Principal CRA Job at Thermo Fisher Scientific, Georgia

  • Thermo Fisher Scientific
  • Georgia

Job Description

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

Job Tags

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