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Research Compliance Officer

1 month ago

Silver Spring, United States Azimuth Corporation Full time
Job DescriptionJob Description

Azimuth Corporation is seeking a Research Compliance Officer, in support of a Navy Customer in Silver Spring, MD. The ideal candidate shall develop, implement, and maintain compliance and training activities for the Human Research Protection Program (HRPP).

Responsibilities for this role include, but are not limited to, the following:

  • Ensure regulatory and policy updates are disseminated to investigators and research staff
  • Perform ongoing monitoring of all areas of research compliance
  • Analyze and evaluate, on a quantitative and/or qualitative basis, the effectiveness of programs or operations in meeting established compliance goals and objectives
  • Analyze the impact, feasibility, practicality, and effectiveness of existing and/or proposed standards, regulations, programs, and policies as they relate to compliance issues
  • Develop a compliance training program, ensuring it meets regulatory requirements, and ensures that it is completed by appropriate staff members
  • 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
  • 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
  • Actively participate in implementing federal regulations on Conflict of Interest (COI) and assist in coordinating any inquiry or investigation of alleged conflict of interest

Minimum Qualifications

  • Bachelor's Degree and 5-10 years of human subjects/regulatory, and compliance monitoring/oversight experience
  • Working knowledge of U.S. Federal government regulations regarding the Protection of Human Subjects Involved in Research
  • Demonstrated expertise in the Human Subject Protection (HSP) regulations with monitoring and compliance program experience
  • Knowledge of HSP, biosafety, and COI requirements
  • U.S. citizenship required and an Automated Data Processing Level II (ADP-II)/National Agency Check with Law and Credit (NACLC)

Physical Requirements / Travel

  • Must be able to work in an office environment at a desk and computer.
  • May travel ~10% to conferences, program reviews, industry meetings, or other collaborative events. Most or all travel would be CONUS.

Company Overview
Azimuth is an award-winning Woman Owned Small Business specializing in providing research and development and professional services support to the federal government. Azimuth's agility, customer driven approach and our commitment to our employees allows us to meet and exceed our client goals. Excellence, Integrity, Accountability, Community and Humility are the core values of Azimuth as we continue to strive as a recognized leader in the management consulting community that both federal agencies and industry partners value doing business with. We are an organization that offers both our employees and clients an exceptional experience; our culture will be contagious, while always maintaining a genuine reputation.

Disclaimer???????
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Azimuth Corporation does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.