IRB Analyst (Hybrid) – Health Sciences Research

The Rector & Visitors of the University of Virginia; Charlottesville (VA); Hybrid; USD 60,000 - 70,000; Full time

Job summary

The University of Virginia seeks an experienced IRB Analyst to support the IRB-HSR within a generalist IRB model. The role manages the full spectrum of human research protections from initial review to reportable information across biomedical, behavioral, and social science studies, with minimal oversight on routine submissions.

Responsibilities include protocol review, modifications, RNI processing, reliance agreements, and general HRPP operations.

Qualifications

• Bachelor's degree required; four years of relevant experience may be substituted.
• Experience interpreting federal regulations (45 CFR 46, 21 CFR Parts 50/56, HIPAA, FERPA) is preferred.

Responsibilities

• Independently review initial submissions for regulatory compliance and risk/benefit.
• Evaluate continuing reviews, amendments, and reportable new information.
• Determine review pathways (exempt, expedited, full-board) and prepare materials for meetings.
• Evaluate modifications to approved protocols and communicate required revisions to researchers.
• Process RNIs and assess impact on safety and approvals; escalate when needed.
• Coordinate with external institutions for sIRB reviews and maintain records.
• Participate in IRB meetings and maintain audit-ready documentation.
• Provide regulatory guidance to investigators and teams to strengthen submissions.
• Stay current with evolving regulations and best practices in human subjects protections.

Skills

Regulatory judgment

Written communication

Attention to detail

Time management

Collaboration

Education

Bachelor's degree

Tools

Electronic IRB systems

Job description

The University of Virginia seeks an experienced IRB Analyst to support the IRB-HSR within a generalist IRB model. The role manages the full spectrum of human research protections from initial review to reportable information across biomedical, behavioral, and social science studies, with minimal oversight on routine submissions.

Responsibilities include protocol review, modifications, RNI processing, reliance agreements, and general HRPP operations.