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 innovationResponsabilidades
- 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 plusRequisitos principales
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📌 Clinical Research Associate (España)
🏢 Beigene
📍 España