Research Compliance Officer

Clearance Level
None
Category
Scientists
Location
Silver Spring, Maryland
Onsite Workplace
Apply
REQ#: RQ139766
Public Trust: NACLC (T3)
Requisition Type: Regular
Your Impact

Own your opportunity to work alongside federal civilian agencies. Make an impact by providing services that help the government ensure the well being of U.S. citizens.

Job Description

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

  • Provide guidance and counsel on incorporating compliance-related activities into the day-to-day operations of the Human Research Protection Program
  • 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
  • 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
  • Actively participate in implementing federal regulations on Conflict of Interest (COI) and assist in coordinating any inquiry or investigation of alleged conflict of interest
  • Coordinates the preparation for surveys and site visits

Required Qualifications:

  • Master’s degree in Biological Sciences or closely related field
  • 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
  • Completion of Collaborative Institutional Training Initiative (CITI) within one month from start date
  • Demonstrated expertise in the Human Subject Protection (HSP) regulations with monitoring and compliance program 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)
Travel Required: Less than 10%
About Our Work

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

COVID-19 Vaccination

GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

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