Cell Therapy Clinical Research Coordinator II

University of Chicago; United States; On-site; USD 60,000 - 75,000; Full time

Job summary

The University of Chicago is recruiting forClinical Research Coordinator II – Cellular Manufacturing to support manufacture of clinical-grade cellular therapies and vaccines within a state-of-the-art cGMP facility. You will compile, document, analyze, and report on moderately complex clinical studies in a cleanroom setting and aid administrative decisions for Phase I–III trials.

Reporting to the Technical Director, you will lead daily ISO 7 operations, manage batch records, assist with CAPA

Qualifications

• Requires college or university degree in related field.
• 2–5 years of work experience in a related job discipline.

Responsibilities

• Compile, document, analyze, and report on moderately complex clinical studies.
• Perform aseptic processing and execute complex protocol-driven manufacturing procedures.
• Maintain batch records and documentation; support CAPA and deviations.
• Train junior staff and assist with equipment maintenance and troubleshooting.
• Ensure compliance with cGMP, ISO 7 cleanroom standards, and regulatory requirements.

Skills

Aseptic technique

GxP knowledge

Documentation

Team coordination

Communication

Education

Bachelor's degree in related field

Master's degree preferred

Tools

IQ/OQ/PQ processes

Microsoft Office Suite

Job description

The University of Chicago is recruiting forClinical Research Coordinator II – Cellular Manufacturing to support manufacture of clinical-grade cellular therapies and vaccines within a state-of-the-art cGMP facility. You will compile, document, analyze, and report on moderately complex clinical studies in a cleanroom setting and aid administrative decisions for Phase I–III trials.

Reporting to the Technical Director, you will lead daily ISO 7 operations, manage batch records, assist with CAPA