at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 53704
Department: IRB Office
Salary/Grade: EXS/11
Job Summary:
The IRB Reliance Manager oversees the implementation and daily operations of Northwestern University’s IRB Reliance program, contributing to the strength and effectiveness of the Human Research Protection Program (HRPP). This role manages reliance activities for research reviewed by both internal and external IRBs, ensuring consistent application of institutional policies and federal regulations.
Serving as a key liaison, the Manager collaborates with the IRB, Principal Investigators, research teams, clinical sites, regulatory agencies, and external IRBs on reliance processes. Under the direction of the Director, IRB Office, the role ensures compliance with institutional and legal requirements related to reliance agreements, as well as applicable federal, state, and local regulations (e.g., Common Rule, ICH GCP, HIPAA).
The Manager supervises and mentors reliance staff, serves as a subject matter expert to the research community, and supports the development and continuous improvement of reliance processes to facilitate efficient and compliant multi-site research.
As a member of the IRB Office leadership team, the IRB Reliance Manager will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.
Specific Responsibilities:
Operational Management/Leadership
- The goal of the following activities is to ensure that all operational priorities are aligned with the mission and direction of the IRB.
- Manages day-to-day IRB reliance activities, including workload coordination and timely execution of reliance activities.
- Serves as primary liaison between Northwestern University IRB, Principal Investigators, clinical study sites, individual study teams, and external organizations and IRBs regarding IRB reliance issues.
- Communicates with federal regulatory agencies, such as the Food and Drug Administration, Office of Human Research Protections, and funding agencies such as the National Institutes of Health and Industry sponsors regarding IRB reliance issues and provides regulatory and policy guidance to IRB members and IRB Office staff as needed.
- Works with the Northwestern University legal counsel to address legal and institutional requirements related to reliance agreements and the reliance process.
- Develops policies, guidelines, and procedures related to the IRB reliance process when Northwestern is serving as the reviewing IRB or the relying IRB.
- Serves as a subject mat
