FSP Sr Clinical Research Associate

Senior Clinical Research Associate responsible for remote and on-site clinical monitoring and site management across investigational trials. Ensures protocol compliance, regulatory adherence, and data integrity through risk-based monitoring activities and collaborative site relationships.

Responsibilities

• Conduct remote and on-site monitoring visits to assess protocol and regulatory compliance
• Perform source data review, verification, and case report form reviews for data accuracy
• Document observations and escalate deficiencies through approved business writing standards
• Assess investigational product inventory and records; initiate and close out trial sites
• Maintain ongoing communication with investigative sites and provide trial status reports to clinical management

Requirements

• Bachelor's degree in life sciences or RN certification with equivalent qualification
• Minimum 2+ years clinical research monitoring experience
• Demonstrated ICH-GCP and regulatory compliance knowledge
• Strong critical thinking and root cause analysis skills
• Proficiency in risk-based monitoring concepts and processes
• Excellent written and oral communication abilities
• Valid driver's license where applicable