Reg Affairs Specialist

Job Summary: The Regulatory Affairs Specialist is responsible for maintenance and submission of all regulatory documentation. This position assists with study related analysis and other clinical research submission requirements, supporting various UHC clinical departments. Performs other duties as needed.

Education and Experience: Bachelor's degree in health care or related field required. Minimum one year of research related experience required. Experience in regulatory affairs in a medical setting preferred. Seven years of experience in research related regulatory work in lieu of degree required.

Knowledge and Skills: Knowledge of HIPAA guidelines; good clinical practice; ICH guidelines. Able to keyboard 40 wpm. Able to use a computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint). Operate/troubleshoot basic office equipment required for the position. Able to work calmly and respond courteously when under pressure; collaborate and accept direction. Able to think critically; manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solve; recall information with accuracy; pay close attention to detail; work independently with minimal supervision. Able to distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position

Licensures and Certifications: Certified Clinical Research Coordinator (SoCRA, ACRP) within one year of eligibility required. Valid Driver's License required at time of hire.