University of Virginia · 2 months ago
Executive Director, Human Research Protection Program
The University of Virginia’s Office of the Vice President for Research is seeking an experienced and visionary leader for the Executive Director, Human Research Protection Program role. The Executive Director will be responsible for promoting ethical conduct in human subjects research, maintaining accreditation, and leading a team to support researchers and study teams across the institution.
Higher Education
Responsibilities
Develop and execute a forward-thinking strategic plan that enhances the institution's human research protection program and aligns with organizational goals and values
Lead initiatives to continually improve research compliance, enhance operational efficiency, and facilitate research
Provide visionary leadership that fosters a culture of excellence, transparency, and collaboration within the HRPP and across the institution
Monitor internal and external risks to program success and institutional compliance, develop risk management strategies, and communicate recommendations to OVPR leadership
Ensure compliance with all relevant regulations and guidelines, including AAHRPP accreditation, HIPAA, FERPA, FDA regulations, and NIH OHRP (Office of Human Research Protections) federal-wide assurance
Serve as the institution’s point of contact for federal regulatory agencies, providing guidance and updates on regulatory changes
Oversee the preparation and submission of accreditation materials and site visits; facilitate audits, inspections, and reviews; receive and investigate compliance reports and oversee necessary corrective actions
Provide leadership to ensure ongoing alignment and robust support for the institution's research programs
Guide the IRBs to ensure proper protocol review, compliance oversight, and training of investigators and staff
Act as a resource for IRB members and investigators on complex regulatory issues and ethical considerations regarding the conduct of research with human subjects/participants
Coordinate with other compliance and ethics professionals across the institution to promote ethical decision-making and a culture of compliance and to align policies, systems, processes, and communications where practicable
Work collaboratively with leadership in the OVPR, UVA Health System, University Counsel, and affiliated hospitals to expand access to and participation in UVA clinical trials
Lead training and mentor staff and study teams in best practices, regulatory compliance, and ethical considerations in research with human subjects/participants, with special emphasis on considerations for vulnerable populations
Promote continuing education and professional development opportunities for HRPP staff, IRB members, and research staff
Drive initiatives to enhance the institution’s HRPP and adapt to changing sponsor and regulatory requirements
Engage in outreach and partnerships with other institutions, community organizations, tribal representatives and government
Stay current with industry trends, new technologies, and best practices for HRPPs
Qualification
Required
Master's degree or equivalent
10+ years of relevant experience
Preferred
Proven leadership in a research institution or academic medical center, with a strong background in regulatory compliance (e.g., OHRP, FDA, HIPAA)
Demonstrated experience with IRB oversight and management, preferably encompassing both social/behavioral/education and biomedical/clinical research
Exceptional strategic planning and organizational skills
Strong change management experience
Experience implementing an enterprise IRB system from a business process owner/stakeholder perspective
Strong teaching and mentoring abilities
Experience with AAHRPP accreditation/reaccreditation processes and requirements
Substantive engagement with relevant professional organizations (e.g., PRIM&R, NCURA, SRA) and/or accrediting bodies (e.g., AAHRPP)
Relevant professional certifications (e.g., CIP, CCRC, CRA)
Experience with clinical research management and Good Clinical Practices (GCP)
Basic computer skills (Microsoft Word, Excel, Outlook)
Excellent written and verbal communication skills
Benefits
This is an exempt-level, benefited position. Learn more about UVA benefits.
Company
University of Virginia
The University of Virginia was founded in 1819 as the model for modern universities that has since been emulated all over the world.
H1B Sponsorship
University of Virginia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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2025 (263)
2024 (223)
2023 (262)
2022 (202)
2021 (163)
2020 (155)
Funding
Current Stage
Late StageRecent News
The Republic Reporter
2024-02-29
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