职位描述：
Responsibilities:
Assist Project Leader and clinical research manager with the identification and selection of investigators to undertake clinical studies, when required;
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 ICH- GCP and according to Merck’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 clinical research manager 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 Merck SOPs and local regulation.
Requirements:
Medical qualifications, bachelor degree or above in Clinical Medicine, Pharmacology and Public Health, etc.;
Good communication skill, possess good English skills;
Proficiency in computer skills;
Clinical research experience is preferred.
|
