Clinical Research Coordinator (open rank) - LCPC ​/ CPS Team

University of Colorado Anschutz Medical Campus

Department:
Cancer Center

Working Title:

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

Position #:  - Requisition #: 40341

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.

• 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 Administration (FDA) audits and responses
• As delegated by supervisor or manager, may 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
• May assist with tracking protocol training and delegation of authority logs.
• Schedules, coordinates, and prepares for Sponsor Monitor Visits and audits in collaboration with Regulatory personnel, Primary CRC and other research team members

• 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…