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FSP - Senior Clinical Research Associate - Philadelphia

Laboratory Corporation of America Holdings (Covance)

Philadelphia, Pennsylvania, United States

<h2>Job Overview:</h2>Senior Clinical Research Associate - Oncology - Philadelphia Why settle for one thing when you can have everything. Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. 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 we have an FSP opportunity to match your area of expertise. You will enjoy the best of both worlds—all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio. This allows your expertise to shine through as you also become engrained in the sponsor culture helping to bring more therapies out to patients. Our FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global – extending to 60+ countries making us one of the largest FSP CROs. So not matter where you are locating on the globe we have an FSP opportunity for you. Essential Job Duties:<ul><li>Responsible for all aspects of study site monitoring and management 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</li><li>Organize and make presentations at Investigator Meetings</li><li>Participate in the development of protocols and Case Report Forms as assigned</li><li>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 as assigned</li><li>Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned</li><li>Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management</li></ul><h2>Education/Qualifications:</h2><ul><li>University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</li><li>In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.</li><li>Thorough knowledge of regulatory requirements</li><li>Thorough understanding of the drug development process</li><li>Fluent in local office language and in English, both written and verbal</li><li>Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job</li><li>COVID-19 vaccination required</li></ul><h2>Experience:</h2><h2>Minimum Required: </h2><ul><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Two (2) years of Clinical Monitoring experience</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Advanced site monitoring skills</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Advanced study site management skills</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Advanced registry administration skills</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Ability to work with minimal supervision</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Good planning and organization skills</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Good computer skills with good working knowledge of a range of computer packages</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Advanced verbal and written communication skills</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Ability to train and supervise junior staff</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Ability to resolve project-related problems and prioritizes workload for self and team</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Ability to work within a project team</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Works efficiently and effectively in a matrix environment</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Valid Driver's License</li></ul> Preferred:<ul><li style="margin: 1.05pt 11.5pt .0001pt .5in;">One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred</li><li style="margin: 1.05pt 11.5pt .0001pt .5in;">Local project coordination and/or project management experience</li></ul>

Job posted: 2021-12-02

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FSP - Senior Clinical Research Associate - Philadelphia

Laboratory Corporation of America Holdings (Covance)

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