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

University of ColoradoAurora, CO
Onsite

About The Position

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.

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.
  • Applicants must meet minimum qualifications at the time of hire.
  • Applicants must be legally authorized to work in the United States without requiring sponsorship.
  • Must be willing and able to pass national criminal and sex offender background checks.
  • Must successfully pass a 10-panel drug screen through Children’s Hospital Colorado.
  • 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.

Nice To Haves

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

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.

Benefits

  • 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: 15/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

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Number of Employees

1,001-5,000 employees

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