Institutional Review Board (IRB) Analyst

UVA Health•Charlottesville, VA

8d•$60,000 - $70,000•Hybrid

About The Position

The University of Virginia’s Office of the Vice President for Research seeks an experienced IRB Analyst to support the Institutional Review Board for Health Sciences Research (IRB-HSR). Working within a generalist IRB model, the analyst independently manages human research protection activities across a diverse portfolio of biomedical, behavioral, and social science research, from initial protocol review through continuing review, modifications, and reportable new information. The role requires sound regulatory judgment, collaborative investigator engagement, and the ability to manage routine and moderately complex submissions with minimal oversight. The position provides regulatory review and guidance to research teams; supports IRB committee operations, reliance agreements, quality assurance, policy development, and education; and maintains accurate, audit-ready records in electronic IRB systems. This is a restricted position dependent on funding, with a one-year term limit; continued employment after that period depends on department need and funding. It is based in Charlottesville, Virginia, and is eligible for a hybrid schedule of two to three days on Grounds per week, with additional onsite presence as needed. The position is exempt-level and benefited. The anticipated hiring range is $60,000–$70,000, commensurate with education and experience.

Requirements

Bachelor’s degree, or four years of relevant experience may be considered in lieu of a degree.
At least two years of relevant experience in compliance, research administration, regulatory affairs, or a related field.
Working knowledge of regulations governing human research protections, including 45 CFR Part 46, 21 CFR Parts 50 and 56, HIPAA, and FERPA.
Ability to interpret regulatory requirements independently and apply sound judgment to research submissions of varying complexity.
Strong analytical and critical-thinking skills, accuracy, and attention to detail.
Excellent written and verbal communication skills, including the ability to explain complex regulatory information clearly.
Ability to handle sensitive and confidential information with discretion and professionalism.
Proficiency with electronic IRB management systems and document management platforms.
Ability to independently manage a diverse portfolio, prioritize work, and meet deadlines in a fast-paced environment.
Candidates requiring immigration sponsorship now or in the future will not be considered.

Nice To Haves

Experience working with a biomedical Institutional Review Board.
Certified IRB Professional (CIP) certification.
Familiarity with ICH Good Clinical Practice guidelines, the Belmont Report, and NIH single IRB policy requirements.
Up to four years of relevant experience in a compliance or regulatory environment.

Responsibilities

Independently review initial protocol submissions for regulatory compliance, risk-benefit considerations, informed consent adequacy, and protections for vulnerable populations.
Process continuing reviews, evaluating interim findings, adverse events, protocol deviations, ongoing compliance, and approval conditions.
Apply federal regulations, ICH GCP guidelines, HIPAA, FERPA, and UVA policies when evaluating submissions.
Determine whether submissions qualify for exempt, expedited, or full-board review, and prepare summary materials for committee meetings when required.
Evaluate modifications to approved protocols, including changes to procedures, consent forms, personnel, and funding sources; determine whether changes require additional committee review.
Communicate review outcomes and required revisions clearly, promptly, and professionally to research teams.
Review and process Reportable New Information, assess effects on subject safety and approval status, and prepare written determinations.
Escalate complex or urgent Reportable New Information to senior staff or the full IRB with documented facts and regulatory considerations.
Process reliance agreements and ceding memos for multi-site and collaborative research, coordinating with external institutions and IRBs and maintaining records in the electronic IRB system.
Participate in IRB committee meetings and prepare agenda items, summary sheets, and minutes as assigned.
Maintain accurate and complete records in IRB electronic submission systems and ensure documentation integrity and audit readiness.
Assist with HRPP quality assurance, policy development, and educational outreach.
Keep current with regulations, guidance, and best practices through continuing education and professional development.
Provide practical, timely, and consistent regulatory guidance to principal investigators, research coordinators, faculty, staff, and students.
Help study teams resolve submission deficiencies and understand regulatory requirements without taking responsibility for developing research protocols.
Participate in education, outreach, office hours, and other activities to improve researcher understanding and submission quality.
Perform other related duties in support of HRPP operations.