05 oct
|
Syneos Health
|
Madrid
05 oct
Syneos Health
Madrid
Experteer Overview
In this CRA II role, you oversee clinical trial sites to ensure regulatory and protocol compliance, data integrity, and patient safety. You coordinate with site staff and cross-functional teams to monitor progress and resolve issues. You contribute to study readiness, data quality, and site performance, enabling trials to stay on track. The position offers integral collaboration, exposure to real-world late-phase designs, and meaningful impact on patient outcomes.
Compensaciones / Beneficios
• Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote)
• Assess site processes and conduct source data verification and query resolution
• Ensure data accuracy in case report forms and electronic data capture
• Manage investigational product inventory and labeling per protocol
• Maintain ISF/TMF alignment and archiving of essential documents
• Support subject recruitment, retention,
and site communications
• Understand project scope, budgets, and timelines; adapt to changing priorities
• Prepare for investigator meetings and sponsor meetings; participate in trainings and audits
• Train junior staff when needed; ensure compliance with regulatory requirements
• Contribute to audit readiness and post-audit follow-up actions
Responsabilidades
• Bachelor's degree or RN in a related field
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Good computer skills and adaptability to new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
• Compliance with site access and data privacy requirements
Requisitos principales
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📌 CRA II Madrid Sponsor dedicated.
🏢 Syneos Health
📍 Madrid