The positions report directly to CMCF Administrator Director and will support the mission and goals of the DFCI-CMF clinical research program. This position will work closely and collaboratively with a variety of faculty and staff at all levels throughout both DFCI and DF/HCC, including faculty, investigators and clinical trials experts, representatives from the pharmaceutical, biotechnology, and medical device industries, federal and international agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Education Office (CTEO), as well as clinical trials offices at other DF/HCC institutions. Coordinates, communicates, and supports PI and study teams throughout DFCI. May serve as a member of various institutional and department/division committees.
Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is required; Master’s degree in Regulatory Affairs or other advanced degree highly preferred. 3-5 years of direct regulatory experience required. Must have knowledge of US and international drug, biologic, and device regulations. Previous experience designing and implementing regulatory strategies to obtain, maintain and extend investigational approval and product registrations for drug, biologic and device products is preferred. Previous experience in the conduct of clinical trials highly desirable.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: