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 as sponsor dedicated full‑time. The role focuses on clinical technology enablement, process innovation, high‑quality efficient study execution, and strong cross‑functional collaboration across global teams.
Guiding Principles
* Collaboration
* Accountability
* Innovation
* Adaptability
* Integrity
* Care
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 escalated site non‑compliance issues; support audits and regulatory inspections.
* Communication & Reporting: Prepare monitoring visit reports, follow‑up letters, study memos, and site correspondence; escalated 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)
* Minimum five years of experience as a CRA 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
Preferred Qualifications
* Experience with CTMS and EDC systems
* Medical device experience, particularly in oncology, cardiac rhythm management, or endoscopy
* Additional language skills (Italian at intermediate level is a plus)
What We Offer
* Opportunity to work in a general 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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