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Research Compliance Specialist

2 months ago

Denver, Colorado, United States InsideHigherEd Full time

Job Summary

The Office of Research Integrity & Education (ORIE) is seeking a highly skilled Research Compliance Specialist to join our team. As a key member of our team, you will be responsible for providing subject matter expertise in the review of human subject research protocols.

Key Responsibilities

  • Perform regulatory review and analysis of research applications submitted to the Institutional Review Board (IRB) for consistency, completeness, and compliance with federal and state regulations and institutional policies and procedures.
  • Solve routine issues within the framework of federal regulations, laws, and guidance to human subjects protection and institutional policies and procedures.
  • Provide guidance and consultation to investigators regarding the interpretation of the Code of Federal Regulations (CFRs), HIPAA, and FERPA laws, and NIH and NSF policies, pertaining to human subjects research.
  • Determine the appropriate level of review for IRB research submissions and will be designated to conduct exempt and expedited reviews.
  • Advise the research community about human subjects protection issues and institutional policies.
  • Develop and present educational programs for IRB members, institutional research courses, and other speaking engagements on research as requested by the institutional community.
  • Assist in the management of the electronic management system; maintaining the database to track and process all active, pending, and terminated protocols/proposals.
  • Attend IRB full committee meetings, contribute to the development of meeting agendas, minutes, and stipulations letters.

Requirements

  • Bachelor's degree.
  • At least three (3) years of experience of direct IRB regulatory experience reviewing and processing human subjects research applications.
  • Experience working with electronic submission systems; ability to learn and master proprietary software, IRBNet, as this program is critical to day-to-day operations.
  • Knowledge and practical application of research ethical principles and federal regulatory requirements.

Preferred Qualifications

  • Advanced degree in scientific research discipline.
  • IRB Professional Certification.
  • Experience working in a university research administration office.
  • Direct IRB regulatory experience involving the review of social, behavioral, and educational research.
  • Experience using the electronic submission system IRBNet.

Working Environment

  • Standard office environment.
  • Unexpected interruptions occur often, and stress level is moderate to high.
  • Noise level is quiet to moderate.