Clinical Research Nurse at The Vascular Care Group

<p style="text-align: center;"><strong>Clinical Research Nurse</strong></p> <p><span style="text-decoration: underline;"><strong>Overview</strong></span></p> <p>Vascular Breakthroughs manages clinical trials for a growing group of vascular surgeons. Trials managed include device and drug trials. The trials range from being first in main pilot studies, IDE trials to post-market registry trials. We utilize a robust clinical trial management system that enables us to store all subject binders and regulatory binders electronically greatly facilitating remote management of trials and regulatory compliance.</p> <p>This role is responsible for supporting clinical trials start-up activities and coordinating enrollment of patients across The Vascular Care Group (“TVCG”) in clinical trials.</p> <p><em>Willingness to drive between TVCG sites to fulfill research requirements required; primary locations for work will be Wellesley, Plymouth, and Hyannis, with additional sites added as necessary. Role is comprised of 80% in person work, 20% remote.</em></p> <p><span style="text-decoration: underline;"><strong>Responsibilities</strong></span></p> <ul> <li>Organize and facilitate weekly meetings with clinic and OBL staff across all practice sites to examine schedules and identify eligible patients</li> <li>Assist with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols</li> <li>Assist with monitoring patients for adverse reactions to study treatment, procedure, or medication and notify appropriate clinical professionals to evaluate patient response, identify the status of complications, &amp; provide the appropriate level of care</li> <li>Assist with device accountability (transport or ship devices to practice site for procedures) on an as needed basis</li> <li>Assist with gathering required regulatory documents for new trials and attend training sessions for new trials</li> <li>Assist with collecting source data to enter into CTMS, enter source data into EDC systems, respond to queries and work with monitors to resolve queries</li> <li>Assist with adding/training additional personnel in MA to be delegated to work on the various clinical trials</li> <li>Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations</li> <li>Assist in building electronic templates into CTMS for new trials to create eSource</li> <li>Regular travel to TVCG offices to assist in trial start-up activities and enrollment activities</li> </ul> <p><span style="text-decoration: underline;"><strong>Education/Experience</strong></span></p> <ul> <li>Minimum of ADN/LPN. BSN preferred.</li> <li>3-5 years of experience in a clinical research capacity or knowledge in clinical research preferred</li> <li>Clinical experience in a surgical specialty field required; vascular preferred</li> <li>Patient facing experience perferred</li> <li>Knowledge of medical terminology required</li> <li>Computer skills required (much of the work involves accessing Electronic Medical Records and Electronic Data Capture systems)</li> <li>Must be detailed oriented, facile with computer systems, able to work independently and willing to take on challenges</li> </ul> <p><strong><span style="text-decoration: underline;">Compensation</span></strong></p> <p>$60,000 - $70,000 per year. Negotiable dependent on skills and experience</p>