Job Summary - IRB ManagerProvides leadership, coordination, and advanced regulatory knowledge and experience for the Corewell Health Institutional Review Boards (IRB). The IRB Manager will contribute 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, 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. Will also cultivate a team-oriented work environment and foster 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 prioritizes work assignments and foster a culture of respect, integrity, and curiosity.
Essential Functions - IRB Manager- 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. Reviewing Analyst work, mentoring and performance management to ensure quality standards are met; coordinates the hiring, training and evaluation and professional development of IRB Analysts.
- Meets with the Sr. Director, ORPI to report metrics, ensure alignment of goals and priorities, management of IRB Analyst workload, escalating 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 the 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.
- Developing and maintaining IRB toolkit materials related to IRB review, including policies and procedures, SOPs, checklists/worksheets, forms/templates, and guidance manuals.
- Acts as 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. Requires maintaining staying current with changing regulatory requirements and ethical standards related to human protections.
- Assisting the Sr. Director, ORPI with the maintenance support the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation, which includes preparing reports and other materials in support of ongoing accreditation; partnering with Sr. Director, ORPI to manage the IRB billing, updating the Fee Schedule to stay current with industry trends and aligning with federal funding requirements.
- Collaborate with the Director, QI/QAand QI/QA staff, in performing regular and annual monitoring of IRB operations, including implementing recommended Corrective Action Plans.
- Lead or participates in research-related initiatives, committees, and activities, including QI/QA, educational, and compliance activities; and establishes and maintains a collaborative partnership with local external institutions, universities, medical colleges, and MI Public Health.
Qualifications - IRB Manager- Required Bachelor's Degree preferred areas of study include clinical, life or social sciences; or equivalent
- Preferred Master'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 Required
- 3 years of relevant experience previous supervisory experience Preferred
- CRT-IRB Professional, Certified (CIP) - UNKNOWN Unknown Upon Hire required
- Hybrid = 50% on site at the Secchia Center, Grand Rapids MI
Physical Demands - IRB Manager- Pallet to Waist (6" from floor) > 5 lbs: Seldom up to 10 lbs
- Waist to Waist > 5 lbs: Seldom up to 10 lbs
- Waist to Chest (below shoulder) > 5 lbs: Seldom up to 10 lbs
- Waist to Overhead > 5 lbs: Seldom up to 10 lbs
- Bilateral Carry > 5 lbs: Seldom up to 10 lbs
- Unilateral Carry > 5 lbs: Seldom up to 10 lbs
- Pushing Force > 5 lbs: Seldom up to 10 lbs
- Pulling Force > 5 lbs: Seldom up to 10 lbs
- Sitting: Frequently
- Standing: Occasionally
- Walking: Occasionally
- Forward Bend - Standing: Seldom
- Forward Bend - Sitting: Occasionally
- Trunk Rotation - Standing: Seldom
- Trunk Rotation - Sitting: Occasionally
- Reach - Above Shoulder: Seldom
- Reach - at Shoulder or Below: Seldom
- Handling: Occasionally
- Forceful Grip > 5 lbs: Seldom
- Forceful Pinch > 2 lbs: Seldom
- Finger/Hand Dexterity: Frequently
How Corewell Health cares for you- Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here.
- 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
- Eligibility for benefits is determined by employment type and status
Primary LocationSITE - Secchia Center - 15 Michigan St NE - Grand Rapids
Department NameSponsored Programs Instiutional Review Board - Grand Rapids Hosp
Employment TypeFull time
ShiftDay (United States of America)
Weekly Scheduled Hours40
Hours of Work8:00 a.m. to 5:00 p.m.
Days WorkedMonday to Friday
Weekend FrequencyN/A
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