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 General 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 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 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. xhfqzwm
Impactful work supporting high‑quality clinical research and patient safety.
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