Clinical Research Associate (CRA) – Spain (Madrid or Barcelona area)About the RoleWe 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 teamsOur 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 ResponsibilitiesSite 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 recordsCompliance & 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 requiredCommunication & Reporting- Prepare monitoring visit reports, follow-up letters, study memos, and site correspondence- Escalate critical issues according to internal processesSite 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 activitiesStudy 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