Job Description
● Collecting, registering and archiving information and documents in accordance with the applicable good clinical practice guidelines for clinical studies.
● Preparing investigator site files, trial master files (TMF) for the initiation of participating centers in clinical studies.
● Identifying needs, bottlenecks and deviations within 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.
● Producing clinical trial documents and reports for review and approval by the Ethics Committee, Scientific committee, and Iran MOH clinical trial office.
● Assisting the principal investigator in patient visit, 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.
● Producing slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
