IRB Operations Leader - Human Subjects Compliance

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

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.