Description
Responsible for conducting pre-review of submissions to the designated research compliance office (human subject/laboratory animals/biologically infectious agent regulations) of new protocols, continuing reviews, and modifications to approved studies. Responsible for pre-review of Unanticipated Problems involving Risks to Subjects or Others and requests to close studies. Other significant responsibilities may include review of correspondence and conducting quality improvement initiatives. Works with other program staff, developing and presenting educational materials, to ensure uniformity of review and compliance with standard operating procedures and applicable federal and state regulations. Serves on relevant administrative committees, such as the Policy Committee, or the Education and Training Committee. Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance. Education and Experience: Bachelor?s degree or equivalent in education and experience, and 3-5 years of related experience of which two years should be of prior research compliance oversight and/or research experience. Experience with biomedical research is preferred. Employees in this classification typically analyze, compare and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision making authority are predominantly performed independently affecting business operations to a substantial degree. Under FLSA, this is the exempt job classification for this title. Incumbents in this position must meet the full criteria for exempt status: salary level, salary basis, and duties tests.