Lead IRB Analyst

Department: IRB Office
Salary/Grade: EXS/9

Job Summary:

Under the direction of the Biomedical IRB Manager, the IRB Analyst Lead serves as the primary resource for regulatory and procedural guidance regarding questions and issues that arise from the day-to-day operation of the IRB Office; analyzes and reviews confidential IRB submissions involving human participants in an effort to protect the participants' safety, rights, and welfare; and, is responsible for the training of new IRB coordinators and panel members.

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

Please note:

This is an exempt position requiring availability on some weekends and after normal working hours.

The position requires multi-tasking in a customer service setting where there may be multiple demands on the individual's time. Successful incumbents must maintain professional demeanor in order to ensure resolution. Response times for all inquiries must be minimal.

This is a primarily remote position; however, there may be times when the individual will be requested to physically be in the office.

Specific Responsibilities:

Operational Management

• The goal of following activities is to ensure that all operational priorities are aligned with mission and direction of the Office of the IRB.
• Serves as the IRB Office's primary resource for complex federal, state, and local regulations when questions and issues arise from day-to-day operations.
• Monitors changes in laws, regulations, and technology and advises management how that may affect the IRB Office.
• Provides regulatory, ethical, and methodology guidance to investigators relating to IRB submissions ensuring all required elements are addressed.
• Independently processes and reviews more complex IRB submissions.
• Writes documents that are subject to professional and technical audit that convey IRB deliberations and determinations.
• Serves as a leader of the IRB analysts and models best practices.
• Fulfills all of the duties and responsibilities of a Senior IRB Coordinator.

Analysis and Training

• The goal of the following activities is to ensure high quality services for Northwestern University's researchers and staff involved with human research subjects administrative procedures.
• Assists in the tracking and reporting of trends related to determinations, clarification requests, and incoming submission quality.

Other

• Participates in specials projects for the office.
• Provides backup to the IRB Manager with regard to IRB process.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

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

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

• Competencies: Computer proficiency, report writing, group management, organization, and research regulations.
• Demonstrated written and oral communication skills and ability to initiate and compose correspondence to investigators and to produce accurate written reports of IRB decisions and the decision-making process.
• Demonstrated working knowledge of medical and behavioral research terminology.
• Ability to work independently and as part of a team in a fast paced and highly stressed environment.
• Possess exemplary interpersonal and time management skills.
• Ability to communicate clearly in writing, in person, and by telephone.

Preferred Qualifications:

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

Preferred Competencies: (Skills, knowledge, and abilities)

• Some knowledge of the Association for the Accreditation of Human Research Protection Program (AAHRPP) process, tools and requirements.
• Experience writing SOP's and training materials.

Target hiring range for this position will be between $87,000-$102,000 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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