Job Details

Institutional Review Board Adm

Position Number: 6547487
Location: Salt Lake City, UT
Position Type: Assessment, Accreditation, and Compliance

Institutional Review Board Adm

Job Summary

Coordinates and oversees all technical, operational and regulatory issues associated with human research protections and compliance for the Institutional Review Board (IRB). Provides direct consultation, facilitation, decision support and educational programming to research faculty and staff.

Responsibilities
Responsibilities:

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.
Composes clear, concise and detailed correspondence to principal investigators to ensure that committee concerns, questions and rationale are appropriately communicated to researchers. Evaluates investigators' responses to determine if they are adequate or if additional information is needed.
Interprets and provides comprehensive guidance to principal investigators and research support staff on complex and dynamic human subjects' research regulations.
Manages all details of review committee meetings.
Prepares meeting agendas and materials, including making assignments to appropriate committee members and liaising between the designated members and research investigators to address and resolve concerns.
Provides expert regulatory and ethical guidance during committee discussions to ensure appropriate review of research.
Records medical and ethical issues discussed and ensures accurate documentation of final committee determinations.
Oversees committee member onboarding, training, and continuing education.
Provides one-on-one support for complex regulatory issues and assistance with IRB electronic systems to document committee member determination recommendations.
Analyzes deviations from policy, clarifies special conditions, and scrutinizes differences from initial protocol applications.
Prepares reports regarding issues in study risk or conduct, including identification of possible unanticipated problems and/or non-compliance.
Notifies appropriate regulatory agencies as applicable. Ensures the conduct of high quality human subject research.
Organizes, develops, and administers comprehensive educational programs pertaining to human research protections and IRB review processes for IRB employees, board members, principal investigators, and research support staff.
Acts as an expert in IRB operations software and makes recommendations to the ongoing development of electronic protocol submission and tracking systems.
Develops and maintains web pages and web-based training programs.
Maintains a current understanding of Federal, State, and University laws, regulations and guidelines governing human subject research; attends educational and professional seminars as required to stay current in areas related to human subject research compliance.
Develops and revises IRB office policies and procedures, forms and content of guidelines, and other materials posted on the IRB website.
Assists in education on these materials for IRB staff and others. Conducts and responds to institutional and external compliance audits.
Educates and provides guidance and resources for principal investigators and research support staff in response to findings.
Prepares audit reports and responds to follow-up responses from investigators.
Conducts assessments to examine internal IRB office activities, evaluate regulatory compliance with IRB documentation requirements, and provide feedback for areas requiring additional need for staff training.
Negotiates terms of agreements, including instances when the University serves as the IRB of record for another institution or relies on another institution to conduct IRB review of a protocol.
Determines relevance and appropriateness of material transfer agreements in applicable protocols.
Conducts local Human Research Protections Program (HRPP) reviews to determine if local policies and requirements are met appropriately.
Meets with members of research staff to address process and procedure improvements. Serves on various University committees.
Problem Solving & Communication: Incumbents face the challenge of staying abreast of continually changing human research regulations 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.

This position demands working in a very fast-paced environment involving:

Balancing multiple ongoing assignments including working as a team member with other IRB staff to address overall review needs
Coordinating with numerous personnel who are often under expeditious timelines
Maintaining positive working relationships with investigators while pursuing responses necessary for the approval of research protocol

Minimum Qualifications
Bachelor's degree in a related field plus four years related experience or equivalency (one year of education can be substituted for two years of related work experience) required. Demonstrated human relations and effective communication skills are also required.

Master's degree in a related field, management experience, knowledge of human research Federal regulations, medical terminology preferred. Experience in the design and conduct of educational or training and IRB certification also preferred.

This position is not responsible for providing patient care.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Special Instructions

Requisition Number: PRN43033B
Full Time or Part Time? Full Time
Work Schedule Summary: Monday - Friday (8am - 5pm)This is a hybrid position. A minimum of 16.0 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: $47,600 to $70,000
Close Date: 12/4/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/188499