Regulatory Coordinator - Genetics at Lurie Children's Hospital
Overview
The Regulatory Coordinator supports clinical trials for rare genetic disorders at Ann & Robert H. Lurie Children’s Hospital of Chicago. This role ensures compliance with regulations protecting human subjects while collaborating with internal and external partners. Responsibilities include guiding submissions, tracking updates, and providing training to research staff. The position differs by focusing on rare genetic diseases and direct collaboration with clinical trial teams.
What You'll Do11
- 1Determines and interprets applicable rules for clinical research involving human subjects to protect safety and rights
- 2Collaborates with Office of Research Integrity and Compliance to maintain ongoing regulatory adherence
- 3Coordinates all trial-related submissions including applications renewals and adverse event reports
- 4Acts as liaison between affiliates sponsors and oversight agencies addressing study status concerns
- 5Serves as resource for regulatory concepts to clinical research staff
- 6Tracks and applies new regulations related to human subject research
- 7Ensures accurate IRB approval letters with sponsor information and NIH identifiers
- 8Provides guidance and training to research staff on complex regulations
- 9Alerts staff to regulatory changes and ensures proper interpretation for studies
- 10Creates reports analyzing compliance requirements to improve practice efficiency
- 11Offers guidance on institutional policies and federal/state funding agency regulations
Requirements9
- 1Bachelor's degree or equivalent with three years regulatory/research experience
- 2Three years experience in regulatory environment with clinical research protocols
- 3Strong knowledge of federal state and local regulations for human subject research
- 4Detailed understanding of ICH-GCP OHRP FDA regulations
- 5Excellent communication and project management skills
- 6Ability to prioritize tasks and meet deadlines under pressure
- 7Proficiency in Excel Word Outlook Access PowerPoint EPIC systems
- 8Experience with risk management education
- 9Commitment to diversity inclusion and equitable practices
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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