About the position The IRB Manager provides leadership, coordination, and advanced regulatory knowledge and experience for the Corewell Health Institutional Review Boards (IRB). This role contributes to fostering a culture of responsible conduct of human subjects research to protect the rights, welfare, and safety of all research participants. The primary responsibility will be the oversight and management of the Office of the IRB, including a team of IRB Analysts, to ensure the IRB submission review process is aligned across the Corewell Health system. This includes ensuring the operational and support functions for the IRB committee are supported and maintained, developing and maintaining a communication plan, education and training related to IRB matters, and providing guidance to the various regulatory and administrative functions of the Human Research Protection Program (HRPP), investigators and research teams, residents, fellows, and students. The role also cultivates a team-oriented work environment and fosters collaboration with research teams, committees, and research cores throughout the system, adhering to the service mission to facilitate excellence in research by providing timely and thorough reviews of research applications. The IRB Manager will delegate, supervise, and prioritize work assignments and foster a culture of respect, integrity, and curiosity.

Responsibilities

• Oversees daily operations and manages a team of IRB analysts working to align operations across the system.
• Ensures IRB business operations and procedures are consistent, defines and addresses operations to ensure efficiency and adherence to applicable federal regulations, state law, and system policies and procedures.
• Reviews Analyst work, mentors, and manages performance to ensure quality standards are met; coordinates the hiring, training, evaluation, and professional development of IRB Analysts.
• Meets with the Sr. Director, ORPI to report metrics, ensure alignment of goals and priorities, manage IRB Analyst workload, and escalate complex decision-making and identified serious/continuing non-compliance or unanticipated problems.
• Assists the Sr. Director, ORPI with the development and maintenance of system-wide policies pertaining to research operations and the various protection committees (i.e., IRB, IACUC, IBC, Radiation Safety, etc.).
• Provides regulatory expertise and guidance for IRB Chairs and members; ensures IRB determinations/decisions are communicated to investigators in a timely manner and IRB minutes meet all regulatory requirements, periodically evaluates committee performance and membership rosters.
• Develops and maintains IRB toolkit materials related to IRB review, including policies and procedures, SOPs, checklists/worksheets, forms/templates, and guidance manuals.
• Acts as a content expert to support enterprise-wide studies, scientists, and physicians; provides guidance on research development, the applicability of human subjects regulations and/or other laws and policies; strategizes with researchers on how to conduct research in a manner that is both compliant with regulatory demands and meets research project expectations.
• Maintains staying current with changing regulatory requirements and ethical standards related to human protections.
• Assists the Sr. Director, ORPI with the maintenance and support of the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation, which includes preparing reports and other materials in support of ongoing accreditation.
• Partners with Sr. Director, ORPI to manage IRB billing, updating the Fee Schedule to stay current with industry trends and aligning with federal funding requirements.
• Collaborates with the Director, QI/QA and QI/QA staff in performing regular and annual monitoring of IRB operations, including implementing recommended Corrective Action Plans.
• Leads or participates in research-related initiatives, committees, and activities, including QI/QA, educational, and compliance activities.
• Establishes and maintains a collaborative partnership with local external institutions, universities, medical colleges, and MI Public Health.

Requirements

• Bachelor's Degree preferred areas of study include clinical, life or social sciences; or equivalent
• 5 years of relevant experience in the field of human subjects research protections
• 3 years of relevant experience previous supervisory experience
• CRT-IRB Professional, Certified (CIP) - UNKNOWN Unknown Upon Hire

Nice-to-haves

• Master's Degree preferred areas of study include clinical, life or social sciences; or equivalent

Benefits

• Comprehensive benefits package to meet your financial, health, and work/life balance goals.
• On-demand pay program powered by Payactiv
• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!
• Optional identity theft protection, home and auto insurance
• Traditional and Roth retirement options with service contribution and match savings