主要职责：

• 负责临床试验的实施和监查工作，确保临床试验按标准操作程序执行；
• 正确理解项目经理的指示；
• 维护临床单位及专家们的良好合作关系；
• 确保试验文件妥善保管，归档以及药品的发放及回收；
• 负责跟踪控制进度，确保试验质量；
• 报告和处理临床试验中的药物安全信息。

基本要求：

• 临床医学、药学等相关专业本科学历；
• 无或1年相关领域工作经验；良好的英文听说读写能力；
• 熟练临床试验监查、SFDA法规、GCP/ICH条例；
• 有较好的沟通表达能力；
• 可以适应频繁的出差；
• 熟练操作电脑。

CRA will be reposnsible for the progress of the GPRD clinical trial, ensuring the trial is conducted, recorded and reported according to the protocol, company SOPs, GCP and relevant regulaitons. And be responsible for site management to administer the protocol and related training to assigned sites and build the communication with assigned sites to achive the project goals.

Description of Job

• Conduct pre-study, initiation, monitoring, and closeout visits for research sites according to Medpace/Sponsor SOPs and GCP;
• Maintain ongoing site correspondence and site files;
• Complete visit reports and maintaining study-related databases;
• Oversight and interaction with clinical research sites; and
• Review of patient charts and clinical research data.

Qualifications/Requirements

• University degree in health-related field;
• 0 to 1 years of experience as a CRA;
• Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities;
• Computer literacy;
• Excellent verbal and written communication skills in English and local language;
• Should be both a team worker and self-motivated professional ;
• Detailed-minded & well-organized;
• Strong determination to grow with the organization

To apply please access our career opportunities on our website at: Medpace.com::Career Opportunities, and apply for this position through our system.

上班地址：上海市浦东新区高科中路