Registered Nurse Clinical Research

Jeffrey T. Taylor, D.M.D.

***** *** *** **

Enumclaw, WA 98022

PH: 360-***-****

FX: 360-***-****

Cellular: 253-***-****

E-mail: *******@******************.***

EXPERIENCE AND ACCOMPLISHMENTS:

Career Background Summary:

Clinical Research Consultant with a background in dentistry (private practice), clinical research, pharmaceutical sales, laborer in a steel mill and employee in a hospital emergency room. Experience in field monitoring, medical writing, quality assurance auditing in device, laboratory, and drug clinical trials. Experience in ALL therapeutic areas. EDC experience in numerous software systems. Drug safety experience in adverse event and drug coding. Versatile experience in various aspects of technical medical writing. Work in investigator initiated trials, sponsor-initiated trials, and studies done in retrospect. Broad based experience in preparing sites in an FDA inspection. Experience acting as a consultant for sites during the FDA inspection process.

Independent Contractor- Clinical Research Consultant, Seattle, WA (1996-present)

Serving as a Clinical Research Consultant in all capacities of Phase I through IV Clinical Trials. Trained and experienced in all disciplines and all phases of clinical monitoring, QA, and medical writing. Clients include, Astra Pharmaceuticals, Adolor, Astra-Zeneca, AmpliMed, Antigentics, Alexion Pharmaceuticals, Aventis, MIMC, Bayer, Berlex/Bayer Healthcare, Boehringer Mannheim, Boston Scientific, Bristol-Myers Squibb, Cara Therapeutics, CareStat, Cephalon, Cerexa/Forest Labs, Covance, DOBI Medical Device, DOR Biopharma, DPSI, Dyax, Eisai, Eli Lilly, E-Pharma, Fujisawa Healthcare Inc., Genentech, GenVec, Genta Incorporated, Glaxo Wellcome, GSK Biologics, HRA, IBAH, Immunicon, Omnicare, TAP Holdings, Hoffman-LaRoche, Inc., Roche Diagnostics, Knoll Pharmaceuticals, New Horizons Research, Beardsworth Consulting, Paragon Biomedical, Sucampo, Amgen, ICON Clinical Research, Ono, Kos Pharmaceuticals, KForce, Ortho Biotech, University of Vermont, Medtronics, Medisearch, AMGEN, Origin Pharmaceuticals ,Octapharma, Organon, Kyowa Pharmaceuticals, Luitpold, Quintiles, Inc., Parallax, PharmaLinkfhi, PRA, Pharmacia & Upjohn, Proctor and Gamble, Novartis, ResearchDx, ClinPath Advisors, R.W. Johnson, Abbott Molecular, Abbott Laboratories, Reata, Registrat, Schering Plough, Searle, Prologue International, Sanofi-Synthelabo, Scios, Target Health, The Medicine Company, Targacept, Tibotec, International Health Care, University of Utah, University of Vermont, Wyeth Pharmaceuticals, MDS Pharma, and others. Experienced in site management internationally.

Concepts in Pharmaceutical Research, Inc., Vero Beach, Florida

1996

Serving as a Clinical Research Consultant in all capacities of Phase I through IV Clinical Trials. Trained and experienced in remote data entry studies.

KENDLE RESEARCH ASSOCIATES-Cincinnati, Ohio

1993 - 1995

Employed as a Clinical Research Consultant in Phase III Investigational Drug Studies.

Requiring 80% travel.

PRIVATE DENTAL PRACTICES - Ohio and Kentucky

1980 - 1996

Practiced dentistry and owned and operated dental practices in Ohio and Kentucky. Also operated a dental laboratory.

Developed and initiated a unique treatment presentation for patient care: presenting long-term overview of treatment plans.

Initiated I.V. and Inhalation Sedation Programs.

VICK CHEMICAL - Wilton, Connecticut

Pharmaceutical sales for Vick Chemical. TOP SALES REPRESENTATIVE.

