1. Primary agent to assist the Principal Investigator (PI) both in Thailand and other countries in execution of research i.e. clinical trials, surveillance, non-human subject research, etc. as assigned.
2. Coordinate with collaborating institutes and/or sponsors to develop the protocol, information sheet, consent form, recruitment material and other associated study documents as required by Institutional Review Board/Ethics Committee (IRB/EC).
3. Managing and maintaining the essential study documents per SOP, ICH-GCP, sponsor and other applicable guidelines.
4. Assist PI in preparing study activities including site preparation, coordinate the training, and prepare the study documents that serve as source documents and other study activities in accordance with approved protocol, ICH-GCP and solving any relevant study related issue under the PI supervision.
5. Assist PI in preparing regulatory documents for monitoring, inspection or audit by external Regulatory Agencies; e.g. U.S FDA, Thai FDA, USAMMDA and study reports for IRB/EC, US/Thai FDA reports as assigned by PI.
6. Serves as a liaison between AFRIMS and collaborators, sponsor and IRB/EC.
7. Regulatory and essential document translation and verification between Thai-English translations i.e. protocol, Informed Consent/Assent Form, Diary card, Memorandum, EC comments, Certificate of Approval Letter etc.
8. Coordinate and assist in participant recruitment, screening, enrollment, and follow-up activities.
9. Other duties as assigned by PI, Supervisor and Department Chief/designee.
Armed Forces Research Institute of Medical Science
