北京招聘

职位描述：
Responsibilities/Duties
Conduct Clinical Quality Control (CQC) visits to ensure:
o Principal Investigator (PI) oversight, Investigator audit / inspection readiness and adherence to the standards of ICH / GCP guidelines.
o Clinical Research Associate (CRA) compliance with monitoring responsibilities as
specified in Covance SOPs, study plans, and ICH / GCP guidelines.
o Site compliance to the protocol to ensure the safety, rights and integrity of subjects is adequately protected.
¨ Prepare, conduct, report and follow up on the CQC visit according to established guidelines.
¨ Ensure that all pertinent issues identified during a CQC visit including but not limited to subject safety, PI oversight, CRA competency issues are escalated appropriately.
¨ Coordinate regional CQC visit conduct to ensure that country specific targets are met.
¨ Ensure that all issues identified within CQC visits are followed-up within the specified
timeframe and learning’s are promptly communicated across functional teams.
¨ Contribute to Country specific quality plans and strategies to identify, address and resolve operational issues and ultimately demonstrate best in class standards.
¨ Coach and mentor members of the Clinical Operations function that either:
o Have involvement within the conduct of CQC visits.
o Are identified as requiring additional support.
¨ As required, conduct site monitoring and management responsibilities according to Covance Standard Operating Procedures (SOPs), ICH / GCP guidelines.

*Education/Qualifications
Required:
¨ University Bachelors degree in a medical or scientific discipline, or related field.
¨ Nursing qualification / certification may be considered in lieu of a University degree.

*Experience
Minimum of four years of clinical research site monitoring experience (including pre-study,
site initiation, routine monitoring and close-out visits).
¨ Working knowledge of ICH / GCP guidelines and the pharmaceutical development process.
¨ Experience of supporting and formally / informally mentoring colleagues.
¨ Track record of meeting commitments and driving change, using a highly collaborative
approach, and emphasising team success versus individual achievement.
¨ Advanced planning and organisational skills
¨ Previous Quality Control or Quality Assurance experience is preferred. 举报 分享

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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