北京招聘

Clinical Research Associate (CRA，临床监查员) - Covance FSPx China

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).
• Good English ability in writing and speaking.

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 at least 2.5 years of clinical research monitoring experience.
• Senior CRA positions require at least 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.

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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。