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238755 Essentials of study management and building quality operationsSunday, October 30, 2011: 10:00 AM
The purpose of this presentation is to familiarize participants with the business aspects of managing a study including attention to risks in schedule, budget, and personnel. In addition, procedures to control the schedule and costs, and the use of study management tools will be taught through sample exercises
Learning Areas:
Administration, management, leadershipEpidemiology Public health or related research Learning Objectives:
Presenting author's disclosure statement:
Qualified on the content I am responsible for because: I have a doctorate in epidemiology and have more than 17 years of experience in operationalizing research protocols and implementing large-scale, NIH-funded epidemiologic research studies, with a focus on the genetics of neurological disorders, and on genetic and environmental influences on chronic diseases including asthma and uterine fibroids. I am currently a Senior Study Manager at Social & Scientific Systems, Inc., working directly with NIEHS Epidemiology Branch intramural scientists to implement and oversee their research projects. My specific experience includes study design; development and implementation of protocols and standards of operation (SOPs) to ensure reliable and valid data; design and creation of data collection instruments including surveys, medical-record abstraction forms, clinical interviews, and tracking/management systems and tools. I have expertise in all areas of project management for telephone, field and clinical epidemiologic research, including construction of Statements of Work (SOWs); hiring, training, and supervision of all other research staff; budget construction and management; monitoring and adjusting strategy of data collection to ensure quality and achieve study aims; and recruitment and retention of research subjects.
I have led or contributed to more than twenty peer reviewed publications and presentations made at professional research organization meetings including the Society for Epidemiologic Research, American Epilepsy Society, and the American Academy of Neurology. I have had extensive teaching experience in the areas of general epidemiology and genetic epidemiology at the Mailman School of Public Health of Columbia University.
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.
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