IRB Compliance Manager

at Northwestern University in

Evanston, Illinois, United States Job Description Job Opening Id:

53705

Department:

IRB Office Salary/Grade:

EXS/11

Job Summary:

The IRB Compliance Manager oversees the implementation and daily operations of Northwestern University's IRB Compliance program, contributing to the strength and effectiveness of the Human Research Protection Program (HRPP). This role manages post-approval monitoring activities and ensures 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, and regulatory agencies on compliance matters and human subjects protections. Under the direction of the Director, IRB Office, the role ensures adherence to applicable regulations (e.g., Common Rule, ICH

GCP, HIPAA

) and institutional requirements. The Manager supervises and mentors compliance staff, serves as a subject matter expert to the research community, and leads the development and implementation of a robust Post Approval Monitoring (PAM) program. This includes identifying trends, informing corrective actions, and supporting targeted training and process improvements in collaboration with leadership. As a member of the IRB Office leadership team, the IRB Compliance Manager will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity. This position will require some in-person presence in the office, as needed, to support compliance-related activities. •

Note:

Not all aspects of the job are covered by this job description.

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 compliance activities, including workload coordination, quality assurance, and timely execution of reliance reviews, post approval monitoring, and compliance activities. Serves as a key point of contact for investigators, research teams, clinical sites and partner organizations to address compliance and human subjects protections questions or issues. Collaborates with federal agencies, sponsors, and institutional legal counsel as directed to clarify regulatory expectations, address compliance concerns, and support risk mitigation efforts for compliance activities. Develops and implements institutional policies and SOPs governing compliance activities. Provides guidance to IRB staff, investigators, research teams, and the broader research community on relevant federal, state, and local human To view full details and how to apply, please login or create a Job Seeker account