1. Charlene M. Jett
329 S 4th Street
Vandalia, Illinois 62471
618-283-4073
charlenemjett@yahoo.com
SUMMARY
Powerful dual track career in clinical aspects of pharmaceuticals, chemicals, medical devices and
diagnostics. She is an ideal senior scientist, Sr. CRA or project manager. In-depth experience managing
clinical research and clinical/regulatory scientific requirements, including assisting in the preparation and
evaluation of submissions to FDA. Current on regulations pertaining to informed consents and clinical
research on patients for medical devices and pharmaceuticals. Demonstrated ability to achieve timely
results while conducting clinical and discovery research, managing and monitoring clinical trials and
critical aspects of regulatory reviews. Very experienced clinical trial monitor, Sr. CRA, writer and
executive. Originator of "Record of Conception of Invention" for pharmaceuticals, chemicals, medical
devices and diagnostics. Strong communicator and negotiator, able to design, build and manage
effective teams to accomplish product goals. Responsible for managing contracts and millions of dollars.
Past DOD clearances (3) and patient homecare responsibilities. Prior management consultant for U S
Army, American Red Cross and others.
EDUCATION
 MS Management-- Lake Forest Graduate School of Management
Lake Forest, Illinois (International-Oxford, UK).
 MS Biology-- minor Biochemistry—Northeastern Illinois University
Chicago, Illinois.
 BS Physiology—minor Biochemistry— University of Illinois Urbana, Illinois.
PROFESSIONAL CAREER EXPERIENCE
Independent Consulting (3R’s Management Consulting etc.)
Founder, President and Principal 1988- present
Clients: St. Jude, Medpace, Monitor for Hire, Home Care (mother), Biovail, Premier, Pentech, Med
Institute/Cook, Lysonics, Baxter-Edwards CVS, Schering Plough, Abbott, G. D. Searle/Monsanto,
In Vivo, US Army/Amdex, American Red Cross, Boston Scientific, Biomerieux, Mallinckrodt,
Allergan, Chiltern, US Army/Cambridge Consulting.
Complete responsibility for business providing advanced consulting services and short term employment
on project by project basis to major pharmaceutical, chemical, medical device and diagnostic corporations
nationwide in areas of science, clinical research, regulatory reviews, and pharmaceutical project/program
management.
Experienced in and knowledgeable on clinical/regulatory SOP's, GCPs, GLPs and regulatory reviews for
FDA and ICH guidelines.
 Audited clinical trials of pharmaceuticals, medical devices, chemicals and combination products.
 Assisted in filings, including INDs, NDAs, 510ks, IDEs, PMAs and In vitro Diagnostics.
 Audited patient and product data prior to FDA submission.
 Wrote scientific reports, protocols, scientific/medical and clinical research monitoring reports.
 Assisted in re-engineering two organizations.
 Conducted clinical trials on new clinical products in various therapeutic/device areas.
 Conducted clinical trials in hypertension, angina, congestive heart failure, Alzheimer's,
schizophrenia, memory problems, heart-valves (mechanical and tissue), surgical sutures, stents,
dental video equipment, anesthesia, in-line glucose and blood pressure sensors, sexual

2. dysfunction, Parkinson’s, arthritis, re-stenosis, glaucoma, anti-infective therapies, diabetes and
chemicals (MRI contrast agent and aquaculture).
o Inventor (Baxter’s Tisseal)
o PC, Laptop and Microsoft Office experience. Experienced with internet, webinars and
security issues.
Abbott Laboratories, North Chicago, Illinois
Project Manager
1987-1988
Sr. Clinical Research Associate
1985-1987
Clinical Research Associate
1980-1985
Fortune 500 developer, manufacturer, and seller of wide range of pharmaceutical products worldwide.
Served as lead scientist and worked in areas including angina, hypertension, congestive heart failure,
medical devices, anesthesia, and veterinary medicine. In addition, worked in regulatory reviews, staffing
and training, interfaced with physicians, scientists, statisticians, nurses etc. Experienced in monitoring,
budgets, data collection, corrections and safety reviews. Phase I-IV and Class I-III experience.
 Assisted in preparation and advised on FDA filings including INDs, NDAs, 510ks and IDEs.
 Researched, designed and wrote medical protocols and summaries.
 Managed clinical research, audits and regulatory compliance of clinical trials, audited clinical trials
of pharmaceuticals. Wrote literature review and in-licensing review for cardiac drugs.
 Audited patient and product data prior to FDA submission.
 Conducted clinical trials (Hytrin and Cartrol) and on medical devices (Transpac II, Etomidate,
Pulse-oxcimeter, surgical canister).
