Primary agent to assist the principal investigator (PI) in planning and execution of research protocols approved by the appropriate institutional review boards (IRBs).
Coordinate the creation of SOPs and SSPs.
Prepare all study documents that serve as source documents for the study.
Ensure that the conduct of the study is in accordance with the approved protocol and that GCP guidelines are followed.
Engages in and promotes oversight to the screening, enrollment, study procedures and clinical follow up of research volunteers.
Manages the Regulatory Documents and coordinates the submission of all study
documents (e.g. protocols, consent forms, serious adverse events, protocol deviation, continuing review report, final report) to IRBs and regulatory Agencies.
Functions as an important liaison between AFRIMS and external collaborators as well as the community.
Prepares regulatory documents for inspection and audits by external Regulatory Agencies; e.g., U.S. FDA, Thai FDA, USAMMDA.
Assists the PI in preparing study report for IRBs and study data for presentations at international scientific meetings and manuscript submission for publication in peer review journals.
Requirements
This hire will work to support clinical research conducts by the Department of Virology, Armed Forces Research Institute of Medical Science (AFRIMS).
A bachelor’s degree of nursing science is required. At least one year of experience involved in the conduct of clinical research, is preferred.
Applicant must: be knowledgeable in Good Clinical Practices (GCP); be able to assist PIs in the planning and execution of research protocol; be able to organize and maintain the Regulatory Documents; have basic to intermediate knowledge of computer skills and information management; be able to compose Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs); able to work on weekends. Fluency in written and spoken English (TOEIC score is required AT LEAST 600) and Thai are required. Applicant must be able to read, comprehend and write the scientific topics.