Director, IRB Office

Department: IRB Office
Salary/Grade: EXS/14

Job Summary:

The Director, who reports to the Associate Vice President, is a critical member of the management team in Northwestern's Office for Research. The Director's primary responsibilities are to effectively manage the IRB staff supporting the University's IRBs and to deliver outstanding service to Northwestern's research community. The Director is responsible for the administration of the University's HRPP and serves as the Human Protection Administrator (HPA). The Director oversees a team responsible for providing direction, training and consultation to IRB Office staff, IRB members and the research community regarding applicable regulations, current issues and ethical concerns. The Director works to maintain continual process improvement so as to bolster the HRPP's effectiveness in meeting its mission to safeguard the rights and welfare of human research participants, and to enhance service to the research community.

The Director will develop and implement the Office's annual budget of approximately $5 million. Active protocols total nearly 9000 with approximately 5,000 annual submissions. The Director is expected to establish long-term direction for the Department after successfully achieving near-term objectives. The Director is also expected to maintain a national presence in human subject protections and regulatory compliance and to represent the University at state and federal levels, as well as with other major research universities. The Director will implement the University's policies and procedures, and refine them as needed, in order to achieve and maintain AAHRPP accreditation. The Director will also manage human subject data effectively; provide direction, training, and consultation to IRB staff, IRB members and investigators regarding current issues and ethical concerns. The Director is responsible for five direct reports and a department staff of 37. The Director chairs the IRB Chairs' Committee and serves as an observer/consultant at IRB meetings. The Director interacts with other offices within the Office for Research and will implement processes to improve and streamline information coordination and sharing. The Director also interacts and coordinates with other University offices at the central and departmental levels.

Specific Responsibilities:

• Collaborates with other directors in the Office for Research to create a collegial and mutually reinforcing management team; specifically, works with colleagues in the Office of Research Integrity, Office of Research Safety, and Office of Sponsored Research, as well as other University offices such as the Office of General Counsel and University Compliance.
  • Develops and maintains important strategic relationships with the University's clinical affiliates.
  • Maintains a cohesive, service-oriented office that supports protection of human research subjects and compliance; supports a work team structure within the IRB that provides close peer relations among the managers and the opportunity for cross-training and staff support during high volume periods.
  • Maintains and develops services for investigators; The Director will continue the progress made towards effective customer service on the part of IRB staff for the research community.
  • Is responsible for obtaining and maintaining the FWA and AAHRPP accreditation, and will be the primary lead responsible for responding to accreditation issues and requirements.
  • The Director will continue the process of implementing and adjusting to an electronic submission process.

Board Business

• Reviews activities of IRB Chairs and ensures consistent practices across panels.
• Attends IRB Panel meetings as an observer when possible.
• Helps identify and interviews candidates for IRB Panels including Chairs and Committee members; oversee appointment and training process.

Other

• Attends relevant professional meetings; participate in national forums related to research subject protection.
• Serves on internal and external advisory committees related to human subjects.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Graduate level degree(s) or equivalent experience with 5 years of experience in management of clinical and/or basic research issues; operational management, and budgetary oversight;
• Demonstrated knowledge of FDA, HHS, OHRP, state law and policies and guidelines for universities pertaining to human subjects.
• Experience with and knowledge of federal oversight agencies (OHRP, FDA, and VA).
• Experience in conducting human subject research, and publications relating to IRB oversight and/or management.

Preferred Qualifications:

• M.D., Ph.D., LLD.

Target hiring range for this position will be between $155,000-$174,000 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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