With supervision, the Analyst provides oversight of the daily operational activities of the Social and Behavioral 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 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.
The goal of following activities is to ensure that operational priorities are aligned with the mission and direction of overall IRB office and the Social and Behavioral IRB specifically. The Analyst is expected to be able to:
Determine adequacy of IRB applications and level of review required as part of pre-review of projects submitted to the IRB.
Review research protocols to identify potential problems and makes recommendations before protocols are submitted for expedited or for convened review.
Serve as designated reviewer for exempt and expedited projects; safety reports; and non-human subject research determinations.
Disseminate information about and assist investigators in the preparation of IRB applications to ensure that required elements have been 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.
In collaboration with colleagues, coordinate monthly Social and Behavioral Board meetings including pre-review, assignment of projects, creation meeting agenda and chair’s agenda, completion of minutes and correspondence as is appropriate.
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 Analyst is expected to be able to:
Provide training as needed on the protection of human participants in research to meet the certification requirement.
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.
Serve as a Social Behavioral IRB expert for other IRB staff members.
Participate in professional development activities, workshops, and conferences as appropriate.
Customer service and outreach responsibilities:
The Analyst is expected to:
Respond to telephone calls and e-mail queries in a courteous and timely manner.
Provide individual and group consultations with the research community as requested, and during designated drop-in hours.
Design and give presentations on IRB-related topics when invited by a professor, department, or school. Collaborate with colleagues as appropriate.
Serve as the IRB liaison for at least two high-volume departments on the Evanston campus and forms positive working relationships with faculty and staff.
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: 37974
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.