The Clinical Trials Assistant (CTA) is responsible for project-supporting clinical drug research and development tasks.
The CTA will provide administrative and clinical trials assistance to the Project Managers and project team for start-up, active phase, and closeout activities for assigned clinical studies.
Responsibilities To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s); To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals; To support the Clinical Operations teams with ongoing conduct of studies; To be familiar with ICH GCP, appropriate regulations and relevant SOPs; To assist project teams with filing and/or finalization of study specific documentation and guidelines as appropriate; To set up, organize and maintain clinical study documentation (e.g., Main Study Files, CRFs, etc.)
including preparation for internal/external audits, final reconciliation and archival; To assist in quality control audits of clinical study documentation (e.g., Main Study Files, CRF Files, Monitoring Files, etc.
); To assist project teams with trial progress tracking; To contact CRO for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.
); To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
Education University degree – Medical Science; Biotechnology; etc.
Minimum one year in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in a clinical research environment; Technical Expertise Fluency in English and Italian – written and spoken; IT Knowledge: Microsoft Office (Word; Excel; PowerPoint) and Google Workspace (Gmail, Calendar, Meet, Chat, Drive, Docs, Sheets, Slides, Forms, Sites etc.
); Knowledge of medical terminology; Knowledge of ICH GCP (Good Clinical Practice); Good organizational skills, ability to manage multiple tasks and meticulous attention to detail; Good written and verbal communication skills; #J-18808-Ljbffr