Assistant Vice President for Research - Human Research Protection Program

About the position

Responsibilities

• Serve as the HRPP Director.
• Oversee the HRPP Associate Director, who has responsibility for the Office of Research Compliance Review.
• Oversee the two IRB Directors (IRBMED, IRB-HSBS) and the Director of the Coordinated Services and Practices unit (CSP) to ensure review of medical and non-medical research meets timely achievement of goals, compliant conduct of the research, and provides participant protections.
• Support the Associate Vice President for Research - Clinical and Human Subjects Research in matters related to overall direction of the HRPP.
• Coordinate and provide oversight of IRB functions; ultimate responsibility for the overall regulatory and operational compliance of the 8 U-M IRBs (6 IRBMED boards and 2 IRB-HSBS boards); receive recommendations and reports from oversight committees regarding operational functions and matters of concern; develop, amend, and implement practices to support the compliant review of human research applications.
• Address IRB strategy/policy within the HRPP and at enterprise level.
• Contribute to enterprise-wide policy development and implementation as it relates to IRB and HRPP initiatives.
• Work with HRPP leadership to develop strategic plans for advancement of critical functional and regulatory requirements; prepare reports detailing metrics and programmatic strategic directions for institutional leadership.
• Assess needs for the combined financial planning/budget management and human resources of the IRBs; responsibility for a cohesive, unified operational team with harmonized policies and procedures.
• Work with the IRB Directors and HRPP representatives to maintain FDA and AAHRPP policy and procedure readiness.
• Collaborate with other HRPP representatives to maintain and update the HRPP Operations Manual (OM).
• Provide supervision on complex risk management issues; support research compliance committees; oversee noncompliance review procedures within the IRBs.
• Assist with the review and reporting of cases involving noncompliance.
• Serve as a liaison with the HRPP Ancillary Committees and other offices at the university with functions closely interrelated to the HRPP.
• Facilitate appropriate content and functionality of the human research application system including participation in the selection and development of new systems.
• Oversee HRPP-related aspects of Michigan Medicine's clinical research statewide expansion.
• Oversee HRPP communications. Facilitate communication and education within the HRPP and to the research community including websites and newsletters.
• As designated, sign Certificates of Confidentiality on behalf of the University.
• As designated, sign or approve IRB reliance agreements, collaborating institution agreements, and individual investigator agreements.

Requirements

• An advanced degree in a scientific, medical, legal, or other relevant discipline.
• 10 or more years of combined and direct experience overseeing and supervising IRB functions for biomedical, health science or social/behavioral science research and providing leadership and decision-making for HRPP functions.
• Expert knowledge of federal, state, and local human research and other regulations, policies, and guidance and their direct application to the research environment.
• Leadership, management, and supervisory experience associated with large-scale offices and complex workflows.
• Experience developing and implementing policies and procedures.
• Excellent analytical and independent problem-solving skills, organizational, coordination and prioritization skills.
• Excellent verbal and written communication skills, computer skills, and experience with electronic IRB systems.
• Ability to produce detail-oriented and accurate documents, reports and announcements.
• Detailed working knowledge of AAHRPP accreditation standards and experience with external inspections and audits (e.g., FDA, OHRP).

Nice-to-haves

• Experience and working knowledge of developing content for electronic IRB application systems.
• Experience with project management.
• Experience in an academic medicine environment and academic research environment that includes social, behavioral or education research.

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