Senior Clinical Research Associate - lecce - Advanced Clinical

    Advanced Clinical
    Advanced Clinical lecce

    1 settimana fa

    Descrizione

    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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