The Office of Research and Sponsored Programs (ORSP) supports the University of Denver community in their pursuit of research and the management of externally sponsored programs. The Office of Research Integrity & Education (ORIE), which is part of ORSP, is the key point of contact for providing regulatory guidance and processing research proposal approvals to faculty, staff and student investigators.
The IRB Analyst has the primary responsibility for providing subject matter expertise in the review of human research applications. This position will be part of a team working to create a culture of compliance at the University of Denver (DU) ensuring compliance with all federal, state and local regulations, policies and guidelines to create a successful human subjects protection program. This will be accomplished by serving as a designated reviewer (reviewing exempt and expedited items); advising researchers about human subjects protection issues; conducting training programs for staff, researchers, administrators and students. The successful candidate will bring to DU a strong background in human subjects research administration, including broad knowledge of compliance regulations. S/he will have outstanding interpersonal and management skills, a collaborative style, and experience working with faculty, staff, and students in achieving their research goals.
- Performs regulatory review and analysis of research study submissions to the DU IRB for consistency, completeness, and compliance with federal and state regulations and DU IRB policies and procedures.
- Solves routine issues within the framework of federal regulations, laws and guidance to human subjects protection and the DU IRB policies and procedures.
- Provides guidance and consultation regarding the interpretation of regulations, laws, and policies to researchers related to IRB research submissions.
- Determines level of review appropriate for IRB research submissions and conducts exempt and expedited reviews.
- Advises the research community about human subjects protection issues and institutional policies.
- Trains the IRB and research community.
- Assists in the management of the Electronic Management System, IRBNet; maintaining the database to track all active, pending, and terminated protocols/proposals.
- Attends IRB committee meetings, contributes to the development of meeting minutes, and issues correspondence
Must have the ability to work as a team member, be very detail-oriented, and have the personality that can adapt to a stressful work environment.
- Assists with special projects to address current and anticipated needs of the University's research compliance program requirements.
- Conducts other human research protection program responsibilities as needed in order to address compliance issues.
- Other duties as assigned.
Knowledge, Skills, and Abilities
- Ability to learn and master proprietary software such as IRBNet, as this program is critical to day-to-day operations.
- Excellent interpersonal, oral, and written communication skills to work effectively with researchers, IRB members, ORSP staff, and other customers.
- Ability to successfully and professionally communicate complex information to a wide variety of audiences.
- Knowledge and practical application for assessing and categorizing human subjects research proposals per OHRP and FDA regulations.
- Demonstrates knowledge-based understanding of the complete IRB review process.
- Ability to independently manage several projects at once, and ability to work under pressure.
- Strong customer service skills and well-developed communication skill level.
- Demonstrated ability to interact effectively with a diverse population.
- Demonstrated organizational skills and attention to detail.
- Ability to uphold ethical practices amid complicated situations.
- Demonstrated ability to communicate effectively, both written and orally, with principal investigators, sponsoring agencies, management, and others.
- Experience using Microsoft Professional software, Zoom, and Microsoft TEAMS.
- Demonstrated ability to utilize skills in problem solving and ability to consider multiple alternatives.
- Must be able to make appropriate decisions independently and seek assistance as appropriate.
- Evidence of self-motivation and ability to work independently and within a team, building professional work relationships with coworkers, faculty and staff.
- Demonstrated ability to multi-task effectively and to take initiative and to identify, prioritize, and plan tasks and projects necessary to meet goals.
- Bachelor's degree.
- At least three (3) years of experience of direct IRB regulatory experience reviewing and processing IRB applications.
- Advanced degree in scientific research discipline.
- IRB Professional Certification.
- Direct IRB regulatory experience involving the review of social, behavioral and educational research protocols in a higher education setting.
- Experience using the IRBNet software program.
Applications will be reviewed as they are received and will continue to be reviewed until the position is filled.
Candidates must apply online through jobs.du.edu to be considered. Only applications submitted online will be accepted.