Clinical Research Associate (CRA) – Spain (Madrid or Barcelona area)
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
o Perform source data verification (SDV) between CRFs and source documents
o Review Informed Consent Forms for accuracy and completeness
o Verify regulatory documentation and device accountability records
* Compliance & Patient Safety
o Ensure adherence to ICH‑GCP, MDR, GDPR, SOPs, and internal procedures
o Identify and escalate site non‑compliance issues appropriately
o Support audits and regulatory inspections when required
* Communication & Reporting
o Prepare monitoring visit reports, follow‑up letters, study memos, and site correspondence
o Escalate critical issues according to internal processes
* Site Management & Training
o Ensure site staff are properly trained on protocol and study requirements
o Maintain training logs, delegation logs, and site documentation
o Support site activation, recruitment, follow‑up, and close‑out activities
* Study Coordination
o Collaborate with Trial Operations, Regulatory Affairs, and Contracts & Budget teams
o Participate in study meetings, teleconferences, and cross‑functional discussions
o 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 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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