Institutional Review Board (IRB) Analyst

The Rector & Visitors of the University of Virginia; Charlottesville (VA); Ibrido; USD 60.000 - 70.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory judgment

Written communication

Attention to detail

Time management

Collaboration

Formazione

Bachelor's degree

Strumenti

Electronic IRB systems

Descrizione del lavoro

The University of Virginia's Office of the Vice President for Research seeks a skilled and experienced IRB Analyst to support the Institutional Review Board for Health Sciences Research (IRB-HSR). Operating within a generalist IRB model, the IRB Analyst independently manages the full spectrum of human research protection activities - from initial protocol review through continuing review, modifications, and reportable new information - across a diverse portfolio of biomedical, behavioral, and social science research. This role requires sound regulatory judgment, a collaborative approach to investigator engagement, and the ability to work with minimal oversight on routine and moderately complex submissions.

The University of Virginia is a prestigious public research university with a strong commitment to integrity, excellence, and the advancement of human knowledge. The Office of the Vice President for Research supports a robust research enterprise and is dedicated to ensuring the ethical conduct of research involving human subjects. UVA is an equal opportunity employer committed to diversity and inclusion.

Responsibilities

Protocol Review - Initial, Continuing, and Determinations

• Independently review new protocol submissions (initial reviews) to assess regulatory compliance, risk/benefit analysis, adequacy of informed consent documents, and appropriate protections for vulnerable populations.
• Process continuing review submissions to verify ongoing compliance, evaluate any interim findings, adverse events, and protocol deviations, 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 the appropriate review pathway (exempt, expedited, or full-board) and prepare comprehensive summary materials for IRB committee meetings when required.

Modifications

• Evaluate modification requests to approved protocols, including amendments to study procedures, consent forms, personnel, and funding sources, applying independent regulatory judgment.
• 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.

Reportable New Information (RNI)

• 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 and prepare written determinations consistent with regulatory requirements.
• Escalate complex or urgent RNIs to senior staff or the full IRB as warranted, with a well‑documented summary of relevant facts and regulatory considerations.

Reliance Agreements & Ceding Memos

• Process reliance (single IRB / sIRB) agreements and ceding memos in support of multi‑site and collaborative research, in accordance with the NIH sIRB Policy and applicable regulations.
• 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.

General IRB Operations

• Participate in IRB committee meetings, preparing agenda items, summary sheets, and recording meeting minutes as assigned.
• Maintain accurate and complete records in the IRB electronic submission system(s), ensuring documentation integrity and audit readiness.
• Assist with quality assurance activities, policy development, and educational outreach efforts of the Human Research Protection Program (HRPP).
• Stay current with evolving federal regulations, guidance documents, and best practices in human research protections through continuing education and professional development.
• Perform other related duties as assigned in support of HRPP operations.

Investigator Guidance and Customer Service

• Provide timely, practical, and consistent regulatory guidance to principal investigators, research coordinators, faculty, staff, and students regarding IRB submission requirements and human research protections.
• Help study teams resolve submission deficiencies and understand the rationale for regulatory requirements, without assuming responsibility for developing the research protocol.
• Participate in education, outreach, office hours, and other activities that strengthen researcher understanding of human subjects protections and improve the quality of IRB submissions.

Minimum Qualifications

• Education: Bachelor's degree. Four years of relevant experience may be considered in lieu of a degree.
• Experience: At least two years of relevant experience in compliance, research administration, regulatory affairs, or a related field.

Preferred Qualifications

• Up to four (4) years of relevant experience in a compliance or regulatory environment.
• Experience working with a biomedical Institutional Review Board (IRB).
• Certified IRB Professional (CIP) certification is preferred.

Desired Knowledge, Skills, and Abilities

• Working knowledge of federal and state regulations governing the protection of human research subjects, including 45 CFR Part 46, 21 CFR Parts 50 and 56, HIPAA, and FERPA.
• Familiarity with ICH Good Clinical Practice (GCP) guidelines, the Belmont Report, and NIH single IRB policy requirements.
• Ability to independently interpret regulatory requirements and apply sound judgment when evaluating research submissions of varying complexity.
• Strong analytical and critical thinking skills with a high degree of accuracy and attention to detail.
• Excellent written and verbal communication skills; ability to convey complex regulatory information clearly to researchers at all levels.
• 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 of submissions, prioritize workload, and meet deadlines in a fast‑paced environment.

Physical Demands

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require walking some distance to attend meetings, and programs.

The anticipated hiring range is $60,000-70,000, commensurate with education and experience.

This is an exempt-level, benefited position. Learn more about UVA benefits.

This is a restricted position, which is dependent on funding and is contingent upon funding availability. This position has a term limit of one year after which continued employment will depend on department need and funding.

This position is based in Charlottesville, VA, and is eligible for a hybrid schedule of 2-3 days on Grounds per week, with additional on-site presence as needed, in accordance with UVA's remote work guidelines.

To learn more about UVA and the Charlottesville area, visit UVA Life and Embark CVA.

Application review will begin October 27, 2026.

Background checks will be conducted on all new hires prior to employment.

This position will not consider candidates who require immigration sponsorship now or in the future.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA's commitment to non-discrimination and equal opportunity employment.