Senior Clinical Research Associate

3 giorni fa

Rome, Italia Advanced Clinical A tempo pieno

Senior Clinical Research Associate (Oncology)Working embedded with a leading global oncology-focused biopharmaceutical companyWe 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 Responsibilities- Conduct routine site monitoring visits and support site selection, initiation, and close-out activities - Ensure clinical trials are conducted in accordance with GCP, ICH guidelines, approved protocols, SOPs, and regulatory requirements - Serve as the primary point of contact for investigators, site staff, CROs, and vendors - Support feasibility assessments and site selection in collaboration with the study team - Assist with the development and review of clinical documentation in including protocols, informed consent forms, monitoring plans, CRFs, and data management plans - Support and manage patient recruitment strategies to increase enrollment and randomisation - Review AEs and SAEs, ensuring appropriate documentation, follow-up, and communication of safety issues - Support data review, validation, and cleaning activities to meet study timelines - Order and coordinate study supplies - Develop and maintain tracking tools to support clinical trial oversight - Plan and participate in investigator meetings and CRA trainings - Participate in co-monitoring activities with CRO CRAs as required - Provide guidance and support to junior CRAs as part of the wider study teamRequirements- Bachelor’s degree or Registered Nurse qualification, preferably in Life Sciences - Minimum of 5 years’ experience as a Clinical Research Associate within the pharmaceutical or biotechnology industry - Experience in monitoring clinical trials from start-up through database lock - Strong oncology monitoring experience across Phase I–III trials, including liquid and solid tumours - Strong knowledge of GCP, ICH, and applicable regulatory requirements - Ability to work independently while collaborating closely with the sponsor and cross-functional teams

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