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 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 knowledge and skills developed through 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. Prior experience in cell culture, molecular biology, viral gene transduction, are highly desirable. Prior experience in equipment maintenance and validation are highly desirable.

Preferred Competencies include the 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.

Working Conditions include ability to perform light/medium work, which includes lifting up to 30 pounds, occasionally must bend, twist, squat, climb, reach, stoop, and kneel, ability to be mobile walking from building to building, ability to sit for some period of up to 2 hours, all employees within this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste, working knowledge of quality control and cGMP, advanced skills with Microsoft Office Suite.

Application Documents include Resume (required) and Cover Letter (preferred). When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.