Clinical Research Coordinator Job at the University of Chicago in the USA | Apply Now
Are you searching for a rewarding clinical research coordinator job in a globally respected research institution? The University of Chicago is hiring a full-time professional to support advanced clinical trials and laboratory operations within its Cellular and Tissue-Based Processing cGMP Facility. This onsite opportunity is ideal for candidates looking to grow in clinical trials jobs, clinical research jobs, and specialized medical laboratory job environments.
Job Details:
- Position Title: Clinical Research Coordinator 1
- Remote Type: Onsite
- Locations: Marjorie B. Kovler Viral Oncology Laboratories
- Time Type: Full-time
- Job Requisition ID: JR32683
- Department: BSD SRF – cGMP
About the Company
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Its commitment to free and open inquiry draws inspired scholars to global campuses, where ideas are born that challenge and change the world. Individuals are empowered to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in a rigorous, interdisciplinary core curriculum. The University continues to contribute significantly to clinical research jobs and clinical trials jobs across multiple disciplines worldwide.
Job Description
This clinical research coordinator job supports the primary mission of the Cellular and Tissue-Based Processing cGMP Facility, which is to manufacture cell-based products and clinical-grade reagents for the treatment of patients on Phase I, II, and III clinical trials. This sub-core was developed in 2001 to accommodate the growing number of clinical trials jobs that require highly manipulated cellular products for patient treatment.
Qualifications
Minimum Qualifications
- Education: Minimum requirements include a college or university degree in related field.
- Work Experience: Knowledge and skills developed through less than 2 years of work experience in a related job discipline, suitable for entry-level clinical research jobs or medical laboratory job roles.
Preferred Qualifications
- Education: Bachelor’s degree in medical laboratory science, medical technology, molecular/bio-engineering, or a closely related field.
- Experience: 2–3 years of post-bachelor laboratory experience preferred in immunology, biochemistry, molecular biology, microbiology, or related field.
Experience in cell culture, molecular biology, viral gene transduction, equipment maintenance, and validation is highly desirable for advanced clinical trials jobs.
Key Responsibilities
- Perform environmental monitoring in Production Areas, including dynamic monitoring, cleanroom particle counts, and air samples.
- Perform personnel monitoring for required campaigns.
- Assist in setting up new lab equipment in cleanrooms and the Quality Control Laboratory, and support upkeep, including maintenance and troubleshooting.
- Support cGMP compliance through validation and qualification of processes, materials, equipment, and vendor supplies.
- Ensure equipment is operating correctly and perform preventive maintenance tests.
- Ensure materials and samples are stored correctly at the required temperatures.
- Perform Endotoxin, Mycoplasma, Cell counting, and other assays under accreditation standards.
- Monitor compliance with institutional, state, and federal regulatory policies
- Process supply orders, manage inventory, and obtain release documentation and quality certificates.
- Prepare supply kits used in manufacturing campaigns.
- Maintain inventory levels for vaccine preparations, cell therapy, and islet preparations.
- Prepare instrumentation error reports and deviations.
- Perform room change-over following campaigns, ensuring compliance with cGMP standards.
- Assist with coordinating facility repairs and maintenance.
- Aseptically prepare cellular product processing procedures under G’X’P guidelines.
- Aseptically prepare cellular infusion procedures under GTP guidelines.
- Aseptically prepare patient treatments under USP 797 pharmaceutical compounding.
- Transport prepared vaccines and cell therapy products to the clinic or pharmacy.
- Support quality assurance reviews conducted by sponsors and federal agencies.
- Coordinate the collection of analyzable clinical research data and samples.
- Perform other related work as needed.
