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Clinical Research Associate I – Remote/On‑site Monitoring

Thermo Fisher Scientific · Argentine

Nuevo
🇬🇧 English

Descripcion del puesto

About the role

Join a global CRO team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Clinical Research Associate I you will conduct remote and on‑site monitoring visits, ensuring trials follow the approved protocol, ICH‑GCP guidelines and regulatory requirements.

Key responsibilities

  • Perform risk‑based monitoring of investigator sites, applying root‑cause analysis and corrective actions.
  • Verify data accuracy through source data verification (SDR), source data review (SDV) and case report form (CRF) checks.
  • Assess investigational product inventory and documentation.
  • Document observations in reports and letters, escalating deficiencies to clinical management.
  • Maintain regular communication with sites to confirm protocol compliance and timely data entry.
  • Participate in investigator payment processing and site initiation/close‑out activities.
  • Support investigator meetings and assist in identifying qualified sites.

Required profile

  • Strong understanding of clinical trial processes and regulatory standards.
  • Ability to apply critical thinking and problem‑solving skills to site issues.
  • Excellent written communication for timely reporting.
  • Detail‑oriented with a focus on audit readiness.

Required skills

  • Knowledge of ICH‑GCP guidelines.
  • Experience with source data verification (SDR) and source data review (SDV).
  • Familiarity with investigational product handling and documentation.

What we offer

  • Opportunity to work on diverse global clinical trials.
  • Collaborative environment with experienced project teams.
  • Professional development in clinical monitoring and site management.

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Publicado hace 20 horas

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Thermo Fisher Scientific

Argentine