Clinical Trial Assistant

Job Area: R&D/Medical

Job Category: Professionals

Job Site: On Site

Location:

Milano, IT

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.

Long Description

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
Minimum one year the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in 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;
Ability to work in a team;
Flexibility and versatility.