Clinical Research Data Specialist (Part-time to Full-time)

Clinical Research Data Specialist (Part-time to Full-time)

University of Colorado Anschutz

Department: Pediatrics - Developmental Pediatrics

Job Title: Clinical Research Data Specialist (Part-time to Full-time)

Position #: 00846388 - Requisition #: 39435

Job Summary:

The eXtraOrdinarY Kids Clinic and Research Program at Children's Hospital Colorado is seeking a Clinical Science Professional to join our growing research team. Our interdisciplinary program is nationally recognized for advancing care and discovery for children and adolescents with sex chromosome aneuploidies, including Turner, Klinefelter, Trisomy X, XYY, and XXYY syndromes. Our team brings together experts in developmental-behavioral pediatrics, endocrinology, genetic counseling, psychology, neuropsychology, cardiology, nephrology, otolaryngology, audiology, sleep medicine, speech and occupational therapy, nursing, and social work, alongside research service professionals and trainees. We are proud to lead NIH-, foundation-, and advocacy-funded translational research that aims to improve both health outcomes and day-to-day life for the families we serve.

We are looking for a collaborative and detail-oriented individual who is excited to lead data management efforts across multiple studies, help transform data into knowledge, and contribute to a supportive, mission-driven environment. The ideal candidate is someone who enjoys problem-solving, values teamwork, and wants to grow professionally while contributing to research that improves care for children and families. This position offers substantial opportunity for skill development, increasing independence, and participation in scholarly work within a highly collaborative academic environment. Flexible scheduling and hybrid work arrangements are supported, with the expectation of reliability, accountability, and in-person availability for key meetings and collaborative activities. This position is part-time (0.5 FTE); however, there is flexibility to build a full-time (1.0 FTE) role for individuals interested in study coordination, regulatory operations, broader program support, or related work.

Key Responsibilities:

Data Management & REDCap Administration (40%)

• Design, build, and maintain REDCap databases across multiple clinical research studies, including development of instruments aligned with common data elements.
• Lead data quality practices, including validation rules, query management, and preparation for monitoring or audit activities.
• Support role-based data security by coordinating user access, permissions, and related documentation.
• Manage participant records, including creation of unique identifiers (GUID) and appropriate data access group assignment.
• Develop and maintain SOPs for data workflows and train study personnel on standardized data entry and QC practices.
• Create dashboards, tables, visualizations, and analytic datasets for investigators, clinicians, community stakeholders, manuscripts, and grant reporting.
• Work closely with biostatisticians to promote well-structured, analysis-ready data.
• Identify and implement opportunities to improve or automate data capture, integration, and reporting processes.
• Maintain data dictionaries, metadata documentation, and version control to promote reproducibility and cross-study harmonization.
• Collaborate with institutional informatics partners and external site teams to facilitate data integration, extraction workflows, and multi-site alignment.
• Coordinate with biorepository partners to understand biospecimen availability and ensure accurate linkage between specimen and clinical datasets.

Study Implementation, Regulatory & Documentation (20%)

• Abstract and integrate data from electronic health records (e.g., Epic), participant-reported outcomes, and external technologies such as wearable devices.
• Contribute to multi-site study execution, including site onboarding, protocol training, and coordination.
• Maintain compliance with HIPAA, GCP, FDA, and institutional policies and support adherence to regulatory systems (e.g., OnCore, ClinicalTrials.gov, regulatory binders).
• Contribute to the development and revision of protocols, MOPs, and SOPs.
• Assist with regulatory submissions, grant applications, and progress reports, including human subjects materials, recruitment planning, milestone tracking, and preliminary data summaries.

Scientific Collaboration & Dissemination (20%)

• Collaborate with investigators and statisticians on analytic planning, data interpretation, and translation of findings.
• Contribute to the preparation of abstracts, posters, presentations, and manuscripts in accordance with sponsor and journal requirements.
• Participate in the presentation of findings at local, regional, and national meetings.

Team Leadership, Training & Outreach (20%)

• Mentor and support student and junior research staff in data procedures and project workflows.
• Serve as a key resource to investigators and other stakeholders regarding data availability, structure, quality, and reporting.
• Contribute to community engagement activities and maintain team communication platforms, including website and publication updates.

Work Location:

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

Why Join Us:

The eXtraOrdinarY Kids program offers a uniquely collaborative environment where clinicians, researchers, and trainees work side-by-side to advance discovery and improve care for individuals with sex chromosome variations. Team members are deeply committed to rigorous science, compassionate engagement with families, and mentoring the next generation of clinical and research leaders. Staff in our program have the opportunity to contribute meaningfully across studies, develop new skills, and see how their work directly supports publications, grants, and improvements in clinical practice. We value curiosity, initiative, and teamwork, and we strive to create an environment where people feel supported, respected, and excited about the work they do. People who thrive on our team are curious, proactive, and collaborative. They enjoy solving problems, building systems that make research easier and more accurate, and working closely with experts from many disciplines. Successful team members are comfortable asking questions, learning new skills, and taking initiative, while also demonstrating reliability, mutual respect, and shared responsibility.

Qualifications:

Minimum Requirements:

• Bachelor's degree in a related field.
• At least one (1) year of experience in clinical research or related experience.*
• At least one (1) year of experience building or managing databases, preferably in REDcap.*
• *Experience may be obtained simultaneously.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year-for-year basis.

Applicants must meet minimum qualifications at the time of hire.

Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Preferred Qualifications:

• Master's degree in data science or related field.
• Experience working with EHR-derived data or integrating data across sources.

Knowledge, Skills, and Abilities:

• Understanding of clinical research workflows and human subjects protections.
• Demonstrated attention to detail and commitment to data quality.
• Working knowledge of clinical research data management principles, including database structure, data validation, and preparation of datasets for analysis.
• Understanding of human subjects research regulations, data privacy, and Good Clinical Practice (GCP).
• Ability to translate research protocols into efficient, accurate data collection systems and workflows.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines simultaneously.
• Comfort working with complex datasets from multiple sources (e.g., EHR, participant-reported outcomes, wearable devices).
• Ability to collaborate effectively with interdisciplinary partners, including investigators, clinicians, biostatisticians, informatics teams, and research staff.
• Strong written and verbal communication skills, including the ability to explain data concepts to both technical and non-technical audiences.
• Experience or interest in developing documentation such as SOPs, data dictionaries, and workflow guides.
• Demonstrated problem-solving skills and initiative in identifying and improving data or operational processes.

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: Karen Regan, RN, karen.regan@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until the position is filled. For best consideration, apply by April 24, 2026.

Anticipated Pay Range:

The starting hiring range for this position has been established as $25,560.50 to $32,572.50 (part-time, 0.5 FTE) or $51,121 to $65,145 (full-time, 1.0 FTE).