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.

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 matter expert in state, local, and federal laws and regulations as they apply to human research.

Analysis

• Provides Analytical and administrative support to the Northwestern IRB related to IRB reliance activities.
• With the Director, IRB Office participates in HRPP evaluation, strategic planning and formulation of goals and objectives.
• Consistently monitors and evaluates eIRB+ and other electronic tracking systems used to support the IRB Reliance Process for gaps and needed improvements.

Training

• Provide oversight and training as necessary for the Reliance Agreement process to IRB Office staff, the Northwestern research community and external stakeholders.
• Provide training for IRB Office staff as required. Facilitate professional development of direct and indirect reports.
• Provides training as necessary to faculty and staff on the regulations and on preparation of reliance agreements.

Other

• Leads and participates in specials projects for the 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 regulation governing human research.
• Demonstrated competencies: computer proficiency, report writing, and human 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
• 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 .

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