Medix™
Key Responsibilities:
Coordinate and oversee the execution of clinical research studies from start-up to close-out
Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
Manage study documentation, including IRB submissions, source documents, and regulatory binders
Recruit, screen, and consent study participants
Collect, enter, and verify clinical data
Monitor patient safety and report adverse events
Liaise with sponsors, monitors, and regulatory bodies
Train and mentor junior CRCs and research staff
Participate in audits, monitoring visits, and sponsor meetings
Maintain accurate study records and timelines