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 Integral 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 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 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 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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