PbClinical Research Associate (CRA) – Spain (Madrid or Barcelona area) /b /ppbr/ppbAbout the Role /b /ppbr/ppWe are looking for a bClinical Research Associate (CRA) /b based in Spain (preferably near Madrid or Barcelona) to join our bGlobal Clinical team being sponsor dedicated full-time. /b /ppIn this role, you will contribute to building a world-class clinical operations function focused on: /pulliClinical technology enablement /liliProcess innovation /liliHigh-quality, efficient study execution /liliStrong cross-functional collaboration across global teams /li /ulpOur guiding principles are: bcollaboration, accountability, innovation, adaptability, integrity, and care /b. /ppYou will play a key role in ensuring bpatient safety, data integrity, and regulatory compliance /b across clinical studies, while supporting study acceleration and operational excellence. /ppbKey Responsibilities /b /ppbSite Monitoring Data Quality /b /pulliPerform source data verification (SDV) between CRFs and source documents /liliReview Informed Consent Forms for accuracy and completeness /liliVerify regulatory documentation and device accountability records /li /ulpbCompliance Patient Safety /b /pulliEnsure adherence to bICH-GCP, MDR, GDPR /b, SOPs, and internal procedures /liliIdentify and escalate site non-compliance issues appropriately /liliSupport audits and regulatory inspections when required /li /ulpbCommunication Reporting /b /pulliPrepare monitoring visit reports, follow-up letters, study memos, and site correspondence /liliEscalate critical issues according to internal processes /li /ulpbSite Management Training /b /pulliEnsure site staff are properly trained on protocol and study requirements /liliMaintain training logs, delegation logs, and site documentation /liliSupport site activation, recruitment, follow-up, and close-out activities /li /ulpbStudy Coordination /b /pulliCollaborate with Trial Operations, Regulatory Affairs, and Contracts Budget teams /liliParticipate in study meetings, teleconferences, and cross-functional discussions /liliMaintain study milestones in Clinical Trial Management Systems (CTMS) /li /ulpbr/ppbRequired Qualifications /b /pulliBachelor’s degree (or equivalent combination of education and experience) /liliFluency in bSpanish and English /b (written and spoken) /liliPrevious experience as bCRA /b /liliMinimum b5 years of experience in clinical field monitoring /b /liliStrong organizational and communication skills /liliAbility to work independently and within a team /liliComfortable working in a fast-paced, dynamic environment /liliAbility to manage multiple studies simultaneously /liliWillingness to travel up to b80% /b (mainly within Spain, with occasional international travel) /liliValid driving license and access to a personal vehicle (for regional travel; train/plane for long distances) /li /ulpbPreferred Qualifications /b /pulliExperience with bCTMS and EDC systems /b /liliMedical device experience, particularly in: /liliOncology /liliCardiac Rhythm Management /liliEndoscopy /liliAdditional language skills (Italian at intermediate level is a plus) /li /ulpbWhat We Offer /b /pulliOpportunity to work in a global clinical operations environment /liliExposure to innovative clinical technologies and processes /liliStrong cross-functional collaboration and professional development opportunities /liliImpactful work supporting high-quality clinical research and patient safety /li /ul