Senior Clinical Research Associate
PDC CRO · Riyadh
وصف الوظيفة
About the role
The Senior Clinical Research Associate will join PDC CRO’s Riyadh team to support end‑to‑end clinical trials across Phase I‑IV and real‑world evidence studies. Reporting to the Clinical Project Manager, the role ensures study sites are selected, qualified and monitored in compliance with ICH‑GCP and local regulations.
Key responsibilities
- Participate in feasibility studies, approach investigators and gather required information within tight timelines.
- Conduct site selection and qualification assessments under senior supervision.
- Assist in study set‑up, including submission of documentation to ethics committees and local authorities.
- Coordinate training sessions, investigator meetings and other study‑specific meetings.
- Plan and perform monitoring visits, review source data verification (SDV) and ensure quality control of investigational sites.
- Report non‑compliances, protocol deviations, adverse events (AE) and serious adverse events (SAE) to the sponsor.
- Prepare regular progress reports for the Clinical Project Manager and participate in project teleconferences.
- Manage investigational product logistics, import/export licences and accountability of biological samples.
Required profile
- Minimum 24 months of experience in clinical research monitoring or site management.
- Strong knowledge of ICH‑GCP, local regulatory requirements and SOPs.
- Proven ability to conduct feasibility assessments, site qualification and monitoring visits.
- Excellent documentation and reporting skills, with attention to detail.
- Fluent English communication skills.
Required skills
- ICH‑GCP
- Site selection
- GCP
- Microsoft Office
Questions fréquentes
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اكتشف المزيد
الرواتب والأدلة وعمليات البحث في المملكة العربية السعودية.
الرواتب حسب المهنة
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اطرحه هنا: ستصلك تفاصيل العرض كاملة عبر البريد الإلكتروني، فوراً.
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PDC CRO
Riyadh