Regulatory Specialist I

Under the direction of the Manager of Budget, Regulatory and Data Management Services, performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned clinical trials by working closely with Principal Investigators (PI) and other Clinical Protocol and Data Management (CPDM) staff members. Responsible for the planning, development, implementation and evaluation of certain phases of the assigned studies. Translates planning and design decisions into concrete activities and tasks, setting priorities as appropriate. Under limited direction, provides operational support for regulatory compliance to research sites conducting multiple FDA-regulated or other clinical trials. Assignments will be adjusted gradually to add increased responsibility based on demonstrated competency. Requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the projects. Works with an assigned mentor on a regular basis and in consultation with the PI.