Clinical Research Associate (CRA) – Spain (Madrid or Barcelona area)
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We are looking for a Clinical Research Associate (CRA) based in Spain, preferably near Madrid or Barcelona, to join our Global Clinical team as a full‑time sponsor dedicated role. In this position you will help build a world‑class clinical operations function focused on clinical technology enablement, process innovation, high‑quality, efficient study execution, and strong cross‑functional collaboration across general teams.
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 a 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 xpzdshu 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, and 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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