IRB Analyst Senior

Department: IRB Office
Salary/Grade: EXS/8

Job Summary:

Under general direction of the Institutional Review Board (IRB) Biomedical Manager, the IRB Senior Analyst is responsible for the oversight of the daily activities of the IRB Office and the /IRB panels; organizes and manages the confidential institutional review and approval process of complex research activities involving human subjects to protect their safety, rights, and welfare; plans, organizes, and implements the IRB program for researchers, external researchers and sponsors; initiates and applies new procedures as necessary to ensure that IRB panels operate at optimum effectiveness and efficiency; and assists recruitment and training of IRB Analysts.

The IRB Analyst Senior 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 Office operations meet legal and regulatory requirements and are in compliance with ever more complex federal, state, and local regulations regarding the activities of the IRB.
• Disseminates information about and assists investigators in the preparation of complex IRB applications to ensure that required elements have been addressed and the language level is appropriate for the intended research population.
• Monitors changes in laws, regulations, and technology and advises management how that may affect operations.
• Assists in the training of appropriate personnel to be IRB committee members and assigns them to review specific protocol submissions based on the appropriateness of their scientific expertise and experience as an IRB member for each panel.
• Knows the scientific expertise of prospective IRB committee members in order to make appropriate assignments to panels.
• Independently determines adequacy of IRB applications and level of technical review required.
• Reviews complex proposed research protocols to identify potential problems and make recommendations for their modifications as appropriate, whenever possible.
• Writes documents that are subject to professional and technical audit that convey IRB deliberations and contingencies for approval of research activities involving human subjects.
• 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 for enhancing communication between the IRB, researchers and staff on the status of protocols and committee deliberations.
• Serves as subject matter expert in state, local, and federal laws and regulations as they apply to human subjects.
• Prepares auditable institutional and federal technical documents needed for IRB panels' review and recommendations.
• Triages various submissions, including emergency use applications, reports of unanticipated problems involving risks to subjects or others and safety reports to present to IRB chair and committee members.
• Reviews request to amend or modify approved protocols and makes determination about which requests require full IRB review and which can be reviewed using an expedited process.
• Supervises the preparation of agendas for each panel meeting based on knowledge of scientific aspects of the research submissions to be reviewed, as well as regulatory requirements and the expertise/role of each panel member.
• Responsible for ensuring compliance with quorum and voting requirements for all IRB approvals deliberated at convened meetings, in the absence of the manager.
• Assists in the development and revision of 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 with human research subjects administrative process.
• Instructs IRB chairs, members, and researchers on the regulations and ethical principles essential to the review process.
• Trains IRB Analysts and support staff on the technical and administrative process required for human subjects research.
• Writes standard operation procedures to ensure consistency within the IRB office.
• Develops and presents training materials on the ethical conduct of research involving human subjects.
• Provides training and advice to faculty and staff on the regulations and on the preparation of applications and consent forms.
• Ensures that IRB Analysts complete their work on a timely basis as outlined by SOP.
• Conducts quality and assurance reports for management.
• Oversees the analysis and creation of reports that tracks turnaround times and backlogs for management and outside regulatory agency review.
• Team leader for IRB Analyst staff.
• Team leader responsible for making assignments and ensuring that all documentation from convened meetings is promptly completed and is adequate to meet institutional standards.

Other

• Provides backup to the IRB Manager with regard to IRB process.
• Supervises and coordinates specials projects for the IRB Manager.
• Represents the IRB Office in committees when issues and concerns regarding administration of human research subjects are involved.
• Performs other duties and responsibilities as assigned.

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

• 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 within two years.
• 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 multi-tasking.
• 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: (Education and experience)

• 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.

Preferred Competencies: (Skills, knowledge, and abilities)

• Some knowledge of the Association for the Accreditation of Human Research Protection Program (AAHRPP) process, tools and requirements
• Knowledge of government and institutional regulations, as well as the ethical principles in the Belmont Report, in order to understand and explain the reasons for the requirements of the IRB.
• Ability to assert her or himself appropriately in IRB meetings and in other contexts in order to represent the IRB Office, the policies and procedures of the Office for Research, and the federal, state, and local regulations and guidance pertaining to human subject protections.

Target hiring range for this position will be between $74,000-$89,000 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.

#LI-EN1