Clinical Trial Monitoring Officer
Research Quality Management Manager
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 activities.
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.
1. Bachelor’s 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
3. Adequate computer skills.
4. Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and ICH/GCP guidelines.
5. Research quality assurance and quality control management.
6. Clinical data monitoring and evaluation skills.
7. Communication skills (written and verbal) in Thai and English.8. Thai citizen