Manager, Institutional Review Board

Florida Gulf Coast University; Fort Myers (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Florida Gulf Coast University is seeking a Manager, Institutional Review Board to oversee the IRB operations, ensure regulatory compliance, and guide protocol review and related activities. The role advises researchers, manages complex compliance matters, and supports continuous improvement of IRB processes.

The position collaborates with university stakeholders, trains staff on IRB requirements, and maintains documentation for federal/state/sponsor obligations while aligning with FGCU’s culture

Qualifications

• Nine years of directly related full-time experience or

Responsibilities

• Provide leadership and operational oversight of the IRB including protocol submission and review

Skills

IRB leadership

Regulatory compliance

Policy development

Training

Education

Bachelor's degree in related field

Master's degree preferred

Tools

Workday

Salesforce

Microsoft Office

Job description

Manager, Institutional Review Board

Florida Gulf Coast University

Job Summary

The Manager, Institutional Review Board provides operationaloversight and management of the University's Institutional ReviewBoard and human subjects research review process. The position isresponsible for ensuring IRB operations, protocol review,regulatory requirements, committee activities, and relatedagreements and documentation comply with applicable federal, state,institutional, and sponsor requirements. The position advisesresearchers and institutional stakeholders on IRB requirements,manages complex compliance matters, and supports continuousimprovement of IRB processes.

FGCU is building a culture of curiosity, commitment andcollaboration. We value employees who successfully work with othersand drive positive change through critical thinking and decisiveaction. If you thrive in an environment of innovation,accountability and mutual respect, you will find a good homehere.

Job Description

Typical duties may include but are not limited to:

• Provides leadership and operational oversight of the IRB,including the protocol submission and review process, committeeactivities, meeting operations, and related documentation.

• 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.

• Manages reliance agreements, multi-site research arrangements,and other agreements supporting the University's human subjectsresearch activities.

• Develops, updates, and implements policies, standard operatingprocedures, guidance, and processes related to IRB operations andhuman subjects research requirements.

• Advises faculty, researchers, staff, and administratorsregarding IRB requirements, protocol preparation and submission,required training and certifications, and applicable Universitypolicies and procedures.

• Reviews protocols and related documentation to ensurecompliance with regulatory, institutional, ethical, andsponsor-specific requirements and coordinates resolution ofdeficiencies and other complex issues.

• Plans and coordinates quality assurance activities,institutional audits, and post-approval monitoring to supportongoing compliance with human subjects research requirements.

• Provides training and education to researchers, faculty, andstaff regarding IRB processes, human subjects researchrequirements, and responsible conduct of research, includingserving as the primary research liaison for CITI training for humansubjects.

• Collaborates with Research Integrity, General Counsel,compliance, and other University offices to address researchcompliance matters and supports the Research Integrity Officer ordesignee with research non-compliance and research misconductmatters, as assigned.

• Maintains communication with external agencies and regulatoryentities regarding IRB and human subjects research compliancematters.

• Identifies, evaluates, and resolves complex issues related toIRB operations and human subjects research compliance andrecommends improvements to processes and practices.

• Supervises assigned staff and manages the resources andactivities necessary to support effective and compliant IRBoperations.

Other Duties:

• Other duties as assigned.

Additional Job Description

Required Qualifications:

• This position requires either nine years of directly relatedfull-time experience or, as an alternative, a Bachelor's degreefrom an accredited institution in an appropriate area ofspecialization and five years of full-time experience directlyrelated to the job functions.

• Seven years, full-time experience in research administration orIBR programs.

• Experience operating a personal computer and proficient withMicrosoft Office (Word, Excel, and Outlook).

• Any appropriate combination of relevant education, experience,and/or certifications may be considered.

Preferred Qualifications:

• Master's Degree from an accredited institution in anappropriate area of specialization.

• Experience with all aspects of grant management.

• Experience with Workday and web-based databases such asSalesforce.

Knowledge, Skills, and Abilities:

• Proven ability to think strategically and approach challengeswith creativity

• Demonstrated track record of reliability, meeting goals, andholding oneself accountable

• Strong interpersonal skills and experience working effectivelyacross teams

• Knowledge of policies, procedures, and regulations pertainingto the position.

• Knowledge of supervisory principles, methods andtechniques.

• Excellent organizational, time management and problem-solvingskills.

• Skill in identifying complex problems and reviewing relatedinformation to develop and evaluate options and implementsolutions.

• Ability to take initiative to plan, organize, coordinate andperform work in various situations when numerous and competingdemands are involved.

• Ability to collaborate and work effectively within thecommunity and willing to contribute to a team effort.

• Detail oriented and the ability to work independently.

• Ability to interact in a professional manner with staff,faculty, students, and the community in a service-orientedenvironment.

• Ability to work in a team and with all levels ofemployees.

• Ability to effectively plan and delegate the work ofothers.

• Ability to effectively manage the work of others by providinginformation, guidance and motivation.

Institutional Values & Behavioral Expectation

• Seek out new approaches to improve outcomes; remain open forfeedback and new ideas.

• Lead with integrity; consistently produce high-quality work;persevere to overcome obstacles to meet deadlines and achievedeliverables.

• Share information and insights thoughtfully; build partnershipsacross departments; communicate respectfully; support colleagues toachieve common goals.

Pay Grade 18

Applications received prior to November 2, 2026, will receive priority review

FGCU is a State University System of Florida member and an EqualOpportunity and Equal Access employer. All qualified applicantswill receive consideration for employment without regard to race,color, religion, sex, age, national origin, disability, orprotected veteran status.