Senior CRA - Sponsor-based

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">WHO ARE WE?</span></strong></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.</span><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"><br /><br /></span><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">THE JOB</span></strong></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"><br /></span><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">We are recruiting for our FSPx business in <strong>Hungary</strong> and are currently seeking to hire a<strong> Senior CRA </strong>with a <strong>permanent</strong>, <strong>full-time </strong>and<strong> sponsor-based contract</strong>. </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">At Labcorp Drug Development, you will have autonomy to organize your work and in return, you will be supported and empowered to</span><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;"> go be</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">yond the typical CRA role, to really be an expert on your protocols and to own your sites. </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsibilities include but are not limited to:</span></strong></p><ul><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Responsible for all aspects of site management as prescribed in the project plan</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Ensure the protection of 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-size: 10.0pt; font-family: 'Verdana',sans-serif;">Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Monitor data for missing or implausible data</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Ensure audit readiness at the site level</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Prepare accurate and timely trip reports</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Responsible for all aspects of registry management as prescribed in the project plans</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Undertake feasibility work when requested</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Participate in and follow up on Quality Control Visits (QC) when requested</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Might be requested to work in a client facing environment</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management</span></li><li><span style="font-size: 10.0pt; font-family: 'Verdana',sans-serif;">Assist with training, of new employees, e.g. co-monitoring</span></li><li>Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned</li></ul><h2>Education/Qualifications:</h2><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">We are searching for a university graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.</span></p><h2>Experience:</h2><ul><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Clinical monitoring in Pharma/CRO </span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Experience in interventional studies</span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Excellent understanding of Serious Adverse Event (SAE) reporting</span></li><li><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Fluent in English and Hungarian</span></li></ul>