The Clinical Research Management Office (CRMO) is the administrative shared resource for the conduct of clinical search at the LCC. The Director of the CRMO, Michael J. Hawkins, M.D., has extensive experience in the conduct and administration of clinical research. The functions of the CRMO are to: facilitate the conduct of clinical search by providing support to clinical researchers and provide regulatory oversight of clinical research. The supervisor for Research Nursing (SRN) has 17 years of clinical oncology, research, and managerial experience and has direct supervisory responsibility for 11 research nurses, 3 data managers, 3 research assistants and 2 protocol coordinators. The Protocol Office, under the SRN's supervision, maintains files on each protocol submitted to the CRMO, submits protocols, amendments, annual reviews and adverse drug reaction reports to the IRB; and maintains current copies of open protocols throughout the LCC. The Supervisor of Research Operations has over 10 years of broad and extensive nursing experience and is responsible for quality control of the CRMO and implementation of new procedures. Support for two research nurses assigned to pilot institutional trials in bon arrow transplantation and developmental therapeutics is also requested in this application. With considerable support from the LCC, the CRMO has established a Clinical Research Database that contains data on each patient who goes onto a clinical protocol, electronically downloads data from the Georgetown Hospital Information System, d provides weekly reports for investigators on LCC single institution trials. Since the last CCSG review, the CRMO, together with the Clinical Protocol Review and Monitoring system and the Biostatistics Shared Resource, been extensively reorganized under new leadership to provides strong and extensive support for LCC clinical trials.
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