The Clinical Research Associate ensures that clinical trials are run in accordance with scientific and regulatory requirements (at site level) to optimise Institute objectives.
The Clinical Research Associate directlly reports to the Project Manager
Duties and Key Responsibilities
Coordinate the identification, feasibility assessment and selection of investigators and sites to undertake the study
Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately
Adhere to the study protocol and study procedures manual.
Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of adverse events/serious adverse events are reported
Assist participating centre research staff in the local management of the study where required.
Skills, Knowledge and Experience
Clinical medicine background, Bachelor degree is a must; Master degree will be preferred;
At least 2 years working experience in clinic; more than 1 year working experience in the clinical research operation is a plus.
Interest in research methodology;
Familiar with the organization of hospital;