"Clinical Research Manager - Endocrinology (NYORC)"

Position Summary

The New York Obesity Research Center, within the Division of Endocrinology, is seeking a Clinical Research Manager to support the Principal Investigator (PI) in all aspects of clinical trials focused on obesity and type 2 diabetes. The study involves participants of diverse backgrounds and age groups. The incumbent will oversee and coordinate data collection, manage logistics for testing and study visits, and supervise the study team at one of the clinical sites participating in a large, ongoing multicenter clinical trial. This position reports directly to the PI.

Responsibilities

• Ensure compliance with all Columbia University clinical research regulations, including COVID-19 safety protocols
• Maintain comprehensive knowledge of study protocols, including inclusion/exclusion criteria, procedures, data collection methods, timelines, and outcome variables
• Complete training and certification in all study procedures per protocol
• Prepare and submit study-related documentation to the Institutional Review Board (IRB), Clinical Research Center (CTSA-CRR), Clinical Trials Office (CTO), NIH, and Data Safety Monitoring Officer
• Oversee day-to-day operations of clinical research projects, including participant retention efforts
• Supervise data acquisition and ensure proper calibration and standardization of study equipment (e.g., blood pressure cuffs, stadiometers, scales)
• Order and manage study supplies, including vendor communication, proper storage, and inventory tracking
• Supervise biospecimen collection, processing, and shipment according to protocol
• Manage data entry into central databases and ensure data safety monitoring compliance
• Participate in monthly national Program Coordinator and Clinical Coordinator meetings (via Zoom) and attend annual in-person meetings
• Assist with grant reporting and other administrative tasks related to research projects
• Provide regular updates to the PI
• Perform additional related duties as needed

Minimum Qualifications

• Bachelor’s degree or equivalent in education, training and experience, plus four years of related experience
• Excellent organizational and time management skills
• Strong interpersonal and communication skills
• Ability to prioritize and manage multiple tasks while meeting deadlines

Preferred Qualifications

• Significant experience in a clinical research setting
• Knowledge of HIPAA, Good Clinical Practice (GCP), and EPIC systems

Other Requirements

• Participation in the medical surveillance program, Contact with patients and/or human research subjects
• Successful completion of applicable compliance and systems training requirements