Regulatory Operations Assistant - Grade V

Job Purpose: START Dublin aims to provide patients with the opportunity to participate in early phase clinical trials. The post holder would be expected to work as part of a multidisciplinary team, to contribute to the delivery of START Dublin’s objectives in conducting clinical research, under the principles of Good Clinical Practice (GCP). The Regulatory Operations Assistant will provide comprehensive regulatory and administrative support for clinical research studies, ensuring study documentation, Investigator Site Files (ISF/eISF), and regulatory records are accurately maintained and compliant with applicable regulations, GCP, and study protocols. The role works closely with the research team, Medical Oncologist, Sponsors, CROs, and other stakeholders to support the smooth and timely conduct of studies. Responsibilities include maintaining essential study documentation, supporting Ethics Committee submissions, tracking investigator and study staff requirements, facilitating monitoring visits, ensuring audit and inspection readiness, and supporting study close-out and archiving. For informal queries please contact Amy Slater, linical Data Manager and Regulatory Affairs at [email protected] We reserve the right to close this competition early if we receive high volume of applications.