Regulatory Affairs Lead — Multi-site Clinical Trials

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

The University of Chicago Comprehensive Cancer Center (UCCCC) within the Biological Sciences Division is seeking a Regulatory Compliance Officer to manage trial regulatory programs, audits, and documentation. This role coordinates internal and external site activities and interfaces with IRB and sponsor agencies.

Minimum 2–5 years in clinical research or regulatory affairs, with a degree in a related field.

Qualifications

• Minimum 2–5 years of related work experience.
• Certification in clinical trial management or regulatory affairs preferred.
• Bachelor's degree in a related field required.

Responsibilities

• Prepares and submits materials to the IRB and other internal review committees.
• Creates and maintains site regulatory files for each assigned study.
• Communicates updates and changes to the clinical research team and sponsor/funding agencies.
• Participates in internal clinical research audit program as assigned.
• Provides multi-site regulatory coordination for external sites.
• Prepares documents to activate protocols (consent forms, Form FDA 1572).
• Prepares protocol updates and coordinates weekly program meetings.

Skills

Regulatory knowledge

Clinical research

Audit experience

Documentation

Communication skills

Microsoft Office

Adobe Acrobat

Education

Bachelor's degree in related field

Tools

Clinical trial management systems

Databases

Job description

The University of Chicago Comprehensive Cancer Center (UCCCC) within the Biological Sciences Division is seeking a Regulatory Compliance Officer to manage trial regulatory programs, audits, and documentation. This role coordinates internal and external site activities and interfaces with IRB and sponsor agencies.

Minimum 2–5 years in clinical research or regulatory affairs, with a degree in a related field.