Overview
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In this CRA role, you monitor oncology/hematology trials and ensure adherence to ICH-GCP, local regulations, and SOPs. You collaborate with the Regional Clinical Operations Manager to meet study milestones and maintain data quality. You identify gaps, propose CAPAs, and support site start-up and local expertise. You work across sites to drive timely recruitment, data collection, and inspections readiness, contributing to BeOne’s mission to fight cancer.
Responsabilidades
Perform feasibility, site identification, selection and evaluation to support site recruitment targets
Provide protocol and study training to sites
Conduct pre-study, initiation, routine monitoring, and closeout visits per plan and SOPs
Co-monitoring visits when required
Complete monitoring visit reports per ICH-GCP and BeOne standards
Track regulatory submissions, recruitment, CRF completion, and data queries at sites
Maintain communication with sites and report progress, issues, and actions to Clinical Operations




Ensure inspection readiness of studies and sites
Collaborate with Regional Clinical Operations Manager and sites to deliver milestones (startup, recruitment, database analyses, closeout)
Attend disease-specific and CRA training; facilitate Study Oversight Visits (SOVs)
Evaluate site practices for quality and GCP, escalate issues as needed
Identify site issues and propose CAPA; pursue operating excellence and innovation
Requisitos principales
BS in a scientific discipline plus minimum 2 years of monitoring experience
Experience in oncology xqbhyrx integral trials preferred
Understanding of clinical trial processes and ICH guidelines
2+ years CRA monitoring experience in pharma or CRO
Excellent communication and interpersonal skills
Strong organizational, prioritization, and multi-tasking abilities
Fluency in English and Spanish (writing and speaking)
Computer skills in Word, Excel, MS Project, PowerPoint, Outlook
Travel up to 60%
communication
interpersonal skills
organization
ICH-GCP knowledge
SOP adherence
CRF data management

📌 Clinical Research Associate (Gijón)
🏢 Beigene
📍 Gijón