Clinical Research Coordinator II Cellular Manufacturing

Clinical Research Coordinator II Cellular Manufacturing

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 IIII trials. You will perform aseptic processing, execute complex protocol-driven manufacturing procedures, and maintain accurate batch records and documentation. Additional responsibilities include supporting deviation investigations and CAPA, managing inventory and materials, and training junior staff. Reporting to the Technical Director, you will help lead daily ISO 7 cleanroom operations, oversee equipment maintenance and troubleshooting, and ensure strict adherence to cGMP and regulatory standards. Strong expertise in aseptic technique, ISO 7 gowning, and complex cell processing and analytical assays is required.

Responsibilities include:

• 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.
• 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.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Uses knowledge of clinical studies to coordinate 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.

Minimum qualifications include a college or university degree in a related field and 2-5 years of work experience in a related job discipline. Preferred qualifications include a Masters Degree in a related field, 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, and advanced skills with Microsoft Office Suite.

Working conditions include the ability to perform light/medium work, which includes lifting up to 30 pounds, occasionally bending, twisting, squatting, climbing, reaching, stooping, and kneeling, ability to be mobile and walking from building to building, ability to sit for some period of up to 4 or more hours, and ability to stand for some period of up to 3 or more hours. All employees within this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste.

Application documents required include a resume and a cover letter (preferred). The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.