li>Has intermediate knowledge and is very proficient in the following areas: DFCI, DFHCC, ICH/GCP, FDA policy, guidance, regulation, an understanding of the IRB submission & approval process, Regulatory Binder maintenance, PI Initiated, Multi-Center Trials protocol and consent design and development, and FDA IND and other regulatory required submissions. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DFHCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations.