Clinical Research Coordinator 1 - cGMP Core

Clinical Research Associate

The job performs routine assignments related to the documentation and reporting of basic clinical studies. Supports decisions that impact clinical research conducted across the University. Under the supervision of the Technical Director and facility manager of the cGMP Core, this position requires the candidate to collaborate within a team atmosphere that process and compound clinical grade vaccines and cell therapy products in the Cellular and Tissue Based Processing cGMP Facility. This position requires the candidate to adhere to sponsored clinical trial protocols and standard operating procedures as well as working off hours at times. The ideal candidate will need to be a self-starter and be responsible for maintaining strict compliance under various regulatory agencies and detailed record keeping. This candidate will be required to juggle multiple/competing priorities and also be assigned back up duties to support facility operations. The candidate must be open to undergoing and pass rigorous training with respect to cGMP and USP standards as well as various technical assays and procedures specific for various cellular manipulation techniques.

Responsibilities include:

• Perform environmental monitoring in the Production Areas including but not limited to: dynamic monitoring for campaigns, cleanroom biweekly particle counts and monthly air samples and prepare environmental monitoring reports.
• Perform personnel monitoring for required campaigns.
• Assist in setting up new lab equipment used in cleanrooms and Quality Control Laboratory and assist with the upkeep including temperature monitoring, daily verification with QC, instrument/operation/performance qualifications (IQ/OQ/PQ), routine maintenance, troubleshooting.
• Support cGMP compliance through validation and qualification of processes, materials and supplies, equipment, facility processes and perform vendor qualification of supplies/materials used in manufacturing.
• Ensure equipment is operating correctly and perform PM tests as required.
• Ensure all materials and samples are stored correctly at the right temperatures.
• Perform Endotoxin, Mycoplasma, Cell counting and other assays as required; demonstrate Proficiency and Competency under College of American Pathologists accreditation.
• Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.
• Process supply orders from Oracle purchasing system and through IDS pharmacy, process inventory and obtain release documentation/quality certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for all items.
• Prepare supply kits used in manufacturing for all campaigns.
• Maintain inventory levels for facility operations, vaccine preparations, cell therapy, and islet preparations.
• Prepare instrumentation error reports (IER) and deviations.
• Perform room change-over following campaigns ensuring specialized cleaning in compliance with cGMP standards.
• Assist with coordinating facility repairs/maintenance by University of Chicago Plant personnel and equipment vendors.
• Attend all required training and comply with all safety and operations procedures.
• Perform all other duties as requested by the Technical Director or QA/QC Manager.
• Aseptically prepare a variety of cellular product processing procedures under G'X'P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.
• Aseptically prepare a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.
• Aseptically prepare a variety of patient treatments under USP 797 pharmaceutical compounding.
• Transport prepared vaccines/cell therapy products to the clinic or pharmacy.
• Accountable for all tasks in basic clinical studies.
• Assists with various professional, organizational, and operational tasks under direct supervision.
• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
• Performs other related work as needed.

Minimum Qualifications include a college or university degree in a related field and less than 2 years of work experience in a related job discipline.

Preferred Qualifications include a Bachelor's degree in biology, medical laboratory science, medical technology, molecular/bio-engineering, or closely related field. A minimum of 2-3 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field is also preferred.