Manager, Institutional Review Board

Florida Gulf Coast University; Lexington (MA); On-site; USD 95,000 - 145,000; Full time

Job summary

Florida Gulf Coast University is seeking a Manager of the Institutional Review Board to oversee the IRB operations, protocol review, regulatory compliance, and associated agreements. You will advise researchers and coordinate complex compliance matters while driving continuous improvement in IRB processes.

The role requires leadership across units, collaboration with legal and compliance teams, and effective training for faculty and staff on human subjects research requirements.

Qualifications

• Nine years of directly related full-time experience or a Bachelor’s degree with five years related experience.
• Seven years, full-time experience in research administration or IRB programs.
• Experience operating a personal computer and proficient with Microsoft Office (Word, Excel, and Outlook).
• Any appropriate combination of relevant education, experience, and/or certifications may be considered.

Responsibilities

• Provides leadership and operational oversight of the IRB, including the protocol submission and review process, committee activities, 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 subjects research activities.
• Develops, updates, and implements policies, standard operating procedures, guidance, and processes related to IRB operations and human subjects research requirements.
• Advises faculty, researchers, staff, and administrators regarding IRB requirements, protocol preparation and submission, required training and certifications, and applicable University policies and procedures.
• 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.
• Plans and coordinates quality assurance activities, institutional audits, and post-approval monitoring to support ongoing compliance with human subjects research requirements.
• 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.
• 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.
• Maintains communication with external agencies and regulatory entities regarding IRB and human subjects research compliance matters.
• Identifies, evaluates, and resolves complex issues related to IRB operations and human subjects research compliance and recommends improvements to processes and practices.
• Supervises assigned staff and manages the resources and activities necessary to support effective and compliant IRB operations.

Skills

Strategic thinking

Reliability

Interpersonal skills

Regulatory knowledge

Supervisory skills

Organizational skills

Problem solving

Initiative

Collaboration

Detail oriented

Education

Bachelor’s degree

Master’s degree

Tools

Microsoft Office (Word, Excel, Outlook)

Workday

Salesforce

Job description

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.

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:

• Provides leadership and operational oversight of the IRB, including the protocol submission and review process, committee activities, 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 subjects research activities.

• Develops, updates, and implements policies, standard operating procedures, guidance, and processes related to IRB operations and human subjects research requirements.

• Advises faculty, researchers, staff, and administrators regarding IRB requirements, protocol preparation and submission, required training and certifications, and applicable University policies and procedures.

• 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.

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

• 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.

• 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.

• Maintains communication with external agencies and regulatory entities regarding IRB and human subjects research compliance matters.

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

• Supervises assigned staff and manages the resources and activities necessary to support effective and compliant IRB operations.

Other Duties:

• Other duties as assigned.

Additional Job Description

Required Qualifications:

• 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.
• Seven years, full-time experience in research administration or IBR programs.
• Experience operating a personal computer and proficient with Microsoft 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 an appropriate area of specialization.
• Experience with all aspects of grant management.
• Experience with Workday and web-based databases such as Salesforce.

Knowledge, Skills, and Abilities:

• Proven ability to think strategically and approach challenges with creativity
• Demonstrated track record of reliability, meeting goals, and holding oneself accountable
• Strong interpersonal skills and experience working effectively across teams
• Knowledge of policies, procedures, and regulations pertaining to the position.
• Knowledge of supervisory principles, methods and techniques.
• Excellent organizational, time management and problem-solving skills.
• Skill in identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Ability to take initiative to plan, organize, coordinate and perform work in various situations when numerous and competing demands are involved.
• Ability to collaborate and work effectively within the community 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-oriented environment.
• Ability to work in a team and with all levels of employees.
• Ability to effectively plan and delegate the work of others.
• Ability to effectively manage the work of others by providing information, guidance and motivation.

Institutional Values & Behavioral Expectation

In this role, the successful candidate will be expected to:

• Seek out new approaches to improve outcomes; remain open for feedback and new ideas.
• Lead with integrity; consistently produce high-quality work; persevere to overcome obstacles to meet deadlines and achieve deliverables.
• Share information and insights thoughtfully; build partnerships across departments; communicate respectfully; support colleagues to achieve 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 Equal Opportunity and Equal Access employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, or protected veteran status.