临床监察员 CRA/SCRA
科文斯医药研发(上海)有限公司GuangzhouUpdate time: August 7,2019
Job Description
广州市 天河区

职位信息



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).

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.


yuanxin.fang@covance.com


职能类别:临床研究员临床协调员

关键字:临床监察临床研究CRA/SCRA

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联系方式

上班地址:珠江新城珠江路12-16号高德置地广场H座

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公司信息

Why Covance?
At Covance, 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, 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, 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 to join us!

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