"Research Services Principal Professional (Barbara Davis Center for Diabetes)"

Job Summary:

Principal 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. Principal Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Principal Clinical Science Professionals either act as work/team leads for 2 or more FTE Professional. Some Assignments will not move beyond this level.

Key Responsibilities:

• Assist with and oversee the day to day operations of clinical trials and studies
• Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
• Perform informed consent process or ensures 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 personal interviews
• 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 Food and Drug Administration (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
• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
• Serve as a resource and participate in study initiation and close out duties
• Oversee and provide informal leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff
• Provide input and feedback to leadership on team members' overall performance, performance evaluations, opportunities for development, and process improvement initiatives
• Identify training and development opportunities for new and existing team members

Why Join Us:

Within the Adult Division is the Pregnancy and Women's Health Clinic, which helps women manage glucose fluctuations across menstrual cycles, pregnancy, and through the menopausal transition. There is a robust clinical and research program in the Pregnancy and Women's Health Clinic designed to improve health conditions in women living with diabetes and conduct research on advanced diabetes technology use in pregnancy, recognizing long-term complications from diabetic pregnancies, and following offspring of pregnant women for the onset of diabetes in their children.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Qualifications:

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
• Three (3) years clinical research or relate experience
• Applicants must meet minimum qualifications at the time of hire.

A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Preferred Qualifications:

• Bachelor's degree in science or health related field
• Four (4) years of clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Knowledge, Skills, and Abilities:

• Advanced 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 levels throughout the institution
• Outstanding customer service skills
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information

How to Apply:

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

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

Questions should be directed to: Susan Aspinall susan.aspinallcarrillo@cuanschutz.edu

Screening of Applications Begins: Immediately and continues until position is filled.

Anticipated Pay Range: The starting salary range (*or hiring range*) for this position has been established as $60,075-$76,415