北京招聘

The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.

I.      Job Summary:

The Study Coordinator is responsible for coordinating the activities of routine and non-routine studies, in compliance with the appropriate company standards, GLP and regulatory guidelines in a timely, efficient manner. General assistance to Study Directors will be an essential part of the role and additional non study specific support may be given to key clients. Additional daily duties may include support of other functions within Safety Assessment.

 Job Duties: 

¨     Provides administrative and scientific support for toxicology studies, including prestudy tasks (e.g., protocol development, costing, scheduling), monitoring the inlife progress of assigned studies, and interacting with clients.

¨     Provides administrative backup support for Study Directors on day to day study-specific activities or tasks.

¨     Learns to ensure study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.

¨     Learns to coordinate the study award process as applicable

¨     Learns to coordinate the efforts of a study team to become a successful project manager.

¨     Learns to plan, prioritize, and manage a workload and the associated responsibilities.

¨     Serves as a contact, along with the Study Director, in communication and interactions with other departments and clients, with assistance as applicable.

¨     Learns to maintain complete, organized, and current study files including study schedule, protocol, and applicable correspondence.

¨     Learns to draft protocols and amendments for Study Director Review and approval.

¨     Ensures all client comments on protocols and amendments are addressed in a timely manner.

¨     Initiates and submits costing and scheduling requests with assistance.

¨     Schedules and participates in preinitiation and other study-related meetings, as required, and takes and distributes preinitiation meeting minutes.

¨     Learns to draft and submit appropriate documents to the IACUC/AWERB for approval.

¨     Verifies the project schedule accurately reflects the requirements of the protocol.

¨     Learns to monitor progress and status of assigned studies with assistance.

¨     Learns to review data and identify deficiencies.

¨     Learns to compile data for clients for regular study progress updates.

¨     Learns to address and review quality assurance audits relating to protocols and amendments and reports (as applicable), with oversight.  Follows up with appropriate personnel to ensure all necessary document/data clarifications are completed in the specified timelines.

¨     Assists with hosting client visits.

¨     Learns to perform QC (peer) reviews on study reports.

¨     Undertakes other administrative or scientific duties as assigned.

¨     Learns to use project tracking systems, as appropriate

¨     Learns to assist the Study Director in monitoring the financial status of ongoing studies, including completion of work scope changes as applicable.

¨     Assist SD by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place

¨     May assist with the preparation (with guidance) CTD tables

¨     Prepare shipping documentation including CITES application requests and any other associated shipping documentation, as required per study

¨     General

o   May attend SD communication meetings as applicable and prepare minutes

o   May assist with the development of team policies, procedures and training manuals

  Minimum Required: ¨     Previous related job experience.  

  Recommended: Bachelor’s degree in a related science field. Experience may be substituted for education.      

Location: 上海市浦东新区周浦康新公路3377号（免费班车） 

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。

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