IRB Reliance Specialist

Job Summary:

Colorado Multiple Institutional Review Board (COMIRB) is the Institutional Review Board (IRB) that serves a consortium of academic and health care facilities in Colorado consisting of University of Colorado Denver | Anschutz Medical Campus, University of Colorado Health, Children's Hospital Colorado, Denver Health and Hospital Authority and VA Eastern Colorado Health Care System.

COMIRB exists to review all proposed human research projects prior to implementation in the affiliated institutions and/or research conducted by faculty or staff members of these institutions, even if it is performed at other locations. COMIRB review is performed in accordance with mandated federal regulations. The main responsibilities of the COMIRB office and panels is to protect human subjects and their rights, protect researchers, and protect the institution.

This position facilitates IRB reliance processes by providing professional and accurate advice to researchers and research staff, and regulatory colleagues at the University and our affiliates. This position will work directly with researchers, COMIRB staff and IRB chairs to help solve IRB-related issues for multicenter research, new and existing studies. This position will attend IRB meetings from time-to-time. This position also provides education and training in IRB reliance procedures and practices for researchers and research staff as needed. These responsibilities requires an excellent working knowledge of human subjects regulations, IRB reliance requirements, thorough knowledge of additional resources and professional staff available to investigators at the university and our affiliates, and excellent customer services skills.

Key Responsibilities:

• Support business practices for external IRB reliances. Consult with research teams relying on external IRBs as necessary. Provide support and backup to External IRB Coordinator. Communicate with reviewing IRBs as necessary.
• Support COMIRB business practices when serving as a sIRB. Consult with research teams considering using COMIRB as sIRB. Communicate with relying IRB offices as necessary. Coordinate with other COMIRB staff and IRB chairs as necessary.
• Work with COMIRB leadership and our regulatory partners at the University and/or our affiliate institutions to improve and implement business practices related to IRB reliances.
• Provide presentations and training as needed for research faculty and staff, as well as COMIRB staff and IRB members.
• Assist with special projects as assigned. Perform internal quality assurance as directed to ensure compliance with OHRP and FDA Regulations for COMIRB panel review and documentation.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 1 days per week on campus and as needed for in-person meetings.

Why Join Us:

The Office of the Vice Chancellor for Research collaborates and engages with the campus research community to advance scientific discovery. Our teams provide comprehensive guidance and expertise to support investigators through every step of the research lifecycle.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Diversity and Equity:

The University of Colorado 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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• A bachelor's degree in public health, public administration, or a directly related field from an accredited institution
• 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 within specified timeframe.)

A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Graduate degree
• Experience working with an IRB

Knowledge, Skills and Abilities:

• Adept at understanding and analyzing technical research, medical and legal language, and research concepts.
• 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
• Familiarity with research and regulatory infrastructure and professional staff at the University and our affiliate institutions
• 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

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Shala.Massey@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position the is filled. For best consideration, apply by November 4, 2024.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $59,996 - $76,314

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado 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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.