Cell Therapy Clinical Research Coordinator II

University of Chicago; Chicago (IL); On-site; USD 60,000 - 75,000; Full time

Job summary

The University of Chicago is seeking a Clinical Research Coordinator II – Cellular Manufacturing to join its state-of-the-art cGMP facility. The role focuses on aseptic processing and complex protocol-driven manufacturing for Phase I–III trials, reporting to the Technical Director, and ensuring strict adherence to cGMP and regulatory standards.

Responsibilities include maintaining batch records, supporting deviation investigations, inventory management, and training junior staff.

Qualifications

• Minimum a college or university degree in related field.
• 2-5 years of work experience in a related job discipline.
• Masters Degree in related field preferred.
• 4 years of post-bachelor laboratory experience preferred.
• Knowledge of 21 CFR Parts 210 and 211 preferred.
• Prior cGMP manufacturing or pharmacy experience preferred.
• Experience in cell culture and analytical assays preferred.
• Certifications such as MLT/CPHT preferred.

Responsibilities

• Perform cellular product processing under GxP guidelines as directed with accuracy.
• Carry out cellular infusion procedures under GTP guidelines as directed.
• Support cGMP compliance and equipment maintenance.
• Transport vaccines/cell therapy products to clinic or pharmacy.
• Train and guide new staff and document regulatory events.
• Assist with validation, qualification and CAPA activities.

Skills

Aseptic technique

ISO 7 gowning

GxP knowledge

Documentation

Education

Bachelor's degree

Master's degree

Tools

Microsoft Office

Job description

The University of Chicago is seeking a Clinical Research Coordinator II – Cellular Manufacturing to join its state-of-the-art cGMP facility. The role focuses on aseptic processing and complex protocol-driven manufacturing for Phase I–III trials, reporting to the Technical Director, and ensuring strict adherence to cGMP and regulatory standards.

Responsibilities include maintaining batch records, supporting deviation investigations, inventory management, and training junior staff.