MAJOR RESPONSIBILITIES, AND DUTIESOverseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical study.
Preparing protocols and other necessary documents required for trial approval by EC and get EC approval on time.
Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.
Giving input to query resolution, site closure and collection of documentation required for clinical trial reports after trail end.
Ensuring EDC/CTMS system is updated in a timely and accurate manner in accordance with requirements.
Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP.
Update investigator file and trial master file Build and maintain positive relationships with the site and investigators.
Ensure site visit reports and correspondence is completed in time.QUALIFICATIONSBachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse, BPharm).
At least 3-6 years clinical operation monitor experience for senior position.
Fluent English.
Good communication and organization skills.
Good and proactive working attitude.ABOUT USAs a contract research organization (CRO) in pharmaceutical R&D and clinical studies, Panacro Pharmaceutical Technology Co., Ltd. is committed to providing overall solutions for clinical studies & IND and NDA of chemical & biological drugs and vaccines.
Since its establishment in ****, Panacro has provided professional technical services to hundreds of customers at home and abroad in 20+ major therapeutic fields.
In addition, it established offices in 20 major provinces or cities in China.
With complete and detailed standard operating procedures (SOPs), and a professional team operating in accordance with international standards (ICH-GCP), it has built close cooperation with 80% study sites in China.
Panacro focuses on providing customers with quality and efficient professional services, in order to shorten the product marketing cycle, and facilitate the product marketization.
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