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-solving Attention to detail MS Word MS Excel MS Project

📌 Research Associate (Vigo)
🏢 Beigene
📍 Vigo