Clinical Research Coordinator II - Cellular Manufacturing
$60k - $75kUniversity of Chicago
- # Clinical Research Coordinator II – Cellular ManufacturingApplyremote type: Onsitelocations: Chicago, ILtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR33636**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 complex 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 within 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 perform aseptic processing, execute complex 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 lead daily ISO 7 cleanroom operations, oversee equipment maintenance and troubleshooting, and ensure strict adherence to cGMP and regulatory standards. Strong expertise in aseptic technique, ISO 7 gowning, and complex cell processing and analytical assays is required.**Responsibilities*** Perform a variety of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.* Perform a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.* Perform a variety of special manufacturing projects under cGMP guidelines as directed with speed and accuracy.* Transport prepared vaccines/cell therapy products to the clinic or pharmacy.* Perform 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.* Perform 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 all safety and operational procedures.* Accountable for all tasks in moderately complex clinical studies.* Assists with various professional, organizational, and operational tasks under moderate supervision.* Facilitates and participates in the daily activities of moderately complex 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 related work as needed.**Minimum Qualifications****Education:**Minimum requirements include a college or university degree in related field.**Work Experience:**Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.**Certifications:****---****Preferred Qualifications****Education:*** Masters Degree in related field.**Experience:*** 4 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related 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 Microsoft 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 all 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 complex instructions.* Self-motivated with the ability to learn new techniques quickly and work independently.**Working Conditions*** 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 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.* All employees within 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 University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. When applying, the document(s) **MUST** be uploaded via 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 Rate Type**Salary **FLSA Status**Exempt **Pay Range**$60,000.00 - $75,000.00The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.**Benefits Eligible**YesThe University of Chicago 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 found in the Benefits Guidebook.**Posting Statement**The University of Chicago 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 origin, shared ancestry, 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 View phone number on click.appcast.io or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check 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 University of Chicago's Annual Security & 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: Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
- J-18808-Ljbffr The University Of Chicago
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Clinical Research Coordinator II - Cellular Manufacturing in Chicago, IL vacancy
- The University Of Chicago is currently seeking a Clinical Research Coordinator II to support the manufacture of clinical-grade cellular therapies and vaccines in the Cellular Manufacturing department. This role requires performing aseptic processing and maintaining accurate...Suggested
- ...Clinical Research Coordinator II Cellular Manufacturing As a Clinical Research Coordinator II Cellular Manufacturing, you will work in a state-of-the-art cleanroom within the UChicago Cellular and Tissue-Based Processing cGMP Facility, supporting the manufacture of...SuggestedWork experience placementWork at office
- The Biological Sciences Division at the University of Chicago is seeking a Clinical Research Coordinator II to support the manufacture of clinical-grade cellular therapies and vaccines for Phase I-III trials. Responsibilities include performing aseptic processing, managing...SuggestedWork experience placement
- The University of Chicago is seeking a Clinical Research Coordinator II - Cellular Manufacturing to join its state-of-the-art cGMP facility. The role focuses on aseptic processing and complex protocol-driven manufacturing for Phase I-III trials, reporting to the Technical...Suggested
- ...The Clinical Research Coordinator II (Denton, TX) will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor....SuggestedFull time
DM Clinical
Melrose Park, IL15 days ago $31 per hour
...Position Details Position Details Job Title CLINICAL RESEARCH COORDINATOR II Position Number 8150021 Work Modality Hybrid - 4 In-Person Is this request for the creation of a new Position (or the modification of an existing Position) to temporarily...Hourly payFull timeWork experience placementLocal areaLoyola University Chicago
Chicago, ILmore than 2 months ago- The University of Chicago is seeking a Clinical Research Coordinator II to partner with the Principal Investigator and manage daily trial activities in Hematology/Oncology. You will screen and enroll participants, collect data, manage specimens, and ensure protocol adherence...
$27.47 - $38.81 per hour
...Medical Center. Training will take place on-site at the Chicago, IL Rush University Medical Center campus. Summary The Clinical Research Coordinator II (CRC II) independently coordinates assigned aspects of clinical research studies across a range of disciplines....Hourly payFull timeLocal areaShift workWeekend workAfternoon shift- The University of Chicago's Biological Sciences Division, Endocrinology Section, seeks a Clinical Research Coordinator II to work with the PI Dr. Silvana Pannain. The CRCII will coordinate participant enrollment, data collection, and study logistics within NIH/academic...
- University of Chicago is seeking a Clinical Research Coordinator II to partner with the PI in endocrinology research. You will recruit and enroll participants, obtain consent, and monitor patient status while ensuring data integrity and regulatory compliance. The role...
- The University of Chicago in Chicago, IL seeks an onsite Clinical Research Coordinator II to support neurology clinical trials under the direction of the clinical PI and the Clinical Research Manager. You will handle screening, consent, data collection, adverse event reporting...
- The University of Chicago is seeking a Clinical Research Coordinator II for Gastroenterology to manage all aspects of clinical trials in a high‑volume setting. You will screen, enroll, follow up with subjects, and ensure accurate data entry and adverse event reporting...
