SCRA
1、Develop a monitoring plan for drug clinical trials, ensure that the test complies with the requirements of GCP and research protocol, supervision of the research center;
2、Establish close relationship with researchers and coordinate with research centers;
3、Report and resolve any issues that arise during clinical trials;
4、Report and assist to deal with all kinds of adverse events in clinical trials timely ;
5、Management of experimental drugs, articles, samples, materials, etc ;
6、Participate in the feasibility study of various clinical trial centers, and conduct center screening and selection;
7、Participate in the organization of clinical trial protocol discussion, researcher training and summary meetings;
8、Assist supervisor to complete project management of clinical trial.
Position Requirements
1、Bachelor degree or above in clinical medicine or pharmacy;
2、At least 3 years clinical research experience in pharmaceutical company or CRO company;
3、International multi-center clinical research supervision experience is preferred;
4、Comprehensive knowledge of clinical trial management standards;
5、Familiar with the basic process of new drug development and the requirement of new drug application;
6、Excellent oral and written communication skills both in Chinese and English.