Senior Clinical Research Associate

Monitoring Duties:

• Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, the study protocol, and CoMind SOPs
• Perform source data review and verification, manage data query resolution, and evaluate site performance, protocol adherence, and enrollment progress
• Identify and escalate site issues, deviations, and risks; support CAPA development and inspection and audit readiness activities

Site Management:

• Build and maintain strong relationships with investigator sites, providing training, guidance, and support to ensure study quality and continuity
• Prepare, submit, and track IRB maintenance submissions including continuing reviews, amendments, and safety updates, coordinating directly with central IRBs to ensure timely approvals
• Maintain Trial Master File quality, support regulatory submissions and site activation activities, and manage IP logistics and accountability documentation

AI Culture:

• AI is fundamental to our culture -- it's not just a tool, but a core part of how we work, collaborate, and innovate
• We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively