RESEARCH COMPLIANCE PROGRAM MANAGER Administrative & Clerical Support Hours: M-F 8-5 Day Shift - Full Time Paygrade/Wages/Salary Info: EX E37 - 40.8500 - 51.2500
Research Compliance Program Manager # Position Highlights: The Research Compliance Program Manager evaluates issues of research non-compliance and manages all areas of an investigation, including oversight, follow up, and resolution. Under the direction of the Research Compliance Officer, the Research Compliance Program Manager will serve as a liaison between Research Operations and Research Compliance utilizing tact and diplomacy to communicate, build rapport, and foster strategic alliances to ensure the appropriate and independent investigation into research non-compliance. This position will also oversee and manage the GCP auditing function and provide education to the research community on research-related topics, ensuring compliance to all regulatory requirements. This position will also provide general support to the Research Compliance Program as needed. Responsibilities: Evaluates issues of non-compliance and leads/oversees the investigation to include follow up and resolution. Assists with the development of an annual work plan based on a risk assessment. Develops and maintains research non-compliance policies, information, tools and resources on the website and other forums. Provides support to the Research Compliance Program as needed. Manages assigned staff Stays abreast of current industry trends and new regulations and compliance efforts related to research non-compliance, regulatory and Good Clinical Practice in order to analyze their impact on the organization. Credentials and Experience: Bachelor#s Degree # field of study: Health Sciences, Healthcare Administration, Research Administration or background in a medical profession Minimum of five (5) years working experience in a research compliance and/or regulatory environment. Expertise, knowledge, and experience with investigating/auditing research non-compliance or research regulatory issues. Thorough knowledge of regulations as they pertain to research compliance, regulatory and Good Clinical Practice. Licensure/Certification: Preferred Certification; not required:#RHIT, RHIA, CCS, CCSP, CCA, CIC, COC, CPC,#ACRP, CCRC, or#CCRP