职位详情

登录

FSP-CRA (北京)
1.3-2.1万
人 · 本科 · 无需经验 · 性别不限2024/11/08发布
五险一金补充医疗保险专业培训弹性工作

北京市

公司信息
富启睿医药研发(北京)有限公司上海分公司

外资(欧美)/1000-5000人

该公司所有职位
职位描述
Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Fortrea 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 Fortrea 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 Fortrea 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】
?Full experience in PSV, SIV, RMV, COV in chemical drug, phase II/III.
?1~3 years CRA experience for CRA I. For reference only
?2~4 years CRA experience for CRA II. For reference only
?At least 4 years CRA experience for SCRA. For reference only
?Oncology study experience is highly preferred.
?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.
?English workable is a MUST.

相关职位
R-01222716 FSP CRA1-2万
RA(医疗器械注册)1-1.6万
专业培训员工旅游餐饮补贴
R-01222716 FSP CRA1-2万
医学研究员1.5-2.5万·16薪
节日福利周末双休
医疗器械产品注册助理专员9千-1.3万
周末双休
查看所有职位
51米多多提醒你:在招聘、录用期间要求你支付费用的行为都必须提高警惕。 以招聘为名的培训、招生,许诺推荐其他工作机会,甚至提供培训贷款,或者支付体检 、服装、押金和培训等费用后才能录用工作的,都属于违法行为,应当提高警惕。一经发现,请立即举报,并向当地公安机关报案。

举报

招聘信息 > 北京招聘 > 生物制药招聘 > 北京临床监查员招聘

收藏

热门职位热门城市周边城市