Institutional Review Board Assistant
Core
Pre-reviews and analyzes research project applications to ensure compliance with IRB policies, federal regulations, and ethical guidelines for human subject protection.
Role type
Junior clinical compliance analyst (human subjects research)
Builds
Monthly IRB meeting agendas, minutes, determination letters, and compliance documentation
Domain
Healthcare / Human Research Protection Program
Deliverable
dashboards & analysis
Required skills
Knowledge of Federal regulations (45 CFR 46, 21 CFR 50/56), Microsoft Office (Word, Excel, Outlook), web-based IRB management systems, medical terminology, detail-oriented accuracy
Preferred skills
Experience with Institutional Review Boards or Human Research Protection Programs, virtual meeting environments (Webex), instructional guidance
Responsibilities
Pre-review research submissions for completeness and compliance, prepare monthly IRB meeting agendas and minutes, document IRB decisions and project closures, manage review fee payments, track conflict of interest statements, assist with post-approval monitoring audits
Seniority
Entry-level, training provided