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.
Responsabilidades
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
Requisitos principales 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
Collaborative
Proactive problem-

📌 Research Associate (León)
🏢 Beigene
📍 León