Clinical Research Associate (CRA), Field-Based

Job Title: Clinical Research Associate (CRA), Field-Based

Work Location: Santa Clara County, California

Summary:

Seeking a Clinical Research Associate (CRA) to support clinical trial activities, focusing on site monitoring, data integrity, and subject safety in CNS/psychiatry studies. The role involves travel to clinical sites, maintaining essential documentation, and ensuring compliance with regulatory standards.

Responsibilities:

• Coordinate and execute site qualification, initiation, interim monitoring, and close-out visits according to study protocols.
• Verify source data and review documentation to ensure protocol adherence, data accuracy, and participant safety.
• Develop and maintain strong relationships with clinical sites to support enrollment and resolve queries efficiently.
• Monitor investigational product accountability and ensure essential documents and trial master files are current at each site.
• Implement rigorous data integrity and enrollment fraud prevention measures, especially for CNS/psychiatry clinical trials.
• Promptly escalate risks and findings, maintaining audit-ready visit reports and tracking systems.
• Support rapid study timelines by driving site performance and ensuring timely completion of study milestones.
• Collaborate with cross-functional teams to address site issues and contribute to continuous process improvement.

Qualifications:

• Minimum 2 years of independent on-site monitoring experience (4+ years for senior/lead roles, including mentoring or lead responsibilities).
• Experience with on-site monitoring at UK/EU sites and knowledge of UK HRA/MHRA and ICH-GCP guidelines (for UK-based applicants).
• Willingness and ability to travel to clinical sites as required by the monitoring plan.
• Strong skills in source data verification and meticulous documentation practices.
• Bachelor’s degree in a life science or related field.
• Experience monitoring CNS, psychiatry, or depression studies, with familiarity in MADRS, C-SSRS, and central-rater workflows preferred.
• Background in risk-based monitoring and comfort with short-duration (less than 12 weeks) and open-label study designs preferred.

Published Category: Clinical Operations & Development