Clinical Research Coordinator; Breast Team

Clinical Research Coordinator (Breast Team)

University of Colorado Anschutz Medical Campus

Department:
Cancer Center - CCTO (Breast Team)

Working Title:
Clinical Research Coordinator (Breast Team)

Position #:  - Requisition #: 38678

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.

• Assist with and oversee the day-to-day operations of clinical trials and studies
• 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, review research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in 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 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)
• Collaborate with other clinical research team members, investigators, and 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
• Meet 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 including Patient Source Document Binder 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
• 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
• Schedules, coordinates, and prepares for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs, 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 (Intermediate Level or CRC II)
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies (Intermediate Level or CRC II)
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives (Intermediate Level or CRC II)
• Act as a Primary Coordinator on multiple trials/studies (Intermediate Level or CRC II)
• Assist and train junior team members (Intermediate Level or CRC II)
• Assist with developing or develop 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 (Senior Level or CRC III)
• Assist with identifying issues related to operational efficiency and shares results with leadership (Senior Level or CRC III)
• Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention (Senior Level or CRC III)
• Serve as a resource and participate in study initiation and close out duties (Senior Level or CRC III)
• This description is a summary only and describes the general level of work being performed, not intended to be all-inclusive. Duties may change over time and/or based on business need. We reserve the right to add or delete duties at discretion of supervisor or hiring authority.

Hybrid – This is not a remote position. This offer is contingent upon working full-time, hybrid, on the Anschutz Medical Campus. Eligible to work a hybrid schedule after six months of employment, subject to…