ThaiNGO

 Position: Clinical Research Associate

Organization:      The Thai Red Cross AIDS Research Center (TRCARC)

Roles and Responsibilities

• coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• managing regulatory authority applications and approvals that oversee the research of new and existing drugs
• identifying and assessing the suitability of facilities to be used as the clinical trial site
• identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site
• liaising with doctors/consultants/coordinator or investigators on conducting the trial
• setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards
• monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis
• verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• collecting completed CRFs from clinical sites/community sites and general practices
• writing visit reports and filing and collating trial documentation and reports;
• ensuring all unused trial supplies are accounted for
• closing down trial sites on completion of the trial
• discussing results with a medical statistician, who usually writes technical trial reports
• archiving study documentation and correspondence

Qualifications

- Thai citizen only

- Bachelor degree in Nursing, Biological Science, Pharmacy, Public Health or other related fields

- Minimum of 1 year experience in monitoring health studies, especially HIV/AIDS and other relevant diseases

- Possess the ability to work independently and in a team environment.

- Excellent time management, project management, organizational, and communication skills (written and verbal) in Thai and English

- Expertise in and excellent working knowledge of core systems and tools

- Proficient in the use of core trial management systems.

- Possess an excellent working knowledge of all applicable ICH/GCP regulations