Clin Quality Control Assessor 北京

月薪： 1.8-2.7万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 年终奖金
  • 专业培训
  • 定期体检
  • 通讯补贴

职位描述

职位描述： Responsibilities/DutiesConduct 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 asspecified 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 specifiedtimeframe 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/QualificationsRequired:¨ University Bachelors degree in a medical or scientific discipline, or related field.¨ Nursing qualification / certification may be considered in lieu of a University degree.*ExperienceMinimum 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 collaborativeapproach, and emphasising team success versus individual achievement.¨ Advanced planning and organisational skills¨ Previous Quality Control or Quality Assurance experience is preferred. 职能类别： 生物工程/生物制药 药品生产/质量管理 关键字： Covance 科文斯 Clin Quality Control Assessor GRO 生物制药

联系方式

朝阳区建国路91号金地中心A座1501-1508

公司信息

Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!

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