Job Details

University of Colorado Anschutz Medical Campus

Quality Assurance and Education Specialist

Position Number: 6459196
Location: Aurora, CO
Position Type: Assessment, Accreditation, and Compliance

Quality Assurance and Education Specialist

Quality Assurance and Education Specialist - 37511 University Staff Description

University of Colorado Anschutz Medical Campus

Department: Colorado Multiple Institutional Review Board

Office of Regulatory Compliance

Job Title: Quality Assurance and Education Specialist

Position #: 00703882 - Requisition #: 37511

Job Summary:

This position resides within the Colorado Multiple Institutional Review Board in the Office of Regulatory Compliance. The Quality Assurance and Education Specialist conducts educationally focused Quality Assurance Reviews, including audits of human research studies conducted at the University and its affiliates. This individual works closely with investigators and their teams to review research records to verify compliance with federal regulations, state laws, and institutional policies. This activity includes identifying opportunities for improvement and providing expert guidance and support, based on regulations and policies, to the research teams for ongoing compliance. The Quality Assurance and Education Specialist writes reports detailing the findings and recommendations and discusses them with investigators and their teams. In this position, there is also the opportunity to provide education and training to researchers on an individual basis or in large group settings.

Key Responsibilities:

50%

Works extensively with individuals in all areas of the University and UCD affiliates to promote collaboration and to further the University's research mission.
Conducts Quality Assurance Reviews and audits of human research studies being done at the University of Colorado Denver | Anschutz Medical Campus and its affiliate institutions as per written policies and procedures to ensure all departments and divisions are in compliance with applicable local and federal laws, regulations, polices, and guidelines.
Assures adherence to all research standards as set forth by the FDA, OHRP, NIH, ICH-GCP, University of Colorado Denver | Anschutz Medical Campus, and its affiliates, IRBs, and other related regulatory agencies.
Communicates compliance reviews and audit findings both in person and in writing to the investigator and their research teams.
Provides guidance documents, templates, and advice on process improvement and best practices as they relate to the conduct of human subject research.

30%

Under the direction of the COMIRB Assistant Director - Quality Assurance & IRB Reliance, assists in the development of educational tools and activities based on compliance review and audit findings.
Provides educational training to individual study teams, departments, and to the campus-at-large on topics including, but not limited to, human subjects protection, informed consent, study documentation practices, and FDA-regulated research.

20%

Serves as an internal resource to address and resolve any questions or issues of a regulatory or quality assurance nature.
Remains informed of evolving regulatory revisions and guidelines that are relevant and ensures that the information is communicated to appropriate parties.

Work Location:

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

Why Join Us:

The Colorado Multiple Institutional Review Board (COMIRB) is part of the Office of Regulatory Compliance. In the review and conduct of human subject research, actions by COMIRB will be to uphold the guiding principles to protect human research participants' rights and welfare and to promote ethical research.

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.

Qualifications:

Minimum Qualifications:

A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
One (1) year of professional-level experience in clinical research.

Substitution: 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:

Experience with academic center regulatory processes as related to clinical trials.
Experience conducting audits/quality assurance reviews.

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.
Working knowledge of FDA and OHRP regulations for human subject research, ICH-GCP guidelines, and sponsor operating procedures.
Knowledge of criteria that meet non-compliance, including serious and/or continuing non-compliance.
Familiarity with research and regulatory infrastructure and professional staff at the University and our affiliate institutions.
Demonstrates accuracy in all details, able to record and report effectively.
Excellent interpersonal and human relations skills.
Able 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 the 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: Christy Williamson, Christin.Williamson@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until the position is filled. For best consideration, apply by September 8, 2025.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $55,495 to $70,590.

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

Equal Employment Opportunity Statement:

The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

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.

Application Materials Required: Cover Letter, Resume/CV, List of References Job Category
: Research Services Primary Location
: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 22182 - ADM AVCRC COMIRB Schedule
: Full-time Posting Date
: Aug 11, 2025 Unposting Date
: Ongoing Posting Contact Name: Christy Williamson Posting Contact Email: Christin.Williamson@cuanschutz.edu Position Number: 00703882

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=37511&lang=en