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抯 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.
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