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Senior Clinical Research Associate (CRA I/II) – Cape Town

Syneos Health · Bloemfontein

Senior 🇬🇧 English
Good Pharmacoepidemiology Practices clinical monitoring site qualification source document review pharmacovigilance

Job description

About the role

Syneos Health is seeking a Senior Clinical Research Associate (CRA I/II) to join its Clinical Solutions team, preferably based in Cape Town. You will support drug development projects by ensuring sites meet regulatory and protocol standards throughout the study lifecycle.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, and close‑out visits, either on‑site or remotely.
  • Ensure compliance with ICH‑GCP, Good Pharmacoepidemiology Practices (GPP), and study protocols.
  • Evaluate overall site performance, provide recommendations, and promptly escalate serious issues.
  • Verify informed consent processes and protect patient confidentiality.
  • Assess safety, data integrity, protocol deviations, and pharmacovigilance concerns at investigator sites.
  • Conduct source document reviews and support site management plans.

Required profile

  • Experience as a CRA I or II in clinical trials.
  • Strong knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
  • Ability to assess site processes and develop corrective action plans.
  • Excellent communication skills for interaction with site staff and internal teams.

Required skills

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

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.

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Published 3 months ago

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Syneos Health

Bloemfontein