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
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
