Clinical Research Coordinator II - Cell Engineering & Therapy

Responsibilities

• Coordinate and conduct cellular therapy clinical trials involving human subjects under the Columbia Initiative in Cell Engineering and Therapy (CICET).
• Assist Principal Investigators with study start-up, regulatory submissions, and maintaining administrative files.
• Manage supply chain and inventory, including the shipping and receipt of investigational products and biological samples.
• Coordinate patient enrollment, protocol treatment, and follow-up care in collaboration with clinical nurses, pharmacy, and lab staff.
• Ensure timely scheduling of clinical procedures and pend laboratory orders according to study protocols.
• Maintain high-quality data management by performing prospective data entry, reconciling queries, and ensuring data integrity.
• Coordinate monitoring visits by medical monitors and resolve pre- and post-monitoring action items.

Requirements

• Bachelor's degree in Health Sciences or equivalent in education and experience.
• Excellent interpersonal, organizational, and communication skills.
• Basic knowledge of medical terminology and clinical procedures.
• Proficiency in Microsoft Office Suite and database management.
• Strong analytical, critical thinking, and problem-solving abilities.
• Ability to exercise professional judgment and discretion regarding confidential information.

Preferred Qualifications

• Two years of related clinical research experience.
• Master’s degree in Health Sciences.
• Experience in a clinical research setting with knowledge of HIPAA and GCP.
• Experience working with paper Case Report Forms (CRFs) or electronic research databases.

About the Company

Columbia University is a world-class research institution dedicated to advancing knowledge and improving lives through groundbreaking medical research and education. The Columbia Initiative in Cell Engineering and Therapy (CICET) focuses on cutting-edge cellular therapy clinical trials.