Research Compliance Officer Jobs

GDIT is seeking to fill a Research Compliance Officer position which is located at Office of Research Administration (ORA) at the Naval Medical Research Center (NMRC) in Silver Spring, MD. The incumbent will serve as a Research Compliance Officer for three major areas of regulatory compliance relevant to the NMRC Research and Development Program. These areas are 1) protection of human subjects in research, 2) bio-safety, and 3) conflict of interest.

Responsibilities

• Analyze and evaluate, on a quantitative and/or qualitative basis, the effectiveness of programs or operations in meeting established compliance goals and objectives
• Coordinates the preparation for surveys and site visits
• Provide guidance and counsel on incorporating compliance-related activities into the day-to-day operations of the Human Research Protection Program
• Develop a compliance training program, ensuring it meets regulatory requirements, and ensures that it is completed by appropriate staff members
• Ensure records contain all documentation required by the Bureau of Medicine and Surgery (BUMED), Food and Drug Administration (FDA), and the Department of Health and Human Services (DHHS) regulations
• Perform ongoing monitoring of all areas of research compliance
• Actively participate in implementing federal regulations on Conflict of Interest (COI) and assist in coordinating any inquiry or investigation of alleged conflict of interest
• Ensure regulatory and policy updates are disseminated to investigators and research staff
• Analyze the impact, feasibility, practicality, and effectiveness of existing and/or proposed standards, regulations, programs, and policies as they relate to compliance issues
• Develop procedures and systems for establishing, operating, and assessing the effectiveness of compliance control systems and the accomplishment; evaluation and/or monitoring of audits, inspections, or management of internal control reviews
• Work closely with the Research Safety Coordinator, Chairman, Institutional Biosafety Committee, and the Radiation Safety Officer to assure compliance with current DoD and DHHS regulations

Required Qualifications:

• Demonstrated expertise in the Human Subject Protection (HSP) regulations with monitoring and compliance program experience
• Master’s degree in Biological Sciences or closely related field
• 5-10 years of human subjects/regulatory, and compliance monitoring/oversight experience
• Knowledge of HSP, bio-safety, and COI requirements
• U.S. citizenship required and an Automated Data Processing Level II (ADP-II)/National Agency Check with Law and Credit (NACLC)
• Working knowledge of U.S. Federal government regulations regarding the Protection of Human Subjects Involved in Research
• Completion of Collaborative Institutional Training Initiative (CITI) within one month from start date