Clinical Trials Regulatory Lead

The University of Chicago; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Benefits

Job summary

The University of Chicago Comprehensive Cancer Center seeks an experienced Regulatory Affairs professional to maintain clinical trial regulatory compliance programs and coordinate internal audits. With moderate direction, you will participate in compliance documentation and submission to required internal committees.

You will serve as regulatory liaison across internal teams and external sites, preparing protocol activations and tracking essential documents to ensure studies run smoothly.

Qualifications

• Education: college or university degree in related field.
• 2–5 years of work experience in a related job discipline.
• Certification: certificate or degree program in clinical trial management/regulatory affairs or related field.

Responsibilities

• Prepares and submits materials to the IRB and other internal review committees.
• Creates and maintains the regulatory files for each assigned study.
• Communicates updates and changes (protocol amendments) to the clinical research team and sponsor/funding agencies.
• Participates in internal clinical research audit program as assigned.
• Provides multi-site regulatory coordination as assigned.
• Acts as primary regulatory liaison for external sites participating in clinical research projects.
• Prepares and collects all necessary documents to activate protocols (consent forms, Form FDA 1572).
• Coordinates compliance meetings and audits to support inspections.

Skills

Microsoft Office

Adobe Acrobat

Clinical trial systems

Education

Bachelor's degree or related field

Tools

Clinical trial management systems

Job description

The University of Chicago Comprehensive Cancer Center seeks an experienced Regulatory Affairs professional to maintain clinical trial regulatory compliance programs and coordinate internal audits. With moderate direction, you will participate in compliance documentation and submission to required internal committees.

You will serve as regulatory liaison across internal teams and external sites, preparing protocol activations and tracking essential documents to ensure studies run smoothly.