Clinical Research Associate
9 hours ago
Girona
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 global 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