Regional Study Coordinator I

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;">We are seeking a Regional Study Coordinator in <strong>Los Angeles, CA</strong> to come and join our team! **This is not a remote position**</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 11.0pt;">The Regional Study Coordinator I is responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world. </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">The Regional Study Coordinator I coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the Dx study life time in collaboration with the Principal Investigator, the regional laboratory testing site and </span><span><span style="font-size: 11.0pt;">the various internal departments involved in the deliverables of the study.</span></span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">The Regional Study Coordinator I maintains a tight collaboration with the other study coordinators counter parts to align processes and production activities.</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">The Regional Study Coordinator I must show flexibility when appropriate and possesses capability to communicate globally to internal and external clients.</span></p><p style="margin: 0px;"><span style="font-size: 12.0pt;"> </span></p><p style="margin: 0px;"><strong><em><span style="font-size: 12.0pt;">General duties:</span></em></strong></p><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Act as ambassador on behalf of the Diagnostic client across Covance departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Provide information related to Dx studies in order to maintain accurate study tracker and workload activities information.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Act as regional <strong>internal</strong> liaison to ensure proper and smooth communication between the Diagnostic Sponsor, the PM Global Study Manager, the Principal Investigators/Scientists, the laboratory operation and the various internal departments involved in the study ( Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology) develop solutions, resolve issues and approve internal database loading/design plan</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Act as regional <strong>external</strong> liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) to ensure an outstanding and timely communication and deliverables</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Act as regional <strong>external</strong> liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) to ensure an outstanding and timely communication </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from win study notice to the closure of the study by working in close </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead in collaboration with the PM Global Study Manager and the DDS Global Study Manager</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Act as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Participate in Covance CLS development through continuous process improvement, quality and productivity</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Demonstrate through appropriate self-organization the ability to manage high administrative load</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Able to act efficiently in an environment with dynamic timelines and priorities</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget </span></li></ul><p style="margin-left: .25in;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-left: .25in;"><strong><span style="font-size: 11.0pt;"> </span></strong></p><p style="margin: 0px;"><strong><em><span style="font-size: 11.0pt;">Principal Day-to-Day duties</span></em></strong></p><p style="margin-left: .25in;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><em><span style="font-size: 11.0pt;">Day-to-day local study related activities- including but not limited to: (80% of time in a single work week)</span></em></p><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Prepare, organize and host CRA visits as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Participate into and prepare Client Audit related to Diagnostic studies</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved</span>.</li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Submit regulatory authority applications</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Manage external and internal meetings </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Track monthly Diagnostic services billable activities</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Serve as back up to Client Coordinator Specialist and Regional Study Coordinator II as needed</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><em><span style="font-size: 11.0pt;">Regulatory/ Study Documentation duties-(20% of time in a single work week)</span></em></p><p style="margin: 0px;"><em><span style="font-size: 11.0pt;"> </span></em></p><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Organize and </span><span style="font-size: 11.0pt;">Archiving study documentation and correspondence as requested by the client</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Filing and collating trial documentation and reports</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Perform physical inventory of study materials as needed</span></li></ul><p style="margin-left: .25in;"><strong><em><span style="font-size: 12.0pt;"> </span></em></strong></p><p style="margin: 0px;"><em><span style="font-size: 11.0pt;"> </span></em></p><h2>Education/Qualifications:</h2><h2 style="margin-left: .25in;">Minimum Required:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Associate of Medical Technology (MLT) degree or Bachelor’s Degree or Equivalent Experience</span></li></ul><h2 style="margin-left: .25in;">Preferred:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Computer literate</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Medical Technology (MT) degree or University degree(BS) in a scientific field is a strong plus</span></li></ul><h2>Experience:</h2><h2>Minimum Required:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;">2 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry.  Experience with multidisciplinary lab background is a plus.  </span></p>