Location: Boston, MA
Cap-Exempt H-1B Position — No lottery required
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham 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 Mass General Brigham. MGB OCR CCI Regulatory Specialist, per diem **Job Summary** We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Regulatory Specialist in the Mass General Brigham (MGB) Office of Clinical Research (OCR) Center for Clinical Investigation (CCI). The candidate will work with the Research Operations Director, Department Managers, and Principal Investigators. The mission of the MGB OCR CCI is to strengthen the culture for clinical research at the Brigham and Women’s Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators. **Summary** Will guide investigators in the IRB review process and will assist with the preparation and submission of protocol documents to the IRB and other regulatory committees to ensure regulatory compliance. Does this position require Patient Care? No **Essential Functions** The preparation and submission of protocols to the IRB - Assists with development of study documents including protocols and informed consent forms - Advising researchers and research teams on the regulatory review process - Tracking and facilitating the progress of new trials through the review process - Maintain working knowledge of current regulations and MGB IRB policies and guidance’s - Facilitate training for the research teams on changes to regulatory process or new regulatory requirements - Track protocol status