The performed duties support researchers in maintaining high standards of research integrity, quality and ethics in compliance with national and international laws, regulations and policies.
Activities
- Support for researchers in the development of the study protocol and the feasibility assessment.
- Submission of the Dossier to the Competent Authorities and Ethics Committees for the application for the required authorization to conduct the study and subsequent amendments.
- Updating and filing of essential trial documentation.
- Management of external Sponsor contacts.
- Support for researchers in establishing relationships with funders of sponsor-initiated trials (initial communications, review of the agreements, investigational drug supply and updates during the trial).
- Organization and integration of secure and legally compliant data collection processes.
- Establishment and coordination of Clinical Trials Review Commitees.
- Arrangement of events for the dissemination of research results and continuous education of researchers.