Clinical Research Associate - Italy

<div><div>Job Description</div></div><div><div><div><div><p><span>Employed permanently by Labcorp Drug Development you will be fully dedicated to one sponsor (a top ten pharmaceutical company) working in multiple therapeutic areas (Cardiology, Respiratory, HIV) with a special focus on </span><b>Oncology</b><span>.</span><br /><br /><span>National travel within Italy will be expected.</span><br /><br /><span>This opportunity sits within the Labcorp Drug Development FSP business model - a very attractive environment with great potential for career development.</span><br /><br /><span>Ideally, we are looking for someone with monitoring experience but we will consider a junior (CRAI level) who is looking to develop, </span><b>as long as you already have some exposure to monitoring clinical trials.</b><br /><br /><span>Outsourced to our Client 100% of the time, you will be well supported by a dedicated Labcorp Drug Development line manager as well as by the Client project teams.</span><br /><br /><span>Your primary focus will be the monitoring of investigational sites within Italy!</span></p><p></p><p><u><b>A CRA at Labcorp Drug Development:</b></u></p><p><span>o Assures the implementation of project plans as assigned<br />o Site administration and site monitoring responsibility for<br />clinical studies according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP<br />o Site management responsibility for clinical studies according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP<br />o Act in the project role of as Local Project Coordinator or Lead CRA as assigned</span></p><p></p><p><span><b>Essential Job Duties</b><br />o 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<br />o Responsible for all aspects of site management as prescribed in the project plans<br />o General On-Site Monitoring Responsibilities<br />o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study<br />o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements<br />o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review<br />o Monitor data for missing or implausible data<br />o 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, including managing travel expenses in an economical fashion according to Labcorp Drug Development travel policy<br />o Travel, including air travel, may be required and is an essential function of the job.<br />o Prepare accurate and timely trip reports<br />o Responsible for all aspects of registry management as prescribed in the project plans<br />o Undertake feasibility work when requested<br />o 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></p><p><span>o Negotiate study budgets with potential investigators and assist the Labcorp Drug Development legal department with statements of agreements as assigned<br />o Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs<br />o Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems as assigned by management<br />o Assist with training, of new employees, e.g. co-monitoring<br />o Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned<br />o Perform other duties as assigned by management</span></p><p></p><div><div><div></div></div></div><p><b><span>Education / Qualifications</span></b><span> </span></p><p>o University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), and a minimum of 2 years of Clinical Monitoring experience.<br />o Thorough knowledge of monitoring procedures<br />o Basic understanding of the clinical trial process<br />o Valid Driver’s License</p><p></p><div><div><div></div></div></div><p><b><span>Experience</span></b></p><div><p><span>As an experienced CRA (with at least 1 year of monitoring) you’ll be involved in initiation, routine & closeout visits for studies in Phases II-IV of clinical development</span><br /><br /><span>Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.</span></p><p></p><p><span><b><u>If You Would Like To Learn More:</u></b><br /><a href="mailto:Mirko.Argentiero@labcorp.com" target="_blank">Mirko.Argentiero@labcorp.com</a></span></p><p><span>+39 </span> <span>345 0383908</span><span> </span></p></div></div></div></div></div><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>