临床监察员 CRA/SCRA
科文斯医药研发(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-11-10
- 工作地点:广州-天河区
- 招聘人数:2人
- 工作经验:1年经验
- 学历要求:本科
- 职位月薪:1.1-2.2万/月
- 职位类别:临床研究员 临床协调员
职位描述
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
公司介绍
欢迎加入科文斯中国团队,我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号,通过移动端迅速查询热招职位并投递申请,与我们并肩实现#CovancePotential。
联系方式
- Email:yuanxin.fang@covance.com
- 公司地址:地址:span浦东新区伽利略路338号9号楼