Executive Director, Human Research Protection Program

State of Virginia•Charlottesville, VA

38d•Onsite

About The Position

The University of Virginia's Office of the Vice President for Research (OVPR) is seeking an experienced and visionary leader to be the Executive Director, Human Research Protection Program (HRPP Executive Director), to build on our existing foundation and prepare for future growth of UVA's research portfolio, particularly in the area of clinical research and clinical trials, including at our affiliated community hospitals across the state. The Executive Director will be responsible for promoting the highest standards of ethical conduct in human subjects research; maintaining UVA's accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP); and facilitating research in compliance with applicable laws, regulations, standards and institutional policies. The successful candidate will hold themselves and others to the highest ethical standards; foster a culture of transparency and accountability; provide clear and consistent guidance; and establish reliable performance expectations and associated metrics. The initial appointment will be for a three-year term but will be renewable based on satisfactory performance and ongoing availability of funds. The HRPP Executive Director will lead a team of knowledgeable and dedicated staff and three Institutional Review Boards (IRBs) providing support for researchers and study teams in all disciplines. A critical responsibility of the HRPP Executive Director will be to lead professional development efforts for staff and provide continuing education opportunities to IRB members. The HRPP staff are currently organized in three functional offices: IRB for the Social and Behavioral Sciences (IRB-SBS), IRB for Health Sciences Research (IRB-HSR), and Post Approval Monitoring & Education (PAM). Reporting to the Associate Vice President for Research Compliance and Regulatory Affairs, the HRPP Executive Director will serve as a key member of the project team implementing a new IRB system. The HRPP Executive Director will serve as the business owner responsible for decisions regarding core IRB functions, processes, and workflows; however, such decisions must be made in close collaboration with colleagues from research administration, compliance, and support offices across Grounds and in consultation with investigators and study teams. The successful candidate will be expected to make data-driven decisions concerning resource allocation (e.g., investments in system development, prioritization and assignment of work, strategic planning and budget development) and to transparently communicate associated impacts. Key collaborating offices for the HRPP include, but are not limited to, the Office of Sponsored Programs, Clinical Trials Unit, Research Integrity & Ethics, Conflict of Interest, Compliance & Privacy, Information Security, Electronic Research Administration, Finance and University Counsel, as well as research institutes and centers. Work Location : The individual in this position must be able to be in person at least 3 days/week. Individuals wishing to be fully remote or hybrid with only occasional trips to Charlottesville will not be considered for this position.

Requirements

Education: Master's degree or equivalent.
Experience: 10+ years of relevant experience

Nice To Haves

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.

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.