 Managed project, hired staff, and designed field trials for new chemical product
 (fluoroquinolone antibiotic for aquaculture).
 Inventor (new diagnostic product - Matrix).
 Designed and placed studies which resulted in FDA approval, monitored and closed sites
for two drug approvals (Hytrin and Cartrol).
 Critiqued In-License Drug Candidate (Cholesterol Reduction).
 Recommended scientific and medical consultants.
G.D. Searle, Skokie, Illinois
Senior Research Biochemist
1975-1980
Research Biochemist
1972-1975
 Major developer, manufacturer and seller of pharmaceutical products serving markets worldwide.
 Laboratory and animal experimentation,trained technicians and wrote numerous scientific reports.
 Lead scientist working in areas of endocrinology and cholesterol metabolism.
 Co-inventor of new chemicals tested for structure activity relationships in cholesterol reduction.
This contributed to M. Brown and J. Goldstein’s Nobel Prize.
 Researched and wrote scientific reports and summaries.
 Developed animal models and biochemical RIA assays (kinetically validated) for endocrinology
and cholesterol-metabolism(3-beta,5-alpha-hydroxy-steroid-dehydogenase,HMG-CoA
Reductase, 7alpha hydroxylase, Acetyl Coenzyme A Transferase- ACAT).
 Modified marketed HDL diagnostics kit for use in animals.
 Prepared and delivered scientific presentations and publications.
 Interfaced with chemists and other scientists on programs.

3. University of Illinois, Physiology and Agronomy Depts.
Research Technician
1970-1971
Research Assistant
1971-1972
 Enzyme (catalase) assay development and atomic absorption of heavy metals from plant
extracts.
PUBLICATION and PRESENTATIONS
1. Hypolipidemic Activity of 5-Aryl-3 Methylvaleric Acid Derivatives. Dygos, JH; Jett, CM; Chinn LJ; Miller,
JE. J. Med. Chem. Dec, 1977, 20 (12) p1705-8.
2. Inhibition of HMG CoA Reductase by Derivatives of Glycyrrhetic Acid. Jett, CM and Miller, JE.
Abstracts of 175th Meeting of the American Chemical Society, Chicago, IL. V174 Aug. 1977. (Conf.
Paper).
3. Control of HMG-CoA Reductase During Reduction of Serum Cholesterol in the Rat. Jett, CM; Taite,
B., and Miller, JE. American Heart Association, Council on Arteriosclerosis. 31st Annual Meeting, Miami
Beach, Fl. Nov. 1977 (Conf. Paper).
4. Regulation of HMG, CoA Reductase Activity by 3 Hydroxy-3 methyl glutaric Acid and Derivatives
During Reduction of serum Cholesterol Levels in Rats. Jett, C, Langford D, Baran J. and Miller J.-
Abstracts of Council on Arteriosclerosis, American Hart Assn. Nov 1977.
5. Attempts to Inhibit De Novo Cholesterol Synthesis by Derivatives of 3-Hydroxy-3-Methylglutaric Acid.
Jett, CM; Langford, D; Baran J. and Miller, J. International Symposium on Prevention and Reversal of
Atherosclerois, Miami Beach, FL Jan. 1978. (Conf. Paper).
6. Effects of Mevalono-Lactone as a Modulator of 3-Hydroxy-3-Methyl Glutaryl Coenzyme A-Reductase,
Toronto, Ont. Canada, July 7, 1979. J. Lipid Research, 20(8) 1979. (Conf. Paper).
7. The Role of Guinea Pigs in the Study of Atherosclerosis Abstracts of Illinois State Academy of
Science, April. 1979.
8. Jett C. and Miller J.E. Shift is Guinea Pig Lipoprotein Profiles Induced by Modulation of HMG-CoA
Reductase Activity. Abstracts of 5th International Symposium an Atherosclerosis, Houston 1979.
9. Inhibition of HMG CoA Reductase by Substitute B Hydroxy B Alkyl Glutaric Acids. 17th National
Medical Chemistry Symposium. Rensselaer, NY June 1980. Baran, JS., Liang CD, Langford D. Laos I
and CM. Jett.
10. Hyperlipemic Serum Induced Cholesterol Esterification Of Smooth Muscle Cells Is Inhibited By 22-
Hydroxy-Cholesterol And Its Analog. Bates, SR; Jett, CM; Miller, JE. 65th Annual Meeting of the
Federation of American Society for Experimental Biology, Atlanta, GA April 12-17, 1981. (Conf. Paper)
Fed Proc 1981(40) p349.
