Clin Quality Control Assessor

Job Location(s) CN-Shanghai
Job Number
Job Category
Quality Assurance
Position Type

Job Overview

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.


University Bachelors degree in a medical or scientific discipline, or related field.
Nursing qualification / certification may be considered in lieu of a University degree.


¨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


Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed