Experteer Overview
As a CRA I at Syneos Health, you will monitor and manage clinical sites to ensure trial integrity and regulatory compliance in a real-world late-phase context. You’ll work with cross-functional teams to support site performance, data quality, and patient safety, while adapting to changing priorities. The role combines on-site and remote activities to enable efficient trial execution and audit readiness. This is a mission-driven opportunity to help advance patient outcomes through robust monitoring and collaboration.
Compensaciones / Ventajas
• Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote)
• Assess site performance and provide recommendations; escalate issues promptly
• Maintain knowledge of ICH-GCP, regulatory guidance, and SOPs; ensure informed consent and patient confidentiality
• Perform CMP/SMP activities: source data verification, query resolution, data capture, and IP handling
• Verify IP labeling, import/release, and pharmacovigilance considerations; ensure compliance with IP storage and dispensing
• Review ISF and TMF alignment; ensure archiving per guidelines
• Support patient recruitment and retention strategies; track observations and action items
• Prepare for Investigator Meetings and sponsor meetings; contribute to audit readiness and follow-up actions
• Collaborate with site staff, CMA or other CRAs; train and ensure compliance with project requirements
• Understand project scope, budgets, and timelines; adapt to changing priorities to meet targets
• Provide site-level liaison activities and support during the study lifecycle
• Document activities through letters, reports, and logs as required by SOPs
Responsabilidades
• Bachelor’s degree or RN in a related field
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong computer skills and adaptability to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to travel up to 75%
• US: compliance with site access and privacy information requirements
Requisitos principales
• career development and progression
• supportive line management
• technical and therapeutic area training
• inclusive culture
• total rewards program
📌 CRA I. Valencia. Sponsor dedicated. (España)
🏢 Syneos Health
📍 España
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