The Institutional Review Board Manager facilitates, provide supports, and oversees the review and determination of all research activities involving human subjects to protect their safety, rights, and welfare in compliance with Institutional Review Board (IRB) regulations for the Human Subjects Protections Program.

This position works closely with the IRB Chair and IRB membership in facilitating the daily activities of the IRB, provides guidance as needed and renders decisions on IRB applications submitted for review. The Manager as part of the leadership team of the IRB, is committed to efficient and effective review of all internal research that involves human subjects. The IRB Manager oversees the intake, review and decision dissemination of all applications to the IRB.

We seek equity-minded applicants who demonstrate a sensitivity to and understanding of the diverse academic, socioeconomic, cultural, religion, disability, gender identity, sexual orientation, and ethnic backgrounds present in our community and of the communities we serve.

Essential Duties

1. Coordinate work of IRB

a. In collaboration with the IRB Chair and committee, ensures compliance with federal policies on Human Subjects Research

b. Oversee the Administrative Assistant’s work for the IRB assuring accurate and timely processing of all materials and record keeping

c. Attends all IRB meetings

d. Coordinates new member orientation and periodic member trainings

2. Liaison with principal investigators regarding human subject protections

a. Advises Pl’s regarding federal and university policies

b. Requests additional information when necessary for a complete application submission

c. Receives and processes reports of unanticipated problems and/or adverse events

3. Conduct designated reviews of all IRB applications and research

a. Reviews and renders decisions on research applications in accordance with federal and university guidelines including exempt and expedited research

b. Reviews and renders decisions on research application amendments, continuing reviews in accordance with federal and university policy, rules, and regulations

c. Facilitates full committee review as needed

d. Secure facility community representative(s) such as a Prisoner Advocate, and others, as needed. Arrange for the inclusion of the outside review when necessary.

e. Meet weekly with IRB Chair to review selected protocols and other issues as may arise.

4. Maintain, facilitate agreements with collaborative organizations utilizing BSU’s IRB

5. Maintain IRB ethics training records

6. Maintain IRB website for the University

7. Maintain all IRB university policy and procedures; review annually and update as needed

8. Maintain online IRB application and review system upgrades, rewrites, and policy changes

9. Remains current on federal rules and regulations and updates internal policies and applications as needed

10. Deliver university wide IRB training for students, faculty and staff

11. Maintain IRB Federal Wide Assurance (DHHS)

12. Maintain Research Misconduct Assurance (ORI)

13. Maintain records of research misconduct allegations

14. Maintain IRB templates, guidance, training materials; update as needed

15. Support faculty, Librarians, staff and student research through outreach (e.g., classroom visits; individual meetings with researchers).

16. Other duties as assigned

Members of underrepresented groups, minorities, women, veterans, persons with disabilities, and all persons committed to diversity and inclusive excellence are strongly encouraged to apply.
Required Qualifications

• Bachelor’s Degree.

• Commitment to providing support and guidance to enhance an environment of compliance with federal IRB and university regulations.

• Ability to deal tactfully with others and to exercise discretion in handling confidential information.

• Ability to establish rapport and maintain harmonious working relationships with persons from various social locations (e.g. race, ethnicity, religion, gender, sexual orientation, disability and cultural and/or economic backgrounds).

• Ability to maintain accurate records and prepare general reports.

• Ability to prepare and use charts, graphs, and tables.

• Ability to communicate appropriately and professionally, both verbally and in writing with a diverse community.

• Ability to exercise sound judgment.

• Ability to understand, explain and apply the rules, regulations, policies, procedures, specifications, standards and guidelines governing departmental activities.

• Knowledge of US Department Health and Human Services (DHHS) regulations regarding 45 CFR 46 for Institutional Review Boards and the Common Rule.

• One to three years of IRB Board membership or having exercised oversight of an institutional IRB.

Preferred Qualifications

• Master’s degree in a social science discipline

• Certification of IRB Professionals (CIP)