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.

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