Do you live and breathe all things regulatory when it comes to medical science? If you’re an expert at overseeing and assessing research compliance needs and love to focus on tracking and reporting, then we’ve got just the opportunity for you.
MedStar Health Research Institute (MHRI), the research arm of the largest healthcare provider in Maryland and the Washington, D.C., region, seeks a Regulatory Associate to join our acclaimed cardiology research department located at the MedStar Washington Hospital Center in the Nation’s capital.
In this role, you will provide detailed regulatory compliance assessments and reporting to the cardiovascular Principal Investigators and Research Coordinators by leveraging efficient tracking and astute project management skills. Your analysis will be pivotal in how we address complex regulatory requirements.
Manage and report on the MedStar Cardiovascular Research Network (MCRN) protocol submissions, amendments, progress reports, final reports to the local and central Institutional Review Boards (IRB)
Track, prioritize, and report on all pending, existing, and closing cardiovascular trials, contracts, and grants
Maintain research compliance at MCRN, including FDA and sponsor audits, CMS approvals, integrity agreements, conflict of interest statements, and institutional and protocol-related training requirements
Assist in writing annual progress reports, final reports, and all correspondence with FDA in regards to all MCRN-sponsored IDEs and INDs for MCRN projects
Work directly with MedStar Washington Hospital Center (MWHC) finance for financial analyses of studies requiring device and drug purchases by MWHC
BS in related field
One plus years of experience in regulatory/contract processes
Experience with cardiovascular contracts and regulatory preferred
MedStar Health has been named one of the “Best Places to Work” by the Baltimore Business Journal and the Washington Business Journal. Join us now to enjoy an attractive Total Rewards package in an environment focused on learning, growth and top-rated research.
MedStar Health is a not-for-profit health system dedicated to caring for people in Maryland and the Washington, D.C., region, while advancing the practice of medicine through education, innovation and research. MedStar’s 30,000 associates, 6,000 affiliated physicians, 10 hospitals, ambulatory care and urgent care centers, and the MedStar Health Research Institute are recognized regionally and nati...onally for excellence in medical care. As the medical education and clinical partner of Georgetown University, MedStar trains more than 1,100 medical residents annually. MedStar Health’s patient-first philosophy combines care, compassion and clinical excellence with an emphasis on customer service.