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更新于 7月1日

CRA(FSP)

1.1-1.4萬
  • 北京朝陽區(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(diǎn)

北京朝陽區(qū)百環(huán)青創(chuàng)大廈

職位發(fā)布者

李經(jīng)敏/HRD

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(jī)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(cè)臨床到上市后各個(gè)研究階段,涵蓋包括:臨床監(jiān)查、項(xiàng)目管理、醫(yī)學(xué)事務(wù)、核心實(shí)驗(yàn)室、研究中心管理、生物統(tǒng)計(jì)、數(shù)據(jù)管理、注冊(cè)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(tuán)隊(duì)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(yàn)。他們能夠?yàn)榭蛻籼峁呐R床研究的策略形成、運(yùn)行實(shí)施、總結(jié)分析直至注冊(cè)申報(bào)等全方位的專業(yè)服務(wù),保證項(xiàng)目運(yùn)營的最高效化,以及運(yùn)營及研究風(fēng)險(xiǎn)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(jī)器人、骨科、口腔、皮膚科等多治療領(lǐng)域的注冊(cè)研究和科研臨床積累了豐富的經(jīng)驗(yàn),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(shí),依托對(duì)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(jī)構(gòu)積極合作,助力客戶制定合理高效的注冊(cè)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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