Experteer OverviewIn this role you will independently conduct site monitoring for clinical trials to ensure protocol compliance and data integrity. You will collaborate with in-house CRAs, Lead CRAs, Directors, and Project Managers to address site questions, support study recruitment and training, and resolve site-related issues. You will manage documentation, adverse event processes, and regulatory binder reviews, contributing to quality and compliant trial execution. This global, collaborative environment emphasizes courage, accountability, honesty, inclusivity, and elevating others while advancing patient-focused research.Retribuzione / BenefitsPerform qualification, initiation, interim, and close-out visits with proper documentationCreate accurate monitoring visit reports detailing site issues, resolutions, deviations, and enrollment statusFacilitate adverse event reporting and reconcile SAE with source data and CRFsEnsure data integrity through source data verification of CRFsConduct investigational product accountability and regulatory binder reviewsCollaborate with in-house CRAs and data management to resolve data queriesIdentify site issues proactively and develop problem-solving strategiesMaintain regular site communication to ensure protocol/GCP compliance and patient accrualPrepare for audit activities at study sites as neededPromote consistency and collaboration within the CRA teamManage competing priorities to meet commitmentsComply with ICH GCP, FDA regulations, and SOPsParticipate in industry and client meetingsPerform additional duties as assignedResponsabilitàBS/BA from an undergraduate program or equivalent experience2 years of clinical research experienceRequisiti fondamentaliBS/BA from an undergraduate program or equivalent experience2 years of clinical research experience
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