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Lead Program Specialist (Protocol)

National Institutes of Health · Posted 8 days ago

Hybrid Montgomery County, MD $122K – $158K Apply by Sep 11, 2026 Miscellaneous Administration And Program ENTJESFJESTJISTJ Healthcare
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About the Role

The ideal candidate has experience reviewing clinical research protocols and ClinicalTrials.gov documentation; providing guidance on regulatory and IRB requirements; monitoring compliance with submission requirements; working with investigators and research staff to resolve protocol-related issues; and mentoring and training staff on clinical research processes, regulatory requirements, and best practices.

What You'll Do

  • Identifying, assigning, distributing and balancing workload and tasks among employees in accordance with established workflow, skill level and/or occupational specialization.
  • Ensuring that each employee has an integral role in supporting protocol actions that are approved by the IRB and submitted to the PSS for final review and processing by staff.
  • Developing and implementing program strategies that support protocol processing, information management, and administrative services for the NIH Intramural Research Program (IRP) to ensure effective support of clinical research activities.
  • Providing oversight of protocol action processing by conducting quality assurance reviews to ensure accuracy, consistency, and compliance with established procedures.
  • Serving as a principal liaison for the NIH Intramural Research Program to support implementation of and compliance with ClinicalTrials.gov registration requirements for human subjects’ research protocols.
  • Identifying and implementing process improvements by analyzing, streamlining, and automating administrative workflows.

Personality Fit

This role is commonly a great fit for these MBTI types:

Job ID: 096d3107-f4ef-453a-a496-cbc3523d71c8

Posted via USAJobs

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