Experteer OverviewAs a CRA for PPD, you monitor investigator sites using a risk-based approach to ensure protocol adherence and data integrity. You will work with cross-functional teams to identify and resolve issues, contributing to high-quality clinical trial delivery on a global scale. Your role supports data accuracy, regulatory compliance, and site performance across study phases, including cell & gene therapy programs. You'll collaborate with clients and investigators to ensure timely, compliant trial conduct and documentation. This opportunity offers a chance to impact patient outcomes while working in a collaborative, flexible environment.Retribuzione / BenefitsMonitor investigator sites using risk-based monitoring and root-cause analysis to ensure compliance and mitigate risksEnsure data accuracy via SDR, SDV, and CRF review during on-site and remote monitoringAssess investigational product through inventory checks and records reviewDocument observations and elevate deficiencies with timely resolutionMaintain communication with sites and project team to verify protocol adherence and data recordingParticipate in investigator payments, issue resolution, and investigator meetings as neededInitiate sites per procedures to ensure regulatory and ICH GCP compliance; conduct trial close-out and materials retrievalEnsure essential documents are complete per ICH-GCP and regulatory standards; perform on-site file reviewsProvide trial status updates to the Clinical Team Manager and update study systems per conventionsSupport project work and process improvement through collaboration and knowledge sharingContribute to project publications/tools and other project initiativesResponsabilitàUniversity degree in a science-related fieldUnderstanding of ICH-GCP, EU and FDA requirementsFluency in EnglishValid driver's licenseProven clinical monitoring skillsExperience with Cell & Gene Therapy studiesStrong medical terminology knowledge and regulatory literacyAbility to perform root cause analysis and risk-based monitoring processesStrong communication and organizational skillsAbility to work independently or in a teamProficiency in Microsoft Office and ability to learn new softwareCRA experience across all study phases (start to close-out)Requisiti fondamentaliFlexible working cultureExtensive benefits packageCompetitive salaryFocus on health and well-beingWork-life balanceGlobal collaboration
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