(Excerpted from Application) The Protocol Specific Research Support has the following objectives: 1) To assist in reviewing protocol eligibility for assignment of these resources in support of appropriate institutional pilot clinical protocols approved by the Protocol Review and Monitoring System of the Cancer Center; 2) To establish research nurse/data management for approved pilot clinical protocols requiring such support, to include coordination or data collection, liaison activities for both patients and referring physicians, patient follow-up, and collaboration with the physician-investigator in assuring compliance with all protocol requirements. 3) To create, as necessary, data collection records for assigned clinical protocols and quality control mechanisms for all such records; 4) To serve as central repository for all data records for approved cancer center protocols and provide a format for the audit of records by sponsoring organizations; 5) To maintain a roster of all patients on assigned studies (including appropriate demographic data such as race, gender, age, city of origin, etc.) and an ongoing patient tracing system for assurance of long-term patient follow-up; to submit patient accrual data as required for inclusion in the centralized SACI protocol data base; 6) To create educational programs about clinical investigations protocols supported by the Cancer Center for the purpose of training new research nurses/data managers and for the education of other cancer center personnel about the principles underlying clinical cancer research; and 7) To serve as a back-up for the Patient Referral Coordinator of the Clinical Investigators Shared Resource at times with the Coordinator may be absent from her duties. The principal role of this cancer center resource will be the support of innovate institutional research studies approved by the PRMS. This support includes data collection and management of approved institutional pilot studies, patient-subject evaluation liaison, and other responsibilities. The Senior Research Nurse many also participate in broader functions for other peer-reviewed clinical trials of this cancer center, including the development of educational programs and assistance in research data quality control and audit preparation.
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