1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB Responsible for trials, which requires technical specialization, the ability to interface with investigators/doctors; Responsible for the drafting protocol and CT report; Summarize and share with RA group the CT study experience.

2.主要职责 / MAIN ACCOUNTABILITIES 1）Ensure the implementation of project plans as assigned; 2）Responsible for plan and protocol writing, data controlling, data reporting, and final report writing; 3）Take part in site selection, site qualification, site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and local regulations; 4）Prepare clinical trials, including ordering reagents, researching & writing trial plans and protocols, setting-up, equipping & training sites; 5）Make CT record and ensure the proper storage; 6）Take part in negotiating site contracts; 7）Conduct & monitor clinical trials and analyze data; 8）Problem solving & troubleshooting efforts on technical issues; 9）Prepare the final trial reports & close the trial; 10）Technical review to launch & close trials; 11）Collaborate with investigators on scientific posters & papers.

3.知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE 1.MSc in a scientific field (biology, pharmacy), medical background preferred 2.Good knowledge of clinical trial process 3.Good knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements, China regulation understanding preferred 4.Basic knowledge of protocol and other record drafting 5.Chinese native speaker with fluent English in both written and oral