Research Services Regulatory Compliance (Entry – Senior) Professional

Job Summary:

The Barbara Davis Center (BDC) for Childhood Diabetes at the University of Colorado Denver is a multi-disciplinary diabetes center affiliated with the University of Colorado School of Medicine. The patient population spans the ages 1 to 70 years with either type 1 or type 2 diabetes. The BDC also serves as a clinical center for TrialNet an international multi-center research organization with the goal of understanding the pathophysiology of type 1 diabetes as well as finding ways to prevent type 1 diabetes. Additionally we have many treatment and prevention industry sponsored clinical trials for type 1 diabetes.

The Prevention Team at the Barbara Davis Center is seeking a full-time Regulatory Compliance Lab Coordinator. The Prevention Teams conducts clinical trials for type 1 diabetes prevention and intervention. This position involves coordinating the Pathway to Prevention NIH funded screening program and independently managing the sample processing shipping and storage of specimens from several NIH funded and industry funded clinical trials. The person in this position will act as the lead screening study coordinator and coordinate laboratory activities for numerous other trials.

Regulatory Compliance Lab Coordinators provide direct professional support of research activities. Functions include contracts and grant solicitation and administration grant/agreement preparation review and negotiation regulatory compliance sponsor communication and post and pre award management human subject compliance research animal management research laboratory coordination and instruction environmental health and safety radiation control hazardous materials use disposal and training.

Key Responsibilities:

• Process human biological samples for multiple clinical research studies including blood centrifugation aliquoting preparation storage data entry samples management and shipping maintaining laboratory compliance to safety regulation.

• Conduct analysis of biological samples to answer research questions: including hemoglobin A1C analysis urine pregnancy tests and blood glucose levels.

• Assist with the day-to-day laboratory operations of clinical trials and studies

• Adhere to research regulatory standards

• Maintain detailed records of sample processing to ensure compliance with requirements of the Food and Drug Administration (FDA) study protocols department hospital/clinical standard operating procedures and other regulatory guidelines

• Ensure that the necessary supplies and equipment for studies are in stock and in working order

• Independently perform sample processing and management

At the Intermediate Rank individuals will also be expected to:

• Oversee the day-to-day laboratory operations of clinical trials and studies

• Perform informed consent process or ensures that the informed consent process has occurred is properly documented and that informed consent form documents are filed as required.

• Schedule subject participation in research study or clinical trial coordinating availability of necessary space and clinical research support (e.g physician nurse practitioner laboratory radiology pharmacy)

At the Senior Rank individuals will also be expected to:

• Obtain study subjects medical history and current medication information reviews research protocol inclusion/exclusion criteria and confirms eligibility of subject to participate in clinical trial

• Independently master study materials including but not limited to protocols informed consent forms and all other essential study documents for assigned studies.

• Independently perform study related processes procedures and assessments as defined in study protocol and in compliance with regulating bodies

Work Location:

Onsite this role is expected to work onsite and is located in Aurora Colorado.

Why Join Us:

The Barbara Davis Center for Diabetes at the University of Colorado at Denver Anschutz Medical Campus is a multi-disciplinary diabetes center affiliated with Childrens Hospital of Colorado as well as the University of Colorado School of Medicine. The patient population is primarily children with type 1 diabetes but also includes youth with type 2 diabetes and genetic forms of addition to the clinical program the Barbara Davis Center has large basic and clinical research programs allowing for many ongoing educational opportunities.

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: Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal state and local laws governing nondiscrimination 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.

Qualifications:

Minimum Qualifications:

Entry Rank:

• A bachelors degree in science or a directly related field from an accredited institution

Intermediate Rank:

• A bachelors degree in science or a directly related field from an accredited institution

• 1 (one) year relevant clinical research experience

Senior Rank:

• A bachelors degree in science or a directly related field from an accredited institution

• 2 (two) years relevant clinical research experience

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelors degree on a year-for-year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Experience recruiting and consenting for human subjects research

• Experience processing biological specimens

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.

• Knowledge and understanding of federal regulations related to human subject research and Good Clinical Practice

• Team-oriented self-motivated and able to work independently

• Excellent organizational and time management skills

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: BDC HR

Screening of Applications Begins:

Applications will be accepted until finalists are identified but preference will be given to complete applications received by December 15 2025. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as:

Entry Rank: $50996- $64867

Intermediate Rank: $55495-$70590

Senior Rank: $59995-$76314

The above hiring range represents the Universitys 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: 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 .

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 othervaccine 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 addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.