Job Description

University of Utah Job Description

Job Summary

Coordinates complex and broad administrative matters for the Institutional Review Board (IRB) and its various review panels. Assists in the identification of potential regulatory issues with human research protocols, provides technical support and procedural guidance to regulatory or compliance staff.

Qualifications

Bachelor’s degree in a related area plus one year of related experience, or equivalency required. Demonstrated human relations, time management and effective written and verbal communication skills also required.

Experience in a research and/or regulatory environment is preferred, as well as experience interpreting guidelines, policies and federal/state regulations. Working knowledge of medical technology is 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.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Essential Functions

1. Reviews human research protocol renewal applications in a timely and efficient manner. Helps analyze protocols and records to ensure completeness and compliance with appropriate regulations, IRB guidelines and institutional policies.
2. Assigns studies for review to IRB members based on member’s expertise and resolves questions or concerns that arise during the review.
3. Coordinates and attends review committee meetings. Prepares meeting agendas and materials. Records medical and ethical issues discussed and ensures accurate documentation of final committee determinations.
4. Composes clear, concise and detailed correspondence to principal investigators to ensure that committee concerns, questions and rationale are appropriately communicated to researchers. Evaluates investigator’s responses to determine if they are adequate or if additional information is needed.
5. Provides guidance to regulatory or compliance staff on IRB policies, submission of application materials and review requirements.
6. Provides day-to-day administrative coordination between investigators, research staff and research reviewers.
7. Makes recommendations to policies and procedures as they are developed or revised.
8. 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.
9. Maintains accurate IRB files in both electronic and hard-copy formats.

Problem Solving

Challenges encountered by the incumbent include working in a very fast-paced environment involving multiple ongoing studies; coordinating with numerous personnel who are often under intense time lines; maintaining positive working relationships with investigators while pursuing responses necessary for the approval of research protocol.

Comments

Incumbents in this position operate under minimal supervision with work that requires great attention to detail. Flexibility in work schedule may be needed in order to meet target deadlines for completion of projects.

Work Environment and Level of Frequency typically required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking. 

Seldom: Bending, reaching overhead.