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Senior Clinical Research Associate (Level II)

Thermo Fisher Scientific

🇬🇧 English
ICH-GCP Root cause analysis

Descripcion del puesto

About the role

We are seeking a Senior Clinical Research Associate (Level II) to join our global team and support clinical monitoring across multiple therapeutic areas. You will be responsible for ensuring protocol compliance, data integrity, and regulatory adherence at investigator sites worldwide.

Key responsibilities

  • Conduct remote or on‑site monitoring visits using a risk‑based approach.
  • Apply root cause analysis and corrective actions to resolve site process failures.
  • Perform Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (CRF) review.
  • Assess investigational product inventory and documentation.
  • Document observations in reports and letters, escalating deficiencies to clinical management.
  • Maintain regular communication with sites to ensure protocol adherence and timely data capture.
  • Participate in investigator payment processing and investigator meetings.
  • Initiate new trial sites, ensure compliance with ICH‑GCP and regulatory requirements, and manage trial close‑out activities.

Required profile

    Required skills

    • ICH‑GCP knowledge
    • Root cause analysis (RCA)
    • Source Data Review (SDR)
    • Source Data Verification (SDV)
    • Case Report Form (CRF) review

    Questions fréquentes

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