Clinical Research Associate, Shanghai&Beijing

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PRIMARY FUNCTION

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

MAJOR RESPONSIBILITIES AND DUTIES
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
• 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 
Internal: staffs within C&R department
External: Investigators and other relevant persons in hospitals or institutes