Clinical Research Associate, Sponsor Dedicated

Clinical Research Associate role supporting sponsor-dedicated monitoring activities across multiple U.S. sites. Responsible for site management, protocol compliance, data integrity oversight, and regulatory documentation in accordance with GCP and ICH guidelines.

Responsibilities

• Conduct site monitoring visits including initiation, ongoing monitoring, and close-out activities per protocol and GCP
• Develop and track subject recruitment plans with sites to meet enrollment targets
• Deliver protocol training and maintain regular site communication to manage expectations and resolve issues
• Monitor study data quality, protocol adherence, and regulatory compliance; escalate concerns as needed
• Track study progress including regulatory submissions, enrollment, CRF completion, and data queries

Requirements

• Bachelor's degree in scientific or healthcare discipline preferred
• At least 2 years independent on-site monitoring experience as CRA
• Strong knowledge of GCP and ICH regulatory requirements
• Proficiency with EDC, CTMS, eTMF, IVRS/IWRS systems
• Advanced Microsoft Office skills (Word, Excel, PowerPoint)
• Excellent written and verbal English communication abilities
• Strong organizational, problem-solving, and time management skills

Compensation: $74,500–$197,500 base (annualized)