University of Colorado Anschutz

Department: Pediatrics | Section of Endocrinology

Job Title: Senior Clinical Science Professional - Pediatrics, Section of Endocrinology

Position #: 00848586 – Requisition #:40013

Job Summary:

The eXtraOrdinarY Kids Team is seeking a highly motivated Senior Clinical Research Services Professional to lead and support a diverse portfolio of investigator-initiated clinical research studies focused on children and adolescents with sex chromosome aneuploidies and related conditions. This senior role integrates clinical research coordination, regulatory oversight, data management, and scientific writing within a dynamic, multidisciplinary environment. The ideal candidate will bring advanced experience in human subjects research, a strong commitment to participant-centered care, and the ability to independently manage complex studies while mentoring junior staff and contributing to the team’s broader mission of improving outcomes through innovative, translational research.

Key Responsibilities:

Clinical Research Coordination (30%)

• Serve as senior study coordinator for multiple investigator-led clinical research studies, including tracking milestone progress.

·         Lead subject recruitment efforts, including preparing recruitment materials, identifying eligible patients, and conducting informed consent.

·         Schedule and conduct virtual and in-person study visits according to study protocol, including anthropometrics, standardized assessments, ancillary service coordination, and biospecimen collection.

·         Coordinate and manage wearable devices, including distribution, data downloads, and diary monitoring.

• Maintain compliance with HIPAA, GCP, and institutional policies.

Regulatory (15%)

• Draft and revise study documents, including protocols, consent forms, case report forms, and IRB applications, amendments, and continuing reviews.
• Maintain electronic regulatory binders.
• Support study start-up and close out, including all institutional requirements for conducting human subjects research.
• Register and/or maintain studies on clinicaltrials.gov.

Data Management (15%)

·         Collect, code, and analyze data obtained from research in an accurate and timely manner.

• Develop, manage, and maintain REDCap databases, including instrument creation, data entry, validation, cleaning, and report generation.
• Collaborate with statisticians and research teams on data cleaning and analysis.

Scientific Writing (15%)

·         Draft and review abstracts, posters, and manuscripts.

• Copyediting and ensuring compliance with submission guidelines.