Details
Open Date
Requisition Number PRN40279B
Job Title Institutional Review Board Adm
Working Title Institutional Review Board Adm
Job Grade F
FLSA Code Administrative
Patient Sensitive Job Code? No
Standard Hours per Week 40
Full Time or Part Time? Full Time
Shift Day
Work Schedule Summary
VP Area President
Department 00938 - Institutional Review Board
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 80000
Close Date 12/31/2024
Job Summary
Manages and oversees all technical, operational, and regulatory issues associated with the review and approval of human research protections and compliance for the Institutional Review Board ( IRB ). Responsible for the comprehensive analysis of research protocols and associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies in preparation for IRB review. Addresses regulatory and ethical issues using critical thinking while interpreting and applying laws, policies, and regulations. Provides direct consultation, mentoring, facilitation, decision support and educational programming to research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes.
Responsibilities
Responsibilities:
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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.
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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.
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Interprets and provides comprehensive guidance to principal investigators and research support staff on complex and dynamic human subjects’ research regulations.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Conducts local Human Research Protections Program ( HRPP ) reviews to determine if local policies and requirements are met appropriately.
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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:
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Balancing multiple ongoing assignments including working as a team member with other IRB staff to address overall review needs
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Coordinating with numerous personnel who are often under expeditious timelines
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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
Type Benefited Staff
Special Instructions Summary
Additional Information
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.
All qualified individuals are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.
The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.
