Clinical Research Project Associate

Role Overview

• Oversees all aspects of study coordination and study conduct for multisite investigator-initiated studies.
• Serves as the primary contact for external subsites on all project-related operational matters.
• Collaborates with Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
• Completes all regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC).
• Coordinates with Clinical Research Subsite Navigators.
• Creates the electronic data capture (EDC) system in collaboration with developers.
• Generates subsite data completion metrics for distribution to subsite PIs and study teams.
• Develops and implements a project-specific monitoring plan.
• Performs remote monitoring visits to review data timeliness and accuracy.
• Plans subsite Site Initiation Visits (SIV).
• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings.

Requirements

• Bachelor's Degree
• Approximately 3 or more years of related research experience in clinical trial management.
• Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.