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Clinical Research Associate II, Bulgaria - FSP

Laboratory Corporation of America Holdings (Covance)

Bulgaria

<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 Labcorp Drug Development Senior Clinical Research Associate. </em></strong></span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Labcorp Drug Development FSP are looking to hire a Clinical Research Associate in Bulgaria. In this position you will be fully dedicated to our sponsor and will be home based. </span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">At Labcorp Drug Development, 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 aLabcorp Drug Development 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 Labcorp Drug Development 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 Labcorp Drug Development 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 aria-hidden="true" style="margin: 0px;"> </p><h2><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Responsibilities</strong> <strong>include:</strong></span></h2><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Own all aspects of site management as described in the project plans</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Review progress of projects and initiate appropriate actions to achieve target objectives</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Interact with internal work groups to evaluate needs, resources and timelines</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Act as contact for clinical trial suppliers and other vendors as assigned</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Independently perform CRF reviews</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Generate queries and resolve issues according to data review guidelines on Labcorp Drug Development or sponsor data management systems</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Assist with training, mentoring and development of new employees, e.g. co-monitoring</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</p><h2>Experience:</h2><ul><li>Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines</li><li>Excellent understanding of Serious Adverse Event (SAE) reporting</li><li>Ability to resolve project-related problems and prioritize workload for self and team</li><li>You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).</li></ul>

Job posted: 2021-07-26

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