Shawnda Bertolini

Eastern Michigan University: Health Administration, B.S.

Eastern Michigan University: Public Administration, M.S.

Mrs. Bertolini is the Associate Director of Clinical Monitoring at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. 

Mrs. Bertolini holds a B.S. in Health Administration and a M.S. in Public Administration, with a healthcare concentration, from the Eastern Michigan University. She is a certified trainer and a certified Clinical Research Associate (CRA).  

Mrs. Bertolini has held a variety of positions within Clinical Operations. Formerly, she was a Clinical Operations Manager at IQVIA Biotech, leading up to twenty-five CRAs at a time, ranging from Senior level to inexperienced staff.  During her time at IQVIA Biotech, she participated in the development and implementation of a CRA Academy, providing robust training and study placement for highly qualified individuals without previous monitoring experience. She has also served as a Senior Project Manager for eClinical Solutions, a Clinical Data Services Company, a Project Manager and Clinical Trials Manager for a mid-sized CRO.  Mrs. Bertolini has participated in more than 30 clinical trials over twenty years.

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Proxima Clinical Research, Inc., Houston, Texas
Associate Director of Clinical Monitoring‍

IQVIA Biotech Morrisville, NC
Clinical Operations Manager‍

eClinical Solution, Inc, Boston, MA
Senior Project Manager‍

MedSource, Inc., Houston, Texas (acquired by Ergomed)
Project Manager
Clinical Trial Lead
Line Manager
Sr. Clinical Research Associate‍

PRA, Health Sciences, Raleigh, NC
Sr. Clinical Research Associate‍

KV Pharmaceutical Company, St. Louis, MO
Lead Clinical Research Associat

‍Ferndale Laboratories, Ferndale, MI
Lead Clinical Research Associat

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Mrs. Bertolini participated in the management or monitoring of assigned studies or study sites to ensure Sponsor and Investigator obligations were being met and were compliant with applicable regulatory requirements and ICH-GCP principals:

1. Phase I and II Multiple myeloma
2. Phase I Glioblastoma
3. Phase I Pediatric neuroblastoma
4. Phase I Advanced or Metastatic Solid Tumors
5. Phase III Malignant Tumor of the Kidney
6. Phase IV Malignant Tumor of the Prostate
7. Phase I AL Amyloidosis
8. Phase III Transplant organ rejection
9. Phase IV Diabetes
10. Phase IV Hypertension
11. Phase III Parkinson’s Disease
12. Phase II Psoriasis
13. Phase II Pediatric Eczema
14. Phase I HIV Infection
15. Phase III Asthma
16. Phase I Cystic Fibrosis
17. Phase I Rheumatology
18. Phase I Attention Deficit Hyperactivity Disorder
19. Phase I Bacterial Vaginosis