Clinical Trial Assistant Bardi

Clinical Trial Assistant
Bardi
Emilia Romagna, Bardi

We are looking for a motivated and organized Clinical Trial Assistant to join our dynamic team in Milan. 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. Key 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; ecc Technical Expertise: ? Minimum one year the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in clinical research environment; ? 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; ? Ability to work in a team; ? Flexibility and versatility.