Clinical Trial Assistant

Job Title :Clinical Trial Assistant
Department Clinical Operation
Report To
Subordinate N/A
Sensitivity Sensitive, NDA is a must
Location Shanghai

Assist Project Leader and Clinical Research Manager with the identification and selection of investigators to undertake clinical studies, when required.
Assist Project Leader and Clinical Research Manager with preparation of study budget.
Prepare documentation for Ethics Committee submission.
Coordinate receipt and distribution of clinical trial supplies.
Identify and source study supplies.
Prepare and conduct initiation visits.
Oversee assigned clinical trials to ensure compliance with the highest standards of GCP and according to company’s SOPs.
Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel.
Liaise with and report to Project Leader/SM regularly on study status through monitoring reports and meetings.
Document all study related communications.
Perform Source Data Verification to ensure accurate data is recorded.
Ensure all Serious Adverse Events are reported and followed up according to company SOPs.

Job Requirements
Bachelor degree or above at Medicine or related field.
At least 1 year experience for CTA
Good working knowledge of GCP guidelines.
Proficiency in Basic Microsoft Word and Excel and familiarity with use of database.
Knowledge of drug development process.
Knowledge of clinical trial methodology.
Result oriented.
Customer focus and teamwork.
Organizational commitment.
Good communication skill.