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Clinical Research Associate - (Experience req'd) Unblinded - Northeast

Laboratory Corporation of America Holdings (Covance)

Philadelphia, Pennsylvania, United States

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Unblinded CRA</strong></span></p><p style="margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Must be located in the Northeast USA</strong></span></p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Labcorp Drug Development is seeking an Unblinded CRA to primarily focus on drug accountability at a site level across a range of protocols and therapeutic areas.   </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Essential Job Duties: </strong></span></p><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Responsible for all aspects of site management as prescribed in the project plans</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Travel, including air travel, may be required and is an essential function of the job.</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Prepare accurate and timely trip reports</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Review progress of projects and initiate appropriate actions to achieve target objectives</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Organize and make presentations at Investigator Meetings</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in the development of protocols and Case Report Forms as assigned</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in writing clinical trial reports as assigned</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Interact with internal work groups to evaluate needs, resources and timelines</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Act as contact for clinical trial supplies and other suppliers (vendors) as assigned</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Responsible for all aspects of registry management as prescribed in the project plans</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Undertake feasibility work when requested</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: Calibri, sans-serif; color: #ffffff;"><span style="font-family: arial, helvetica, sans-serif;">#LI-Remote</span> </span></p><h2>Education/Qualifications:</h2><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">COVID-19 vaccination required</span></li></ul><h2>Experience:</h2><ul><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of 1 year of Onsite Clinical Monitoring experience is preferred</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Early Stage experience is preferred.</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Thorough knowledge of monitoring procedures </span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Basic understanding of the drug accountability process</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Valid Driver's License</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Good planning, organization and problem-solving abilities</span></li><li style="color: black;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work with minimal supervision</span></li></ul>

Job posted: 2021-10-14

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