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Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?ResponsibilitiesConduct site evaluation and setup for SCENESSE® commercial distribution, including dosing training in collaboration with the Clinical Project Manager or designeeMaintain communication with sites involved in SCENESSE® commercial distribution and potential clinical trial sitesCollect essential documents in compliance with ICH‑GCP E6 (R2) and applicable regulationsMonitor data collection and pharmacovance/safety reporting at post‑authorisation study sitesManage site setup, initiation, monitoring, and close‑out for clinical and post‑authorisation studies as neededOversee site operations including supply management and payment processesTrack study and clinical trial status and provide progress updates to the teamPrepare and submit documentation to EC/IRB and regulatory authoritiesParticipate in investigator meetings, and relevant conferencesContribute to newsletters and other communications as directed by the Clinical Project Manager or designeeAssist with audits as requiredSupport process improvement initiatives and contribute to workflow enhancementsConduct literature reviews to support clinical and regulatory activitiesQualificationsHold a graduate degree in Biological Sciences, Nursing, Pharmacy, or a related disciplinePostgraduate qualifications are considered an advantageMinimum of 2 years of proven experience as a Clinical Research Associate (CRA)Strong working knowledge of ICH‑GCP guidelinesDemonstrated experience in managing clinical trials and projects #J-18808-Ljbffr