Senior Clinical Research Associate

📋 Description

• Serve as the primary sponsor/CRO contact for assigned sites, maintaining regular communication with
• Track site performance against follow-up visit schedules, data entry timelines, and query
• Support sites through staff turnover, including retraining of new personnel and updates to the
• Ensure sites maintain adequate resources, equipment calibration (e.g., PSG/HSAT devices, CPAP or
• Conduct on-site, remote, and risk-based monitoring visits per the Clinical Monitoring Plan, and
• Perform source data verification (SDV) and source data review (SDR) of follow-up visit data

🎯 Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related health field (or equivalent
• 2+ years of independent on-site monitoring experience as a CRA with a sponsor, CRO, or medical
• Working knowledge of ICH E6 Good Clinical Practice, FDA regulations (21 CFR Parts 11, 50, 54, 56
• Experience monitoring studies through follow-up, database lock, and site closeout.
• Hands-on experience with EDC, CTMS, and eTMF systems.
• Valid driver's license and ability to travel to assigned sites.