Clinical Research Coordinator III - CICET

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $70,000 - $90,000

Position Summary

The Clinical Research Coordinator (CRC) will play an integral role in coordinating and conducting cellular therapy clinical trials involving human subjects under the Columbia Initiative in Cell Engineering and Therapy (CICET). The CRC will ensure efficient management of data and relevant clinical information. This position reports directly to the Senior Program Nurse Manager.

Responsibilities

Clinical Research Coordination

• 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

Patient Management

• 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.

Data Management

• 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.

Minimum Qualifications

• 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

Preferred Qualifications

• 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

Other Requirements

• 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

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.