Clinical Coordinator

About the Role

The Clinical Coordinator performs clinical research related functions involving human subjects. This includes research on mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. The role may also involve assisting with epidemiologic, behavioral, outcomes, and health services research.

Key Responsibilities

• Perform day-to-day operations of clinical trials and studies.
• Obtain medical history from consented participants, including follow-up for off-site medical records and completion of a participant health survey. Must be able to reliably transcribe orally reported medical history as written notes.
• Obtain informed consent and/or assent from study participants, ensure proper documentation, and file informed consent forms as required.
• Schedule subject participation in research clinical trials and coordinate the availability of necessary space and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy).
• Adhere to research regulatory standards.
• Collect, code, and summarize information obtained from research accurately and in a timely manner.
• Master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.

Work Location

• Hybrid – eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings (80% onsite, 20% remote).

Qualifications

Minimum Qualifications

• Bachelor’s degree in any field from an accredited institution.
• 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.

Intermediate Level Minimum Qualifications

• Bachelor’s degree in any field from an accredited institution.
• 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.
• One (1) year of clinical research or related experience.

Senior Level Minimum Qualifications

• Bachelor’s degree in any field from an accredited institution.
• Two (2) years clinical research or related experience.
• Substitution: An advanced degree (Masters or Doctorate) may be substituted for experience on a year-for-year basis if the degree is in a field of study directly related to the work assignment.
• Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

Entry Level Preferred Qualifications

• Bachelor’s degree in a science or health-related field.
• Experience working with individuals with Down syndrome or other intellectual disability.
• Experience with electronic data capture systems (e.g., REDCap, EDC systems, electronic health records, or other clinical research databases).

Intermediate Level Preferred Qualifications

• Bachelor’s degree in a science or health-related field.
• Experience conducting research involving individuals with Down syndrome or other intellectual and developmental disabilities.
• Two (2) years of clinical research or related experience.
• Experience with electronic data capture systems (e.g., REDCap, EDC systems, electronic health records, or other clinical research databases).

Senior Level Preferred Qualifications

• Bachelor’s degree in a science or health-related field.
• Experience conducting research involving individuals with Down syndrome or other intellectual and developmental disabilities.
• Three (3) years of clinical research or related experience.
• Experience with electronic data capture systems (e.g., REDCap, EDC systems, electronic health records, or other clinical research databases).
• Experience performing data review, validation, query resolution, and data cleaning activities to ensure completeness, accuracy, and readiness for analysis.
• Extensive experience preparing and submitting IRB applications, amendments, continuing reviews, reportable events, and study closures.
• Experience serving as a primary regulatory contact and liaison between investigators, IRBs, sponsors, and institutional research offices.
• Experience using project tracking tools and metrics to anticipate risks, monitor study progress, and ensure timely resolution of study challenges.
• Experience mentoring, training, and onboarding junior research personnel and facilitating adherence to study procedures and Good Clinical Practice standards.
• Demonstrated success coordinating multidisciplinary teams, investigators, sponsors, and external collaborators to achieve study objectives.
• Experience navigating study start-up processes within both Children's Hospital Colorado (CHCO) and University of Colorado Anschutz Medical Campus environments, including contracting, budgeting, regulatory submissions, and site activation requirements.
• Experience with institutional processes and research support offices at CHCO and the University of Colorado.

Knowledge, Skills and Abilities

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
• Ability to communicate effectively, both in writing and orally.
• English/Spanish bilingual is beneficial.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Ability to comfortably work with diverse populations and their families.
• Knowledge of basic human anatomy, physiology, medical terminology.
• Ability to interpret and master complex research protocol information.
• Organized and able to complete multi-step tasks independently.
• Knowledge of electronic data capture systems (e.g., EMR or HER and data management systems).
• Demonstrated ability to anticipate study needs, identify operational challenges, and contribute to the planning and execution of research activities.
• Demonstrated ability to identify and resolve data discrepancies and incomplete documentation.
• Demonstrated ability to independently lead clinical research studies from start-up through participant enrollment, including coordination of regulatory, operational, and site activation activities across participating institutions.
• Advanced knowledge of human subjects research regulations, IRB processes, and regulatory reporting requirements, with the ability to independently prepare, submit, and maintain study regulatory documentation throughout the study lifecycle.
• Proven ability to drive project milestones and study deliverables through effective collaboration, influence, and coordination of multidisciplinary teams, including providing mentorship and operational guidance to peer-level research coordinators.
• Demonstrated ability to independently identify operational inefficiencies, develop process improvements, and implement solutions that enhance study quality, regulatory compliance, enrollment performance, or data integrity.
• Ability to independently manage multiple complex studies simultaneously while balancing competing priorities and deadlines.
• Ability to lead a project from start-up through enrollment.
• Familiarity with regulatory reporting requirements.
• Ability to drive projects among peer-level collaborators.

Conditions of Employment

• 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.

How to Apply

For full consideration, please submit the following document(s):

• A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
• Curriculum vitae / Resume.
• Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.

Questions should be directed to: Sydney Ashton, [email protected]. Screening of Applications Begins: Immediately and continues until 5 days after the posting date.

Anticipated Pay Range

• Entry Level Salary Range: $49,899 - $60,729
• Intermediate Level Salary Range: $54,302 - $66,088
• Senior Level Salary Range: $58,705 - $74,673
• This position may be eligible for overtime compensation, depending on the level.