Job Descriptions1. Assists clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout conduct of study.
2. Maintains awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines.
3. Prepares all practical arrangements (e.g. budgets, supplies, etc.) for approval by line management.
4. Design of CRFs and ICFs as agreed within the project team.
5. Ensures all personnel at study sites are appropriately informed and trained, if necessary, before study starts.
6. Monitors the study trial throughout its duration, which will involve visiting the study centers on a regular basis.
7. Conducts Source Data Verification (SDV) as required to data monitoring guidelines.
8. Collects completed CRFs from the study sites, and resolve any data queries / protocol deviations identified.
9. Provide assistance, where directed by Director of Clinical Research Development Section, in specific tasks relating to the preparation of the project (e.g. preparation of; ICF, planning documents).