Michelle T. Sowell, C.C.R.C.
Clinical Research Atlanta
________________________________________________________________ revised 01/10_ 175 Country Club Dr. Bldg. 100 St. A 980 Johnson Ferry Rd, St. 1080 Stockbridge, GA 30281 Atlanta, GA 30342 PHONE: 770.507.6867 PHONE: 404.252.0699 FAX: 770.507.1539 FAX: 404.705.9171 ________ Education:
1989-1991 Brunswick College—Brunswick, GA
Registered Nursing Program
1987-1989 Georgia College—Milledgeville, GA
Professional Experience:
1993-Present Georgia Allergy and Respiratory Institute d/b/a/
Clinical Research Atlanta Atlanta/Stockbridge, GA
Clinical Research Atlanta Phase 1
245 Country Club Drive, Suite 200 AB
Stockbridge, GA 30281
Clinical Operations Director
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Develop and manage a multi-faceted recruitment, study and contact database
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Direct and oversee daily activities for each protocol in accordance with assigned staff
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Review and create budgets for each study
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Recruit, screen and enroll subjects
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Prepare and submit all IRB documents
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Backup coordinator to lead coordinator
Clinical Research Coordinator
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Recruited, screened, and enrolled trial subjects in multi-specialty practice per protocol-specific requirements
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Obtained Informed Consent
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Conducted study visits per protocol
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Proper storage, dispensing, and overall accountability for study drug supplies
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Completed Case Report Forms and Source Documents accurately and maintained proper storage
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Prepared for Monitor/CRO site visits/site initiations
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Ensured that IND safety reports from sponsors are properly submitted to IRB and filed in regulatory binder
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Collected and packaged lab specimens per IATA guidelines
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Performed phlebotomy and ECG procedures
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Responsible for Adverse Event/SAE reports and notifications
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Responsible for adherence to study protocol
Michelle Sowell, C.C.R.C., page 2 cont
Clinical Research Assistant
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Prepared IRB documents
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Interviewed and conducted patient screenings
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Obtained and documented vitals signs; insured accurate data entries; EKG, and Venipuncture
.1992-1993 Alpharetta Oncology Alpharetta, GA
Clinical Oncology Assistant
1989-1992 Island Oncology Clinic St. Simons Island, GA
Clinical Oncology Assistant
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Conducted patient screenings
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Performed venipuncture, port-a-cath flushes, obtained and handled specimens
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Provided administrative support
Certifications:
A.C.R.P. Certified Clinical Research Coordinator
ANAM (Automated Neuropsychological Assessment Metrics)
Clinical Trials Training for Medical Professionals
The American Lung Association Smoking Cessation Leader Training Program
Certified Phlebotomist, ECG Technician
American Heart Association CPR Certification
NIH Certification “Protecting Human Research Participants”
CITI Good Clinical Practice
Electronic Data Capture Certifications:
InForm Phase Forward, e-trials, e-caselinks
Medidata Rave, Oracle, Cool, Impala, Enable
Clinical Trial Research Experience: Available Upon Request
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