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Job Description |
Assist in the operational and logistical aspects of clinical trials according to GCP (Good Clinical Practice) and relevant Novartis procedures and assist in delegated tasks to support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study.
1. Provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth running of clinical trials in compliance with Novartis processes. Collaborate with the CTL in taking action to address issues as they arise.
2. Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary.
3. Translate study documents from English to Chinese and Chinese to English.
4. Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met e.g. contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups.
5. Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings e.g. internal CTL meetings or external investigator meetings. May attend and present at these meetings as appropriate.
6. Help ensure accuracy of clinical trial databases and resource tracking tools providing information and following up questions as necessary. Help check for discrepancies and take actions to correct as necessary.
7. Identify areas for process or technology improvements with regard to tasks undertaken within the role; propose and complete a project to enhance efficiencies and promote standardization across the organization based on this.
8. Assist in the forecasting, identification and ordering of clinical trial supplies. Recognize problems or delays and take action to prevent or address issues. Inform relevant project members as appropriate.
9. Responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guide-lines.
10. Attend Investigator/Site Initiation Meeting and First Dose/Monitoring Visit where required, and assist the CTL in organizing and conducting the meetings
Keyword:CNIBR, NIBR Shanghai |
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Minimum requirements |
1. A Bachelor’s degree or in the final year of a Bachelor’s degree program (for undergraduates), in life sciences.
2.Fluent English (oral and written)
3.Good organizational and interpersonal skills.
4.Attention to details.
5.Capable of clear written and verbal expression of ideas.
6.Ability to work independently and manage multiple priorities.
7.Computer literate. Good knowledge of Microsoft Office (Word, Excel, PowerPoint).
8.Some knowledge of clinical trial design, execution and operations would be beneficial. |
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