ThaiNGO

JOB DESCRIPTION

Position Tittle: Clinical Trial Monitor

Organization: Prevention Department, The Thai Red Cross AIDS Research Center (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.

Key Duties and Responsibilities:

1. coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
2. managing regulatory authority applications and approvals that oversee the research of new and existing drugs
3. identifying and assessing the suitability of facilities to be used as the clinical trial site
4. liaising with doctors/consultants/coordinator or investigators on conducting the trial
5. monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis
6. verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
7. collecting completed CRFs from clinical sites/community sites and general practices
8. writing visit reports and filing and collating trial documentation and reports;
9. ensuring all unused trial supplies are accounted for
10. closing down trial sites on completion of the trial
11. discussing results with a medical statistician, who usually writes technical trial reports
12. archiving study documentation and correspondence

Qualifications

1. Thai National
2. Bachelor degree in Nursing, Biological Science, Pharmacy, Public Health or other related fields
3. Minimum of 1 year experience in monitoring health studies, especially HIV/AIDS and other relevant diseases
4. Possess the ability to work independently and in a team environment.
5. Good management skills, project management, organizational, and communication skills (written and verbal) in Thai and English
6. Expertise in and good working knowledge of core systems and tools
7. Proficient in the use of core trial management systems.
8. Possess an excellent working knowledge of all applicable ICH/GCP regulations