1. Managing regulatory authority applications and approvals that oversee the research of new and existing drugs.
2. Coordinates and manages the activities of investigator and the investigator’s trial staff to ensure compliance with study protocol requirements.
3. Obtain informed consent of the participant or their guardians.
4. Assist with the compilation of required documents for trial activation.
5. Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis.
6. Evaluates clinical data and coordinates data query resolutions.
7. Conducts clinical research and data monitoring and completes monitoring visit reports.
8. Quality Assurance and Quality Control.
9. Performs other tasks as assigned.