit your application. Applications must be submitted online from January 8, 2024, until 11:59 p.m. Eastern Time on January 12, 2024.

Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere.

HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, inclusion, and accessibility.