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FSP CRA (Level II)

Thermo Fisher Scientific · Zhejiang, 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 conduct remote and on-site monitoring of investigational sites across clinical trials. The role involves ensuring protocol compliance, managing documentation, assessing regulatory adherence, and maintaining collaborative relationships with trial sites in a fast-paced clinical operations environment.

What they're looking for

  • Bachelor's degree in life sciences or registered nursing certification
  • Approximately one year clinical research monitoring experience or PPD fellowship completion
  • Proficiency with ICH-GCP guidelines and applicable regulatory requirements
  • Strong critical thinking, root cause analysis, and problem-solving abilities
  • Risk-based monitoring knowledge and practical application experience
  • Excellent oral and written communication skills with medical personnel
  • Valid driver's license where applicable

What you'll be doing

  • Conduct risk-based monitoring visits to assess site compliance with protocol and regulatory standards
  • Review source documentation, case report forms, and investigational product records for accuracy
  • Identify site process failures and implement corrective and preventive actions
  • Initiate and close out clinical trial sites while managing essential documentation requirements
  • Prepare status reports and updates for clinical management and maintain trial tracking systems

Privacy & handoff

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What RoleLantern checked

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Date posted10 days ago
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