Full-Time
Clinical Research Coordinator 1
cGMP Core
Deadline 8/10/26
University of Chicago
Compensation Overview
$50k - $65k/yr
Chicago, IL, USA
In Person
Category
 Biology & Biotech (2) |
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Required Skills
Inventory Management
Oracle
Requirements
- A college or university degree in a related field.
- Knowledge and skills developed through less than 2 years of work experience in a related job discipline.
Responsibilities
- 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 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.
Desired Qualifications
- Bachelor's degree in biology, medical laboratory science, medical technology, molecular/biomedical engineering, or closely related field.
- Graduate degree strongly preferred.
- A minimum of 2-3 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field.
- Prior experience in cell culture, molecular biology, viral gene transduction, are highly desirable.
- Prior experience in equipment maintenance and validation are highly desirable.
- Ability to sterilely gown and work in a cGMP cleanroom setting.
- Ability to read, write and follow documents including protocol and Standard Operating Procedures (SOPs).
- Capacity to handle multiple tasks and competing demands under tight timeframes.
- Execute and comply with all oral and written procedures including Batch Records and SOPs.
- Attention to detail.
- Ability to demonstrate excellent interpersonal and communication skills.
- Strong emphasis on documentation according to FDA regulations and other regulating bodies.
- Excellent verbal and written communication skills.
- Capacity to exhibit organizational skills.
- Ability to work in a collaborative team environment.
- Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment.
- Ability to understand, retain, and carry out instructions and solve problems in complex situations.
- Ability to independently learn new techniques.
- Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality.
- Excellent customer/staff interpersonal skills.
- Working knowledge of quality control and cGMP.
- Advanced skills with Microsoft Office Suite.
- Must be detail-oriented, well organized and approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment.
- Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills.