Clinical Coordinator

University of Colorado; Aurora (CO); Ibrido; USD 52.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical plans

Dental plans

Retirement 401(a)

Paid time off

Vacation 22 days/year

Sick days 15/year

Holiday days 15/year

Tuition benefit

ECO Pass

Descrizione del lavoro

University of Colorado Anschutz Linda Crnic Institute for Down Syndrome seeks a Clinical Coordinator to manage day-to-day clinical research tasks, obtain histories, and coordinate trial activities. The role emphasizes regulatory compliance and accurate documentation within a hybrid work model.

The position requires a Bachelor's degree with experience in clinical research and familiarity with IRB processes, REDCap, and EDC systems.

Competenze

• Bachelor’s degree in any field required.
• One year of clinical research or related experience preferred (varies by level).
• Experience with regulatory documentation and IRB processes is beneficial.
• Knowledge of Good Clinical Practice (GCP) and regulatory standards.
• Experience with electronic data capture systems (e.g., REDCap, EDC) recommended.

Mansioni

• Oversee day-to-day operations of clinical trials and studies.
• Obtain medical history and document informed consent.
• Coordinate scheduling and availability of study resources.
• Adhere to regulatory standards and ensure documentation is complete.
• Assist with study materials and regulatory filings as needed.

Conoscenze

Clinical research

IRB oversight

GCP

Data management

Regulatory submissions

Communication

Spanish beneficial

Formazione

Bachelor’s degree

Advanced degree substitute

Strumenti

REDCap

EDC systems

EMR/EHR

Descrizione del lavoro

University of Colorado Anschutz

Linda Crnic Institute for Down Syndrome

Job Title: Clinical Coordinator

Position #00854120 – Requisition #41623

Job Summary:

Clinical Coordinators perform clinical research related functions which includes research conducted with human subjects. This participant-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Coordinators may also assist with epidemiologic and behavioral studies and/or outcomes research 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 and ensure that the process is properly documented, and that informed consent form documents are filed 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 in an accurate and 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 – this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings. (80% onsite, 20% remote).

Why Join Us:

The Linda Crnic Institute for Down Syndrome is the largest academic home for Down syndrome research. The Crnic Institute collaborates with prominent scientists and leaders around the globe to enable precision medicine approaches to improve health outcomes in Down syndrome. Learn more at: https://medschool.cuanschutz.edu/linda-crnic-institute.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• 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.

Qualifications:

Minimum Qualifications:

Entry Level:

• 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:

• 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:

• 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:

• Bachelor’s degree in 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:

• Bachelor’s degree in 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:

• Bachelor’s degree in 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.

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.

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