Shanghai Innogen Pharmaceutical Technology
Clinical Research Associate
ShanghaiFull timeSalary: To be discussed
Posted:
You will coordinate site work from selection and initiation through enrolment, monitoring and close-out. You will help investigators and study teams keep trials on plan, maintain GCP compliance, and manage practical needs such as supplies, payments and application documents.
Your work
- Carry out site selection, initiation, patient enrolment, routine monitoring and close-out in line with the protocol and GCP regulations and guidance.
- Help the Clinical Project Manager and Operations Director prepare feasibility reports for study sites and investigators.
- Oversee study sites and lead the coordination of site matters so that work meets the study plan, project requirements and GCP standards.
- Prepare documents for ethics committee and human genetic resources applications.
- Manage amounts payable to study sites, keeping payments timely and within budget.
- Coordinate receipt and distribution of clinical trial supplies.
What you bring
- At least two years of clinical monitoring experience.
- Clear communication, effective teamwork and the ability to work under pressure.
Preferred experience
- A background in pharmacology, nursing or pharmacy.
- Experience with diabetes or weight-management studies.
- Experience with a clinical study from initiation through completion.
Original posting · Chinese
临床监察员
岗位职责
岗位职责 1、基于药品临床研究GCP相关法规指南要求，维护临床试验活动的法规符合性； 2、协助临床项目经理和运营总监完成研究中心和研究者的可行性分析报告； 3、根据试验方案进行中心筛选、项目启动、患者入组、常规监查、中心关闭等工作； 4、负责监督管理临床研究中心，主导临床研究中心的事务协调，使其满足临床研究计划、项目要求及GCP法规符合性； 5、为伦理委员会和人类遗传资源管的项目申请准备资料； 6、管理研究中心项目应付款项以保证付款及时性以预算控制； 7、协调临床试验供给物资的接收和发放； 8、其他：完成上级交办或授权处理的其他事项。
任职要求
1、药理、护理、药学专业优先； 2、两年及以上临床监查工作经验，具有糖尿病或减重项目经验优先； 3、有完整项目启动至结束的经验优先； 4、具有良好的表达能力、团队合作能力及抗压性。