Clinical Research Associate (CRA) – Belgium
Syneos Health
Job description
About the role
Syneos Health is seeking an experienced Clinical Research Associate (CRA) to support a single‑sponsor partnership in Belgium. You will be responsible for ensuring that clinical sites operate in compliance with regulatory standards and study protocols, contributing to the successful delivery of therapeutic trials.
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, 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 maintain accurate monitoring reports.
Required profile
- Proven experience as a CRA in clinical trial monitoring.
- Strong knowledge of ICH‑GCP guidelines and applicable regulations.
- Ability to assess site processes and communicate findings effectively.
- Attention to detail and commitment to patient safety and data quality.
Required skills
- ICH GCP compliance
- Good Pharmacoepidemiology Practice (GPP)
- Regulatory monitoring
- Source document review
What we offer
- Opportunity to work with a global leader in biopharmaceutical solutions.
- Collaborative environment with continuous learning and career development.
- Access to diverse therapeutic areas and innovative clinical projects.
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Published 3 weken geleden
Expires over 1 maand
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