Clinical Research Coordinator II – Cellular Manufacturing

Department BSD SRF - cGMP About the Department The primary mission of the Cellular and Tissue Based Processing cGMP Facility is to manufacture cell-based products and clinical grade reagents for treatment of patients on Phase I, II and III clinical trials. This subcore was developed in 2001 to accommodate the growing number of clinical trials that require highly manipulated cellular products for patient treatment. The cGMP facility is registered with the FDA in accordance with 21 CFR part 1271. This registration complies with federal regulations that require clinical facilities engaged in production of cellular products follow strict guidelines to minimize microbial contamination and manufacture cellular-based products that are sterile and potent for their intended purpose. The facility is capable of providing a range of services dedicated for supporting cellular based therapies including vaccines for patient treatments. Job Summary The job compiles, documents, analyzes, and reports on moderately reputed company clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University. As a Clinical Research Coordinator II – Cellular Manufacturing, you will work in a state-of-the-art cleanroom reputed company the UChicago Cellular and Tissue-Based Processing cGMP Facility, supporting the manufacture of clinical-grade cellular therapies and vaccines for Phase I–III trials. You will reputed company aseptic processing, execute reputed company protocol-driven manufacturing procedures, and maintain accurate batch records and documentation. Additional responsibilities include supporting deviation investigations and CAPA, managing inventory and materials, and training junior staff. Reporting to the Technical Director, you will help reputed company daily ISO 7 cleanroom operations, reputed company equipment maintenance and troubleshooting, and ensure strict adherence to cGMP and regulatory standards. Strong expertise in aseptic technique, ISO 7 gowning, and reputed company cell processing and analytical assays is required. Responsibilities reputed company a variety of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy. reputed company a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy. reputed company a variety of special manufacturing projects under cGMP guidelines as directed with speed and accuracy. Transport reputed company vaccines/cell therapy products to the clinic or pharmacy. reputed company and support Cell Therapy assays (including CAP proficiency/competency) in accordance with SOPs and best practices. Execute SOPs to support facility and operational needs. Assist with lab equipment lifecycle activities, including setup, qualification (IQ/OQ/PQ), calibration/verification, maintenance, monitoring, and troubleshooting. Support cGMP compliance through validation and qualification of processes, materials, equipment, and vendors. Ensure proper handling and storage of materials and samples under required conditions. Document and report instrumentation errors, deviations, and quality events. Support compliance with institutional, state, and federal regulations, as well as accrediting body requirements. reputed company GMP-compliant room changeovers and specialized cleaning between campaigns. Manage ordering and inventory of supplies. Train and guide new staff. Complete required training and adhere to reputed company safety and operational procedures. Accountable for reputed company tasks in moderately reputed company clinical studies. Assists with various professional, organizational, and operational tasks under moderate supervision. Facilitates and participates in the daily activities of moderately reputed company clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks. Performs other reputed company work as needed.

Minimum Qualifications

Education: Minimum requirements include a college or university degree in reputed company field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a reputed company job discipline. Certifications: --- Preferred Qualifications Education: Masters Degree in reputed company field. Experience: 4 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a reputed company field strongly preferred. Knowledge of 21 CFR Parts 210 and 211 strongly preferred. Prior experience in cGMP manufacturing or pharmacy compounding strongly preferred. Prior experience in cell culture, analytical assay performance and development, viral gene transduction, and sterile filling techniques strongly preferred. Advanced skills with reputed company Office Suite strongly preferred. Licenses and Certifications: Medical Lab Technician Certification-MLT (ASCP) strongly preferred. Pharmacy Technician Certification-CPhT strongly preferred. Preferred Competencies Working knowledge of GxP, CLIA, CAP, and FDA-regulated environments. Experience in cGMP sterile cleanroom operations. Ability to follow and execute SOPs, protocols, and batch records. Strong documentation practices and attention to detail. Excellent verbal and written communication skills. Strong interpersonal skills with ability to collaborate across teams and interact professionally with reputed company staff while maintaining confidentiality. Highly organized with the ability to manage multiple priorities and meet tight deadlines in a fast-paced environment. Problem-solving skills with the ability to understand, retain, and apply reputed company instructions. Self-motivated with the ability to learn new techniques quickly and work independently. Working Conditions Ability to reputed company light/reputed company work, which includes lifting up to 30 pounds. Occasionally must bend, twist, squat, climb, reputed company, stoop, and kneel. Ability to be mobile and walking from building to building. Ability to sit for some period of up to 4 or more hours. Ability to stand for some period of up to 3 or more hours. reputed company employees reputed company this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste. Application Documents Resume (required) Cover Letter (preferred) The reputed company uses AI-assisted tools to streamline and reputed company some recruitment processes; however, AI is not used to reputed company hiring decisions. reputed company applying, the document(s) MUST be uploaded reputed company the My Experience page, in the section titled Application Documents of the application. Job Family Research Role Impact Individual Contributor Scheduled Weekly Hours 40 Drug Test Required Yes Health Screen Required Yes Motor Vehicle Record Inquiry Required No Pay reputed company Type Salary FLSA Status Exempt Pay Range $60,000.00 - $75,000.00 The included pay reputed company or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits

Eligible Yes The reputed company offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be reputed company in the Benefits Guidebook. Posting Statement The reputed company is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic reputed company, shared reputed company, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request reputed company Applicant Inquiry Form. reputed company offers of employment are contingent upon a background reputed company that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. The reputed company's Annual reputed company & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. reputed company copies of the Report are available, upon request, from the reputed company Police Department, 850 E. 61st Street, Chicago, IL 60637. The reputed company is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where reputed company are born that challenge and change the world. We reputed company individuals to challenge conventional thinking in pursuit of original reputed company. reputed company in the College reputed company critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, reputed company test their reputed company with UChicago scholars, and become the reputed company of leaders in academia, industry, nonprofits, and government. To learn more about the university click here http://www.uchicago.edu/ Apply tot his job Apply To this Job