Clinical Trial Assistant Bardi

Clinical Trial Assistant
Bardi
Emilia Romagna, Bardi

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.

ResponsibilitiesProvide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s);Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals;Support the Clinical Operations teams with ongoing conduct of studies;Be familiar with ICH GCP, appropriate regulations and relevant SOPs;Assist project teams with filing and/or finalization of study specific documentation and guidelines as appropriate;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;Assist in quality control audits of clinical study documentation (e. g. , Main Study Files, CRF Files, Monitoring Files, etc. );Assist project teams with trial progress tracking;Contact CRO for specific requests (e. g. , enrollment updates, missing documentation, meeting arrangements, etc. );Assist in the production of slides, overheads, etc. , as needed for project, departmental, sponsor and/or business development presentations. EducationUniversity 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 ExpertiseFluency 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;

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