Clinical Trials Regulatory Specialist (12-Month Fixed-Term)

The Division of Body MRI, within the Stanford University Department of Radiology, is internationally recognized for excellence in clinical care, research, and education, as it relates to the diagnostic and interventional application of MRI in the body. The Body MR division aims to provide outstanding patient care, lead innovations in the practice of Body MR, and train the next generation of clinician scientists. The overall direction of the group is development of a tight link between diagnosis and therapy to enable highly personalized care.

We are seeking a Clinical Trials Regulator Specialist to coordinate planning for eventual clinical research, regulatory approval, and commercialization of the technologies developed from our ARPA-H LIGHT funded research team centered around improving the ability of MRI to evaluate the lymphatic system. Initially the hire will coordinate the development and implementation of commercialization plans and regulatory roadmaps by facilitating collaboration among investigators, sponsor representatives (ARPA-H), and institutional stakeholders. The plan will predominantly focus on the commercialization potential of new MRI contrast agents for lymphatic imaging, but may also include novel MR sequences for lymphatic imaging that we are also developing. The hire will also be tasked with project management duties such as coordinating team meetings, keeping track of completion task requirements, assisting in the organization of presentations including gathering of slide material from co-investigators, completing milestone billing material, centralizing team communication, assisting in scheduling of clinical research activity, maintaining IRB protocols, and serving as the lead contact for ARPA-H when the PI is unavailable. Pending confirmation of funding for phase 2 of the ARPA-H LIGHT program, this hire will transition to predominantly focus on coordination of translational and clinical research conducted for regulatory approval of the anticipated MR contrast agents. The role operates with minimal supervision and requires strong organizational skills, professionalism, and the ability to anticipate needs and solve problems independently. The ideal candidate brings together prior experience with research teams, drug development regulation, clinical trials, commercialization efforts, and Institutional Review Board (IRB) protocols, in addition to a basic knowledge of MRI technology.