IRB Operations Leader & Research Compliance Manager

Florida Gulf Coast University; North Lake Village (FL); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Florida Gulf Coast University is seeking a Manager, Institutional Review Board to provide leadership and operational oversight of the IRB and human subjects research review process on campus.

The role ensures regulatory compliance across federal/state requirements and supports researchers with protocol preparation, training, and complex compliance matters. Strong collaboration across units and continuous process improvement are essential.

Qualifikationen

• Nine years of directly related full-time experience or a Bachelor's degree with five years related experience.
• Seven years of full-time experience in research administration or IRB programs.
• Experience with Microsoft Office (Word, Excel, Outlook).
• Experience with Workday and Salesforce is preferred.

Aufgaben

• Provides leadership and operational oversight of the IRB, including protocol submission and review process, committee activities and related documentation.
• Ensures compliance with federal regulations (45 CFR 46, 21 CFR 56), FWA, IRB registration, and sponsor requirements.
• Manages reliance agreements and multi-site research arrangements and related agreements.
• Develops and implements policies, SOPs, guidance, and processes for IRB operations.
• Advises researchers, staff, and administrators on IRB requirements, training, and policies.
• Coordinates audits, post-approval monitoring and quality assurance activities.

Kenntnisse

Research administration

Microsoft Office

Collaboration across teams

Ausbildung

Master's Degree

Bachelor's degree

Tools

Workday

Salesforce

Jobbeschreibung

Florida Gulf Coast University is seeking a Manager, Institutional Review Board to provide leadership and operational oversight of the IRB and human subjects research review process on campus.

The role ensures regulatory compliance across federal/state requirements and supports researchers with protocol preparation, training, and complex compliance matters. Strong collaboration across units and continuous process improvement are essential.