Manager, Institutional Review Board
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Before you apply
LocationMain Campus
Work modeon-site
SenioritySenior
Experience7+ yrs
Company size1,001–5,000 people
PostedOct 19, 2026 · 2w ago
Verified live2d ago
At a glanceSummarised by Seekless from the posting.
Nine years of directly related full-time experience
Bachelor's degree from an accredited institution in an appropriate area of specialization
Five years of full-time experience directly related to the job functions (alternative path)
Seven years full-time experience in research administration or IRB programs
Experience operating a personal computer
Proficient with Microsoft Office (Word, Excel, and Outlook)
Skills
Microsoft Office
Word
Excel
Outlook
Job Summary
The Manager, Institutional Review Board provides operational oversight and management of the University’s Institutional Review Board and human subjects research review process. The position is responsible for ensuring IRB operations, protocol review, regulatory requirements, committee activities, and related agreements and documentation comply with applicable federal, state, institutional, and sponsor requirements. The position advises researchers and institutional stakeholders on IRB requirements, manages complex compliance matters, and supports continuous improvement of IRB processes.
About the company
FGCU is building a culture of curiosity, commitment and collaboration. We value employees who successfully work with others and drive positive change through critical thinking and decisive action. If you thrive in an environment of innovation, accountability and mutual respect, you will find a good home here.
Job Description
Typical duties may include but are not limited to:
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Provides leadership and operational oversight of the IRB, including the protocol submission and review process, committee activities, meeting operations, and related documentation.
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Ensures compliance with applicable federal regulations, including 45 CFR 46 and 21 CFR 56, Federal wide Assurance (FWA) requirements, IRB registration requirements, and applicable state, institutional, and sponsor requirements.
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Manages reliance agreements, multi-site research arrangements, and other agreements supporting the University’s human subjects research activities.
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Develops, updates, and implements policies, standard operating procedures, guidance, and processes related to IRB operations and human subjects research requirements.
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Advises faculty, researchers, staff, and administrators regarding IRB requirements, protocol preparation and submission, required training and certifications, and applicable University policies and procedures.
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Reviews protocols and related documentation to ensure compliance with regulatory, institutional, ethical, and sponsor-specific requirements and coordinates resolution of deficiencies and other complex issues.
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Plans and coordinates quality assurance activities, institutional audits, and post-approval monitoring to support ongoing compliance with human subjects research requirements.
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Provides training and education to researchers, faculty, and staff regarding IRB processes, human subjects research requirements, and responsible conduct of research, including serving as the primary research liaison for CITI training for human subjects.
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Collaborates with Research Integrity, General Counsel, compliance, and other University offices to address research compliance matters and supports the Research Integrity Officer or designee with research non-compliance and research misconduct matters, as assigned.
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Maintains communication with external agencies and regulatory entities regarding IRB and human subjects research compliance matters.
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Identifies, evaluates, and resolves complex issues related to IRB operations and human subjects research compliance and recommends improvements to processes and practices.
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Supervises assigned staff and manages the resources and activities necessary to support effective and compliant IRB operations.
Other Duties:
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Other duties as assigned.
Additional Job Description
Required Qualifications:
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This position requires either nine years of directly related full-time experience or, as an alternative, a Bachelor’s degree from an accredited institution in an appropriate area of specialization and five years of full-time experience directly related to the job functions.
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Seven years, full-time experience in research administration or IBR programs.
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Experience operating a personal computer and proficient with Microsoft Office (Word, Excel, and Outlook).
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Any appropriate combination of relevant education, experience, and/or certifications may be considered.