医药-CRC/Clinical Research Manager

Responsibilities
• Interfaces with a multi-facete******** project team including clinicalan******** researchers, b******** data management an******** monitors toachieve successful clinical studies.
• Involves in recruitment of potential Invest******** preparation ofEthics Committee/Independent Regulatory Board (EC/IRB) subm********notifications to regulatory author******** translation of studyrelate********, organization of meetings an******** tasks asinstructe******** the PM.
• Prepares for HGRAC submissions if applicable.
• Initiates an******** study sites including site personnel, sitee******** an******** overs******** while maintaining protocol an********compliance.
• Supports for protocol ******** informe******** ******** investigatorbrochures, case report forms, study manuals an******** studyrelate********.
• Establ******** up******** tracks an******** study specific projectmanagement tool********, an******** reports.
• Performs pre-study visits
• Performs initiation visits
• Communicates effectively with site personnel, including the PrincipalInvestigator (PI), an******** management to relay protocol/studydeviations an******** timely implementation of corrective actions.
• Develops an******** strong working relationship with Investigatorsan******** staff, serving as an ambassador to promote HLT's high qualityan******** image.
• Maintains study track******** in accordance with the demands of thestudy.
• Support in Electronic Data Capture (EDC) system monitoring orup******** data management rev******** including in-house CRFrev******** if applicable.
• Demonstrates the understanding of the Serious Adverse Events (SAE)reporting process to regulatory authorities

Qualifications
• Bachelor’s degree in a scientific relate********, life sc******** orrelate********.
• CRA or clinical project experience.
• Knowledge of CFDA regulations an******** Clinical Practices essential.
• Experience in project management an******** research