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Clinical Research Associate – CRA II

Syneos Health · Buenos Aires

🇬🇧 English
ICH/GCP Guidelines Good Pharmacoepidemiology Practice (GPP) clinical monitoring source document review pharmacovigilance

Job description

About the role

Syneos Health® is seeking a Clinical Research Associate (CRA II) to join its Clinical Solutions team. You will support drug development projects by ensuring sites comply with regulatory standards and study protocols, contributing to the delivery of high‑quality clinical data.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, management, and close‑out visits, either on‑site or remotely.
  • Evaluate site performance, identify issues, and develop corrective action plans.
  • Verify informed consent processes and protect patient confidentiality.
  • Assess safety, data integrity, protocol deviations, and pharmacovigilance concerns.
  • Conduct source document reviews and verify clinical data accuracy.

Required profile

  • Strong understanding of ICH/GCP guidelines and applicable regulations.
  • Experience with Good Pharmacoepidemiology Practice (GPP) is advantageous.
  • Ability to communicate issues promptly and work collaboratively with project teams.

Required skills

  • ICH/GCP Guidelines
  • Good Pharmacoepidemiology Practice (GPP)
  • Clinical monitoring and site management
  • Source document review
  • Pharmacovigilance awareness

What we offer

  • Career development and progression opportunities.
  • Supportive line management and technical training.
  • Inclusive culture focused on delivering impact for patients.

Questions fréquentes

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Published 3 months ago

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Syneos Health

Buenos Aires