Experteer Overview
In this role you support clinical monitoring and site management across the study lifecycle, ensuring adherence to ICH-GCP and regulatory standards. You collaborate with cross-functional teams to drive data integrity, patient safety, and audit readiness in Real World Late Phase studies. You will operate both on-site and remotely, managing site relationships and monitoring deliverables to help bring therapies to patients faster. This is a hands-on, impact-driven position at a mission-focused life sciences services company.

Compensaciones / Ventajas
• Perform site qualification, initiation, monitoring, and close-out visits with regulatory and protocol compliance
• Assess site processes, conduct source data review, and verify CRF data accuracy and completeness
• Resolve data queries remotely and on-site to ensure timely closure
• Manage investigational product inventory and distribution per protocol
• Maintain ISF/TMF integrity and archiving per guidelines




• Prepare and participate in Investigator Meetings and sponsor meetings
• Support audit readiness and regulatory inspections readiness
• Coordinate with sponsors, sites, and cross-functional teams to meet timelines and budgets
• Train junior staff and prepare for lifecycle site support in Real World Late Phase
• Identify potential sites and communicate out-of-scope activities to leadership

Responsabilidades
• Bachelor's degree or RN in related field or equivalent
• Knowledge of GCP/ICH guidelines and regulatory requirements
• Strong computer skills and ability to adapt to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to travel up to 75%
• US-specific site access compliance requirements

Requisitos principales
•

📌 SSU CRA II Barcelona. Sponsor dedicated
🏢 Syneos Health
📍 Barcelona