Study Coordinator II

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Covance is currently hiring for a <strong≥<em≥Study Coordinator II</em≥</strong≥ to join our growing team in Somerset, New Jersey.</span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Responsibilities include (but are not limited to):</span≥</p≥<ul≥<li style="color: #000000;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Provides administrative and scientific support for toxicology studies, including prestudy tasks (e.g., protocol development, costing, scheduling), monitoring the inlife progress of assigned studies, and interacting with clients.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Provides administrative backup support for Study Directors on day to day study-specific activities or tasks.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to ensure study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to coordinate the study award process as applicable</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to coordinate the efforts of a study team to become a successful project manager.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to plan, prioritize, and manage a workload and the associated responsibilities.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Serves as a contact, along with the Study Director, in communication and interactions with other departments and clients, with assistance as applicable.</span≥</li≥<li style="color: black; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="color: black; font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to maintain complete, organized, and current study files including study schedule, protocol, and applicable correspondence.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to draft protocols and amendments for Study Director Review and approval.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Ensures all client comments on protocols and amendments are addressed in a timely manner.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Initiates and submits costing and scheduling requests with assistance.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Schedules and participates in preinitiation and other study-related meetings, as required, and takes and distributes preinitiation meeting minutes.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to draft and submit appropriate documents to the IACUC/AWERB for approval.</span≥</li≥<li style="color: black; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="color: black; font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Verifies the project schedule accurately reflects the requirements of the protocol.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to monitor progress and status of assigned studies with assistance.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to review data and identify deficiencies.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to compile data for clients for regular study progress updates.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to address and review quality assurance audits relating to protocols and amendments and reports (as applicable), with oversight. Follows up with appropriate personnel to ensure all necessary document/data clarifications are completed in the specified timelines.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Assists with hosting client visits.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to perform QC (peer) reviews on study reports.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Undertakes other administrative or scientific duties as assigned.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to use project tracking systems, as appropriate</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Learns to assist the Study Director in monitoring the financial status of ongoing studies, including completion of work scope changes as applicable.</span≥</li≥<li style="color: black; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Assist SD by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place</span≥</li≥<li style="color: black; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="color: black; font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥May assist with the preparation (with guidance) CTD tables</span≥</li≥<li style="color: black; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="color: black; font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Prepare shipping documentation including CITES application requests and any other associated shipping documentation, as required per study</span≥</li≥</ul≥<h2≥Education/Qualifications:</h2≥<h2 style="margin: 0in 0in 0pt;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Recommended:</span≥</h2≥<h2 style="margin: 0in 0in 0pt;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"≥Bachelor’s degree in a related science field. Experience may be substituted for education.  </span≥</h2≥<h2≥Experience:</h2≥<p style="margin: 0px;"≥<span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"≥Two or more years working in regulated toxicology.</span≥</p≥