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CRA II – Clinical Research Associate (FSP)

Syneos Health · Buenos Aires

🇬🇧 English
Good Pharmacoepidemiology Practice (GPP) Source document review Clinical monitoring Site management

Job description

About the role

Syneos Health is seeking a CRA II to join its Clinical Solutions team. You will support site qualification, initiation, monitoring, and close‑out activities for clinical studies, ensuring compliance with regulatory standards and study protocols.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, management, and close‑out visits (on‑site or remotely).
  • Evaluate site performance, provide recommendations, and escalate serious issues to the project team.
  • Verify informed consent processes and protect patient confidentiality.
  • Assess safety, data integrity, protocol deviations, and pharmacovigilance issues at investigator sites.
  • Conduct source document reviews and verify required clinical data according to the Clinical Monitoring/Site Management Plan.

Required profile

  • Working knowledge of ICH/GCP guidelines and applicable regulations.
  • Familiarity with Good Pharmacoepidemiology Practice (GPP).
  • Strong attention to detail and ability to assess site processes.
  • Effective communication skills for reporting and action planning.

Required skills

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

What we offer

  • Career development and progression opportunities.
  • Supportive line management and peer recognition.
  • Technical and therapeutic area training.
  • Inclusive culture focused on delivering impact for patients.

Questions fréquentes

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Published 2 months ago

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Syneos Health

Buenos Aires