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猎头职位---医药专业应届研究生
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Dear All we are TTC Our team focus on pharmaceutical industry especially in clinical operation, medical dept. and quality management. Currently we are looking for Fresh graduate in 2012 of Pharmacology or Clinical Medicine related for a global CRO company. major. Email：queenayang@toptconsult.com telephone：01052898103 Our Weibo: http://weibo.com/toptconsult JOB TITLE: Clinical Research Associate 1. PURPOSE OF THE JOB: Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with company’s SOPs/WPs, applicable regulations and the principles of ICH –GCP 2. JOB FUNCTIONS/RESPONSIBILITIES: • Familiarity with company’s SOPs/WPs, ICH-GCP and appropriate regulations. • Familiarity with company systems. • Maintain timelines. Ensure accuracy and completeness of data entered into company systems. • Familiarity with principles of investigator recruitment. • Assist with coordinating all the necessary activities required to set up and monitor a study, including the following: - Identify investigators. - Help, when requested, in preparation of regulatory submissions. - Design patient information sheets and consent forms. - Coordinate documents translation, verification and back translations where required. - Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements. - Pre-study/placement and initiation visits. - Conduct regular monitoring visits in accordance with the company site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate - Maintain all files and documentation pertaining to studies. - Motivate investigators in order to achieve recruitment targets. - Complete accurate study status reports. - Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs. - Keep the Project Manager regularly informed. - Process case record forms to the required quality standards and timelines. JOB DESCRIPTION - Deal with sponsor generated queries in a timely manner. - Ensure the satisfactory close-out of investigator sites. - Ensure correct archiving of files on completion of a study. - Co-operate with sponsor and/or company QA personnel in the conduct of QA audits. - Participate in feasibility studies for new proposals, as required - Maintain patient and sponsor confidentiality. • To participate, if requested, in the preparation of and review of study documentation e.g., draft protocols, draft CRFs, monitoring guidelines and elements of final report. • Participate in data listing reviews, as applicable. • To be cost effective. • Ability and willingness to travel at least 60% of the time (international and domestic: fly and drive). • Assist with marketing the company if and when appropriate. • Other duties as assigned. 3. QUALIFICATIONS/EXPERIENCE REQUIRED: • Master degree or equivalent degree/experience and a background in Pharmacology or Clinical Medicine related major • Good oral and written communication skills. • Fresh graduate in 2012 [ Last edited by 酷爱娃娃 on 2012-5-6 at 00:28 ] |
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