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更新于 7月1日

CRA(FSP)

1.1-1.4萬
  • 上海徐匯區(qū)
  • 1-3年
  • 大專
  • 全職
  • 招2人

職位描述

醫(yī)療器械監(jiān)查
In general, it provides site monitoring and management services on DUA/RWE/PMS studies within MAO function and coordinate the operational budget and resources across multiple tasks to ensure that studies conduction meets performance targets and results. - Arranging Site/Investigator Selection visit to assess the eligibility of the site. - Support on EC submission and approval before any study activities. - Acting as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout study period. (Investigator meetings, site visits, study progress, issues/resolutions, etc.). - Proper training and communication to ensure the study procedure and data collection requirement are well understood. - Discussion of the recruitment plan and study timeline with PI and site personnel to get alignment with targeted goal. - Oversight of site study supplies and drugs/device/biologic supplies to ensure the proper handling, storage and return with accurate inventory and dispense records. - ISF maintenance and ensuring secured storage on site. - Ensuring the data collection and query resolution in a timely manner. - Ensuring safety events are well documented and timely reported per protocol requirement. - Reporting of site progress regularly and working with project leader on issues found on site in time and providing updates until the issues are well resolved. Metrics/KPIs: Metrics/KPIs governing these services are based on the feedbacks from service- related stakeholders and project leaders. Education and Experience Requirements: · A minimum of a BA/BS degree, major in Medicine/Nursing/Biomedicine are preferred. · 1-2 years of relevant experience. · Able to work effectively with all levels of the organization. · Teamwork and collaboration · Fluent in English reading and writing. · Skillful at organizing and coordinating. · Willingness to travel with overnight stay away from home. · Good time management skill. · Good problem-solving skills and initiatives. · Good computer skill (Word, Excel, Outlook, PowerPoint). · Attention to detail.

工作地點

上海徐匯區(qū)亞太企業(yè)大樓

職位發(fā)布者

李經(jīng)敏/HRD

昨日活躍
立即溝通
君岳醫(yī)藥科技(上海)有限公司
君岳醫(yī)藥科技(上海)有限公司,是一家專研于器械科技(即醫(yī)療器械,體外診斷和AI科技)領(lǐng)域的臨床研究服務(wù)機構(gòu)(CRO)。從2015年成立,已經(jīng)為多家國內(nèi)外知名器械科技公司提供了專業(yè)的臨床研究服務(wù)。公司提供的全方位臨床研究服務(wù)范圍覆蓋從上市前研發(fā),注冊臨床到上市后各個研究階段,涵蓋包括:臨床監(jiān)查、項目管理、醫(yī)學(xué)事務(wù)、核心實驗室、研究中心管理、生物統(tǒng)計、數(shù)據(jù)管理、注冊事務(wù)、器械安全管理、醫(yī)學(xué)翻譯等服務(wù),為客戶提供器械科技研發(fā)的全生命周期一站式服務(wù)。公司核心管理團隊均來自國際一線CRO公司和國際知名器械公司,擁有超過15年以上臨床經(jīng)驗。他們能夠為客戶提供從臨床研究的策略形成、運行實施、總結(jié)分析直至注冊申報等全方位的專業(yè)服務(wù),保證項目運營的最高效化,以及運營及研究風(fēng)險的可控化。公司分別在心血管介入、神經(jīng)介入、腫瘤、呼吸介入、人工智能、機器人、骨科、口腔、皮膚科等多治療領(lǐng)域的注冊研究和科研臨床積累了豐富的經(jīng)驗,和臨床研究中心及研究者保持著長期緊密的合作關(guān)系。同時,依托對于大中華區(qū)、歐美及亞太器械法規(guī)環(huán)境的熟悉了解,公司與各國當(dāng)?shù)乇O(jiān)管機構(gòu)積極合作,助力客戶制定合理高效的注冊策略,加速中國器械科技廠家的全球市場布局。公司網(wǎng)站:www.ccrcmed.com
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