Regulatory Coordinator

Job ID : 52573

Location : Chicago, Illinois

Department : MED-Transplant Center

Salary / Grade : EXS / 5

Target hiring range for this position will be between be Salary range is as be $56,000 To $65,000 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.

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 Comprehensive Transplant Center and will serve as a contact liaison for regulatory matters among the research staff and Principal Investigators, sponsor companies and the IRB. Interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance. The Comprehensive Transplant Center conducts a wide variety of clinical research, including drug trials, biological sample studies, interventional studies, and retroactive and prospective data studies. Studies are funded by the NIH, industry and foundations.

Specific Responsibilities

• Assists 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. Assists 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.
• Supports regulatory activities related to multiple clinical research projects under the direction of clinical research nurses. Works 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.
• Assists research staff in formatting study protocol using transplant research template. Assists manager 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. Supports data management and the maintenance of study records and databases. Aids clinical research nurses in preparing final reports for close-out submissions
• Provides assistance with submission of IND applications and renewals with the FDA as needed. Corresponds with the FDA throughout the IND process

Minimum Qualifications

Minimum Competencies

Preferred Qualifications

Preferred Competencies

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 University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern\'s non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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