Job Description

University of Utah Job Description

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.

Qualifications

Bachelor’s degree in a related field plus four years related experience or equivalency 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.

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. 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.
2. Approves deviations from policy, clarifies special conditions and analyzes differences from initial protocol applications.
3. 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.
4. Plans, develops and administers comprehensive educational programs pertaining to human research protections and IRB review processes for members of the IRB principal investigators, research and support staff.
5. Makes recommendations to the ongoing development of electronic protocol submission and tracking system. Develops and maintains web pages and web-based training programs.
6. Develops and revises IRB office policies and procedures, forms and content of guidelines and other materials posted on the IRB website.
7. Responds to external compliance audits. Regularly prepares reports on IRB office activities and assesses regulatory compliance with IRB documentation requirements.
8. Meets with members of research staffs to address process and procedure improvements. Serves on various University committees.
9. Responsible for the day-to-day supervision of the IRB support staff, which includes training, evaluating performance, ensuring adequate office coverage and ensuring procedural deadlines are met.

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.

Comments

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.