clinical project coordinator(contractor) 北京

月薪：

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： POSITION RESPONSIBILITIES?Support Clinical Research Specialist (CRS)/Clinical Study Manager (CSR) to ensure successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct.?Attend study team meeting, take minutes and follow up on action items. Assist CRS/CSM in meeting preparation, as needed?Assist in the development and updates of study-related materials and plans (training materials, study plans, patient materials, etc) and ensure appropriate approvals before implementation?Maintain trackers for and file documents for sponsor and site training, IRB approvals, site documents (CV, medical licenses, etc), and monitoring activities?Maintain trackers for management of study enrollment?Assist in tracking site initiation and activation activities?File all study documents (general and site documents) in the Trial Master file (TMF, paper and electronic study files as requested), track study documentation in TMF, assist in conducting TMF reviews, ensure proper documentation of TMF reviews?Contribute to accurate and timely study status reports to study team and management and follow action items through resolution.?Maintain documentation to be consistent with regulations and SOPs.?Support efforts for vendor selection, negotiation and execution of contracts and payments?Work with Operations with device management (e.g., forecasting, procurement, shipment and receipt, accountability, failure analysis, SAP transactions).?Assist with configuration of the Clinical Trial Management System (CTMS) for the study?Ad hoc projects as assigned in the optimization of procedures and processes.?Works within and actively promote Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct.BASIC QUALIFICATIONS:?Bachelor’s degree, preferably in Sciences?1+ years of experience in academia, medical device, biologics, or pharmaceutical industry?Work Experience directly supporting clinical research or similar experience in a medical/scientific area?Experience with GCPs and regulatory compliance guidelines for clinical trials?Attention to detail and accuracy and ability to manage multiple tasks. 职能类别： 临床协调员 关键字： 药品监察 药物监察 临床协调

联系方式

北京

公司信息

About Medtronic Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others. We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

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