IRB Reliance & Compliance Manager

Department: IRB Office
Salary/Grade: EXS/11

Job Summary:

The IRB Reliance and Compliance Manager is responsible for the implementation and daily management of Northwestern University's IRB Reliance and Compliance program, contributing to the strength of the Human Research Protection Program (HRPP). This position manages operational activities related to IRB reliance, post approval monitoring, and regulatory compliance for research approved by both internal and external IRBs, ensuring consistent application of institutional policies and federal regulations.

Serving as a key liaison, the Manager works closely with the Northwestern University IRB, Principal Investigators (PIs), research teams, clinical study sites, federal regulatory agencies, and external IRBs on matters involving reliance processes, compliance expectations, and human research protections. Under the direction of the Director, IRB Office, this role manages institutional and legal requirements related to reliance agreements, post approval monitoring, and adherence to federal, state, and local regulations governing human subjects research (e.g., Common Rule, ICH GCP, HIPAA).

The Manager supervises and mentors staff engaged in reliance and compliance activities and functions as a subject matter expert and resource to the research community. The role is responsible for the design and implementation of an effective Post Approval Monitoring (PAM) program, identifies trends and areas for improvement, and works collaboratively with leadership to develop corrective actions, training initiatives, and process enhancements.

As a member of the IRB Office leadership team, the IRB Reliance and 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.

Specific Responsibilities:

Operational Management and Leadership

• Oversight of IRB Reliance, Monitoring, and Compliance Operations
  • Manages day to day IRB reliance and compliance activities, including workload coordination, quality assurance, and timely execution of reliance reviews, post approval monitoring, and compliance activities.
• Institutional & External Partnership Coordination
  • Serves as a key point of contact for investigators, research teams, clinical sites, external IRBs, and partner organizations to support reliance operations and address compliance and human subjects protections questions or issues.
• Regulatory Legal and Policy Implementation
  • Collaborates with federal agencies, sponsors, and institutional legal counsel as directed to clarify regulatory expectations, address compliance concerns, and support risk mitigation efforts for reliance and compliance activities.
• Policy Application & Subject Matter Support
  • Develops and implements institutional policies and SOPs governing reliance and compliance activities. Provides guidance to IRB staff, investigators, research teams, and the broader research community, on relevant federal, state, and local human subjects regulations.

Reliance and Compliance Program Management

• Audit, Monitoring, and Compliance Oversight
  • Develops and implements compliance review measures, monitoring tools, and risk based approaches. Oversees staff in conducting internal/external audits and post approval monitoring to identify process gaps, discrepancies, and potential noncompliance.
• Cross-Functional Collaboration & Program Coordination
  • Works with IRB committees, IRB leadership, and the Office of Research Integrity on compliance and research misconduct matters, ensuring consistent coordination, documentation, and regulatory reporting
• Regulatory Liaison Support & Reporting
  • Under the direction of the Director, IRB Office serves as the institutional contact for compliance inquiries from federal agencies and stakeholders. Ensures timely and accurate reporting of audit findings and compliance outcomes in accordance with SOPs and regulatory requirements.
• Program Evaluation, Process Improvement & Operational Coordination
  • Provides analysis and operational leadership for reliance processes, assessing documentation standards and workflow efficiencies. Contributes to HRPP strategic planning, ongoing evaluation, and continuous quality improvement initiatives.
• Systems Management & Data Integrity
  • Maintains accurate and confidential compliance records. Monitors and evaluates enhancements to eIRB+ and related systems to improve tracking, reporting, and operational consistency for both IRB compliance and reliance processes.

Regulatory Analysis and Training

• Regulatory Monitoring & Operational Integration
  • Monitors and interprets emerging regulations and guidance that affect human subjects research and IRB reliance. Translates these changes into updated operational procedures, staff guidance, and training materials.
• Program Evaluation & Continuous Improvement Reporting
  • Collects and analyzes data on compliance activities, workflow performance, and quality indicators. Prepares summary reports for IRB leadership outlining trends, risks, and quality improvement recommendations.
• Training for Institutional and External Stakeholders
  • Develops and delivers training on reliance processes, regulatory expectations, and documentation requirements to IRB Office staff, researchers, and external partners to promote consistent and compliant practices
• Research Community Development & Knowledge Building
  • Provides coaching, day-to-day guidance, and regulatory training to faculty and research staff. Supports professional development and ensures team members maintain current knowledge in compliance and reliance procedures

Special Projects

• Leads and participates in special projects for the IRB Office

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Bachelor's Degree or equivalent degree in relevant academic field.
• CIP eligible.
• 5+ years of relevant experience, including demonstrated knowledge of federal, state, and local regulations governing human research.
• Demonstrated characteristics: adaptability, agility, coaching, collaboration, collegiality, customer focus, ethics and integrity, judgment, and multi-tasking.
• Demonstrated knowledge of federal, state, and local regulations governing the participation of human subjects in research.
• Computer proficiency, report writing, and research regulations.

Preferred Qualifications:

• Master's degree or equivalent in a relevant academic field.
• Certification as an IRB professional (CIP)
• Active participation in the community of IRB professionals
• Experience with Huron's Click IRB software and HRPP Toolkit
• Some knowledge of the Association for the Accreditation of Human Research Protection Program (AAHRPP) process, tools, and requirements

Target hiring range for this position will be between $107,000-$124,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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