University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: Clinical Research Coordinator (open rank) - LCPC / CPS Team

Position #: 00678098 – Requisition #: 40341

Job Summary:

Clinical Science Professionals at all levels 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. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.

Key Responsibilities:

Entry Level or CRC I:

Level of clinical or data focused tasks will be determined at the discretion of the supervisor/manager based on team needs.

• The position will require understanding workflows and requirements for performing studies at both UCHealth and the Rocky Mountain Regional VA Medical Center

• Assist with and oversee the day-to-day operations of cancer prevention and survivorship research studies and clinical trials

• Independently abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into clinical trials database in an accurate and timely fashion 

• 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 and 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)

• Collaborates with hospital staff to ensure tests and procedures, required by research protocols, are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures); follow-up with appropriate persons on missing or discrepant data

• Perform data entry for all assigned studies and subjects

• Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor

• 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

• Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administrat