With supervision, the IRB Analyst provides oversight of the daily operational activities of the Biomedical Institutional Review Board (IRB); manages the confidential institutional review and approval process of research activities involving human subjects to protect their safety, rights, and welfare; helps organize, implement and maintain the IRB with Board members, researchers, and external researchers; and provides training and guidance to Board members, faculty, staff and students. The IRB Analyst must have the ability to be independently functioning in decision making with regard to project review and helping the research community and colleagues with IRB related issues and activities.
Please note: 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.
The goal of the following activities is to ensure that operational priorities align with the mission and direction of overall IRB office and the Biomedical Panels specifically. The IRB Analyst is expected to be able to:
Conduct pre-review of submissions to the IRB and determine if the submissions include adequate information for review and determine the level of review required.
Make recommendations to eliminate problems before submissions are forwarded for expedited or convened review.
Serve as designated reviewer for exempt and expedited projects; Reportable New Information reports; and non-human subject research determinations.
Disseminate information about and assist investigators in the preparation of IRB applications to ensure that required elements are addressed and that all documents are prepared in accordance with appropriate standards.
Know the expertise of IRB committee members in order to make appropriate assignments for review.
Prepare 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.
Recommend improvements for enhancing communication between the IRB, researchers, and staff on the status of protocols and committee deliberations.
Serve as subject matter expert in federal, state, and local laws and regulations as they apply to human subjects.
Training and education responsibilities
The goal of the following activities is to ensure high quality services for Northwestern University’s Board members, researchers, staff and students involved with human research subjects administrative process. The IRB Analyst is expected to be able to:
Provide training and advice on preparation of applications and related documents such as protocol, recruitment materials, and consent forms.
Provide appropriate resources to IRB chairs, members, and researchers including providing them with information from the regulations, guidance documents, and ethical principles essential to the review process.
Participate in professional development activities, workshops, and conferences as appropriate.
Manages specials projects for the office.
Provides backup to Senior IRB Analysts with regard to IRB process.
Performs other duties and responsibilities as assigned.
Bachelor’s Degree in relevant academic field.
2+ years of relevant work experience including demonstrated knowledge of federal and state regulation governing the participation of human subjects in research.
CIP and/or CIM eligible within a year.
Demonstrated characteristics in the following areas: adaptability, flexibility, collegiality, customer focus, ethics and integrity, judgment, and ability to multi-task.
Minimum Competencies: (Skills, knowledge, and abilities.)
Competencies: computer proficiency, report writing, and research regulations.
Demonstrated written and oral communication skills.
Demonstrated working knowledge of behavioral research terminology and methods.
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.
Advanced degree in related academic field.
Experience in human subject research.
Preferred Competencies: (Skills, knowledge, and abilities)
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 be appropriately assertive 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.
Internal Number: 35577
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.