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Clinical Research Associate (Home based)

Laboratory Corporation of America Holdings (Covance)

Madrid, Spain

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">Covance FSP<span style="font-family: verdana, geneva;"> are looking to hire a CRA I <strong>based preferably in MADRID</strong></span></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;">In this position you will be fully dedicated to our sponsor and will be home based.</span><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;">At Covance, 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;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;">As a Covance 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 has an FSP opportunity to match your area of expertise. </span></p><p style="margin: 0px;"><span style="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 studies.</span></p><p style="margin: 0px;"><span style="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><strong>Responsibilities</strong> <strong>include:</strong></span></h2><ul><li><span style="font-size: 10pt;">All details of site management as prescribed in the project plans</span></li><li><span style="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-size: 10pt;">Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements</span></li><li><span style="font-size: 10pt;">Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.</span></li><li><span style="font-size: 10pt;">Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 10pt;">University degree in life sciences (preferrably in pharmacy), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</span></li><li> </li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10pt;"><strong>Ability & experience monitoring study sites independently</strong> according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines</span></li><li><span style="font-size: 10pt;">Excellent understanding of Serious Adverse Event (SAE) reporting</span></li><li><span style="font-size: 10pt;">Ability to resolve project-related problems and prioritize workload for self and team</span></li></ul><p style="margin: 0px;"><span style="font-size: 10pt;">REMOTE - HOME BASED</span></p>

Job posted: 2021-09-29

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