Senior Clinical Research Associate

8 ore fa

Livorno, Italia Advanced Clinical A tempo pieno

OverviewSenior Clinical Research Associate (Oncology).Working embedded with a leading global oncology-focused biopharmaceutical company.We are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands-on clinical role.This position offers the opportunity to work closely with a sponsor team, supporting Phase I–III oncology studies (liquid and solid tumours) and contributing across the full clinical trial lifecycle.Key ResponsibilitiesConduct routine site monitoring visits and support site selection, initiation, and close-out activitiesEnsure clinical trials are conducted in accordance with GCP, ICH guidelines, approved protocols, SOPs, and regulatory requirementsServe as the primary point of contact for investigators, site staff, CROs, and vendorsSupport feasibility assessments and site selection in collaboration with the study teamAssist with the development and review of clinical documentation in including protocols, informed consent forms, monitoring plans, CRFs, and data management plansSupport and manage patient recruitment strategies to increase enrollment and randomisationReview AEs and SAEs, ensuring appropriate documentation, follow-up, and communication of safety issuesSupport data review, validation, and cleaning activities to meet study timelinesOrder and coordinate study suppliesDevelop and maintain tracking tools to support clinical trial oversightPlan and participate in investigator meetings and CRA trainingsParticipate in co-monitoring activities with CRO CRAs as requiredProvide guidance and support to junior CRAs as part of the wider study teamRequirementsBachelor's degree or Registered Nurse qualification, preferably in Life SciencesMinimum of 5 years' experience as a Clinical Research Associate within the pharmaceutical or biotechnology industryExperience in monitoring clinical trials from start-up through database lockStrong oncology monitoring experience across Phase I–III trials, including liquid and solid tumoursStrong knowledge of GCP, ICH, and applicable regulatory requirementsAbility to work independently while collaborating closely with the sponsor and cross-functional teamsSenior Clinical Research Associate • Livorno, ITALY#J-*****-Ljbffr

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