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 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
* 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