SENIOR REGULATORY CONSULTANT (223315)

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Bronx, New York

Montefiore

<h4 class=""><strong>WHY TOP TALENT PICKS MONTEFIORE EINSTEIN&nbsp;<br /><br /></strong>Since its inception in 1884, Montefiore Einstein&rsquo;s mission has been to heal, to teach, to discover and advance the health of the communities we serve.<br /><br />Montefiore Einstein&rsquo;s state-of-the-art facilities include the&nbsp;<span class="">internationally-recognized</span>&nbsp;Children&rsquo;s Hospital at Montefiore Einstein and our Notable Centers of Excellence - Montefiore Einstein Center for Cancer Care, Montefiore Einstein Center for Heart and Vascular Care, Montefiore Einstein Center for Transplantation. Combined with a growing number of locations throughout the Bronx and Westchester County, Montefiore Einstein is the ideal organization to apply and hone your expertise.<br /><br /><span style="text-decoration: underline;"><a href="https://montefiore.wd12.myworkdayjobs.com/en-US/MMC/login" target="_blank" title="Candidate Home" rel="noopener noreferrer">Sign In</a></span>&nbsp;- Candidate Home<br /><span style="text-decoration: underline;"><a href="https://montefiore.wd12.myworkdayjobs.com/en-US/MMC/introduceYourself" target="_blank" title="Introduce Yourself " rel="noopener noreferrer">Introduce Yourself&nbsp;</a></span>-&nbsp;Please let us know about yourself so we can keep in touch about future job openings!<br /><br /><strong><span class="">NURSE&nbsp;RECRUITMENT&nbsp;HOTLINE:</span>&nbsp;<span class="">718-920-6697 (</span><span class="">Monday-Friday: 9am-4pm)&nbsp;&nbsp;</span></strong><br /><br /><strong>Check Out Our Employee&nbsp;<span style="text-decoration: underline;"><a href="https://healthymebenefits.com/" target="_blank" title="Benefits" rel="noopener noreferrer">Benefits</a></span></strong></h4> <h4 class="p1"><span style="text-decoration: underline;"><strong><a href="https://s3.us-east-1.amazonaws.com/vizi.vizirecruiter.com/MontefioreHealthSystem+RecruitingPractices.pdf" target="_blank" title="Safe Online Recruiting" rel="noopener noreferrer">Our Commitment to Safe Online Recruiting</a></strong></span></h4> https://www.montefiore.org/

keywords: position summary,compliance,management,reporting,degree,experience,knowledge

Day / 9 AM-5:30 PM

$72,000.00-$90,000.00 annually*

Overview: <p><strong>City/State:&nbsp;</strong>Bronx, New York</p> <p><strong>Grant Funded:&nbsp;</strong>Yes</p> <p><strong>Department:&nbsp;</strong>Cancer Clinical Trials Office</p> <p><strong>Work Shift:&nbsp;</strong>Day</p> <p><strong>Work Days:&nbsp;</strong>MON-FRI</p> <p><strong>Scheduled Hours:&nbsp;</strong>9 AM-5:30 PM</p> <p><strong>Scheduled Daily Hours:&nbsp;</strong>7.5 HOURS</p> <p><strong>Pay Range:&nbsp;</strong>$72,000.00-$90,000.00</p> <p>A Senior Regulatory Compliance Coordinator position is currently available within the Montefiore Einstein Cancer Center Clinical Trials Office (CCTO). The incumbent will work with investigators and the CCTO infrastructure to manage cancer clinical trials for the division.</p>
Responsibilities: <ul> <li>Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols.</li> <li>The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff- providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams.</li> <li>The position will report into the Assistant Director of Regulatory Compliance.</li> </ul>
Requirements: <ul> <li>Bachelors Degree in Science or Health Policy required</li> <li>Masters Degree in Science or Health Policy preferred SOCRA or ACRP certification preferred.</li> <li>Minimum of 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance with wide knowledge of Phase I-IV clinical studies and data management aspects of clinical research.</li> <li>Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations</li> <li>Oncology experience required; some medical knowledge preferred.</li> </ul>