Covance Clin Quality Control Assessor in Shanghai, China

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.

Education/Qualifications

¨ 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 Required:

¨ 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

Job Number 2018-20069

Job Category Quality Assurance

Position Type Full-Time

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