Description
Responsible for ensuring the institution's compliance with policies regarding the use of human subjects, laboratory animals or biologically infectious agents in research. Develops, directs and implements compliance program components including protocol and consent form review, record keeping, monthly and annual reporting, program evaluation and other compliance issues that meet the applicable government and local regulations and the institution's policies and practices. Pro-actively identify protocols that need special review or assistance. Secures the cooperation of and negotiates with University personnel, University departments, and members of the community. Maintains confidentiality regarding subjects, records, and review of issues. Evaluates studies for their potential risk to subjects and determines the most expeditious processing mechanism to be followed. Works with research program management administrators to determine when a contract should be created to build partnership with industry. Directs, implements and manages a protocol and consent form review process that meets all regulatory and University requirements and is responsive to investigators' needs. Trains principal investigators and administrators in the preparation of IRB applications Education and Experience: Bachelor's degree or equivalent and 5 or more years related experience. Requires significant knowledge of complex Federal, State and Local regulations. The primary duty of employees in this classification is the management of a customarily recognized department or subdivision, including the supervision of three or more full-time equivalent employees every week. Direction is over a permanent status-continuing function, not a collection of employees assigned to complete a project. Management duties include interviewing, selecting and training of employees; setting and adjusting their rates of pay and hours of work; planning and directing their work; appraising their productivity and efficiency for the purpose of recommending promotions or other changes in their status; handling their complaints and grievances and disciplining them when necessary. Management responsibilities include the authority to hire, fire, or promote assigned employees or make recommendations that are given particular weight. Employees have impact on budgeting, controlling costs, planning, scheduling, and procedural change. 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.