Description
Responsible for conducting pre-review of complex submissions that include federal agency contracts and cooperative agreements spanning multiple institutions to the designated research compliance office (human subject/laboratory animals/biologically infectious agent regulations) of new protocols, continuing reviews and modifications to approved studies. Provides technical expertise and mastery of complex research compliance relationships. Provides leadership and mentoring to other Compliance Specialists. Responsible for pre-review of Unanticipated Problems involving Risks to Subjects or Others and requests to close studies. Other significant responsibilities includes 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. Conducts all aspects of compliance board meetings and independently handles communications with principal investigators and/or designated research staff. 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 the protection of human subjects in research. Education and Experience: Bachelor?s degree or equivalent in education and experience, 8 years or more of professional experience in research compliance and/or research Experience with biomedical research is preferred. Possesses and applies comprehensive knowledge of particular field of specialization to the completion of complex assignments. Interprets and applies organization policy. Recommend changes in procedures. 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.