Regulatory Coordinator

Job Summary

This position will assist with the submission process to the Institutional Review board (IRB) of new studies, revisions, and renewals being processed through the department and will serve as a contact liaison for regulatory matters among the research staff and Principal Investigators, sponsor companies and the IRB.

Specific Responsibilities

• Aids PI's in gaining Institutional Review Board (IRB) approval for new research protocols involving less than minimal risk to research subjects, i.e. retrospective and prospective medical record reviews by submitting new study applications through the eIRB system.
• Aids in the preparation and tracking of IRB submissions including annual renewals, revisions and safety reports as needed for principal investigators and research coordinators for transplant research studies.
• Completes IRB requests for modifications as needed.
• Serves as a liaison between research staff and the IRB. Serves as contact between sponsor, PI and IRB. Communicates with collaborating faculty both inside and outside the University.
• Aids in the formatting of study protocol using transplant research template. Assists in the drafting of informed consents and coordinates gaining IRB approval.
• Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
• Works with research staff and study sponsors to maintain research binders and documentation to ensure studies are in compliance with applicable regulations.
• Serves as a point of contact for submission of IND applications and renewals with the FDA as needed.
• Corresponds with the FDA throughout the IND process.

Minimum Qualifications

• Bachelor’s degree knowledge or equivalent combination of experience or education from which comparable skills may be acquired;
• One year experience in research, clinical trials research, or regulatory knowledge;
• CITI certification;

Preferred Qualifications

• At least one year of experience supporting clinical trials with hands-on responsibility for IRB submissions, correspondence, and compliance activities;

Benefits

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html.

Work-Life And Wellness

Northern Illinois University 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

Northern Illinois University 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.