PRIMARY FUNCTION

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？ Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring

MAJOR RESPONSIBILITIES AND DUTIES

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Site management for assigned trial

？ Be familiar with trial execution process of assigned trial

？ Be responsible for following activities:

® Site selection

® Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix etc.

® Site initiation

® Site monitoring based on applicable monitor plan

® Site close out visit

® Key personnel to coordinate with trial specific vendors to complete the trial related activities.

® Complete all trial related report within SOP defined timeline

？ Site master file and investigator file management

？ Deliver trial related training to site staffs

？ Update site status to project manager at timely manner

？ Prepare all required report to line manager at timely manner

Qualifications

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？ At least 2 year clinical trial on site management experience

？ At least bachelor degree in Clinical Medicine or Pharmacy or related major

？ Good communication skill and team player

？ Good command of computer skill

？ Adequate verbal and written communication skills in English

Internal-External Relations

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Internal: staffs within C&R department

External: Investigators and other relevant persons in hospitals or institutes

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