Position Title: Clinical Trial Monitoring Supervisor
Report to: Research Quality Management Manager
PREVENTION, The Thai Red Cross AIDS Research Centre (TRCARC) in Bangkok, Thailand, is an organization under the umbrella of the Thai Red Cross Society. We provide outstanding HIV/AIDS treatment and care, foster innovative and responsible research, and train health care practitioners in HIV/AIDS.
The Clinical Trial Monitoring Supervisor is a team member of Clinical Trial Monitoring and delegates tasks to the team members according to required research studies, and ensures quality of work related to clinical research activities. He/she is also responsible for participating in the 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.
- Managing the Clinical Trial Monitor team
- 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.
- Bachelor’s degree or Master degree in Nursing, Biological Science, Pharmacy, Public Health or other related fields
- Minimum of 5 years of experience in monitoring clinical studies, especially HIV/AIDS and other relevant diseases
- A few year work experience as a supervisor, specialist, senior staff, leading teamwork, or similar roleAdequate computer skills.
- Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and ICH/GCP guidelines
- Research quality assurance and quality control management
- Clinical data monitoring and evaluation skills
- Project management
- Communication skills (written and verbal) in Thai and English
- Time management and organizing skills (ability to manage, prioritize, and routinely report progress on multiple projects and tasks)
- Expertise in and good working knowledge of core systems and tools
- Strong skills in building and maintaining relationships with investigative sites
- Strong presentation skills to internal and external collaborators9. Coaching and supervising skills
เจ้าหน้าที่ประจำสำนักงาน / Officer