Clinical Trials Assistant
The Clinical Trials Support Group (CTSG) is a group that supports researchers by assisting with protocol development, ethics applications, quality monitoring, training, data management, statistical analyses and other administrative support.
The Bangkok unit is responsible for all aspects of the conduct of clinical trials, including the complex logistical challenges of resourcing the trial sites located across South East Asia and Africa. Trials are currently being conducted in Thailand, Vietnam, Cambodia, Laos, Myanmar, Democratic Republic of Congo, India, Bangladesh, Ethiopia and Afghanistan. The post of the Clinical Trials Assistant is pivotal to the Tropical Medicine Clinical Trials Programme, ensuring that we source and deliver all necessary supplies, complying with any country specific regulations, throughout the lifecycle of the trial.
The MORU CTSG works in close collaboration with investigators, other departments and units across the MORU network, and a broad range of other collaborators. The candidate will contribute to projects including clinical trials and observational studies. They will work closely with the study investigators and team members which may include MORU project coordinators, other functional CTSG staff, and site team members across Southeast Asian or other study sites.
- Provide clinical operations and/or regulatory support and management, for one or multiple projects contracted to CTSG. Daily work will include:
- Oversight of applications to regulatory authorities and ethics committees, including ongoing correspondence and amendments through conclusion of project
- Assist in review of the protocols, information sheets, consent forms and other associated documents related to the research projects assigned
- Management of study operations, including coordination of project milestones, teleconferences and status tracking with MORU investigators and senior CTSG staff
- Support processing and tracking of study safety notifications to CTSG
- Support in document translation both Thai and English
- Ensure development of appropriate study-specific procedures and documentation to support research conduct within MORU network
- Coordinate with Finance for study-related financial documents
- Generate reports for project teams and management as required
- Other duties as assigned by supervisor
- A relevant degree e.g. nursing, medicine, or other health-related field
- Experience working in a clinical research environment
- Good written and spoken ability in both English and Thai
- Ability to communicate and work well with multinational teams
- Good attention to detail
- Strong IT skills, e.g., ability to use MS Word, Excel, Powerpoint and study databases proficiently
Interested applicants, please submit your application with detailed resumé to Khun Salwaluk Panapipat.