Site: The General Hospital Corporation<p style="text-align:left"><a href="https://himalayas.app/companies/mass-general-brigham">Mass General Brigham</a> relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of <a href="https://himalayas.app/companies/mass-general-brigham">Mass General Brigham</a>.</p><p style="text-align:left"><u><b>Job Summary</b></u></p>Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research.<p></p><h3>Essential Functions:</h3><p>-Maintain and organize study-specific regulatory binders.<br>-Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB. <br>-Revise informed consent documents to include new risk information and/or updated protocol requirements throughout the course of the study.<br>-Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.<br>-Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.<br>-Collect, complete, and submit essential regulatory documents to various regulatory entities. <br>-Participate in monitoring visits and maintain a record of all correspondence related to these visits.</p><div><div><div><div><div><div><div><p style="text-align:left"><u><b>Qualifications</b></u></p></div></div></div></div></div></div></div><h3>Education:</h3><ul><li>Bachelor's Degree in a Related Field of Study required</li></ul><h3>Experience:</h3><ul><li>Research-Related Experience 1-2 years preferred</li></ul><h3>Knowledge, Skills and Abilities:</h3><ul><li>Attention to detail.</li><li>Ability to recognize compliance and data integrity issues and respond appropriately.</li><li>Working knowledge of clinical research protocols.</li><li>Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.</li><li>Effective interpersonal and communication skills.</li></ul><div><div><div><div><div><div><div><p style="text-align:left"><u><b>Additional Job Details (if applicable)</b></u></p></div></div></div></div></div></div></div><div><div><div><div><div><div><div><p style="text-align:left"><u><b>Remote Type</b></u></p></div></div></div></div></div></div></div>Remote<div><div><div><div><div><div><div><p style="text-align:left"><u><b>W