Clinical Research Associate – Belgium
Syneos Health · Bruxelles
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.
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Published 13 uur geleden
Expires over 1 maand
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Syneos Health
Bruxelles
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