Clinical Trial Assistant (STAGE)
Evidilya
- Milano
- Formazione
- Full time
- Collaborate and support the study team members for project execution (from the beginning to the end).
- Prepare, manage, share, and archive the study documents and reports according to protocols, SOPs and applicable regulations.
- Evaluate the quality and integrity of study site, performing periodical reviews (TMF and TCF)
- Support CPM and CRA on the development and maintenance of Trial Master File and Trial Center Files
- Assist the CPM, tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Support start-up phase and the on-boarding of the main stakeholders/suppliers.
- Manage the relationship with the sponsor and update the CPM on the status of the trial.
- Master’s Degree in scientific discipline or health care preferred.
- Strong organizational and decision-making skills
- Fluent in English