Clinical Research Associate (CRA)

Job Description:
1, Conduct the clinical study a/c to the requirement of Sponsor
2, Assist to organize the investigator meeting, including the pre-preparation, communication, speech materials and problem solution and follow-up
3, ensure the timely EC submission and other trial materials, such as protocol, IC etc., and get the approval of EC
4, Conduct the on-site monitoring, including the site qualification audit, site initiation, monitoring and close-out.
5, Ensure the clinical operation complying with GCP/ICH-GCP and GCP in EPS Intl or the sponsor
6, Keep the regular communication with the sites, ensure the compliance of the protocol and GCP, the timely, real and accurate of the clinical data record
7, Encourage the investigator to accomplish the aim of enrollment
8, Maintain all the trial related dossiers and documents
9, Ensure the normal storage and inventory of the IP a/c to SOP requirement
10, Communicate with the project manager, senior CRA and other team member about the trial process related information
11, Timely and accurate trial process report to be accomplished
12, Timely dealing with the query
13, Ensure the proper archiving of the document after the trial ends
Qualifications:
1, Bachelor degree of pharmaceutical, nursing, medicine or related majors
2, A minimum of 1-2 experience of clinical trials
3, Master the related regulation of GCP, ICH/GCP
4, Familiar with the terminology of clinical research and laboratory
5, excellent analysis capability and problem solution
6, proficient in both oral and written English, Japanese is a plus
7, Skillful at Microsoft Office and Outlook
8, Dynamic, initiative and team work