Assistant Vice President for Research - Human Research Protection Program

JOB OPENING ID: 269761 MODES OF WORK Hybrid REGULAR/TEMPORARY: Regular ORGANIZATIONAL GROUP: Umor Rsrch Pol&Compl DEPARTMENT: HRPP-Human Research Protection How to Apply A cover letter and resume are required for consideration for this position. Include the cover letter as the first page of your application. The letter should specifically address your interest in this position and outline relevant skills and experience. Job Summary As a premier R1 research university, the University of Michigan is a world-renowned institution with a large portfolio of human subjects research extending around the globe and across diverse disciplines. The University of Michigan Office of Research is committed to supporting our internationally-recognized researchers in their transformative work to improve the wellbeing of the citizens of Michigan and beyond. Our team's goal is to enhance the research enterprise, facilitate the educational mission in research, maintain an investigator-focused infrastructure, streamline research processes, and reduce regulatory burden while adhering to the highest standards for protecting human research participants and regulatory compliance. 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. Required Qualifications* 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). Desired Qualifications* 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. Modes of Work Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes. Background Screening The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act. Application Deadline Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended. U-M EEO Statement The University of Michigan is an equal employment opportunity employer. Apply tot his job