University of Virginia
Executive Director, Human Research Protection Program
University of Virginia, Charlottesville, Virginia, United States, 22904
Overview
Executive Director, Human Research Protection Program (HRPP Executive Director) at University of Virginia. The University of Virginia’s Office of the Vice President for Research (OVPR) seeks an experienced and visionary leader to build on the foundation and guide future growth of UVA’s research portfolio, particularly in clinical research and clinical trials, including at affiliated community hospitals across the state. The HRPP Executive Director will promote the highest standards of ethical conduct in human subjects research; maintain UVA’s AAHRPP accreditation; and ensure compliance with applicable laws, regulations, standards and institutional policies. Key Responsibilities
Leadership & Strategic Planning:
Develop and execute a forward-thinking strategic plan that enhances the HRPP 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. Compliance & Regulatory Oversight:
Ensure compliance with regulations and guidelines including AAHRPP accreditation, HIPAA, FERPA, FDA regulations, and NIH OHRP federal-wide assurance; serve as point of contact for federal regulatory agencies; oversee accreditation materials and site visits; facilitate audits, inspections, and reviews; manage corrective actions. Oversight Of HRPP Functional Offices (IRB-SBS, IRB-HSR, PAM):
Provide leadership to ensure alignment and robust support for research programs; guide IRBs in protocol review, compliance oversight, and training; support IRB members and investigators on complex regulatory issues; coordinate with other offices to promote ethical decision-making and policy alignment. Clinical Research Support:
Collaborate with OVPR leadership, UVA Health System, University Counsel, and affiliated hospitals to expand access to UVA clinical trials. Education & Training:
Lead training and mentoring for staff and study teams in best practices, regulatory compliance, and ethics; promote continuing education for HRPP staff, IRB members, and research staff. Program Development & Enhancement:
Drive initiatives to enhance the HRPP and adapt to sponsor and regulatory changes; engage with external partners; stay current with industry trends and best practices. Qualifications
Minimum Requirements:
Master’s degree or equivalent; 10+ years of relevant experience. Preferred Qualifications:
Proven leadership in a research institution or academic medical center with regulatory compliance experience (OHRP, FDA, HIPAA); IRB oversight experience; strong strategic planning, change management, and budget/IRB system implementation experience; excellent teaching and mentoring; AAHRPP accreditation experience; professional affiliations and certifications (e.g., CIP, CCRC, CRA); strong communication skills. Additional Details
Work Location:
The individual must be able to be in person at least 3 days/week. Fully remote or hybrid arrangements with only occasional travel to Charlottesville will not be considered. Physical Demands:
This is primarily sedentary with extensive computer use; travel to attend meetings and programs may be required. Anticipated Compensation:
Commensurate with qualifications and experience. Application Instructions:
Apply online and search for R0077340. Internal applicants must apply through Workday. Include CV/Resume and Cover Letter/Personal Statement of Interest. Upload all materials; multiple documents may be submitted. Applications lacking required documents may not receive full consideration. Questions:
For questions about the application process, contact Jessica Speth at js9rk@virginia.edu. EEO Statement
The University of Virginia is an equal opportunity employer. Veterans and individuals with disabilities are encouraged to apply. See UVA’s non-discrimination and equal opportunity employment policy for details.
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Executive Director, Human Research Protection Program (HRPP Executive Director) at University of Virginia. The University of Virginia’s Office of the Vice President for Research (OVPR) seeks an experienced and visionary leader to build on the foundation and guide future growth of UVA’s research portfolio, particularly in clinical research and clinical trials, including at affiliated community hospitals across the state. The HRPP Executive Director will promote the highest standards of ethical conduct in human subjects research; maintain UVA’s AAHRPP accreditation; and ensure compliance with applicable laws, regulations, standards and institutional policies. Key Responsibilities
Leadership & Strategic Planning:
Develop and execute a forward-thinking strategic plan that enhances the HRPP 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. Compliance & Regulatory Oversight:
Ensure compliance with regulations and guidelines including AAHRPP accreditation, HIPAA, FERPA, FDA regulations, and NIH OHRP federal-wide assurance; serve as point of contact for federal regulatory agencies; oversee accreditation materials and site visits; facilitate audits, inspections, and reviews; manage corrective actions. Oversight Of HRPP Functional Offices (IRB-SBS, IRB-HSR, PAM):
Provide leadership to ensure alignment and robust support for research programs; guide IRBs in protocol review, compliance oversight, and training; support IRB members and investigators on complex regulatory issues; coordinate with other offices to promote ethical decision-making and policy alignment. Clinical Research Support:
Collaborate with OVPR leadership, UVA Health System, University Counsel, and affiliated hospitals to expand access to UVA clinical trials. Education & Training:
Lead training and mentoring for staff and study teams in best practices, regulatory compliance, and ethics; promote continuing education for HRPP staff, IRB members, and research staff. Program Development & Enhancement:
Drive initiatives to enhance the HRPP and adapt to sponsor and regulatory changes; engage with external partners; stay current with industry trends and best practices. Qualifications
Minimum Requirements:
Master’s degree or equivalent; 10+ years of relevant experience. Preferred Qualifications:
Proven leadership in a research institution or academic medical center with regulatory compliance experience (OHRP, FDA, HIPAA); IRB oversight experience; strong strategic planning, change management, and budget/IRB system implementation experience; excellent teaching and mentoring; AAHRPP accreditation experience; professional affiliations and certifications (e.g., CIP, CCRC, CRA); strong communication skills. Additional Details
Work Location:
The individual must be able to be in person at least 3 days/week. Fully remote or hybrid arrangements with only occasional travel to Charlottesville will not be considered. Physical Demands:
This is primarily sedentary with extensive computer use; travel to attend meetings and programs may be required. Anticipated Compensation:
Commensurate with qualifications and experience. Application Instructions:
Apply online and search for R0077340. Internal applicants must apply through Workday. Include CV/Resume and Cover Letter/Personal Statement of Interest. Upload all materials; multiple documents may be submitted. Applications lacking required documents may not receive full consideration. Questions:
For questions about the application process, contact Jessica Speth at js9rk@virginia.edu. EEO Statement
The University of Virginia is an equal opportunity employer. Veterans and individuals with disabilities are encouraged to apply. See UVA’s non-discrimination and equal opportunity employment policy for details.
#J-18808-Ljbffr