更新于 今天
职位描述
ICHGCP临床试验监查肿瘤适应症监查药品临床监查生物工程医药制造
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.
职位福利：五险一金、年底双薪、补充医疗保险、带薪年假、定期体检、弹性工作
工作地点
天津河北区望海楼街道
公司信息
富启睿医药研发(北京)有限公司
已上市 · 1000-9999人 · 医药制造
已审核
公司介绍
2023年7月1日，Fortrea 正式从LabCorp拆分成为一家独立运营并公开上市的全球CRO。Fortrea将持续专注于不断增长的I-IV期临床研究以及患者服务领域，扩大在肿瘤学、临床药理学等方向上的行业地位。继续致力与新兴生物技术公司、跨国大型医药公司、医疗器械和诊断公司合作，驱动生命科学的创新，加速变革为推动惠及患者的疗法不断砥砺前行。
工商信息
企业名称 富启睿医药研发（北京）有限公司
企业类型 有限责任公司（外国法人独资）
法人代表 戴维·霍华德·库珀
经营状态 存续
成立时间 2005-01-20
注册资本 440万美元
认证资质
营业执照信息