CRA
職位描述
Are you a Clinical Research Associate who wants to work with one of leading global CROs in the industry? Covance is seeking CRAs with at least 1 year clinical monitoring experience NATIONWIDE, and has a variety of CRA needs in Phase II-IV and Phase I (Early Clinical Development) in multiple therapeutic areas such as oncology, cardiovascular, diabetes mellitus, endocrinology, etc. Whether you’re ready to make a move or just interested in learning more, apply TODAY and let’s talk together!
Covance China is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Trial Operations Team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies.
Responsibilities/Duties:
Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Responsibilities and duties include, but are not limited to the following:
? Take charge of all aspects of Site Management as prescribed in the project plans.
? Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.
? Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned.
? Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
? Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.
? Assist with training, mentoring, and development of new employees, e.g. co-monitoring.
? Perform other duties as assigned by management.
Education/Qualifications:
? University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Experience:
In lieu of the above requirement, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
? Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
? Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
? CRA II positions require 2+ years of clinical research monitoring experience
? Senior CRA positions require 4+ years of clinical research monitoring experience. Alternatively candidates with 4+ years supervisory experience in a health care setting and 3+ years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may also be considered.
Preferred:
One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. More years of experience preferred if apply senior level CRA positions.
About Covance:
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 11,000 employees in 60 countries. We began operations in Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Why Covance China?
At Covance China, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance China, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
We Offer
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance China, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time and choice to join us!
企業(yè)簡(jiǎn)介
科文斯,全球性的合同研究組織(CRO)Covance Inc.是全球服務(wù)最全面的藥物研發(fā)公司。
我們致力于推動(dòng)醫(yī)療保健事業(yè)發(fā)展并實(shí)現(xiàn)Solutions Made Real?,通過向制藥公司和生物科技公司提供高質(zhì)量的非臨床、臨床前試驗(yàn)、臨床和商業(yè)化服務(wù),幫助減少藥物研發(fā)的時(shí)間和成本。憑借豐富的經(jīng)驗(yàn)與深厚知識(shí),我們具備獨(dú)特的優(yōu)勢(shì),能為客戶合作伙伴提供不僅僅局限于測(cè)試的獨(dú)到見解。
我們還向化學(xué)品、農(nóng)用化學(xué)品和食品行業(yè)提供實(shí)驗(yàn)室測(cè)試服務(wù),同時(shí)也是毒理學(xué)分析服務(wù)、中心實(shí)驗(yàn)室服務(wù)、藥物篩選服務(wù)的市場(chǎng)領(lǐng)導(dǎo)者,以及III期臨床試驗(yàn)管理服務(wù)的全球頂級(jí)提供商。
科文斯官網(wǎng): https://www.covance.com/
職位發(fā)布企業(yè)
科文斯醫(yī)藥研發(fā)(北京)有限公司上海分公司
企業(yè)性質(zhì):外資企業(yè)
企業(yè)規(guī)模:5000-10000人
成立年份:2006
企業(yè)網(wǎng)址:www.covance.com
企業(yè)地址:上海市普陀區(qū)嵐皋路555號(hào)602-606室
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職位發(fā)布日期: 2018-03-09