Clinical Research Associate
hace 5 días
Santander
Clinical Research Associate (CRA) – Spain (Madrid or Barcelona area) About the Role We are looking for a Clinical Research Associate (CRA) based in Spain (preferably near Madrid or Barcelona) to join our Global Clinical team being sponsor dedicated full-time. In this role, you will contribute to building a world-class clinical operations function focused on: • Clinical technology enablement, • Process innovation, • High-quality, efficient study execution, • Strong cross-functional collaboration across global teams Our guiding principles are: collaboration, accountability, innovation, adaptability, integrity, and care. You will play a key role in ensuring patient safety, data integrity, and regulatory compliance across clinical studies, while supporting study acceleration and operational excellence. Key Responsibilities Site Monitoring & Data Quality • Perform source data verification (SDV) between CRFs and source documents, • Review Informed Consent Forms for accuracy and completeness, • Verify regulatory documentation and device accountability records Compliance & Patient Safety • Ensure adherence to ICH-GCP, MDR, GDPR, SOPs, and internal procedures, • Identify and escalate site non-compliance issues appropriately, • Support audits and regulatory inspections when required Communication & Reporting • Prepare monitoring visit reports, follow-up letters, study memos, and site correspondence, • Escalate critical issues according to internal processes Site Management & Training • Ensure site staff are properly trained on protocol and study requirements, • Maintain training logs, delegation logs, and site documentation, • Support site activation, recruitment, follow-up, and close-out activities Study Coordination • Collaborate with Trial Operations, Regulatory Affairs, and Contracts & Budget teams, • Participate in study meetings, teleconferences, and cross-functional discussions, • Maintain study milestones in Clinical Trial Management Systems (CTMS) Required Qualifications • Bachelor’s degree (or equivalent combination of education and experience), • Fluency in Spanish and English (written and spoken), • Previous experience as CRA, • Minimum 5 years of experience in clinical field monitoring, • Strong organizational and communication skills, • Ability to work independently and within a team, • Comfortable working in a fast-paced, dynamic environment, • Ability to manage multiple studies simultaneously, • Willingness to travel up to 80% (mainly within Spain, with occasional international travel), • Valid driving license and access to a personal vehicle (for regional travel; train/plane for long distances) Preferred Qualifications • Experience with CTMS and EDC systems, • Medical device experience, particularly in:, • Oncology, • Cardiac Rhythm Management, • Endoscopy, • Additional language skills (Italian at intermediate level is a plus) What We Offer • Opportunity to work in a global clinical operations environment, • Exposure to innovative clinical technologies and processes, • Strong cross-functional collaboration and professional development opportunities, • Impactful work supporting high-quality clinical research and patient safety
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