11. Prevention Of The Hyperlipidemic Serum Of LDL-Induced Cellular Cholesterol Ester Accumulation By
22-Hydroxycholesterol And Its Analogue. Bates, SR; Jett, CM;Miller, JE; Biochem. Biophys. Acta. 1983,
753 (3) p281-93.

4. 12. Correlation Of In Vitro Inhibition of Liver HMG-CoA Reductase With Reduction Of Rat Serum Total
Cholesterol By 3-Hdroxy-3 Methylglutaric Acid Derivatives. Stewart, L; Miller, JE; Baran, J; Rohrbacher,
E; Jett, CM; Taite, B; J. Lipid Research 1983 (10) p1414
13. Presentation at Abbott Laboratories to Divisional, President- HPD. ”Solutions to Problems in Clinical
Research”. 1985.
14. 22-Hydroxycholesterol Derivatives as HMG CoA Reductase Suppressors and Serum Cholesterol
Lowering Agents. Chorvat, RJ; Desai, BN; Radak, SE; McLaughlin, KT; Miller, JE; Jett, CM;
Rohrbacher, E. J. Med. Chem. 1985, 28 (2)p194-200.
15 3-Alky-l,3-Hydroxyglutaric Acid A New Class of Hypocholesterolemic 3-Hydroxy-3-Methylglutaric-Acid
Coenzyme A Reductase Inhibitors, Baran , JS; Laos, I; Langford, DD; Miller, JE; Jett, CM; Taite, B;
Rohrbacher, E. J. Med. Chem. 1985, 28 (5) p597-601.
16. Created and delivered “3R’s-Talent for Hire” 1991-North Shore Chamber of Commerce, Wilmette,
Illinois.
17. Created a presentation for In Vivo-3/1992 “Aging”, Princeton, NJ.
18. Created and delivered-Poster presentation at Baxter-Edwards CVS 3/1993 “Denaflex CABG (
Coronary Artery Bypass Graft) Graft”. Palm Springs, California.
19. Created and delivered-Internal Presentation at Baxter on 3/1993 “Status of Denaflex Graft Clinical
Trials”. Irvine, California.
20. Created and delivered “3R’S- Talent for Hire” 1993 Irvine, CA. and 1995 Carpinteria Chamber of
Commerce, Carpinteria, CA.
21. American Business Women’s Association-Summer, 1994-Created and Delivered-Presentation on
“Stress Management.” Carpinteria, California.
22. Redhill Lutheran (Tustin) and Methodist Churchs, joint Choir Special (~ 1994)
23. Created a presentation for Lysonix, Inc., 7/1997 “Clinical Trials in Liposuction”. Carpinteria, CA.
24. Created a presentation for Solvay 3/1998 “Clinical Research on Women’s Health Problems ”A
Review of Hypertension, Angina and Cholesterol Reduction.”
25. Good Clinical Practices in Monitoring Antihypertensive Clinical Trials (Hytrin and Carteolol). Am.
Journal of Hypertension, 1999, New York, New York.
26. Good Clinical Practices Review- Battelle, Columbus, Ohio ~2000.
27. Quality and Compliance- Clinical Research Issues in the Post 9/11 World. Oct 13,2004.
Regulatory Affairs Professionals Annual Conference, Oct 13, 2004. Washington DC.
28. A Hypothesis for the Heart (Nuclear Magnetic Resonance). 41st Midwest Regional Meeting of
American Chemical Society. Oct 25-27, 2006. Quincy, Illinois.
29. Created a “Review of Basic Clinical Statistics”, Regulatory Affairs Professionals (RAPS) 2007.
Unpublished.
30. First United Methodist Church, Chancel Choir and Christmas Cantata- 2008, 2011 – 2015, Vandalia,
Illinois.

5. 31. QA/QC and Validation in Clinical Trials of Pharmaceuticals or An Ounce of Prevention is Worth a
Pound of Cure. OMICs, Philadelphia Dec 3, 2012
32. Created a presentation for ComplianceOnline.com "Basic Clinical Research" to be delivered in
Oakland Ca in Jan 2014 (canceled).
Professional Affiliations : Sigma Xi, American Chemical Society, past member of Regulatory Affairs
Professionals, Linkedin Professional Network.
Additional Professional classes since 1990 - Global Clinical Research, Advanced Project
Management, and Planning and Managing a Drug Research Portfolio: Improved Decision Making.
Also studied University classes in electron microscopy, advertising, marketing, strategic planning,
statistics, lasers, law and computers.
Volunteer Activities:
Church: Sing in choir regularly, teach Sunday school monthly, write in devotional booklet, member of
Church women's group, member of Evergreen Outreach and write weekly.
Community Activities: Singing and lead devotions for Fayette County Nursing Home occasionally in the
summer and holidays.