Clin Quality Control Assessor

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Conduct Clinical Quality Control (CQC) visits to ensure:</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">o Principal Investigator (PI) oversight, Investigator audit / inspection readiness and</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">adherence to the standards of ICH / GCP guidelines.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">o Clinical Research Associate (CRA) compliance with monitoring responsibilities as</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">specified in Covance SOPs, study plans, and ICH / GCP guidelines.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">o Site compliance to the protocol to ensure the safety, rights and integrity of subjects is</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">adequately protected.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ Prepare, conduct, report and follow up on the CQC visit according to established guidelines.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ Ensure that all pertinent issues identified during a CQC visit including but not limited to</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">subject safety, PI oversight, CRA competency issues are escalated appropriately.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ Coordinate regional CQC visit conduct to ensure that country specific targets are met.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ Ensure that all issues identified within CQC visits are followed-up within the specified</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">timeframe and learning’s are promptly communicated across functional teams.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ Contribute to Country specific quality plans and strategies to identify, address and resolve</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">operational issues and ultimately demonstrate best in class standards.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ Coach and mentor members of the Clinical Operations function that either:</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">o Have involvement within the conduct of CQC visits.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">o Are identified as requiring additional support.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">¨ As required, conduct site monitoring and management responsibilities according to Covance</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Standard Operating Procedures (SOPs), ICH / GCP guidelines.</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;">University Bachelors degree in a medical or scientific discipline, or related field.</p><p style="margin: 0px;"><span style="font-family: Times-Roman; font-size: medium;">Nursing qualification / certification may be considered in lieu of a University degree.</span></p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-family: Symbol; font-size: medium;">¨ </span><span style="font-family: Times-Roman; font-size: medium;">Minimum of four years of clinical research site monitoring experience (including pre-study,</span></p><p style="margin: 0px;">site initiation, routine monitoring and close-out visits).</p><p style="margin: 0px;"><span style="font-family: Symbol; font-size: medium;">¨ </span><span style="font-family: Times-Roman; font-size: medium;">Working knowledge of ICH / GCP guidelines and the pharmaceutical development process.</span></p><p style="margin: 0px;"><span style="font-family: Symbol; font-size: medium;">¨ </span><span style="font-family: Times-Roman; font-size: medium;">Experience of supporting and formally / informally mentoring colleagues.</span></p><p style="margin: 0px;"><span style="font-family: Symbol; font-size: medium;">¨ </span><span style="font-family: Times-Roman; font-size: medium;">Track record of meeting commitments and driving change, using a highly collaborative</span></p><p style="margin: 0px;">approach, and emphasising team success versus individual achievement.</p><p style="margin: 0px;"><span style="font-family: Symbol; font-size: medium;">¨ </span><span style="font-family: Times-Roman; font-size: medium;">Advanced planning and organisational skills</span></p><p style="margin: 0px;"><span style="font-family: Symbol; font-size: medium;">¨ </span><span style="font-family: Times-Roman; font-size: medium;">Previous Quality Control or Quality Assurance experience is preferred</span></p>