Institutional Review Board (IRB) Specialist

University of Utah; Salt Lake City (UT); Hybrid; USD 57,000 - 65,000; Full time

Job summary

University of Utah is seeking an Institutional Review Board (IRB) Specialist to coordinate and oversee regulatory, operational, and technical aspects of human research protections across all review pathways. The role emphasizes reading dense protocols and translating them into defensible actions and decisions.

The position requires knowledge of IRB guidelines, ability to consult with researchers and staff, and participation in educational programming.

Qualifications

• Equivalency statement: 1 year of higher education can be substituted for 1 year of directly related work experience.
• IRB Specialist II/III requires a bachelor’s (or equivalency) + 4 years of related work experience or a master’s (or equivalency) + 2 years of related work experience.
• Hybrid in-person/remote schedule may apply and campus location is required for in-person portions.

Responsibilities

• Coordinate initial review of human research protocols and amendments to determine risk and ensure compliance with IRB guidelines.
• Explain policies and provide guidance to investigators and staff on complex human subjects regulations.
• Develop and deliver educational programs on human research protections and IRB review processes.
• Develop and revise IRB office policies and procedures, forms and guidelines.
• Support IRB meetings by documenting discussions, motions, and determinations for the official record.

Skills

Regulatory compliance

IRB processes

Reading and writing dense technicals

Clear communication

Education

Bachelor's degree (or equivalency)

Master's degree (or equivalency)

Job description

Institutional Review Board (IRB) Specialist

Job Summary

Coordinates and oversees all technical, operational and regulatoryissues associated with human research protections and compliancefor the Institutional Review Board (IRB) across all review pathways(exempt, expedited, and convened), including preparation for,participation in, and follow-up from convened IRB meetings.Provides direct consultation, facilitation, decision support andeducational programming to the research faculty, staff, andcommunity. This is a reading and writing-intensive role. You willspend most of your day reading dense protocols, regulations, andpolicies, and turning what you read into clear, defensible actionsand decisions.

Learn more about the great benefits of working forUniversity of Utah: benefits.utah.edu

The department may choose to hire at any of the below joblevels and associated pay rates based on their business need andbudget.

Responsibilities

1. Conducts initial review of human research protocolapplications, reviewing all amendments and determining the level ofrisk to ensure compliance with appropriate regulations, IRBguidelines and institutional policies. Prepares convened-reviewsubmissions, including hand-off notes that summarize outstandingissues and anticipate board questions.
2. Reviews deviations from policy, clarifies special conditionsand analyzes differences from initial protocol applications.
3. Interprets and provides comprehensive guidance to principalinvestigators, research and support staff on complex humansubjects' research regulations. Ensures the conduct of high qualityhuman subject research.
4. May plan, develop, and administer or help plan, develop, andadminister comprehensive educational programs pertaining to humanresearch protections and IRB review processes for members of theIRB principal investigators, research and support staff.
5. May make recommendations to the ongoing development ofelectronic protocol submission and tracking system. Develops andmaintains web pages and web-based training programs.
6. May develop and revise, or help to develop and revise IRBoffice policies and procedures, forms and content of guidelines andother materials posted on the IRB website.
7. May respond or help to respond to external compliance audits.May help prepare or prepare regularly prepares reports on IRBoffice activities and assesses regulatory compliance with IRBdocumentation requirements.
8. Meets with members of research staffs to address process andprocedure improvements. Serves on various Universitycommittees.
9. Participates in the day-to-day workings of IRB staff, which mayinclude training, evaluating performance, ensuring adequate officecoverage and ensuring procedural deadlines are met.
10. May support convened IRB meetings by documenting discussion,motions, and determinations in minutes that serve as the officialrecord, and drafting post-board correspondence that accuratelyreflects board determinations and their basis in the Criteria forApproval (45 CFR 46.111; 21 CFR 56.111).
11. Participates in cross-training across review pathways,completes assigned readings and competency assessments, and applieslessons from board deliberations to pre-review practice.
12. Provides coverage across teams and review pathways forabsences, leave, and workload rebalancing, and arranges in-teamcoverage for planned absences.
13. Participates in QA audits, process reviews, and accreditation(AAHRPP) documentation, and uses operational data and performancemetrics to inform workflow and professional development.
14. Other duties and responsibilities as needed and assigned.

Problem Solving

Incumbents face the challengeof staying abreast of continually changing human researchregulations in order to make changes to internal policies andprocedures to ensure compliance with the new regulations, as wellas communicating the changes in an effective and timely manner.Incumbents use considerable discretion in their daily work and mustcommunicate effectively with a variety of constituencies regardingdelicate matters. Incumbents are expected to demonstrate increasingindependence and cross-functional competency with experience,including working across review pathways and in convened boardadministration, as well as increased work product responsibilityand expectations as competency grows.

Minimum Qualifications

EQUIVALENCY STATEMENT: 1 year of higher educationcan be substituted for 1 year of directly related work experience(Example: bachelor's degree = 4 years of directly related workexperience).

Department may hire employee at one of the following joblevels:

Institutional Review Board (IRB) Specialist, II: Requires a bachelor's (or equivalency) + 4 years or a master's (orequivalency) + 2 years of directly related work experience.

Institutional Review Board (IRB) Specialist, III: Requires a bachelor's (or equivalency) + 6 years or a master's (orequivalency) + 4 years of directly related work experience.

Requisition Number: PRN46591B

Full Time or Part Time? Full Time

Work Schedule Summary: Monday - Friday (8am - 5pm)This iscurrently a hybrid position. A minimum of 24 hours per week must be in-person at the IRB office on University of Utah campus. In-office requirements are subject to change per University and department policy.

Department: 00938 - Institutional Review Board

Location: Campus

Pay Rate Range: $57,000 - $65,000

Close Date: 01/26/2027

Open Until Filled: