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Associate Study Coordinator - Metabolism

Laboratory Corporation of America Holdings (Covance)

Madison, Wisconsin, United States

<h2>Job Overview:</h2><p style="margin-bottom: 6.75pt;"><span style="font-family: 'times new roman', times; font-size: 12pt;"><span style="color: #333333;">Do you have a passion for Science? Writing? Accuracy? Please keep reading…</span></span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">We have a great opportunity for an Associate Study Coordinator in our Drug Metabolism Department at our Madison, WI lab. Covance by Labcorp’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-bottom: .0001pt;"> </p><p style="margin-bottom: 12.0pt;"><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">In this role, you will be responsible for 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-bottom: .0001pt;"><span style="font-family: 'times new roman', times; font-size: 12pt;">Duties and Responsibilities:</span></p><ul><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Drafts protocols, amendments, and study schedules as appropriate using study outline or client supplied information</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Reviews study compliance against protocol, SOP, and regulatory agency guidelines</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Participates in and assists SD/PI with pre-initiation and other study related meetings as required</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Proactively communicates and interacts with study team (SD’s and operational staff) to ensure key milestones are achieved</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">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: 'times new roman', times; color: black;">Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Assists SD/PI in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Assists in interpreting and evaluating data for reports</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Participates in the peer review process for scientific reports</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Reviews QAU report audit sand client comments with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Responsible for and drives report production through finalization, including archiving of data as appropriate.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Prepares for and participates in routine client visits under direction of the SD/PI. Learns to host routine client visits and interacts/communicates with client as necessary.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Maintains an awareness of the financial status of ongoing studies, including work scope changes</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: black;">Begins to act as a basic project coordinator for assigned clients(s) across the metabolism discipline</span></li></ul><p style="margin: 0px;"><span style="font-size: 8pt; font-family: 'times new roman', times; color: black;">#LI-DZ1</span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: #333333;">Relevant degree (i.e. Life Sciences) plus 2 years of appropriate experience; relevant experience may be substituted for academic qualifications.</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: #333333;">Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.</span></li><li><span style="font-size: 12pt; font-family: 'times new roman', times; color: #333333;">Skilled in the use of standard laboratory equipment.</span></li></ul>

Job posted: 2021-05-22

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