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Clinical Data Associate I - Medical Device & Diagnostics

Laboratory Corporation of America Holdings (Covance)

Minneapolis, Minnesota, United States

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Labcorp Drug Development has an exciting opportunity for a Clinical Data Associate I within the Medical Device & Diagnostics team. The Clinical Data Associate I can be remotely located anywhere within the United States.</span></p><p style="margin: 0px;"> </p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) are achieved.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform reconciliation of the clinical database against safety data, laboratory data and other third-party data.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Generate, resolve, and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Run ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trials.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as necessary.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Create or review data listings.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist with creation/review of edit checks.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Create dummy data to test edit checks and to test database screen.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist in creation of Study Test Plan and Study Test Report.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Perform database decommissioning and create supportive documentation.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist in preparing Access Rights forms for EDC.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support team members by creating forms/memos.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">File Data Management documentation and Data Management related administrative tasks as requested, including maintenance of eTMF as required.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Run study stats reports.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: 29.4pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">BS in Biology, Nursing, Chemistry, or related field preferred.</span></li><li style="margin-left: 29.4pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">HS Diploma or equivalent degree.</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: 30.4pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">2 years of clinical research.</span></li><li style="margin-left: 30.4pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Good organizational ability, communication, oral and written communication, and interpersonal.</span></li><li style="margin-left: 30.4pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to work in a team environment and collaborate with colleagues.</span></li><li style="margin-left: 30.4pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Additional experience may be substituted for education.</span></li></ul><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#LI-REMOTE</span></p>

Job posted: 2021-07-20

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