Report To :
Research Quality Management Manager / ผู้จัดการแผนกบริหารคุณภาพงานวิจัย
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 PREVENTION. 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
Core Accountability & Responsibility:
regulatory authority applications and approvals that oversee the research of
new and existing drugs.
and manages the activities of investigator and the investigator's trial staff
to ensure compliance with study protocol requirements.
informed consent of the participant or their guardians.
4. Assist with
the compilation of required documents for trial activation.
the trial throughout its duration, which involves visiting the trial sites on a
clinical data and coordinates data query resolutions.
clinical research and data monitoring and completes monitoring visit reports.
Assurance and Quality Control.
other tasks as assigned.
Qualifications and Experience
degree or Master degree in Nursing, Biological Science, Pharmacy, Public Health
or other related fields.
2. Minimum of 3
years of experience in monitoring clinical studies, especially HIV/AIDS and
other relevant diseases
knowledge of drug development process, clinical trial monitoring procedures,
medical terminology and ICH/GCP guidelines.
quality assurance and quality control management.
data monitoring and evaluation skills.
skills (written and verbal) in Thai and English.
8. Thai citizen