¨ Conduct Clinical Quality Control (CQC) visits to ensure compliance to the requirements of the clinical study protocol, standard operating procedures (SOPs), ICH / GCP guidelines and
relevant local, national and international legislation.
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
¨ 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