Clinical Research Professional

University of Colorado Anschutz Medical Campus

Department: Anna and John J. Sie Center for Down Syndrome, Children’s Hospital Colorado

Job Title: Clinical Research Professional

Position #: 00839037 – Requisition #:37574

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:

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