Clinical Research Professional

Job Summary:

Established in 2010, the Anna and John J. Sie Center for Down Syndrome at Children's Hospital Colorado is one of the leading Down syndrome clinics in the United States. Our world-renowned team of experts provides medical, educational, and therapeutic care that helps children and adolescents with Down syndrome thrive. Through close partnership and collaboration with the Global Down Syndrome Foundation and Linda Crnic Research Institute, the Sie Center is a model for Down syndrome care, combining excellence in clinical care, research, community engagement, advocacy, and education.

In the first 14 years, the Sie Center has served over 2,500 patients from 32 states, Puerto Rico, and 11 countries. Our pediatric specialists work together to provide the best possible collaborative care for children with Down syndrome using a multidisciplinary team-based approach. Our services include evaluation, consultation, and therapies for infants, children, teens, and young adults through the age of 22.

This position will support two clinical trials - Birthday-Early Development in Down Syndrome and CAPEabilities (Communication and Play Early Abilities in Children with Down Syndrome). These trials focus on the developmental, behavioral, and biomedical factors impacting young children with Down syndrome.

Key Responsibilities:

• Act as a Primary Coordinator on multiple trials/studies, managing the day-to-day operations.

• Develop protocol-specific source documents and organize and prepare research materials for research study visits.

• Lead participant recruitment, communication, and scheduling.

• Administer developmental assessments and conduct study interviews.

• Responsible for data management for all clinical trial data. Collect, code, and analyze data obtained from research in an accurate and timely manner.

• Review and resolve data discrepancies in data management systems.

• Accurately and timely enter clinical trials data into centralized data management systems, ensure data quality, and review participant records for completeness, accuracy, and quality.

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

• Assist Team Leads, Supervisors, and/or management with the creation and implementation of processes and procedures and quality improvement initiatives.

• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities.

• Complete regulatory maintenance of assigned clinical trials (IRB and FDA initial submissions, amendments, continuing reviews, etc.).

Work Location:

On-site - this role is expected to work onsite and is located in Aurora, CO.

Why Join Us:

In just 14 years, the Sie Center has become one of the leading medical clinics for the pediatric population with Down syndrome. Our innovative care directly improves not only the lives and clinical care of our own patients and families, but through our clinical research, extends nationally and globally to set new standards for children and young adults with Down syndrome, including:

• Multiple Sie Center studies were used to create the 2022 American Academy of Pediatrics Down Syndrome Guidelines.

• Establish standardized medical and developmental references.

• Develop best practices, medical testing, and procedures.

• Improve the identification and treatment of complex comorbidities.

• Create tangible support resources for children and families.

• Identify biomarkers to improve diagnoses and reduce costs.

• Improve access to care for the high-risk, underserved Spanish-speaking population.

The mission of the Sie Center for Down Syndrome research program is to improve the quality of care and life of children and young adults with Down syndrome. We accomplish this by serving as a model of multidisciplinary collaboration through the synthesis of our medical, behavioral, mental health, therapy, and educational expertise, as well as our partnership with internal and external investigators.

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:

• Bachelor's degree in any field.

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

• One (1) year of clinical research or related experience.

Condition of Employment:

• Must successfully pass a drug test through Children's Hospital Colorado.*

• Must be willing and able to pass a national criminal background check.

*For questions regarding Children's Hospital drug testing requirements, please contact Children's Human Resources at 720-777-8598. Some positions may require testing if access to the Children's Hospital or their systems is needed at any time during employment with the University. If drug testing is required, it will be listed in the job posting.

• Bachelor's degree in science or a health-related field.

• Two (2) years of clinical research or related experience.

• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).

• 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.

• Knowledge of basic human anatomy, physiology, and medical terminology.

• Ability to interpret and master complex research protocol information.

• Ability to multitask and meet deadlines.

• Ability to proactively identify and solve problems.

• Demonstrated initiative and strong follow-through 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 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: Kristine Wolter-Warmerdam, kristine.wolter-warmerdam@childrenscolorado.org

Screening of Applications Begins:

Immediately and continues until the position is filled. For best consideration, apply by August 29, 2025.

Anticipated Pay Range:

The hiring range for this position has been established as $52,721 to $67,061.

The 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

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.