Northwestern University · 17 hours ago
Regulatory Specialist
Chicago, IL
Full-time
Onsite
Entry Level
$19.89/hr - $24.86/hr
1+ years expNorthwestern University is seeking a Regulatory Specialist to support the Institutional Review Board (IRB) regulatory submission process. The role involves assisting with IRB submissions, serving as a liaison for regulatory matters, and ensuring compliance with applicable regulations.
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Responsibilities
Assists in the preparation and tracking of IRB submissions including continuing reviews, revisions/amendments, subject recruitment materials and safety reports (UPIRSO) for BCVI CTU research studies. Completes IRB requests for modifications as needed. Maintains an open dialog with supervisor regarding the IRB process and project modifications
Works as a liaison between research staff and the IRB. Serves as contact between sponsor, PI, project coordinators and IRB. Communicates with collaborating faculty both inside and outside the University. Maintains an open dialog with supervisor regarding project modifications and communications
Prepares, circulates and obtains signatures on regulatory documents for new and on-going research projects. Files and maintains study related paperwork. Submits regulatory paperwork to sponsoring agencies (i.e. 1572, investigator CVs, financial disclosure forms)
Maintain regulatory binders and documentation in collaboration with the research staff and study monitors to ensure studies are in compliance with applicable regulations
Participates and assists with routine monitoring visits and study close-out visits ensuring regulatory documents are accounted for. Collaborates with research staff to coordinate monitoring visits
Sends study related documents to storage and maintain the filing systems
Performs other duties as assigned
Qualification
Required
Bachelor's degree knowledge or equivalent combination of experience or education from which comparable skills may be acquired
Consistently displays accuracy and attention to detail
Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
Preferred
CITI certification
One year experience in research, clinical trials research, or regulatory knowledge
Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar
Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement
Benefits
Meaningful, competitive, high-quality health care plans
Retirement benefits
Tuition discounts
Comprehensive programs and services to help you and your family navigate life’s challenges and opportunities
Flexible work arrangements
Programs to help you locate and pay for quality, affordable childcare and senior/adult care
Employee career development
Variety of tools and resources
Company
Northwestern University
Northwestern University is a private research and teaching university that offers academic programs across various fields of study. It is a sub-organization of Northwestern Athletics.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
$98.02MKey Investors
National Peanut BoardAdvanced Research Projects Agency for HealthGRAMMY Museum
2024-10-30Grant
2024-10-04Grant· $34M
2023-11-28Grant· $0.02M
Leadership Team
Diego Klabjan
Professor
Henry Bienen
Interim President
Recent News
2026-01-25
Digital Journal
2026-01-23
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