دستیار مطالعات بالینی

Job Description

Key responsibilities and duties: ● Collecting, registering, and archiving information and documents in accordance with the applicable good clinical practice guidelines for clinical studies. ● Preparing investigator site files, and trial master files (TMF) for the initiation of participating centers in clinical studies. ● Identifying needs, bottlenecks, and deviations within the study team. ● Maintaining the complete documentation for the studies assigned. ● Ensuring complete and correct study administration in accordance with the standard operating procedures and the ICH-GCP guidelines. ● Assisting the principal investigator in patient visits, follow-up, data entry, and data analysis. ● Setting up, organizing, and maintaining clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation, and archival. ● Producting slides, overheads, etc., as needed for the project, departmental, sponsor, and/or business development presentations.