Harvey Clinical Resume
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Dr. Shirley Harvey has extensive experience in clinical research and education. She received her EdD in Organizational Leadership from Jones International University in 2012 and has over 15 years of experience conducting and monitoring clinical research studies focused on high school graduation rates. Currently, Dr. Harvey works as a clinical research associate where she oversees study start up, ensures regulatory compliance, and verifies study data quality.
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Harvey Clinical Resume
- 1. Dr. Shirley Harvey 2239 Thornton Lansing Rd Lansing, IL 60438 Phone: 708-200.3289 Email: shirl6732@comcast.net Education: EdD, Organizational Leadership, Jones International University, 2012 Masters of Health Science, Addictions,Governor State University, 1997 Bachelor of Arts, Criminal Justice, Indiana University, 1980 Professional Experience Clinical Research Jones International University October 2009-Present Centennial, Co Thornton Fractional North High School Calumet City, IL Responsible for conducting and monitoring clinical research studies for students,parents,and schooladministrators in efforts to add to the body of knowledge on how to promote high school graduation in light of a significant lack of performance as evidenced by low standardized test scores. Specific responsibilities included: Lead monitor (CRA) mentoring and supervising other monitor (s) Lead investigative study and site selection and study start up Created clinical protocol documents according to IRB, including but not limited to, informed consents, source documentation, forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports. Implement and monitor clinical trial to ensure sponsor/investigatorobligations are compliant with applicable requirements of IRB Perform investigative site file reconciliation: requests any new and updated site-related essentialand non- essentialdocuments and reviews for content,consistency with other documentation and compliance with appropriate regulatory bodies. Verify data in source documents are in agreement with source,initiate data query resolution and confirm resolution in a timely manner. Ensure subject safety and adverse event reporting to dissertation chairs and IRB. Responds to requests from investigative sites in a timely fashion. Completed IRB application, including protocol and informed consents and obtained approvalto conduct study from IRB. Conduct telephone interviews and on site interviews to determine subject eligibility. Schedule intake appointments to recruit subjects to study. Obtained informed consent HIPAA authorization, conducted intake interview, and enrolled subjects in study, Maintained source documents and regulatory documentation for clinical trial. Ensured quality of data on CRFs. Skills and Experience: Advanced degrees in clinical, scientific fields (EdD, MHS) Clinical Project Management Experience Monitoring Experience Supervisory Experience Substantial experience using computerized information systems,Outlook, Word, Excel, PowerPoint, CTMS