Clinical Trial Assistant

1 mese fa

Milano, Italia Dompé farmaceutici S.p.A. A tempo pieno

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;
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