Clinical Research Coordinator II – Cellular Manufacturing

About the role

The job compiles, documents, analyzes, and reports on moderately complex clinical studies. It provides input to support the 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.

Responsibilities

• Perform a variety of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.
• Perform a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.
• Perform a variety of special manufacturing projects under cGMP guidelines as directed with speed and accuracy.
• Transport prepared vaccines/cell therapy products to the clinic or pharmacy.
• 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.
• 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.
• Accountable for all tasks in moderately complex clinical studies.
• Aids in coordinating the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence.
• Contributes to the problem solving on assigned clinical research studies and tasks.
• Performs other related work as needed.

Requirements

• Strong expertise in aseptic technique, ISO 7 gowning, and complex cell processing and analytical assays is required.

Qualifications

• Minimum requirements include a college or university degree in related field.
• Knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

• Masters Degree in related field.
• Experience: 4 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field strongly preferred.
• Knowledge of 21 CFR Parts 210 and 211 strongly preferred.
• Prior experience in cGMP manufacturing or pharmacy compounding strongly preferred.
• Prior experience in cell culture, analytical assay performance and development, viral gene transduction, and sterile filling techniques strongly preferred.
• Advanced skills with Microsoft Office Suite strongly preferred.

Skills

• Working knowledge of GxP, CLIA, CAP, and FDA-regulated environments.
• Experience in cGMP sterile cleanroom operations.
• Ability to follow and execute SOPs, protocols, and batch records.
• Strong documentation practices and attention to detail.
• Excellent verbal and written communication skills.
• Strong interpersonal skills with ability to collaborate across teams and interact professionally with all staff while maintaining confidentiality.
• Highly organized with the ability to manage multiple priorities and meet tight deadlines in a fast-paced environment.
• Problem-solving skills with the ability to understand, retain, and apply complex instructions.
• Self-motivated with the ability to learn new techniques quickly and work independently.

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.