RESEARCH COMPLIANCE ANALYST

$72,000 - $81,000/Yr

University of Denver - Denver, CO

Full-time - Mid Level

Remote - Denver, CO

Educational Services

About the position

The Research Compliance Analyst position at the University of Denver (DU) is a vital role within the Office of Research Integrity & Education (ORIE), which is dedicated to ensuring adherence to ethical principles and professional standards in research. This position primarily focuses on providing subject matter expertise in the review of human subject research protocols. The Research Compliance Analyst will work collaboratively with a team to foster a culture of compliance at DU, ensuring that all research activities comply with federal, state, and local regulations, as well as institutional policies and guidelines. This role is essential for maintaining a successful human subjects protection program, which is critical for the integrity of research conducted at the university. As a designated reviewer, the Research Compliance Analyst will advise researchers on human subjects protection issues and conduct training programs for faculty, staff, and students. The successful candidate will possess a strong background in human subjects research administration, demonstrating a comprehensive understanding of federal research compliance regulations. The position requires excellent interpersonal and management skills, as well as the ability to collaborate effectively with faculty, staff, and students to help them achieve their research goals. Remote work options are available, providing flexibility in the work environment. The essential functions of this role include performing regulatory reviews and analyses of research applications submitted to the DU Institutional Review Board (IRB), ensuring consistency, completeness, and compliance with relevant regulations. The analyst will also provide guidance to investigators regarding the interpretation of federal regulations, including the Code of Federal Regulations (CFRs), HIPAA, and FERPA laws, as they pertain to human subjects research. Additionally, the analyst will determine the appropriate level of review for IRB submissions, advise the research community on human subjects protection issues, and develop educational programs for IRB members and the broader DU research community. The position also involves managing the electronic submission system and attending IRB meetings to contribute to the development of meeting agendas and minutes.

Responsibilities

• Perform regulatory review and analysis of research applications submitted to the DU IRB for consistency, completeness, and compliance with federal and state regulations and DU IRB policies and procedures.
• Solve routine issues within the framework of federal regulations, laws, and guidance to human subjects protection and DU IRB 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 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, DU research courses, and other speaking engagements on research as requested by the DU community.
• Assist in the management of the electronic management system; maintain 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 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.

Nice-to-haves

• 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.

Benefits

• Medical insurance
• Dental insurance
• Retirement plan
• Paid time off
• Tuition benefit
• ECO pass