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Clinical Research Associate – Belgium

Syneos Health · Bruxelles

New
🇬🇧 English
Good Pharmacoepidemiology Practice Source document review

Job description

About the role

Syneos Health is seeking a Clinical Research Associate (CRA) to support a single sponsor partnership in Belgium. The CRA will be responsible for overseeing site activities throughout the clinical trial lifecycle, ensuring compliance with regulatory standards and study protocols.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remotely).
  • Ensure adherence to ICH‑GCP, Good Pharmacoepidemiology Practice (GPP), and local regulatory requirements.
  • Evaluate 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.
  • Conduct source document reviews and assess site processes according to the Clinical Monitoring/Site Management Plan.

Required profile

  • Experience in clinical monitoring or site management within a pharmaceutical or CRO environment.
  • Strong knowledge of ICH‑GCP guidelines and applicable regulatory frameworks.
  • Ability to assess site performance and develop corrective action plans.
  • Excellent communication skills for reporting and escalation.

Required skills

  • ICH‑GCP compliance
  • Good Pharmacoepidemiology Practice (GPP) knowledge
  • Regulatory compliance expertise
  • Source document review proficiency

What we offer

  • Career development and progression opportunities.
  • Supportive line management and peer recognition.
  • Technical and therapeutic area training.
  • Total rewards program and a culture that values diversity and authenticity.

Questions fréquentes

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Published 13 uur geleden

Expires over 1 maand

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Syneos Health

Bruxelles