Clinical Research Associate

1. Responsible for the management of designated clinical trials including preparation of trial related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organising Ethics committee submissions with follow through to ensure successful outcome.
2. Organise investigator’s start-up meeting and study site initiation meetings.
3. Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH/GCP guidelines.
4. Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
5. Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.
6. Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
7. Liaise with colleagues in monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
8. Review the translated medical documents, the package inserts and report writing. Coordinates report and protocol-writing activities.
9. Other tasks as required.

1. University degree. Health related is preferred (Pharmacist/ Doctor/Public health).
In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes
2. Excellent organization and management skills
3. Fluency in writing and reading English
4. Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System, Electronic Documents Management System, MS-Office products such as Excel and Word
5. Good communication skills
6. Administrative excellence
7. Self-motivated and proactive

- 13th month salary
- Company bus from Dist.1 to Hitech Park
- Lunch

Hồ sơ theo yêu cầu của nhà tuyển dụng khi liên hệ trực tiếp