Northwestern Medicine · 13 hours ago
Clinical Trial Coordinator - Cell Therapy Laboratory, Full-Time, Days
Chicago, IL
Full-time
Onsite
Entry Level
1+ years expNorthwestern Medicine is a leader in the healthcare industry, focusing on patient-first interactions. The Clinical Trial Coordinator will support and coordinate daily clinical trial and commercial product activities, ensuring compliance with relevant regulations and facilitating communication among various stakeholders.
Emergency MedicineHealth CareHospitalMedicalNutritionRehabilitation
Responsibilities
Mathews Center for Cellular Therapy (MCCT) liaison between NU study coordinators and Lurie Children’s Hospital study coordinators as well as between NMH and Lurie Children’s commercial process coordinators
Obtaining and organization of clinical trial and commercial process documentation – protocols, study manuals, study SOPs, forms, IRB approval, Biosafety SOP (as applicable), memos, training
Reviews and comprehends the clinical trials and commercial processes
Perform feasibility analysis of clinical trials and commercial processes at MCCT determining capability, logistics, personnel, supplies and equipment needs
Participation in SIV, SQVs and arrange for necessary staff members to attend. Follow up with clinical trial and commercial product sponsors as necessary following the initiation visits
Prepare and justify clinical trial and commercial process budgets including staff time, equipment and supply usage, and quality aspects
Prepare clinical trial and commercial process charge codes and work with Finance and Information Systems to build codes and set up in EPIC
Assist manager and Office of General Counsel in reviewing and revising clinical trial quality agreements, non-disclosure agreements, and clinical trial arrangements between NU and MCCT as well as Lurie Children’s Hospital and MCCT
Assist manager with clinical trial and commercial process related Equipment Short Term Lease Agreement documentation and process by communicating with sponsors, NM Office of Research, Purchasing, Property Accounting and Biomedical Engineering
Interacting with NU to obtain and maintain active IRB clinical trial documentation
Ensure that clinical trials and commercial processes related to the MCCT are performed in accordance with federal regulations, NM and NU policies and procedures
Participate in clinical trial and commercial process meetings – leadership, biosafety, participant care, and sponsor, as applicable
Coordinate clinical trial administrative fees processing, both initial and annual
Development of MCCT SOPs and associated forms for clinical trials and commercial processes
Perform clinical trial and commercial process training of MCCT staff
Ensures and maintains proof that all MCCT staff ‘engaged’ in the clinical trials or commercial processes have met training requirements in accordance with federal regulations, NM, NU, and sponsoring agency policies and procedures
Ensure sufficient clinical trial and commercial process supplies inventory and verification of expiration dates
Ensure clinical trial and commercial process product accountability
Participate in clinical trial and commercial processes procedures, on a backup basis
Coordinate clinical trial procedures and commercial processes scheduling in MCCT – including processing, shipping, receiving, storing, and infusion preparation
Work with the MCCT quality staff to perform RCA and CAPA as it pertains to clinical trials or commercial products as necessary. Report back to the sponsor events and associated RCA & CAPA
Ensure staff are informed of their role in clinical trials and commercial products and arrange coverage in times of staff PTO
Establishes, organizes, and retains clinical trial and commercial processes files, including but not limited to, regulatory binders, specific source documentation and other materials such as protocols, manuals, forms and batch records
Coordinate clinical trial and commercial process billing and verification
Work with NM Office of Research to ensure correct charging of clinical trial activities
Participate in clinical trial and commercial process audits
Coordinate clinical trial closure process by arranging secure storage of documents that will be maintained according to NM, NU, and clinical trial and commercial process policies or for the contracted length of time, whichever is longer
Adheres to Patients First management standards on leadership, communication and visibility
Coordinates critical situations involving clinical trial or commercial process patients and consults with Manager and trial or commercial administrators for guidance, as needed
Promotes philosophy and objectives of the hospital, division and department
Identifies and communicates key issues and trends to Manager
Adheres to hospital and department policies and procedures
Participates in and presents at meetings
Performs other duties as assigned
Participates in departmental quality improvement activities related to clinical trials and commercial processes
Collects data to support the measurement and tracking of quality management related to clinical trials and commercial processes
Participates in the incorporation of results of QM audits in the improvement of services and enhancement of clinical trials and commercial processes for patient care consistent with hospital policies
Provides ideas and suggestions for process improvements within the department
Communicates customer satisfaction issues to appropriate individuals
Qualification
Required
Bachelor's Degree in Medical Laboratory Science, Chemistry, Biology, or Allied Health
Minimum of 1 year of relevant laboratory experience
Preferred
At least 1 year of relevant clinical trial and commercial processes experience
Experience with data analysis
Benefits
Tuition reimbursement
Loan forgiveness
401(k) matching
Lifecycle benefits
Company
Northwestern Medicine
Northwestern Medicine is the collaboration between Northwestern Memorial HealthCare and Northwestern University Feinberg School of Medicine around a strategic vision to transform the future of health care.
10001+ employees
H1B Sponsorship
Northwestern Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (75)
2024 (66)
2023 (70)
2022 (78)
2021 (35)
2020 (39)
Funding
Current Stage
Late StageTotal Funding
$25M2018-06-26Grant· $25M
Leadership Team
Howard Chrisman, MD
President and CEO
John A. Orsini, CPA
Senior Vice President and Chief Financial Officer
Recent News
2026-01-13
Near North Health
2025-12-01
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