Clinical Research Coordinator

Position: Clinical Research Coordinator 1
* 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 clean rooms 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.
* 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 time frames.
* 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.
* 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…