Job Details

Institutional Review Board (IRB) Specialist

Position Number: 9922129
Location: Salt Lake City, United States
Position Type: Sponsored Programs, Grants, and Contracts

Institutional Review Board (IRB) Specialist

Job Summary

Coordinates and oversees all technical, operational and regulatory issues associated with human research protections and compliance for 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 and educational programming to the research faculty, staff, and community. This is a reading and writing-intensive role. You will spend most of your day reading dense protocols, regulations, and policies, and turning what you read into clear, defensible actions and decisions.

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

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

Responsibilities
Responsibilities - Essential Functions

Conducts initial review of human research protocol applications, reviewing all amendments and determining the level of risk to ensure compliance with appropriate regulations, IRB guidelines and institutional policies. Prepares convened-review submissions, including hand-off notes that summarize outstanding issues and anticipate board questions.
Reviews deviations from policy, clarifies special conditions and analyzes differences from initial protocol applications.
Interprets and provides comprehensive guidance to principal investigators, research and support staff on complex human subjects' research regulations. Ensures the conduct of high quality human subject research.
May plan, develop, and administer or help plan, develop, and administer comprehensive educational programs pertaining to human research protections and IRB review processes for members of the IRB principal investigators, research and support staff.
May make recommendations to the ongoing development of electronic protocol submission and tracking system. Develops and maintains web pages and web-based training programs.
May develop and revise, or help to develop and revise IRB office policies and procedures, forms and content of guidelines and other materials posted on the IRB website.
May respond or help to respond to external compliance audits. May help prepare or prepare regularly prepares reports on IRB office activities and assesses regulatory compliance with IRB documentation requirements.
Meets with members of research staffs to address process and procedure improvements. Serves on various University committees.
Participates in the day-to-day workings of IRB staff, which may include training, evaluating performance, ensuring adequate office coverage and ensuring procedural deadlines are met.
May support convened IRB meetings by documenting discussion, motions, and determinations in minutes that serve as the official record, and drafting post-board correspondence that accurately reflects board determinations and their basis in the Criteria for Approval (45 CFR 46.111; 21 CFR 56.111).
Participates in cross-training across review pathways, completes assigned readings and competency assessments, and applies lessons from board deliberations to pre-review practice.
Provides coverage across teams and review pathways for absences, leave, and workload rebalancing, and arranges in-team coverage for planned absences.
Participates in QA audits, process reviews, and accreditation (AAHRPP) documentation, and uses operational data and performance metrics to inform workflow and professional development.
Other duties and responsibilities as needed and assigned.

Problem Solving
Incumbents face the challenge of staying abreast of continually changing human research regulations in order to make changes to internal policies and procedures to ensure compliance with the new regulations, as well as communicating the changes in an effective and timely manner. Incumbents use considerable discretion in their daily work and must communicate effectively with a variety of constituencies regarding delicate matters. Incumbents are expected to demonstrate increasing independence and cross-functional competency with experience, including working across review pathways and in convened board administration, as well as increased work product responsibility and expectations as competency grows.

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

Department may hire employee at one of the following job levels:

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

Preferences

Special Instructions

Requisition Number: PRN46591B
Full Time or Part Time? Full Time
Work Schedule Summary: Monday -- Friday (8am -- 5pm)This is currently 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:

To apply, visit https://utah.peopleadmin.com/postings/211422