Overview

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 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 (Granada)
🏢 Beigene
📍 Granada