Columbia University Irving Medical Center · 11 hours ago
Clinical Research Coordinator III - CICET
New York, NY
Full-time
Onsite
Mid Level
$70K/yr - $90K/yr
3+ years expColumbia University Irving Medical Center is seeking a Clinical Research Coordinator III to coordinate and conduct cellular therapy clinical trials involving human subjects. The role involves managing data, ensuring compliance with regulatory documentation, and coordinating patient enrollment and follow-up care for clinical trials.
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Responsibilities
Execute Cellular Therapy research protocols
Assist Principal Investigators in study start-up and submit studies to the appropriate CU offices
Assist with tracking and escalating clinical and institutional delays in trial activity
Collaborate with the regulatory team to maintain regulatory documentation and administrative files for each protocol
Comply with the essential regulatory needs to comply with protocol activities
Manage supply chain and inventory, including coordination of shipping and receipt of investigational products, biopsies, and other samples
Liaise with the CICET Translational Laboratory and CICET GMP QC Laboratory for patient sample delivery
Maintain updated training in human research protection rules and regulations, GCP, ICH, etc
Comply with various institutional and CICET standard operating procedures involving patient care and trial conduct
Coordinate cell therapy-related study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, apheresis, cell therapy lab, CICET GMP facility, infusion center, and other hospital units and study staff
Ensure timely scheduling of appointments/clinical procedures and pend laboratory orders as per study schedules
Work with research nurses, treating physicians, and Principal Investigators to confirm patients’ eligibility as specified in clinical protocols
Collect follow-up data on patients' post-treatment as required by the protocol and submit monthly reports to the clinical protocol office, tracking patient enrollment and accounts/payments for sponsored protocols
Complete timely research billing review
Maintains and updates sponsor-related, university and department databases/logs
Under the supervision of the senior program nurse manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings
Implementing research protocol and CICET agreements for appropriate data management requirements
Ensure completeness of patient visit data at each study visit, reconcile data queries and discrepancies, and perform prospective data entry of ongoing research activities and other activities related to data management
Collaborate with research nurses, study coordinators, and Principal Investigators to ensure data quality, integrity, and compliance with all regulatory, institutional, and department requirements
Maintain patient research records and work in conjunction with study teams to gather all required data and relevant clinical information. Work with the study team to resolve any outstanding data queries
Coordinate monitoring visits by medical monitors, support query resolution, resolve pre-and post-monitoring action items, and review monitoring reports
Qualification
Required
Bachelor's degree in Health Sciences with three years of related experience or equivalent
Excellent interpersonal and organizational skills
Basic knowledge of medical terminology and procedures
Strong analytical, critical thinking, and problem-solving skills
Ability to exercise professional judgment and discretion in dealing with confidential matters
Excellent verbal and written communications
Proficient in Microsoft Office Suite and database management
Excellent verbal and written communications
Medical clearance and participation in the medical surveillance program
Contact with patients and or human research subjects
Potential bloodborne pathogen exposure
Successful completion of applicable compliance and systems training requirements
Preferred
Master's degree in Health Sciences with three years of related experience or equivalent
Experience in clinical research setting with knowledge of HIPAA and GCP
Experience with paper Case Report Forms (CRFs) and/or electronic research databases
Company
Columbia University Irving Medical Center
Columbia University Irving Medical Center is a clinical and educational enterprise that offers medical, dental, and nursing services. It is a sub-organization of Columbia University.
10001+ employees
H1B Sponsorship
Columbia University Irving Medical Center 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
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Trends of Total Sponsorships
2025 (433)
2024 (353)
2023 (333)
2022 (370)
2021 (283)
2020 (221)
Funding
Current Stage
Late StageLeadership Team
D
Donna Lynne
Senior Vice President and COO
Recent News
2025-10-17
2025-10-06
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