หน้าที่ความรับผิดชอบ

Role Overview: The Clinical Trial Monitoring Officer will preparation and execution of clinical HIV and non-HIV research studies. Support to oversee the progress of clinical investigations by conducting site evaluation, initiation, and close out visits. Monitors clinical trials in accordance with Good Clinical Practices and standard operating procedures set by IHRI. Works closely with principal investigators and study team to ensure all monitoring activities are conducted according to study requirements. Supervises a team of Senior Clinical Trial Monitors and delegates tasks to clinical trial team members according to required research studies. Ensures quality of work related to clinical research activities.

Key Accountability/Responsibility:

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