Senior Clinical Research Associate

7 giorni fa

Pescara, Italia Advanced Clinical A tempo pieno

Senior 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 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 team Requirements 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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