Clinical Research Associate - Sponsor Dedicated

Clinical Research Associate responsible for monitoring clinical trial sites and ensuring protocol compliance, regulatory adherence, and data quality. The role involves site visits, recruitment oversight, training, documentation management, and cross-functional collaboration with study teams.

Responsibilities

• Conduct site monitoring visits including selection, initiation, ongoing monitoring, and close-out activities per protocol and regulations
• Develop and track subject recruitment plans with sites to support enrollment goals
• Train assigned sites on protocol requirements and maintain regular communication regarding expectations and issues
• Assess study site practices for protocol adherence and regulatory compliance; escalate quality concerns
• Generate visit reports, follow-up documentation, and maintain Trial Master Files and Investigator's Site Files per GCP/ICH standards

Requirements

• Bachelor's degree in scientific or healthcare discipline, or equivalent education and experience
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Prior clinical research monitoring experience or completion of CRA training program
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and laptop/mobile devices
• Strong written and verbal English communication skills
• Organizational, problem-solving, and time management abilities

Compensation: $74,500.00 - $197,500.00 base