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University of Colorado Denver/Anschutz Medical Campus Colorado Multiple Institutional Review Board, Office of Regulatory Compliance Job Title: IRB Review Specialist Position Number 634329 - Requisition Number 07797
Nature of Work: Process and review as a designated IRB member COMIRB protocol submissions eligible for expedited IRB review, exempt research, and submissions for determinations of not human subjects. Submissions will include eligible biomedical and social/behavioral research. These reviews will require expert understanding of criteria for expedited review, exempt research, and the definition of human subjects research. Processing will require expert understanding of COMIRB business systems and policies. Provide advice to researchers on how to correctly submit and describe their research, and how to conduct their research in compliance with IRB requirements. Attend IRB meetings as necessary. Provide occasional support to other COMIRB panels as necessary. Provide regular advice and support to researchers. Be available as scheduled or as necessary for inquiries managed through the COMIRB Help Desk. Promptly and accurately answer researchers’ questions related to IRB review and the rules and regulations related to human subjects research. Assist in COMIRB training activities, including attending COMIRB Office Hours as necessary. Maintain and contribute to high quality customer service, consistency, and teamwork within COMIRB.
Examples of Work Performed Include, but are not limited to: 1. Conduct expedited review of eligible research as a designated IRB member. Process IRB submissions as necessary for COMIRB business systems. When appropriate for more complex research or where particular expertise is needed, assign a faculty IRB member as expedited reviewer.
Make exempt determinations for qualifying research proposals. Make determinations of not human subjects research for qualifying proposals. Process submissions as necessary for COMIRB business systems.
Conduct pre-review of applicable protocols submitted involving an external IRB or non-affiliated site.
Work with the Director and Assistant Director to continue to develop, implement and refine business processes and procedures for the efficient and effective COMIRB registration and oversight of human research reviewed by COMIRB for external IRBs and/or external sites.
Serve as a liaison and information resource to University of Colorado Denver (UCD) and affiliate faculty and staff by advising them on all federal requirements and university policies for approval of research with humans.
Assist in problem solving by acting as the key COMIRB administrative liaison between the external IRB and the investigator. Generate post-review feedback to investigators.
Must be able to understand and analyze technical research, medical and legal language, and research concepts, synthesizing the essential points from complex multiple participant discussion.
Ensure that the documentation complies with federal and accreditation standards and are processed in a timely manner.
Perform quality assurance as directed to ensure compliance with OHRP and FDA Regulations for COMIRB panel review and documentation, and coordinate with external IRBs /sites relying on COMIRB.
Assist with initial and ongoing training of the external IRB / site staff, administrative staff and panel members relating to the process of using COMIRB as a central IRB.
Work closely with the Financial Manager to ensure that invoicing is conducted for appropriate studies.
Assist the Director/Assistant Director with special projects as assigned.
This is a full-time, University Staff (non-classified) position with minimum work hours of Monday-Friday, 8 am. - 5 pm. The position is not eligible for overtime compensation.
Salary and Benefits:
The hiring salary for this position is $48,675 - $50,500 and is negotiable and commensurate with skills and experience.
The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
Minimum Requirements: • Bachelor’s degree in business, public administration or a closely related field. • Experience in an academic setting with a minimum of one year’s experience in research or compliance. • Experience working with OHRP/FDA regulations regarding human subject research. • Certified as an IRB Professional. (CIP may be obtained after starting.)
Preferred Qualifications: 1. Graduate degree
Experience working with an IRB Knowledge, Skills & Abilities:
Working knowledge of OHRP and FDA regulations for human subject research
Knowledge of higher educational and/or research environment
Ability to communicate effectively both orally and in writing
Excellent interpersonal and human relations skills
Excellent analytical and problem solving skills
Ability to plan, meet deadlines, work under pressure, and organize multiple projects or tasks
Comprehensive personal computing skills and ability to access complex relational databases
Ability to effectively support the panel team and contribute to working groups, staff meetings, and other committees as assigned
Ability to work independently
Preferred Qualifications: 1. Graduate degree in life sciences. 2. Experience working with an IRB
About University of Colorado, Denver, Anschutz Medical Campus
We educate more than 14,000 students at CU Denver, our comprehensive campus in downtown Denver, and more than 4,000 students in our research and advanced health care programs at the CU Anschutz Medical Campus in Aurora.
On our two campuses, you can choose from more than 140 programs in 13 schools and colleges at the undergraduate, graduate, doctoral and professional health levels, including so...me that rank among the nation’s best.
Through our partnerships with business and industry, public schools and local governments, health care clinics and other community outreach programs, we’re an integral part of the Denver metro area and Colorado.