Entry/Intermediate/Senior Clinical Science Professional

University of Colorado Anschutz Medical Campus

Department: School of Medicine Radiology General Operations

Job Title: Entry/Intermediate/Senior Clinical Science Professional

Position #: 00845964 – Requisition #: 39241

Job Summary:

Entry/Intermediate/Senior 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. Entry/Intermediate/Senior Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Some Assignments will not move beyond the senior level.

Examples of Duties Performed

• 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 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