Entry Clinical Sciences Professional

University of Colorado Anschutz Medical Campus

Department:
Pediatrics | Section of Endocrinology

Job Title:

Entry Clinical Sciences Professional

Position #:  - Requisition #: 41077

An Entry Clinical Science Professional is being sought for a part-time position in the section of Pediatric Endocrinology to work as a study coordinator for clinical research studies dealing with underserved youth with obesity who are at risk for developing type 2 diabetes. The professional research assistant will work with study physicians in endocrinology and pediatrics, midlevel providers, co-investigators, and staff both locally and nationally as a part of local studies and a multi-center study and will be responsible for study coordination, participant recruiting, consent, and scheduling, performing study visits, processing of research blood samples and other study samples, placing continuous glucose monitors for home blood sugar monitoring, use of a metabolic cart, exercise testing, institutional review board requirements, tracking of study costs, assisting with MRI and other imaging procedures, entering data and other study-related duties.

Travel by car to other sites within Colorado for study recruiting will likely be needed, and may infrequently travel to central study meetings at the NIH in Washington, DC.

• The duties and responsibilities of the position include, but are not limited to:

• Assist with the day-to-day operations of clinical trials and studies.

• Participate in subject recruitment efforts, including educating potential subjects on the details of the studies through phone contacts, electronic contact, and/or personal interviews, communicating with patients, and all pre-screening/screening activities.

• Obtain study subject's medical history and current medication information, review research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in a study 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 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/or 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.

• Maintain familiarity with study protocols and documents of assigned research studies.

• Inventory, handle, and maintain accountability for study supplies and investigational products in collaboration with research pharmacy.

• Perform data and sample collection at in-person and telephone research visits.

• Blood and tissue specimen handling and processing.

• Enter data and send to coordinating center.

• Work as a team member in coordination of assigned primary studies.

• Participant recruitment, consent, and retention.

• Work with investigators and other staff to prepare IRB submission and maintain study approval and certification.

• Maintain…