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Clinical Research Associate I (Entry Level)

Laboratory Corporation of America Holdings (Covance)

Raleigh, North Carolina, United States

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 14pt; font-family: calibri, sans-serif;"><strong>Seeking Entry Level CRAs for our Oncology Monitoring Excellence Academy across the US!! Can be located in any major hub!  </strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 14pt; font-family: calibri, sans-serif;"><strong>Previous CRC, Site Management, Remote Monitoring, or other applicable experience required. </strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Are you ready to redefine what’s possible, and discover your extraordinary potential at Labcorp? A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Essential Job Duties:</span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Responsible for all aspects of study site monitoring with or without direct supervision (as per the training status of the CRAI-OMEA). This includes remote and/or onsite conduct of pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites. Conduct site management activities, maintain study files, liaise with vendors; perform other duties, as assigned. </span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Responsible for aspects of registry management as prescribed in the project plans</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">General On-Site Monitoring Responsibilities:</span><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Assist Clinical Research Associate I, II and Sr. CRAs with on-site tasks as required and according to training goals (e.g. review of Case Report Forms, Site Regulatory Files and conduct of drug accountability).</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Clinical Research Associate I, II and Sr. Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. Until Evaluation Sign-Off visit successfully completed for the CRA I – MEA, should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management). </span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Perform visits as required by the monitoring plan to include those indicated in the chart below.</span></li></ul></li></ul><table style="width: 341.25pt; margin-left: 45.0pt; border-collapse: collapse;" width="0"><tbody><tr><td style="width: 341.25pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="455"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"><strong>Onsite with Supervision</strong></span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">PSV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">SIV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X </span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV with SDV/SDR</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">COV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Other (motivational, observational and training  visits )</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 341.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="455"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"><strong>Onsite without Supervision</strong></span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">PSV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">SIV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">COV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Other (motivational, observational and training  visits )</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 341.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="455"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"><strong>Remote</strong></span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">PSV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">SIV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV with remote SDV/SDR</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">COV</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 315.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="420"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Other (motivational, observational and training visits )</span></p></td><td style="width: 26.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="35"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr></tbody></table><ul><li style="list-style-type: none;"><ul><li><span style="font-size: 12pt; font-family: calibri, 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: 12pt; font-family: calibri, 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: 12pt; font-family: calibri, 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: 12pt; font-family: calibri, sans-serif;">Monitor data for missing or implausible data</span></li></ul></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Ensure the resources of the Sponsor and Labcorp 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 travel policy</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Travel, including air travel, may be required as per essential job functions.</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Prepare accurate and timely trip reports</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by management</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Provide coverage for clinical contact telephone lines, as required</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Update, track and maintain study-specific trial management tools/systems</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Generate and track drug shipments and supplies, as needed</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Track and follow-up on serious adverse events as assigned</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Implement study-specific communication plan as assigned</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Attend face-to-face meetings or remote meetings/teleconferences as needed (Investigators’ meetings, project team meetings, Sponsor meetings, Kick-off meetings etc.) and present certain topics, as assigned.</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Perform other duties as assigned by the monitoring plan to include those indicated in the chart below. </span></li></ul><table style="width: 395.25pt; margin-left: .5in; border-collapse: collapse;" width="0"><tbody><tr><td style="width: 395.25pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="527"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"><strong>Other job duties</strong></span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Essential doc collection</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Essential doc review</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Contact for study teams</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Manage subject screening/enrollment</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">In-house site management</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Review study data (eCRF)</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Submission/Renewal to IRB-IEC (as needed per country)</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Conduct Site training</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Regular telephone contact with Sites</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Documentation of site contacts</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Assist with preparation of Site Visits</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Liaise with sponsor/medical monitor</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Support site payment/budget activities</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Track and follow up on SAEs</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Management of study supplies & Investigational Product</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 316.25pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="422"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Mentoring of junior staff</span></p></td><td style="width: 79.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="105"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p></td></tr></tbody></table><h2>Education/Qualifications:</h2><h2><span style="font-size: 12pt; font-family: calibri, sans-serif;">Minimum Required:</span></h2><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">External Candidates</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">AND</span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, )</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Basic understanding of the clinical trial process</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Valid Driver’s License</span></li></ul><h2><span style="font-family: calibri, sans-serif; font-size: 12pt;"> Preferred:</span></h2><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Working knowledge of Labcorp SOPs for site monitoring</span></li></ul><h2>Experience:</h2><h2><span style="font-size: 12pt; font-family: calibri, sans-serif;">Minimum Required:</span></h2><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">AND</span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">a minimum of 2 years of industry experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Ability to work within a project team</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Good planning, organization and problem solving abilities</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Good communication skills, oral and written</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Good computer skills</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Works efficiently and effectively in a matrix environment</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Fluent in local office language and in English, both written and verbal</span></li></ul><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Preferred:</strong></span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical laboratory, research, data analysis, data management or technical writing) is preferred.</span></li></ul>

Job posted: 2022-01-04

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