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Clin Quality Control Assessor

Covance 5/31/2018 6:03:29 AM
JOB ID: 20472 Category: Quality Assurance
Shanghai, China

   

 

Job Overview

¨ 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
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


Position Type: Full-Time

Location: Shanghai, CHN - China



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).