Clinical Research Associate (CRA) – Spain (Madrid or Barcelona area)
Inscríbase (haciendo clic en el botón correspondiente) después de revisar toda la información relacionada con el trabajo a continuación.
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 enablementProcess innovationHigh-quality, efficient study executionStrong cross-functional collaboration across global teamsOur 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 ResponsibilitiesSite Monitoring & Data QualityPerform source data verification (SDV) between CRFs and source documentsReview Informed Consent Forms for accuracy and completenessVerify regulatory documentation and device accountability recordsCompliance & Patient SafetyEnsure adherence to
ICH-GCP, MDR, GDPR
, SOPs, and internal proceduresIdentify and escalate site non-compliance issues appropriatelySupport audits and regulatory inspections when requiredCommunication & ReportingPrepare monitoring visit reports, follow-up letters, study memos, and site correspondenceEscalate critical issues according to internal processesSite Management & TrainingEnsure site staff are properly trained on protocol and study requirementsMaintain training logs, delegation logs, and site documentationSupport site activation, recruitment, follow-up, and close-out activitiesStudy CoordinationCollaborate with Trial Operations, Regulatory Affairs, and Contracts & Budget teamsParticipate in study meetings, teleconferences, and cross-functional discussionsMaintain study milestones in Clinical Trial Management Systems (CTMS)
Required QualificationsBachelor's degree (or equivalent combination of education and experience)Fluency in
Spanish and English
(written and spoken)Previous experience as
CRAMinimum
5 years of experience in clinical field monitoringStrong organizational and communication skillsAbility to work independently and within a teamComfortable working in a fast-paced, dynamic xhfqzwm environmentAbility to manage multiple studies simultaneouslyWillingness 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 QualificationsExperience with
CTMS and EDC systemsMedical device experience, particularly in:OncologyCardiac Rhythm ManagementEndoscopyAdditional language skills (Italian at intermediate level is a plus)What We OfferOpportunity to work in a integral clinical operations environmentExposure to innovative clinical technologies and processesStrong cross-functional collaboration and professional development opportunitiesImpactful work supporting high-quality clinical research and patient safety