Clinical Coordinator

University of Colorado•Hybrid, CO

5d•$49,899 - $74,673•Hybrid

About The Position

The Clinical Coordinator performs participant-oriented clinical research involving human subjects, including research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies. The role may also support epidemiologic and behavioral studies, outcomes research, and health services research. The coordinator manages day-to-day study operations, works directly with participants to obtain medical histories and consent, coordinates research visits and clinical support, maintains regulatory compliance, and ensures research information and study documentation are handled accurately and promptly. This position is with the Linda Crnic Institute for Down Syndrome at the University of Colorado Anschutz. The institute collaborates with scientists and leaders worldwide to advance precision medicine and improve health outcomes for people with Down syndrome. The position is hybrid, with four days per week on campus and in-person attendance as needed for meetings (80% onsite and 20% remote). The role may be eligible for overtime compensation depending on its level.

Requirements

Entry level: Bachelor’s degree in any field from an accredited institution; a combination of education and related technical, military, or paraprofessional experience may substitute year for year.
Intermediate level: Bachelor’s degree in any field from an accredited institution and one year of clinical research or related experience; a combination of education and related technical, military, or paraprofessional experience may substitute year for year for the degree.
Senior level: Bachelor’s degree in any field from an accredited institution and two years of clinical research or related experience. An advanced degree in a field directly related to the work assignment may substitute for experience on a year-for-year basis.
Applicants must meet the minimum qualifications at the time of hire.
Must be legally authorized to work in the United States without requiring sponsorship; visa sponsorship or employment authorization will not be provided.
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
Ability to communicate effectively in writing and orally, establish effective working relationships throughout the institution, provide outstanding customer service, and work comfortably with diverse populations and their families.
Knowledge of basic human anatomy, physiology, and medical terminology; ability to interpret and master complex research protocols.
Organized and able to complete multistep tasks independently; able to manage competing priorities and deadlines.
Knowledge of electronic data capture systems, such as electronic medical/health records and data management systems.
Ability to anticipate study needs, identify operational challenges and data discrepancies, and resolve incomplete documentation.
For senior-level responsibilities, ability to independently lead studies from start-up through enrollment, prepare and maintain regulatory documentation, coordinate multidisciplinary teams, drive milestones, and identify and implement process improvements.

Nice To Haves

English/Spanish bilingual ability.
Entry level: Bachelor’s degree in a science or health-related field.
Entry level: Experience working with individuals with Down syndrome or other intellectual disabilities.
Entry level: Experience with electronic data capture systems such as REDCap, EDC systems, electronic health records, or other clinical research databases.
Intermediate level: Bachelor’s degree in a science or health-related field.
Intermediate level: Experience conducting research involving individuals with Down syndrome or other intellectual and developmental disabilities.
Intermediate level: Two years of clinical research or related experience.
Intermediate level: Experience with electronic data capture systems such as REDCap, EDC systems, electronic health records, or other clinical research databases.
Senior level: Bachelor’s degree in a science or health-related field.
Senior level: Experience conducting research involving individuals with Down syndrome or other intellectual and developmental disabilities.
Senior level: Three years of clinical research or related experience.
Senior level: Experience with electronic data capture systems such as REDCap, EDC systems, electronic health records, or other clinical research databases.
Senior level: Experience performing data review, validation, query resolution, and data cleaning to ensure completeness, accuracy, and readiness for analysis.
Senior level: Extensive experience preparing and submitting IRB applications, amendments, continuing reviews, reportable events, and study closures.
Senior level: Experience serving as a primary regulatory contact and liaison among investigators, IRBs, sponsors, and institutional research offices.
Senior level: Experience using project tracking tools and metrics to anticipate risks, monitor study progress, and resolve study challenges promptly.
Senior level: Experience mentoring, training, and onboarding junior research personnel and supporting adherence to study procedures and Good Clinical Practice standards.
Senior level: Demonstrated success coordinating multidisciplinary teams, investigators, sponsors, and external collaborators.
Senior level: Experience with study start-up at Children's Hospital Colorado and the University of Colorado Anschutz Medical Campus, including contracting, budgeting, regulatory submissions, and site activation.
Senior level: Experience with institutional processes and research support offices at Children's Hospital Colorado and the University of Colorado.

Responsibilities

Perform day-to-day operations of clinical trials and studies.
Obtain medical histories from consented participants, follow up to obtain off-site medical records, and complete participant health surveys; reliably transcribe orally reported medical history into written notes.
Obtain informed consent and/or assent from study participants, ensure the process is properly documented, and file informed consent forms as required.
Schedule participant involvement in clinical trials and coordinate necessary space and clinical research support, including physicians, nurse practitioners, laboratories, radiology, and pharmacy.
Adhere to research regulatory standards.
Collect, code, and summarize research information accurately and in a timely manner.
Master study materials for assigned studies, including protocols, informed consent forms, and other essential study documents.
Depending on level, lead clinical research studies from start-up through enrollment and coordinate regulatory, operational, and site activation activities across participating institutions.
Depending on level, prepare and maintain regulatory documents and submissions, coordinate with investigators, IRBs, sponsors, and institutional research offices, and support study milestones and data quality.
Depending on level, mentor and train junior research personnel and implement process improvements to study quality, compliance, enrollment, or data integrity.