Project Coordinator - Emergency Medicine

Responsibilities

• Provide centralized operational leadership for the STIckER R01 multi-site clinical trial across 13 emergency departments.
• Maintain master project workplans, milestone trackers, regulatory documents, and study files.
• Serve as the central regulatory coordinator for WCG IRB, managing amendments, protocol modifications, and deviations.
• Coordinate NIH reporting and compliance activities, including RPPRs, subaward inputs, and Public Access compliance.
• Act as the primary operational contact for site research coordinators at partner academic medical centers.
• Monitor enrollment targets, develop site implementation plans, and oversee qualitative research arm coordination.
• Manage vendor relationships, track deliverables, and support data quality monitoring.
• Support the Data and Safety Monitoring Board (DSMB) by preparing meeting packets and managing logistics.
• Coordinate manuscript and abstract timelines for project dissemination and scientific meeting submissions.

Requirements

• Bachelor's degree or equivalent in education and experience.
• 3 years of related experience in clinical research or project management.
• Knowledge of NIH grant administration and regulatory compliance.
• Understanding of HIPAA compliance and Good Clinical Practice (GCP).

Preferred Qualifications

• Master's degree (MPH, MS, or MHA) with comparable clinical research management experience.
• Experience managing multi-site, federally funded research projects.
• Proficiency with electronic data capture systems such as REDCap.
• Experience with single IRB models and ClinicalTrials.gov compliance.
• Familiarity with implementation science frameworks or stepped-wedge trial operations.

About the Company

Columbia University is a leading research institution dedicated to advancing knowledge and improving lives through groundbreaking medical research and clinical excellence.