Experteer Overview
In this CRA role, you will lead clinical monitoring at trial sites to ensure quality data and adherence to ICH-GCP and local regulations. You will collaborate with regional operations to meet study milestones and identify gaps for CAPA. The position supports site start-up, training, and ongoing oversight in oncology/hematology trials. You will work in a cross-functional team to uphold regulatory standards and study integrity, contributing to faster, safer cancer research. This role offers meaningful impact by ensuring site readiness and timely trial execution in a fast-paced environment.

Compensaciones / Ventajas
• Feasibility, site identification and evaluation to support site list and recruitment targets
• Provide protocol and study training to sites
• Conduct monitoring visits (pre-study, initiation, routine, closeout) per plan and SOPs
• Co-monitoring visits when required
• Complete monitoring visit reports per ICH-GCP and internal standards
• Manage site performance by tracking regulatory submissions, recruitment, CRF completion, data query resolution




• Establish regular communication with sites and report progress/issues to Clinical Operations
• Ensure inspection readiness of studies and sites
• Collaborate with Regional Clinical Operations Manager to meet milestones (startup, recruitment, database analyses, closeout)
• Attend disease indication-specific and general CRA training
• Facilitate Study Oversight Visits, site audits, and inspections as required
• Evaluate site practices for quality and integrity; escalate issues and propose CAPA
• Identify gaps and opportunities; promote operating excellence and innovation

Responsabilidades
• Clinical trial monitoring experience in oncology/hematology (CSA context)
• Ability to travel
• Experience with regulatory submissions and data quality processes
• Strong communication with sites and internal teams
• Experience with CAPA and quality improvement processes
• Knowledge of ICH-GCP and SOPs
• SSU experience is a plus

Requisitos principales
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📌 Clinical Research Associate (España)
🏢 Beigene
📍 España