Experteer OverviewIn this CRA II role, you will monitor sponsor-dedicated clinical sites in Madrid to ensure regulatory and protocol compliance. You will work with cross-functional teams to protect data integrity and patient safety while supporting site qualification, initiation, and ongoing monitoring. The role focuses on quality monitoring, site performance assessment, and timely issue resolution to keep trials on track. This is an opportunity to contribute to impactful clinical research in a fast-paced, collaborative environment.Compensaciones / BeneficiosSite qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) with regulatory and GCP/GPP adherenceAssess site performance, escalate issues, and develop action plansMaintain knowledge of ICH/GCP and relevant SOPs/processesVerify informed consent processes and protect subject confidentialityConduct Source Document Review and ensure accurate CRF data; drive query resolutionIP inventory, dispensing verification, and labeling/release in compliance with protocolISF vs TMF reconciliation and archiving of essential documentsDocument activities via letters, reports, and logs; support recruitment andretention strategiesEnter data into tracking systems and monitor observations to resolutionUnderstand project scope, budgets, and timelines; manage site-levelcommunicationsLiaise with study site personnel and attend Investigator Meetings and sponsor meetingsSupport audit readiness and post-audit follow-up actionsMaintain ongoing training and regulatory knowledgeReal World Late Phase responsibilities include site lifecycle support and potential junior staff trainingIdentify and communicate out-of-scope activities to Lead CRA/PMResponsabilidadesBachelor's degree or RN4 years of pharmaceutical industry or clinical research experience2-3 years of monitoring experienceKnowledge of GCP/ICH guidelines and regulatory requirementsStrong computer skills and aptitude for new technologiesExcellent communication, presentation and interpersonal skillsWillingness to travel up to 75%US-specific privacy considerations as applicable to site accessRequisitos principalescareer development and progressionsupportive line managementtechnical and therapeutic area trainingpeer recognitiontotal rewards programTotal Self culture