Biomedical IRB Manager

Department: IRB Office
Salary/Grade: EXS/11

Job Summary:

Responsible for regulatory and accreditation compliance of the IRB review and oversight process as it relates to human research at Northwestern University. Manage workflow and processes for assigned IRB office and IRB Panel review. Oversees all routine and non-routine IRB administrative functions, including the supervising and training of IRB Analysts and other assigned staff. Manages issue and complaint resolution related to IRB submission and review processes. Work closely with research community on matters related to the determinations and decisions of the IRB. This position is a member of IRB Office leadership team, with shared responsibility for success of the office in accomplishing strategic goals.

This position is a member of IRB Office leadership team, with shared responsibility for success of the IRB Office in accomplishing strategic goals. The Biomedical IRB Manager will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.

Specific Responsibilities:

Operational Management/Leadership

• Manages staff workload and assignments.
• Oversees workflow and processes of the IRB Panels in order to ensure processes are in compliance with federal and state regulations for human subject research.
• Prepares technical institutional and federal documents that may be auditable for IRB panels.
• Oversees the review of research protocols to identify potential problems.
• Serves as subject matter expert in State and Federal laws and regulations as they apply to human subjects.
• Leads collaborative efforts regarding IRB processes within the research community to facilitate improved communication and foster research growth while assuring a quality human research protection program.
• Facilitate collaborative conflict resolution and problem solving for complex regulatory and ethical issues related to human research.

Analysis

• Oversees process for tracking turnaround times and backlogs for audit purposes.
• Serve as a primary resource to the NU research community as well as to the Panel Chairs, the Chair for Administrative Review and IRB members regarding pertinent regulatory requirements.
• Identify areas of risk and potential non-compliance and collaborate with IRB leadership, IRB staff, IRB chairs and IRB Compliance Program to develop and implement corrective and preventative action plans.
• Coordinates resolution of compliance problems, issues and decisions with IRB leadership and IRB staff, as well as other departments within the Office of Research, e.g Research Integrity (RI), Sponsored Research (SR).
• Oversees staff as they assist IRB chairs, members, and researchers on the regulations and ethical principles essential to the review process.
• Serves as a Designated Reviewer making regulatory determinations
• Oversees the development and implementation process of the eIRB system.

Training

• Provide training for IRB staff as required. Facilitate professional development of direct and indirect reports.
• Develop and presents training materials on the ethical conduct of research involving human subjects.
• Provides training as necessary to faculty and staff on the regulations and on preparation of applications and consent forms.

Other

• Participates in specials projects for the office.
• Provides backup to the IRB staff with regard to IRB process.
• Performs other duties and responsibilities as assigned.

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• Bachelor's Degree or equivalent degree in relevant academic field.
• CIP and/or CIM 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.
• Desire to advance professional career in the IRB Office.

Minimum Competencies: (Skills, knowledge, and abilities.)

• 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.
• Demonstrated written and oral communication skills.
• Ability to work independently and as part of a team in a fast paced and highly stressed environment.
• Possess interpersonal and time management skills.
• Demonstrated working knowledge of medical and behavioral research terminology.

Preferred Qualifications: (Education and experience)

• Master's degree or equivalent in a relevant academic field.
• CIP and/or CIM professional certification.
• Active participation in the community of IRB professionals
• Experience with Huron's Click IRB software and HRPP Toolkit

Preferred Competencies: (Skills, knowledge, and abilities)

• 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-$121,000 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 strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness. More information can be found on the COVID-19 and Campus Updates webpage.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Click for information on EEO is the Law.

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