Strategic IRB Program Manager

Florida Gulf Coast University; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Florida Gulf Coast University in Fort Myers, FL is seeking a Manager, Institutional Review Board to oversee the University’s IRB operations and human subjects research review processes. You will ensure compliance with federal, state, and sponsor requirements, advise researchers, and manage complex compliance matters.

The role requires strong leadership, collaboration across university offices, and the ability to drive continuous improvement in IRB operations and training status for researchers

Qualifications

• Nine years of directly related full-time experience or, as an alternative, a Bachelor's degree with five years of related experience.
• Seven years of 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 and IRB requirements.
• Manages reliance agreements and multi-site research arrangements.
• Develops, updates, and implements policies, SOPs, guidance, and processes for IRB operations.
• Advises faculty, researchers, staff, and administrators on IRB requirements and training.
• Reviews protocols and coordinates resolution of deficiencies and complex issues.
• Plans quality assurance activities, institutional audits, and post-approval monitoring.
• Provides training on IRB processes and CITI training for human subjects.
• Collaborates with Research Integrity and other offices to address compliance matters.
• Maintains communication with external agencies regarding IRB matters.
• Identifies and resolves complex issues and recommends process improvements.
• Supervises assigned staff and manages resources for IRB operations.

Skills

Leadership

Interpersonal skills

Organization & time management

Problem-solving

Collaboration

Education

Bachelor's degree

Master's degree

Tools

Microsoft Office

Workday

Salesforce

Job description

Florida Gulf Coast University in Fort Myers, FL is seeking a Manager, Institutional Review Board to oversee the University’s IRB operations and human subjects research review processes. You will ensure compliance with federal, state, and sponsor requirements, advise researchers, and manage complex compliance matters.

The role requires strong leadership, collaboration across university offices, and the ability to drive continuous improvement in IRB operations and training status for researchers