Clinical Research Coordinator II – Cellular Manufacturing

About The Department

BSD SRF - cGMP

The primary mission of the Cellular and Tissue Based Processing cGMP Facility is to manufacture cell-based products and clinical grade reagents for treatment of patients on Phase I, II and III clinical trials. This subcore was developed in 2001 to accommodate the growing number of clinical trials that require highly manipulated cellular products for patient treatment. The cGMP facility is registered with the FDA in accordance with 21 CFR part 1271 and complies with federal regulations that require clinical facilities engaged in production of cellular products to follow strict guidelines to minimize microbial contamination and manufacture cellular-based products that are sterile and potent for their intended purpose.

The facility provides a range of services dedicated to supporting cellular based therapies including vaccines for patient treatments.

The job compiles, documents, analyzes, and reports on moderately complex clinical studies. It provides input to support administrative and operational decisions that impact clinical research conducted across the University. As a Clinical Research Coordinator II – Cellular Manufacturing, you will work in a state-of-the-art cleanroom within the UChicago Cellular and Tissue-Based Processing cGMP Facility, supporting the manufacture of clinical-grade cellular therapies and vaccines for Phase I–III trials.

You will perform aseptic processing, execute complex protocol‑driven manufacturing procedures, maintain accurate batch records and documentation, support deviation investigations and CAPA, manage inventory and materials, and train junior staff.

• Perform a variety of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines with speed and accuracy.
• Perform a variety of cellular infusion procedures under GTP guidelines with speed and accuracy.
• Perform a variety of special manufacturing projects under cGMP guidelines with speed and accuracy.
• Transport prepared vaccines/cell therapy products to the clinic or pharmacy.
• Perform and support Cell Therapy assays (including CAP proficiency/competency) in accordance with SOPs and best practices.
• Execute SOPs to support facility and operational needs.
• Assist with lab equipment lifecycle activities, including setup, qualification (IQ/OQ/PQ), calibration/verification, maintenance, monitoring, and troubleshooting.
• Support cGMP compliance through validation and qualification of processes, materials, equipment, and vendors.
• Ensure proper handling and storage of materials and samples under required conditions.
• Document and report instrumentation errors, deviations, and quality events.
• Support compliance with institutional, state, and federal regulations, as well as accrediting body requirements.
• Perform GMP‑compliant room changeovers and specialized cleaning between campaigns.
• Manage ordering and inventory of supplies.
• Train and guide new staff.
• Complete required training and adhere to all safety and operational procedures.
• Be accountable for all tasks in moderately complex clinical studies.
• Assist with various professional, organizational, and operational tasks under moderate supervision.
• Facilitate and participate in the daily activities of moderately complex clinical studies, including patient data retrieval, documenting clinical research records, and participation in program audits.
• Use knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence and contribute to problem solving on assigned studies and tasks.
• Perform other related work as needed.

• Education:
  
  A college or university degree in a related field.
• Experience:
  
  2–5 years of work experience in a related job discipline.

• Education
  :
  Master’s Degree in a related field.
• Experience
  :
  • 4 years of post‑bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field.
  • Knowledge of 21 CFR Parts 210 and 211.
  • Prior experience in cGMP manufacturing or pharmacy compounding.
  • Prior experience in cell culture,…