IRB Review Specialist

Job Summary:

This position facilitates IRB review by providing outreach and consultations for researchers and research staff at the University and our affiliates. This position will work directly with researchers to help solve IRB-related issues for new and existing studies, both within the COMIRB office through management of the COMIRB Help Desk, and by meeting with the researchers. This position also provides education and training for researchers and research staff as needed. These responsibilities requires an excellent working knowledge of human subjects regulations, thorough knowledge of additional resources and professional staff available to investigators at the university and our affiliates, and excellent customer services skills. This is full-time position with minimum work hours of 8am-5pm Monday through Friday.

Key Responsibilities:

• Conduct expedited, exempt, and not-human subjects review of 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.
• Serve as front line IRB support for researchers and research staff at the University and our affiliates. Provide advice on COMIRB policies and procedures, and federal requirements for human subjects research. Support the COMIRB Help Desk and COMIRB Office Hours. Meet in with researchers and research teams in person or by video conference to help solve IRB-related problems.
• Provide support to IRB panels. Ensure that protocol review documentation complies with COMIRB policies and procedures, federal regulations, and AAHRPP accreditation standards. Ensure protocols are reviewed and processed in a timely manner.
• Support COMIRB business practices when serving as a sIRB. Consult with research teams considering using COMIRB as sIRB. Communicate with external IRB reliance contacts and AVC Regulatory Compliance.
• Provide presentations and training as needed for research faculty and staff, as well as COMIRB staff and IRB members.
• Work with COMIRB leadership and our regulatory partners at the University and/or our affiliate institutions to improve and implement IRB-related business practices.
• 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

Why Join Us:

The Colorado Multiple Institutional Review Board (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 in the order of priority are: 1) protect human subjects and their rights, 2) protect researchers, and 3) protect the institution. This is a critical role to ensure that COMIRB is fulfilling its mandate of human subject protection and maintains compliance with federal regulations.

Benefits statement to include in all benefits-eligible positions:

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

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, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. 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 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.

Applicants must meet minimum qualifications at the time of hire.

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

Preferred Qualifications:

• Graduate degree
• Experience working with an IRB
• Certified as an IRB Professional. (CIP may be obtained after starting.)

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
• 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

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 (only use if a cover letter is necessary)

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: Mary Brown, Mary.Brown@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled.

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.