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Research Services Regulatory Compliance (Entry Senior) Professional

Description

University of Colorado Anschutz Medical Campus

Department: Barbara Davis Center for Diabetes, Pediatric Division

Job Title: Research Services Regulatory Compliance (Entry - Senior) Professional

Position: 00842778- Requisition:38373

Job Summary:

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

+ 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)

+ Obtain study subject's 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

Why Join Us:

Equal Employment Opportunity Statement:

Qualifications:

Minimum Qualifications:

+ A bachelor's degree in science, or a directly related field from an accredited institution

+ A bachelor's degree in science, or a directly related field from an accredited institution

+ 1 (one) year relevant clinical research experience

+ A bachelor's degree in science, or a directly related field from an accredited institution

+ 2 (two) years relevant clinical research experience

Preferred Qualifications:

+ Experience recruiting and consenting for human subject's 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:

Screening of Applications Begins:

December 15, 2025.

Anticipated Pay Range:

ADA Statement:

Background Check Statement:

Vaccination Statement:

Job Category

Primary Location

Schedule

Posting Date

Unposting Date

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=38373&lang=en (https://apptrkr.com/6755064)

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Research Services Regulatory Compliance (Entry - Senior) Professional - 38373 University Staff

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.At the Intermediate Rank, individuals will also be expected to:At the Senior Rank, individuals will also be expected to:

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

The Barbara Davis Center for Diabetes at the University of Colorado at Denver, Anschutz Medical Campus is a multi-disciplinary diabetes center affiliated with Children's 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 diabetes. In 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: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get\_redirect.php?id=6755064&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .

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.

Entry Rank:Intermediate Rank:Senior Rank:Substitution: 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.

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 position2. Curriculum vitae / Resume3. Three to five professional references including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: BDC HR, [email protected] (https://apptrkr.com/get\[email protected])

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

The starting salary range (or hiring range) for this position has been established as:Entry Rank: $50,996- $64,867Intermediate Rank: $55,495-$70,590Senior Rank: $59,995-$76,314The above 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 (https://apptrkr.com/get\_redirect.php?id=6755064&targetURL=http://www.cu.edu/node/153125)

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 [email protected] (https://apptrkr.com/get\_redirect.php?id=6755064&targetURL=hr.adacoordinator@cuanschutz.edu) .

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.

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get\_redirect.php?id=6755064&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get\_redirect.php?id=6755064&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 21770 - SOM-BDC Pediatric : Full-time : Nov 26, 2025 : Ongoing Posting Contact Name: BDC HR Posting Contact Email: [email protected] (https://apptrkr.com/get\[email protected]) Position Number: 00842778jeid-b35c0e16b7014044a8e5334e3c539ea5

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.