Clinical Research Associate (Level II) – Dubai
Thermo Fisher Scientific · Dubai
وصف الوظيفة
About the role
Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to join its Dubai team. In this role you will support the monitoring and management of clinical trial sites, ensuring compliance with protocols, regulations and Good Clinical Practice standards.
Key responsibilities
- Perform risk‑based on‑site and remote monitoring visits to assess protocol adherence and regulatory compliance.
- Conduct source data verification (SDR), source data validation (SDV) and case report form (CRF) review to ensure data accuracy.
- Review investigational product inventory and related documentation.
- Document observations, prepare monitoring reports and correspondence in accordance with company standards.
- Escalate findings, track corrective and preventive actions, and follow issues through to resolution.
- Maintain regular communication with investigative sites to verify ongoing compliance and timely data capture.
- Participate in investigator meetings and support the investigator payment process.
Required profile
- Experience in clinical monitoring or site management, preferably at a Level II capacity.
- Strong understanding of ICH‑GCP guidelines, applicable regulations and SOPs.
- Ability to apply root‑cause analysis, critical thinking and problem‑solving to site issues.
- Excellent written communication for report generation and correspondence.
Required skills
- Knowledge of ICH‑GCP and regulatory requirements for clinical trials.
- Familiarity with source data verification, source data validation and CRF review processes.
Questions fréquentes
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اكتشف المزيد
الرواتب والأدلة وعمليات البحث في الإمارات العربية المتحدة.
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اطرحه هنا: ستصلك تفاصيل العرض كاملة عبر البريد الإلكتروني، فوراً.
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Thermo Fisher Scientific
Dubai
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