IRB Reliance Analyst Senior

Department: IRB Office
Salary/Grade: EXS/8

Job Summary:

Under general direction of the Institutional Review Board (IRB) Reliance Manager, the IRB Reliance Analyst Sr is responsible for the oversight of the daily activities associated with IRB Reliance activities within the IRB Office; organizes and manages the confidential institutional review and approval process of complex Reliance activities involving relationships between Northwestern University and external entities engaging in IRB oversight; plans, organizes and implements the IRB Reliance requirements for internal and external researchers collaborating in research activities associated with Single IRB federal policies and sponsor mandates; initiates and applies new procedures as necessary to ensure that Reliance Unit activities operate at optimum effectiveness and efficiency.

The IRB Reliance Analyst Sr will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.

Specific Responsibilities:

Operational Management

• The goal of the following activities is to ensure that all operational priorities are aligned with the mission and direction of the IRB Office.
• Ensures that IRB Reliance Unit operations meet legal and regulatory requirements and comply with ever more complex federal, state, and local regulations activities associated with Reliance.
• Disseminates information about and assists investigators in preparing complex IRB Reliance applications to ensure that required elements have been addressed.
• Monitors changes in laws, regulations, and technology and advises management on how that may affect operations.
• Serves as liaison between Northwestern University IRB, Principal Investigators, clinical study sites, individual study teams, external organizations, and IRBs regarding IRB Reliance activities.
• Independently determines adequacy of IRB applications and provides administrative review of those associated with ceding review to an external IRB.
• Review complex proposed research protocols associated with Reliance to identify potential problems and make recommendations for their modifications as appropriate, whenever possible.
• Provides regulatory, ethical, and method advice to individual faculty and staff in preparation of applications for research proposals involving human subjects and consent documents.
• Recommends improvements to enhance communication between the IRB, researchers, and staff on the status of Reliance review processes.
• Serves as subject matter expert in state, local, and federal laws and regulations as they apply to human subjects.
• Supervises the management of internal Reliance Workshop meetings, including reviewing proposed agendas and discussion topics.
• Assists in developing and revising Standard Operating Procedures for the IRB Office.
• Assists IRB Managers in ensuring the university's performance excellence program is administered responsibly and uniformly throughout the IRB Office.

Analysis and Training

The goal of the following activities is to ensure high-quality services for Northwestern University's researchers and staff involved in the administrative process of human research subjects and Reliance activities.

• Assists in training IRB Analysts and support staff on the technical and administrative process required to ensure Reliance requirements are met during IRB review.
• Assists in preparing drafts and contributes to the development of standard operation procedures to ensure consistency within the IRB office.
• Assists in the development of training materials related to reliance activities.
• Presents training materials related to Reliance to IRB staff and the research community.
• Provides training and advice to faculty and staff on the regulations and on the preparation of IRB applications and consent forms.
• Tracks and analyzes reliance process metrics for presentation to IRB and Office for Research Leadership.

Other

• Provide backup to the IRB Reliance Lead concerning Reliance processes.
• Supervises and coordinates special projects.
• Represents the IRB Office in committees when issues and concerns regarding the administration of human research subjects and Reliance are involved.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Bachelor's degree or the equivalent combination of education, training and experience from which comparable knowledge and skills can be acquired.
• CIP and/or CIM eligible.
• 3+ years of relative experience, including demonstrated knowledge of federal, state, and local regulations governing the participation of human subjects in research.
• Demonstrated characteristics: adaptability, agility, coaching, collaboration, collegiality, customer focus, ethics and integrity, judgment, and multitasking.
• Desire to advance professional career in the IRB Office

Preferred Qualifications:

• Bachelor's or advanced degree in related academic field.
• CIP and/or CIM professional certifications are strongly preferred.
• Experience with Huron Click IRB software and HRPP toolkit.

Target hiring range for this position will be between $76,000-$83,000 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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