IRB Review Specialist
University of Colorado Denver l Anschutz Medical Campus
Research Compliance Office - COMIRB
Job Title - IRB Review Specialist
Position #634329 - Requisition #10485
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
COMIRB has an opening for a full-time University Staff (unclassified) IRB Review Specialist position.
The University of Colorado Denver Anschutz Medical Campus is a public research university serving more than 18,000 students. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer more than 140 highly rated degree programs through 13 schools and colleges. The university receives over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at CU Anschutz in Aurora, Colo. a significant number of undergraduate and graduate degree programs are taught at CU Denver, our comprehensive campus in the heart of downtown Denver-one of America's most vibrant urban centers. CU Denver is located steps from the Denver Center for Performing Arts and the LoDo District affording our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.
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.
Help to operationalize IRB reliance agreements for multicenter research where COMIRB serves as the lead IRB. Facilitate the IRB reliance process, serve as COMIRB liaison with external researchers/IRBs/site liaisons when necessary. Oversee COMIRB work flow and communications to ensure that COMIRB maintains effective oversight of human subject research in accordance with federal requirements, COMIRB policies and procedures, accreditation standards, and IRB Authorization Agreements or memoranda of understandings, when COMIRB is the reviewing IRB for unaffiliated sites.
This is full-time position with minimum work hours of 8am-5pm Monday through Friday.
Salary and Benefits:
The hiring range for this position has been established at $48,675 to $50,000 and is commensurate with skills and experience.
This position is not eligible for overtime compensation.
- A bachelor's degree in public health, public administration, or a directly related field from an accredited institution and 2 years of professional level 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.)
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
- Graduate degree
- Experience working with an IRB
Knowledge, Skills, and Abilities:
- Ability to communicate effectively, both in writing and orally.
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills.
- Demonstrated commitment and leadership ability to advance diversity and inclusion.
- 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
Special Instructions to Applicants:Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin 7/28/2017 and will continue until the position is filled.
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.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)
Job Category: Research Services
Primary Location: Denver
Department: U0001 -- Denver-Anschutz Administration - 60068 - ADM-VCR COMIRB
Posting Date: Jul 27, 2017
Closing Date: Ongoing
Posting Contact Name: Catherine Sutherland
Posting Contact Email: firstname.lastname@example.org
Position Number: 00634329