01 sep
|
Syneos Health
|
Madrid
01 sep
Syneos Health
Madrid
Experteer Overview
Senior CRA II to monitor and manage clinical sites for sponsor-dedicated studies, ensuring ICH-GCP, GPP, and protocol adherence across on-site and remote activities. You will support site qualification, initiation, monitoring, and close-out, while safeguarding data integrity and patient safety. You’ll collaborate with cross-functional teams, train junior staff, and contribute to real-world late-phase initiatives. This role offers impact through optimizing site performance and contributing to trial success in a fast-paced, global environment.
Compensaciones / Incentivos
• Perform site qualification, initiation, interim monitoring, management and close-out visits (on-site or remote) ensuring regulatory and protocol compliance
• Assess site performance and staff, escalates issues, and develop action plans
• Verify informed consent processes and protect subject confidentiality
• Review source documents and CRFs, drive query resolution within timelines
• Oversee IP inventory, labeling, and handling per protocol
• Review ISF for accuracy and reconcile with TMF
• Document activities and support recruitment, retention, and status tracking
• Manage project scope, budgets,
and timelines; adapt to changing priorities
• Coordinate with study sites and lead meetings; train junior CRA staff
• Support audit readiness and participate in sponsor/vendor meetings
• Provide mentorship to junior staff; contribute to proposals and defense meetings
• For RWLP, support site identification, chart abstraction, and regulatory updates
• Identify process improvements and develop site management strategy
• Contribute to Case Report Form design and edit checks
• Participate in bid defense meetings and RFP input
Responsabilidades
• Bachelor's degree or RN in related field or equivalent experience
• Knowledge of GCP/ICH and applicable regulatory requirements
• Proficient computer skills and quick to adopt new technologies
• Excellent communication, presentation, and interpersonal skills
• Moderate critical thinking ability
• Ability to travel up to 75% regularly
Requisitos principales
• career development and progression
• supportive line management
• technical and therapeutic area training
• peer recognition
• total rewards program
• inclusive culture
📌 Senior Clinical Research Associate II - Sponsor Dedicated. Madrid.
🏢 Syneos Health
📍 Madrid