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

• Recruitment of studies through communication with sponsors

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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
  

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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
  

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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
  

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  Obtained and documented vitals signs
  
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  Performed venipuncture, port-a-cath flushes
  
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  Provided administrative support for the front desk
  

1989-1992 Island Oncology Clinic St. Simons Island, GA

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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

Clinical Trials Training for Medical Professionals

The American Lung Association Smoking Cessation Leader Training Program

American Heart Association CPR Certification

NIH Certification “Protecting Human Research Participants”

CITI Good Clinical Practice

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