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更新于 4月3日

杭州-臨床監(jiān)查員

1.5-1.6萬
  • 杭州上城區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

新藥仿制藥Ⅰ期Ⅱ期Ⅲ期
Primary Responsibilities: ? Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work, SOPs (and / or the Sponsor’s SOPs as appropriate) and the ICH GCP and associated regulations. May perform co-monitoring visits and other types of site visits as needed. ? Support development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan to meet project recruitment target. ? Administer protocol and related study training to assigned sites and establish regular lines of communication with sites, ensure that study milestones for sites responsible are met as planned with high quality (i.e., study startup, recruitment, database lock, closeout, etc.) ? Create and maintain appropriate documentation regarding site management, monitoring visit activities by submitting regular visit reports and/or other required study documentation. ? Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Take corrective action and preventative actions to mitigate the risk. Escalate quality issues as appropriate. ? Manage the daily progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, Ethics Committee documents submissions and approvals, study drug management, document filing, site payments, data query generation and resolution. May support start-up phase and additional site-self assessment requirements. ? Collaborate and liaise with study team members for other project execution support as appropriate. ? Performs additional task as assigned by line manager. ? May be assigned as the mentor of less experienced CRAs ? Other activities/tasks assigned by supervisors.

工作地點(diǎn)

上城區(qū)杭州站

職位發(fā)布者

彭女士/HR

今日活躍
立即溝通
公司Logo昆翎(北京)醫(yī)藥科技發(fā)展有限公司
昆翎(ClinChoice)是一家致力于為生物醫(yī)藥和醫(yī)療器械客戶提供高品質(zhì)一站式服務(wù)的臨床階段CRO,服務(wù)包括臨床運(yùn)營、項(xiàng)目管理、生物統(tǒng)計(jì)、數(shù)據(jù)管理、注冊(cè)事務(wù)、醫(yī)學(xué)事務(wù)和藥物警戒。昆翎已經(jīng)在中國、美國、歐洲、印度、日本和菲律賓建立了主要的臨床交付中心,目前在全球擁有1800多名員工,其臨床運(yùn)營團(tuán)隊(duì)覆蓋了亞、歐、北美等七個(gè)國家和地區(qū)。高盛直投部董事總經(jīng)理、昆翎董事會(huì)成員許小鷗先生認(rèn)為,“隨著創(chuàng)新療法在全球的增長(zhǎng),CRO公司提供高效、可靠的研發(fā)服務(wù)能力變得尤其重要。昆翎獨(dú)特的價(jià)值主張結(jié)合了其對(duì)于本地市場(chǎng)的了解、國際藥物研發(fā)的經(jīng)驗(yàn)以及高效的團(tuán)隊(duì)執(zhí)行能力。我們堅(jiān)信公司強(qiáng)勁的管理層團(tuán)隊(duì)以及其高效的執(zhí)行能力,將為昆翎的發(fā)展開啟新的篇章。
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