北京招聘

工作内容：

• 负责对公司临床试验项目进行现场监督和核查，以确保试验按照相关标准操作程序、临床试验方案、SOPs、 GCP法规进行，发现问题并提出建议，及时提交稽查报告；

• 负责对临床试验文件、试验数据、监查员的工作总结与计划及其它相关资料进行定期检查，并及时提交稽查报告；

• 及时与监查员及研究者沟通，确保临床试验符合GCP和SOP规范；

• 合理制定稽查计划并组织实施，撰写稽查报告。及时跟踪稽查工作中发现的问题，并予以解决；

• 负责临床项目档案的管理、审核工作，形成审核报告，并提出纠正建议；

• 按规定对临床项目实施质量控制，分析质量问题并提出质量改进措施；进行质量记录，对通过稽查获得的信息和数据进行分析和处理，并对质量记录进行管理；

• 参与临床试验相关文件的制定、审核；参与标准操作规程的制定及实施过程的监督；

• 完成上级交办的其它工作

           

任职资格：

• 医学、药学相关专业，本科及以上学历；

• 熟悉GCP法规以及有关临床研究的相关法规，熟悉项目管理和监查流程，熟悉试验方案；

• 能够适应出差。

 

Responsibility:

• Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s); 

• Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Medpace/Sponsor Standard Operating Procedures (SOPs);

• Serve as the primary resource to the clinical investigator and site staff;

• Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams;

• Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak ? Monitoring Portal;

            

Qualifications:

• Bachelor's degree in Pharmaceutical or related major.

• Comprehensive knowledge of practices and procedures relating to all clinical monitoring visit types, including practical application of this knowledge;

• Demonstrated ability to act as a Lead CRA (as applicable);

• Act as a resource for new CRAs and ability to facilitate training and serve as a mentor for new CRAs; and

• Implements new ideas/solutions, without prompting, within their authority.

          

北京MEDOACE医药科技有限公司是一家美资独资在全球排名前十的CRO 公司，主要为欧美及亚太地区的新药上市提供临床监察，注册，数据统计及实验室服务。公司总部设立在美国俄亥俄州的辛辛那提，全球有超过4500名员工分布在28个国家。