Job Summary - IRB Manager
Provides 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 (https://careers.corewellhealth.org/us/en/benefits-new) .
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 Location
SITE - Secchia Center - 15 Michigan St NE - Grand Rapids
Department Name
Sponsored Programs Instiutional Review Board - Grand Rapids Hosp
Employment Type
Full time
Shift
Day (United States of America)
Weekly Scheduled Hours
40
Hours of Work
8:00 a.m. to 5:00 p.m.
Days Worked
Monday to Friday
Weekend Frequency
N/A
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Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.
Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.
An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From worksh
