Clinical Research Coordinator

Job Summary

The Barbara Davis Center for Diabetes is seeking a full-time (40 hours per week) Research Services Professional. This is a clinical research position with no laboratory duties. The professional will contribute to new and ongoing diabetes related studies, primarily including clinical trials using emerging diabetes technologies for management of type 1 diabetes in youth. At the intermediate rank, duties are less limited in scope and are performed independently with occasional guidance and direction from other professionals.

Intermediate Clinical Science Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Intermediate Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Obtain study subject's medical history and current medication information, review research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in clinical trial
• Perform informed consent process or ensure that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and in person discussions.
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• Adhere to research regulatory standards
• Maintain detailed records of studies to ensure compliance with requirements of the FDA, study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members

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

The Barbara Davis Center (BDC) for Childhood Diabetes at the University of Colorado Denver is a multi-disciplinary diabetes center affiliated with the University of Colorado, School of Medicine. The patient population spans the ages 1 to 70 years with either type 1 or type 2 diabetes.

Benefits statement to include in all benefits-eligible positions:

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: 10/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.

Minimum Qualifications:

• Bachelor's degree in any field
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
• One (1) year clinical research or related experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelor's degree in science or health related field
• Two (2) years of clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Previous phlebotomy experience.

Knowledge, Skills and Abilities:

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Ability to communicate effectively, both in writing and orally
• Ability to establish and maintain effective working relationships with employees at all…