Study Coordinator II BioAnalytics

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">We have an excellent opportunity for a <strong>Remote Based Study Coordinator </strong>on our BioAnalytical Team in <strong>Indianapolis, IN.  </strong>Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.</span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner.</span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif;"><strong><span style="font-size: 12pt;">Essential Job Duties:</span></strong><span style="font-size: 12pt;"> </span></span></p><ul><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Reviews study compliance against protocol, SOP, and regulatory agency guidelines.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Learns to serves as the primary contact in communication and interaction with other departments and clients as applicable.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Updates and maintains project tracking systems as appropriate.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Learns to manage increasingly complex projects and study designs and/or increased study load.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Responsible for report preparation, including table and figure preparation.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assists in evaluating data for reports.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Reviews QAU report audits and submits audit responses for approval as appropriate.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Responsible for report production through finalization, including archival of data as appropriate.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assists with routine client visits as requested. Manages data transfer to clients as requested.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assists SD/PI in monitoring study phases.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Bachelor of Science (BS) degree in science or related field. </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Experience may be substituted for education.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Ability to utilize word processing software, database, spreadsheet, and specialized software.</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Minimum of 1.5 years of related experience.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent communication, presentation, and interpersonal skills.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent attention to detail.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Ability to prioritize and manage time.</span></li></ul>