Responsibilities
* Overseeing 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.
Qualifications
* Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse, BPharm)
* At least 3-6years clinical operation monitor experience for senior position.
* Good communication and organization skills
* Good and proactive working attitude
As 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 2004, 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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