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- Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical study.
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- Preparing protocols and other necessary documents required for trial approval by EC and get EC approval on time.
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- Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.
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- Giving input to query resolution, site closure and collection of documentation required for clinical trial reports after trail end.
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- Ensuring EDC/CTMS system is updated in a timely and accurate manner in accordance with requirements.
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- Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP.
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- Update investigator file and trial master file
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- Build and maintain positive relationships with the site and investigators.
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- Ensure site visit reports and correspondence is completed in time.
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Qualifications
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- Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse , BPharm)
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- At least 3-6years clinical operation monitor experience for senior position.
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- Good communication and organization skills
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- Good and proactive working attitude
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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.
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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.
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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.
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Panacro focuses on providing customers with quality and productive professional services, in order to shorten the product marketing cycle, and facilitate the product marketization.
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📌 Clinical Research Associate (New South Wales)
🏢 PanaCRO
📍 New South Wales
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