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.

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 subjects regulations.

Compliance Program Management

• 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.
• Actively solicits input from other IRB Office Managers in the design and implementation of compliance strategies to ensure a comprehensive IRB Compliance Program.
• Maintains accurate records of all compliance activities and ensures the appropriate level of confidentiality is maintained.
• Works closely with the Office of Research Integrity and other relevant University offices (e.g., University Compliance, Office of General Counsel, and Office for Research units) on compliance matters, including those involving research misconduct.
• Under the direction of the Director, IRB Office, serves as the primary liaison with federal regulatory agencies as well as internal and external parties on all IRB Compliance-related matters.

Analysis

• Monitors and interprets emerging regulations and guidance that affect human subjects research. Translates these changes into updated operational procedures, staff guidance, and training materials.
• 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.
• Critically analyzes current research practices and policies through observation, data collection, peer reviews, interviews, and industry analysis to assess the quality of existing workflow processes and identify improvements needed to maximize quality and efficiency of human research protections and good clinical practices, as it pertains to regulatory affairs/compliance.

Miscellaneous

Performed other duties

Minimum Qualifications (Education, Experience, Certifications, Skills)

• Identify the minimum qualifications required to successfully perform the job. Qualifications include education, experience, specialized knowledge, professional certification.
• 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 regulation governing the participation of human subjects in research.
• Demonstrated competencies: computer proficiency, report writing, and research regulations.

Preferred Qualifications (Education, Experience, Certifications, Skills)

• 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.
• Ability to assess risk.

Target hiring range for this position will be between $110,000-$119,000 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 and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, 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 .