张女士
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- 职位介绍
- CRF
- CE认证
- Are you a Clinical Research Associate who wants to work with global CROs in the industry? Fortrea is seeking CRAs with at least 3 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! Responsibilities/Duties: 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 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.
- 其他信息
- 语言要求：英语、普通话
- 行业要求：全部行业
公司简介
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。继续致力与新型生物技术公司、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。
我们在全球拥有19,000多名员工，支持来自90多个国家和地区，涉及20多个不同治疗领域；我们有超过30年的临床研究经验、近700名医师和1,500名博士；平均每年＞100篇同行评审发表，科学期刊文章，治疗领域研讨与讲座及项目展示。为药物研发咨询，科学咨询委员会和FDA顾问委员会等专业机构提供支持。
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