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Senior Program Specialist

3 months ago

Rockville, United States Office of the Assistant Secretary for Health (OASH) Full time

Public Health Program Specialist (Expression of Interest)

Department of Health and Human Services (HHS), Office of the Secretary (OS), Office of the Assistant Secretary for Health (OASH), Office for Human Research Protections (OHRP)

Rockville, MD.

HHS is seeking exceptional candidates for a senior position as a Program Specialist in OHRP's Division of Compliance Oversight.

Office Description:

At the Office of the Assistant Secretary for Health (OASH), we are fueled by a workforce committed to serving as the Secretary's primary advisor on matters involving the nation's public health. OASH oversees the U.S. Department of Health and Human Services' key public health offices and programs including the Office for Human Research Protections and the Office of Research Integrity, several Presidential and Secretarial advisory committees, ten regional health offices across the nation, the Office of the Surgeon General, and the U.S. Public Health Service (PHS) Commissioned Corps.

OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

OHRP's Division of Compliance Oversight (DCO) reviews allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations; and when it receives indications of noncompliance, determines whether to conduct a for-cause compliance investigation. DCO also conducts a program of not-for-cause surveillance evaluations of institutions and institutional review boards (IRB). As part of OHRPs ongoing oversight mission, DCO reviews and responds to reports of serious or continuing noncompliance, unanticipated problems involving risks to research participants or others, and IRB suspensions or termination of research conducted at assured institutions.

Job Description:

As a senior Program Specialist in the Office for Human Research Protections (OHRP), Division of Compliance Oversight, you will have primary responsibility for initiating and conducting investigations and not-for-cause evaluations of human research protections programs and IRBs in adherence with OHRP's policies, procedures, guidance, and HHS regulations for the protection of human subjects at 45 CFR part 46. You will actively support OHRP's mission to provide leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in HHS-conducted or supported research.

This position does not have an educational requirement, but suitable candidates are likely to have a background in one or more of the following fields: clinical trial management, medical or social behavioral research, public health, human research compliance, or IRB membership.

Applicants must possess specialized experience that includes the following:

  • Proficiently interpreting and applying federal laws, policies, and regulations, particularly the Department of Health and Human Services (HHS) regulations for human research protections at 45 CFR part 46.
  • Proficiently explain orally and in writing federal regulations and policies (particularly on human research protections in biomedical and health research) including communicating accurately and effectively to a diverse audience (including scientists, legislators, and senior policymakers).
  • Proficiently manage multiple investigations and evaluations.

Expression of interest:

We are currently soliciting interest prior to a job opportunity announcement.

***Please Note: This is an Expression of Interest. This is not an official job announcement. All applications must be submitted through for consideration.

Please follow the prompts to express interest in this position and/or for more information about this position.