Clinical Regulatory and Operations Specialist

Quick Facts

• Hiring Agency: National Institutes of Health
• Department: Department of Health and Human Services
• Location: Montgomery County, Maryland
• Salary: $143913 – $187093/yr
• Hiring Path: Fed Transition
• Number of Openings: 1
• Telework Eligible: Yes
• Security Clearance: Other
• Date Posted: 2026-09-21
• Application Deadline: 2026-09-25

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Job 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).

Key Responsibilities

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.

Requirements & Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Contact

OHRCSDBRANCHDSRVDSK@od.nih.gov

Frequently Asked Questions

Which agency is hiring for this position?

This position is with National Institutes of Health, Department of Health and Human Services.

What is the salary for this position?

The posted pay range is $143913 – $187093/yr.

Is this position remote or telework eligible?

This position is eligible for telework.

What security clearance is required?

This position requires a Other security clearance.

What is the application deadline?

Applications close on 2026-09-25.

Who is eligible to apply?

This position is open under the 'Fed Transition' hiring path.

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Source: USAJOBS.gov — U.S. Federal Government