Genetics Clinical Trials Regulatory Coordinator

Ann & Robert H. Lurie Children's Hospital of Chicago; Chicago (IL); On-site; USD 65,520 - 107,120; Full time

Job summary

Ann & Robert H. Lurie Children's Hospital of Chicago is seeking a Regulatory Coordinator in the Division of Genetics to support clinical trials in rare genetic disorders.

You will manage submissions, document control, and reporting to IRB and oversight bodies, coordinating with sponsors and CROs to meet timelines. The role requires a Bachelor's degree in Risk Management with 3+ years in regulatory/research settings, strong knowledge of regulations (ICH-GCP, FDA), and excellent communication

Qualifications

• Bachelor's degree in risk management or equivalent with 3+ years in regulatory/research environment.
• Deep knowledge of federal, state, and local regulations and ethics in human subjects research (ICH-GCP, OHRP, FDA).
• Excellent customer service, project management, and process improvement skills.
• Strong organizational and analytical abilities with initiative and deadline focus.
• Excellent oral and written communication across all levels of the organization.
• Ability to perform multiple tasks with high accuracy and attention to detail.

Responsibilities

• Determine and interpret regulatory rules for complex clinical studies involving human subjects and ensure safety and rights protections.
• Coordinate clinical trials submissions, documentation, and reporting to IRB and oversight groups.
• Serve as liaison between affiliates, sponsors, coordinators, investigators, and regulatory bodies.
• Track and apply new regulations; submit documents to IRB and relevant groups for new projects, amendments, and adverse events.
• Draft protocols and informed consent, ensuring accuracy of IRB letters with sponsor info and NIH identifiers.
• Provide guidance and training to research staff on regulatory requirements and compliance.
• Alert staff to regulatory changes and interpret for current studies to ensure compliance.
• Create reports and analyses to improve compliance efficiency and effectiveness.
• Advise investigators on institutional policies and funding agency regulations including safety, effort reporting and COI.

Skills

Customer service

Project management

Process improvement

Oral and written communication

Organizational skills

Analytical skills

Problem solving

Education

Bachelor's Degree in Risk Management

Tools

Excel

Word

Outlook

Access

PowerPoint

EPIC

Job description

Ann & Robert H. Lurie Children's Hospital of Chicago is seeking a Regulatory Coordinator in the Division of Genetics to support clinical trials in rare genetic disorders.

You will manage submissions, document control, and reporting to IRB and oversight bodies, coordinating with sponsors and CROs to meet timelines. The role requires a Bachelor's degree in Risk Management with 3+ years in regulatory/research settings, strong knowledge of regulations (ICH-GCP, FDA), and excellent communication