职位描述:
As a Clinical Research Associate, you will be respoible for making sure that the proper standard of protocol is being met at all terms of the clinical trial study, and you are to eure that the scheduled methods are being executed in the manner in which they should.
?Respoible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendo; and other duties, as assigned
?Respoible for all aspects of site management as prescribed in the project pla
?Recruitment of potential investigato, submissio preparation, notificatio to regulatory authorities, tralation of study-related documentation, organization of meetings and other tasks as itructed by supervisor
?Negotiate study budgets with potential investigato and assist the Covance legal department with statements of agreements as assigned
?Complete Serious Advee Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
?Independently perform Case Report Forms (CRF) review; query generation and resolution agait established data review guidelines on Covance or client data management systems as assigned by management