Clinical Research Associate (CRA- Contract)

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    "requisitionDescription": "<div><div><div><div><div><div><link href=\"https://cdn.jsdelivr.net/npm/[email protected]/css/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\"><br></div><h1 id=\"isPasted\">Clinical Research Associate (CRA &ndash; Contract)</h1><p>Are you an independent contract CRA passionate about advancing human health? Are you driven by a constant desire to enhance your exposure to industry leading clinical trials? &nbsp;Are you ready to work with a company leading multiple projects with a shared sense of purpose? If this grabs your attention, please consider the opportunity below.</p><p><br></p><p>Beaufort seeks a skilled and dedicated Contract Based Clinical Research Associate with experience supporting in vitro diagnostic (IVD) clinical trials. &nbsp;We participate in an exciting and growing industry. &nbsp;We share our passion, knowledge and commitment to our projects and clients. &nbsp;Our clinical team works with multiple sponsors in multiple therapeutic areas with an emphasis in IVD.</p><p><br></p><p>A Clinical Research Associate at Beaufort holds the following key responsibilities:&nbsp;</p><ul><li>Build relationships with investigators and site staff</li><li>Understand the protocol and therapeutic area in sufficient detail to be able to advise and&nbsp;discuss with&nbsp;the study site personnel</li><li>Monitor patient recruitment timelines at sites and report this information to the project leadership.</li><li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol, SOPs and adherence to applicable regulations and GCP compliance</li><li>Participate in Investigator and other external or internal meetings as required</li><li>Perform site qualification visits, initiation visits, interim monitoring visits, and close-out visits as&nbsp;necessary</li><li>Responsible for conducting source data verification and providing written follow-up requests to the site in order to correct any issues identified at the monitoring&nbsp;visit</li><li>Update all relevant tracking systems on an ongoing basis</li><li>Generate site visit reports and expense reports within specified timelines</li><li>Arrange on-site visits and logistics (e.g., travel arrangements)</li><li>Conduct on-site study-specific training (if applicable)</li><li>Maintain day-to-day contact with the study sites, including regular telephone contact with the sites as agreed with Sponsor and Project Manager</li></ul><p>&nbsp;</p><p>There is a great amount of depth and breadth in this role. &nbsp; Because of this, we ask that you bring with you the education and/or experience that sets you up for success in this position. &nbsp;This generally looks like:</p><ul><li>Bachelor&#39;s Degree required</li><li>Must have at least 5 years of experience as a field monitor CRA</li><li>Experience monitoring IVD clinical trials is required</li><li>Experience working in a self-driven capacity, with a sense of urgency and limited oversight</li><li>The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s)</li><li>Must have excellent communication and interpersonal skills</li><li>Demonstrate&nbsp;flexibility regarding project or organization shifts in priorities</li><li>Ability travel: at least 1 to 2 site-visits per week (regionally)</li></ul><ul type=\"disc\"><li>Familiarity and working knowledge of electronic data capture systems (eDC), clinical databases, Case Report Forms, edit checks, query resolution, and resolving data management issues</li></ul><p><br></p><p>While the above are the standard requirements, you&rsquo;d really impress with:</p><ul><li>&nbsp;If you were&nbsp;well versed in current industry standards (GCP, ICH, FDA) and guidelines</li><li>&nbsp;If you had a&nbsp;proven track record of monitoring sites and executing successful projects</li><li>&nbsp;The ability to work with multiple sponsors in multiple therapeutic areas and indications</li></ul><p>&nbsp;</p><p>This position reports to Beaufort&rsquo;s CRA Manager. &nbsp; As a contract role, it offers flexibility and the opportunity for you to partner with a great team.</p><p><br></p><p>Beaufort offers a different CRO experience. It&rsquo;s not just about what we do, it&rsquo;s how we do it. &nbsp;Together our team brings a level of passion knowledge and commitment to our projects and clients. &nbsp;We foster a culture of excellence specializing in in vitro Diagnostic clinical project management and regulatory support. &nbsp;</p><p><br></p><p>At Beaufort you will be part of industry leading expertise with a shared sense of purpose and unwavering accountability to help clients achieve successful market authorization.</p><p><br></p><p>Beaufort is an equal opportunity employer and values diversity.</p><p>&nbsp;</p><div><link href=\"https://cdn.jsdelivr.net/npm/[email protected]/css/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\"><div class=\"fr-view\"><p style='margin-right:0in;margin-left:0in;font-size:15px;font-family:\"Calibri\",sans-serif;margin:0in;'><br></p></div></div></div></div></div></div></div>\n",
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