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 sponsor dedicated full‑time member.
About the Role
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 integral 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 elevate 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 five 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 licence 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 integral 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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