Clinical Research Associate

Descripción del empleo

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

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

Spain

Tipo de contrato

Trabajo estudiantes

Publicado el

16-05-2026

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español