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Thermo Fisher Scientific logo

FSP CRA (Level II)

Thermo Fisher Scientific · Guangdong, China

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Clinical OperationsFull timeCompany career page

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Role summary

Thermo Fisher Scientific seeks a Level II Clinical Research Associate to monitor investigator sites using risk-based approaches, ensure data accuracy, and maintain regulatory compliance in clinical trials. The role involves on-site and remote monitoring, documentation, and coordination between study sites and management teams.

What they're looking for

  • Root cause analysis and critical thinking skills for identifying site process failures
  • Experience with Source Data Review (SDR), Source Data Verification (SDV), and CRF review
  • Knowledge of ICH-GCP guidelines and clinical trial regulatory requirements
  • Proficiency in written and oral communication for cross-functional coordination
  • Ability to manage administrative tasks and clinical trial management systems
  • Experience conducting on-site monitoring visits and remote monitoring activities

What you'll be doing

  • Monitor investigator sites using risk-based approaches and implement corrective/preventive actions
  • Verify data accuracy through SDR, SDV, and CRF reviews via on-site and remote activities
  • Document observations in reports and escalate deficiencies to clinical management
  • Initiate and close out clinical trial sites while ensuring essential documents are complete
  • Facilitate communication between sites, client company, and project team; maintain study system records

Privacy & handoff

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What RoleLantern checked

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted8 days ago
Last source check1 day ago
Salary listedNeeds clarity
Location clearClear
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