Clinical Research Associate (CRA) – Spain (Madrid or Barcelona area) Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. 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 xbhjioe - 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