Clinical Sciences Intermediate Professional; Part-time, FTE

Clinical Sciences Intermediate Professional (Part-time, 0.4 FTE)

University of Colorado Anschutz Medical Campus – College of Nursing – Clinical Sciences Intermediate Professional. This part‑time position supports assigned faculty members in ongoing studies and clinical trials in the clinical/hospital setting.

Key Responsibilities:

• Assist with and oversee the day‑to‑day operations of clinical trials and studies.
• Obtain the study subject’s medical history and current medication information, review the research protocol inclusion/exclusion criteria, and confirm the eligibility of the subject to participate in the clinical trial.
• Perform the 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 and educate potential subjects on the details of the studies through phone contacts and personal interviews.
• Schedule subject participation in research clinical trials, 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 working order.
• Independently master study materials, including protocols, informed consent forms, and all other essential study documents for assigned studies.
• Independently perform study‑related processes, procedures, and assessments as defined in the study protocol and in compliance with regulating bodies.
• Assist Team Leads, Supervisors, and/or management with the 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.
• Serve as gift card manager for grants.
• Conduct supervised statistical coding/programming.

Onsite – Aurora, CO.

• Bachelor's degree in any field.
• One (1) year of clinical research experience or related experience.

• 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 such as REDCap and/or Atlas.ti).
• Experience with quantitative and/or qualitative research and relevant software.

• 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.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Outstanding organizational skills and attention to detail.
• Ability to represent the University in a professional and positive manner.
• Ability to collaborate as a member of a team and to work highly independently to meet competing demands.
• Innovative problem‑solving skills and ability to thrive on challenges encountered in a fluid, complex environment.
• Knowledge of institutional and governmental research administration policies and procedures, and ability to strictly follow IRB, FDA, and HIPAA regulations.
• Proficient use of computers and relevant software and database applications, including REDCap, OnCore, Microsoft Office, as well as the ability to master new software programs.
• Excellent project management, organizational, and time management skills.

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