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Clinical Research Associate I - sponsor dedicated

Laboratory Corporation of America Holdings (Covance)

Budapest, Hungary

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥<strong≥<em≥Discover new opportunities to grow your career as a Covance by Labcorp FSP Clinical Research Associate I. </em≥</strong≥</span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Covance by Labcorp FSP are looking to hire a <strong≥<span style="text-decoration: underline;"≥CRA I in Hungary</span≥.</strong≥ In this position you will be fully dedicated to our sponsor and will be home based. </span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥At Covance by Labcorp, you can redefine what is possible and discover your extraordinary potential within our <strong≥Functional Service Provider</strong≥ team (FSP).</span≥</p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥As a Covance by Labcorp employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.  Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance by Labcorp has an FSP opportunity to match your area of expertise. </span≥</p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance by Labcorp studies.</span≥</p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.</span≥</p≥<p style="margin: 0px;"≥ </p≥<h2≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥<strong≥Responsibilities</strong≥ <strong≥include:</strong≥</span≥</h2≥<p style="margin: 0px;"≥ </p≥<ul≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥All details of site management as prescribed in the project plans</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Negotiation of study budgets with potential investigators and collaboration with Covance by Labcorp legal department with statements of agreements</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance by Labcorp or client data management systems</span≥</li≥</ul≥<h2≥Education/Qualifications:</h2≥<ul≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Life Science degree preferred or similar qualification.</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Previous experience in monitoring study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines <strong≥<span style="text-decoration: underline;"≥is required</span≥</strong≥</span≥</li≥<li≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Excellent understanding of Serious Adverse Event (SAE) reporting</span≥</li≥<li≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Ability to resolve project-related problems and prioritize workload for self and team</span≥</li≥<li≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).</span≥</li≥</ul≥

Job posted: 2021-02-09

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