| Department: IRB Office
Salary/Grade: EXS/8 Job Summary: Under general direction of the Institutional Review Board (IRB) manager, the Senior IRB Analyst is responsible for the oversight of the daily activities of the IRB; 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. 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 IRB.
- Ensures that IRB operations meet legal and regulatory requirements and are in compliance with ever more complex federal, state, and local regulations regarding the activities of 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.
- Assists IRB Managers in ensuring the university’s performance excellence program is administered responsibly and uniformly throughout IRB.
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.
Miscellaneous - Provides backup to the IRB Manager with regard to IRB process.
- Supervises and coordinates specials projects for the IRB Manager.
- Represents IRB in committees when issues and concerns regarding administration of human research subjects are involved.
- Performs other duties and responsibilities as assigned.
Minimum Qualifications: - Bachelors plus 5 years’ experience, or Masters in lieu of Bachelors plus 5 years’ experience.
- CIP and/or CIM eligible within 2 years of beginning position.
Minimum Competencies: (Skills, knowledge, and abilities.) 5 years’ experience must include use of the following tools and skills: - Computer proficiency, report writing, group management, organization and compliance with research regulations.
- 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 stressful environment.
- Exemplary interpersonal and time management skills.
- Ability to communicate clearly in writing, in person, and by telephone.
Must have 1 year of experience in the following areas: - Initiating and composing correspondence to investigators pursuant to IRB standards.
- Producing accurate written reports of IRB decisions and the decision-making process.
Preferred Qualifications: - Advanced degree in an academic field related to Health Sciences.
- CIP and/or CIM professional certifications are strongly preferred.
- Demonstrated possession of the following characteristics: adaptability, agility, coaching, collaboration, collegiality, customer focus, ethics and integrity, judgment and multi-tasking ability.
Preferred Competencies: (Skills, knowledge, and abilities) - Knowledge of government and institutional regulations, as well as the ethical codes that serve as the foundation for the conduct of research with human participants (i.e., the Belmont Report, the Declaration of Helsinki, and the Nuremburg Code).
- Ability to assert her or himself appropriately in IRB meetings and in other contexts in order to represent the IRB, the policies and procedures of the Office for Research, and the federal, state, and local regulations and guidance pertaining to human subject protections.
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. Hiring is contingent upon eligibility to work in the United States.
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