$60k - $75k
The University Of Chicago is seeking a Clinical Research Coordinator II in Chicago, IL. This role involves managing multiple clinical trials, recruiting participants, and ensuring compliance with protocols. The ideal candidate will have a Bachelor's degree and 2-5 years...$60k - $75k
Clinical Research Coordinator II BSD MED - Endocrinology - Pannain Research Staff Job Summary The Clinical Research Coordinator II (CRCII) is a specialized researcher partnering with the clinical Principal Investigator (PI), Dr. Silvana Pannain in the Section of Endocrinology...Work experience placement$60k - $75k
Department BSD SUR - Research Services: Clinical Research About The Department Since the founding of the Department in 1927, many scientists... ...environment. Job Summary The Clinical Research Coordinator II (CRC2) is a specialized researcher working with the Principal...Work experience placement$60k - $75k
BSD MED - Hematology and Oncology - Clinical Research Staff - Cluster 4 About The Department The Section of Hematology/Oncology has a proud... ...experimental therapies. Job Summary The Clinical Research Coordinator II - Hematology/Oncology (CRCII) is a specialized researcher...Contract workWork experience placementWork at office$27 - $31 per hour
A prominent educational institution in Chicago is seeking a Clinical Research Coordinator II to manage multiple research protocols efficiently. This role includes data collection, participant interaction, and compliance with regulations. The ideal candidate should possess...- University of Chicago is seeking a Clinical Research Coordinator II to support the administration of clinical studies under the PI and study team. This role emphasizes compliance, data management, and coordination across sponsor visits and site activities. The CRC2 will...
- The Biological Sciences Division at the University of Chicago is seeking a Clinical Research Coordinator II to manage multiple clinical trials with a focus on compliance and data management. This role requires collaboration with principal investigators and study personnel...
- The Biological Sciences Division at the University of Chicago seeks a Clinical Research Coordinator II to support daily trial activities onsite, partnering with the PI and the Clinical Research Manager. The CRC II coordinates screening, enrollment, consent, data collection...
- The University of Chicago in Chicago, IL seeks a Clinical Research Coordinator II to partner with the PI and Clinical Research Manager in the Gastroenterology section of the Department of Medicine. The role involves coordinating multiple clinical trials, ensuring protocol...
- The Biological Sciences Division at the University of Chicago is hiring a Clinical Research Coordinator II for managing comprehensive clinical trials in Hematology/Oncology. This role demands a Bachelor's degree and 2-5 years of related experience, focusing on subject...
- The Clinical Research Coordinator II (CRCII) at The University Of Chicago partners with the Principal Investigator in the Endocrinology section to recruit, consent, and monitor study participants, collect data and specimens, and ensure adherence to GCP and all regulatory...
- Department BSD MED - Gastroenterology - Clinical Research Staff Department BSD MED - Gastroenterology - Clinical Research Staff About... ...at the highest level. Job Summary The Clinical Research Coordinator II (CRCII) is a specialized researcher, partnering with the clinical...Full timeContract workWork experience placementWork at office
$49.92k - $81.62k
## Clinical Research Coordinator II-Pediatric NeurosurgeryApplylocations: Streeterville, Chicago, ILtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR2026-2079Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a...Hourly payFull timePart time- Rush University Medical Center in Chicago is seeking a Clinical Research Coordinator II to independently coordinate assigned aspects of clinical research across disciplines. You will recruit and retain participants, manage study data, submit regulatory documents, and maintain...
- The University of Chicago seeks a Clinical Research Coordinator 2 (Pediatrics) to support pediatric trials within the BSD PED - Clinical Trials Office. You will work under the Director of Clinical Research and PI teams to manage study activities, data collection, and regulatory...Work at office
$60k - $75k
The Biological Sciences Division at the University of Chicago is seeking a Clinical Research Coordinator 2 (CRC2) to oversee and facilitate complex clinical research studies while ensuring compliance with regulations. The role involves coordinating with investigators to...$60k - $75k
The University Of Chicago in Hyde Park is seeking a Clinical Research Coordinator 2 to manage clinical trials focused on innovative biomedical research. Responsibilities include overseeing recruitment and screening, ensuring adherence to protocols, and managing data accuracy...Full time$49.92k - $81.62k
Ann & Robert H. Lurie Children's Hospital of Chicago is seeking a Clinical Research Coordinator to oversee clinical research activities. This position involves managing studies, ensuring compliance with regulations, and collecting data from participants. Qualified candidates...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Research Coordinator II - Cellular Manufacturing. Be the first to apply!
Related searches
- clinical research coordinator Chicago, IL
- clinical project manager Chicago, IL
- sr. clinical trial manager Chicago, IL
- neuroscience clinical research coordinator Chicago, IL
- clinical research coordinator ii Chicago, IL
- senior clinical trials manager Chicago, IL
- clinical trials manager Chicago, IL
- clinical research regulatory Chicago, IL
- clinical research Chicago, IL
- clinical research remote Chicago, IL