Junior IRB Analyst

University of Virginia•Charlottesville, VA

8d•$50,000 - $60,000•Hybrid

About The Position

The Human Research Protection Program (HRPP) at the University of Virginia seeks applications for multiple Junior IRB Analysts. The Junior IRB Analyst serves as an IRB generalist within the HRPP. Under the supervision of the IRB Manager or a Senior IRB Analyst, the incumbent is responsible for reviewing and processing a full spectrum of IRB submissions to ensure compliance with federal regulations, institutional policies, and ethical standards governing the protection of human research subjects. This is a hybrid position requiring on-site presence 2–3 days per week at the University of Virginia campus in Charlottesville, Virginia. The Junior IRB Analyst must exercise sound judgment, maintain meticulous attention to detail, and demonstrate a commitment to upholding the highest standards of human research protections. The HRPP administers the Institutional Review Board (IRB) and works collaboratively with investigators, sponsors, and regulatory agencies to ensure that research involving human subjects is conducted with the highest standards of safety, integrity, and ethical conduct. The HRPP is committed to fostering a research environment that supports scientific advancement while protecting the rights and welfare of all research participants.

Requirements

High school diploma
At least two years of relevant experience. Any combination of equivalent education and experience may be considered.
Demonstrated understanding of or coursework in research ethics, human subjects research regulations, or clinical research.
Strong written and verbal communication skills with the ability to convey complex regulatory information clearly to diverse audiences.
Excellent organizational skills and ability to manage a high-volume, deadline-driven workload with accuracy.
Proficiency with Microsoft Office Suite (Word, Excel, Outlook); ability to learn electronic IRB management systems.
Ability to work independently and collaboratively in a hybrid work environment.

Nice To Haves

Bachelor’s degree in a health science, life science, social science, public health, law, or closely related field.
1–2 years of experience in an IRB office, research compliance, or clinical research administration.
Familiarity with federal human subjects research regulations (45 CFR 46, 21 CFR Parts 50 & 56) and the Belmont Report.
Certified IRB Professional (CIP®) credential or eligibility to sit for the exam within 24 months of hire.
Experience with electronic IRB management platforms (e.g., Cayuse, IRBNet, Click Commerce).
Knowledge of single IRB (sIRB) review requirements under the NIH sIRB Policy and the Revised Common Rule.

Responsibilities

Review new protocol submissions (initial reviews) to assess regulatory compliance, risk/benefit analysis, and adequacy of informed consent documents.
Process continuing review submissions to verify ongoing compliance, evaluate any interim findings, and confirm that approval conditions remain appropriate.
Apply applicable federal regulations (45 CFR 46, 21 CFR Parts 50 & 56), ICH GCP guidelines, HIPAA, FERPA and UVA institutional policies when evaluating submissions.
Determine appropriate review pathway (exempt, expedited, or full-board) and prepare summary materials for IRB committee meetings when required.
Evaluate modification requests to approved protocols, including amendments to study procedures, consent forms, personnel, and funding sources.
Confirm that proposed changes do not alter the risk/benefit profile in a manner requiring additional committee review beyond the assigned pathway.
Communicate review outcomes and required revisions to research teams in a clear, timely, and professional manner.
Review and process Reportable New Information submissions, including unanticipated problems involving risks to subjects or others, adverse events, and protocol deviations.
Assess the potential impact of reported information on subject safety and ongoing approval status.
Escalate complex or urgent RNIs to senior staff or the full IRB as warranted.
Process reliance (single IRB / sIRB) agreements and ceding memos in support of multi-site and collaborative research.
Coordinate with external institutions and IRBs to obtain, execute, and document appropriate agreements for reviewing or ceding review authority.
Maintain accurate records of all executed reliance agreements and associated protocols within the electronic IRB management system.
Provide regulatory guidance and customer service to principal investigators, study coordinators, and research staff.
Maintain accurate and complete records in the IRB electronic submission system(s).
Participate in IRB committee meetings, preparing agenda items and recording meeting minutes as assigned.
Assist with quality assurance activities, policy development, and educational outreach efforts of the HRPP.
Stay current with evolving federal regulations, guidance documents, and best practices in human research protections.
Perform other related duties as assigned in support of HRPP operations.