Sr CRA (Level I)

Thermo Fisher Scientific seeks a Senior Clinical Research Associate to manage clinical trial monitoring and site oversight. The role involves conducting remote and on-site visits, ensuring protocol compliance, maintaining data quality, and collaborating with investigational sites and sponsors across multiple studies.

Responsibilities

• Perform remote and on-site monitoring activities using risk-based monitoring approach
• Conduct Source Data Review, Source Data Verification, and CRF review to ensure data accuracy
• Identify, document, and escalate site deficiencies until resolution
• Initiate clinical trial sites and support site close-out activities
• Maintain accurate CTMS information and provide regular study status updates to Clinical Team Manager

Requirements

• Bachelor's degree in life sciences or nursing qualification
• 2+ years of experience as Clinical Research Monitor or CRA
• Valid driver's license where applicable
• Strong understanding of ICH-GCP and regulatory compliance
• Experience with risk-based monitoring principles
• Critical thinking and root-cause analysis capabilities
• Excellent written and verbal communication skills