User:Cmjleaks/sandbox

Charlene M. Jett 329 S. 4th St									     6 Pages Vandalia, Ill. 62471						618-283-4073 charlenemjett@yahoo.com

3R's Management Consulting and Therapeutics, Inc. Pharmaceuticals, Medical Devices, Chemicals and Diagnostics: Clinical Research... Discovery Research...Project Management

Powerful dual track career in clinical aspects of pharmaceuticals, chemicals, medical devices and diagnostics. She is an ideal senior scientist, project manager or both. In-depth experience managing clinical research and clinical/regulatory scientific requirements, including assisting in the preparation and evaluation of submissions to FDA. 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 and Sr. CRA. 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 products and profit goals. Responsible for managing contracts and millions of dollars. Past DoD clearances (3) and patient homecare responsibilities. Prior management consultant for U S Army and American Red Cross.

Education: 1990 – MS Management-- Lake Forest Graduate School of Management Lake Forest, Illinois (International, Oxford). 1980 – MS Biology-- minor Biochemistry—Northeastern Illinois University Chicago, Illinois. 1972 -- BS Physiology—minor Biochemistry— University of Illinois Urbana, Illinois.

•	American Red Cross- Pharmacy Volunteer- Scott Air Force base, Illinois March 2011 – March 2012 •	Home care Expertise Primary caregiver – January 2005- January 2011 Patient caregiving expertise includes managing transportation, hospitalizations, doctor visits, medical devices, home care nurses, pharmacists, injections, bandages, medical record access, medicare and tricare   (military) coverages, legal issues, banking, pastoral and religious care, family access, physical therapy, nutritional and hydration needs and homecare facilities for 6 years, 24/7. This included local and military hospitals, clearances and identification. Scheduling and purchasing all supplies and  medications. Experience with Alzheimer’s, diabetes, stroke, heart disease, infections, colostomy and retinopathy. •       Professional Career Experience 3R's Management & Research Consulting Founder, President and Principal 1988- present 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 protocols, scientific/medical and clinical research monitoring reports. •        Assisted in re-engineering two organizations. •        Conducted clinical trials on new clinical products in various therapeutic 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 dysfunction, Parkinson’s, arthritis, re-stenosis, glaucoma, anti-infective therapies, diabetes and chemicals (MRI contrast agent and aquaculture). •        Inventor (Baxter’s Tisseal) •        PC, Laptop and  Microsoft Office experience. 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 and 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. Audited patient and product data prior to FDA submission. Conducted clinical trials ( Hytrin and Cartrol) and on medical devices ( Transpac II, Etomidate, Pulse-oxcimiter, surgical cannister). 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 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. •       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. PUBLICATIONS 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. 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, 2012 Vandalia, Illinois. 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.

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. University classes in advertising, marketing, strategic planning, statistics, lasers, law and computers. Volunteer Activities: Church: Sing in choir regularly, teach Sunday school monthly, write in devotional booklet yearly, member of Church women's group,  member of Evergreen Outreach and write weekly, minor repairs of church. Community Activities: Singing and devotions for Fayette County Nursing Home occasionally in the summer and holidays.