INTERLAKE STEEL CORPORATION - Wilder, Kentucky

Operated a steel splitter machine (double shifts) summers while attending college.

ST. LUKE HOSPITAL - Ft. Thomas, Kentucky

Worked the night shift while attending college classes during the day.

EDUCATION:

B.S., Northern Kentucky University, Alexandria, Kentucky

D.M.D., University of Louisville, Louisville, Kentucky

Graduated top 10% of college class

3.9 grade point average in all chemistry courses (including general, biochemistry, organic and inorganic)

Biology major

Graduate courses in Pharmacology

ASSOCIATIONS AND AFFILIATIONS:

Commissioned Officer USAF Captain US Dental Corp ’80-83

Member American Medical Writers Association

Former Member American Dental Association

Former Member Ohio Dental Association

Former Member Kentucky Dental Association

Former Member Association of Clinical Research Professionals

Former Member Drug Information Association

Former Member ASCO

DEVICE & DIAGNOSTICS:

orthopedic surgery including TMJ implants

coronary artery stents

abdominal aortic stenting

device used in mammography

diagnostics in HPV/HCV

diagnostics in the enumeration of cancer cells in peripheral blood

diagnostic testing for bladder cancer

device to stimulate ganglia in head and neck to promote vasodilation for stroke subjects

many, many others

INFECTIOUS DISEASE:

10 years collectively, on infectious disease clinical trials including viral, fungal, bacterial, vaccines:

Phase III- vaccines for meningitis MEN ABC,X, Y (1 study 3 years)

Phase II & III- acute and chronic hepatitis (multi- 3 years); diagnostic for HCV

Phase III- Acquired Immunodeficiency Syndrome (HAE)- 2 years

Phase II- actinomycosis and histoplasmosis- 1year

Phase II- 2 studies coccidiomycosis

Phase II and III- CAP and nosocomial pneumonia

Phase III- pivotal trials for the treatment of influenza healthy adults, healthy peds, and asthmatic peds

Phase II and III- various indications for macrolides, cyclines, quinolones, and oxazolidinones (5 years multiple)

Phase II- other fungal (multiple- 2 years)

Phase II both in HSV and pain control herpes zoster

Phase I, II, III- multiple HIV infection (4 years)

Many more

27 Jul 2010

SUSAN Doyle Taylor, RN, BSN

46732 248th Way SE

Enumclaw, WA 98022

Phone: 360-***-****

Fax: 360-***-****

Email: *******@******************.***

OBJECTIVE

To provide thorough, compliant, and professional monitoring of Clinical Trials in a time

efficient and cost effective manner.

QUALIFICATIONS

An Independent Clinical Research Monitor since 1991. My responsibilities included monitoring and managing Domestic and International Clinical Trials for numerous Sponsors and CRO’s in the therapeutic areas of: Pulmonary/Respiratory, Cardiology, Neurology, Oncology, Dermatology, Osteoporosis, Psychiatric, Gastrointestinal, Female Reproductive, Biologic and Immuno-therapy. This included both drug, diagnostics, and device trials.

As an Independent Monitor my duties included all aspects of monitoring numerous sites conducting Phase I-IV Clinical Trials such as: Site qualification and initiation, patient enrollment/randomization, training site staff in their responsibilities conducting clinical trials and adhering to GCP and FDA regulations, assuring accurate completion of CRF’s, data validation from source documents, regulatory compliance and maintenance, drug and device accountability, site closure procedures and query resolution.

As a Registered Nurse since 1980, and a study coordinator for 5 years, my duties included:

Conducting all levels of Phase I-IV Clinical Trials, Screening and Randomizing eligible

subjects, completing all CRF’s and study data, maintaining and updating study files and

Regulatory Documents, administering and monitoring study drug, assisting P.I. in medical

Management of subjects, and query resolution and study close-out procedures.

EDUCATION

1980 Bachelor of Science in Nursing, University of Texas, Austin, Texas.

EMPLOYMENT

1991-Present Independent Clinical Research Monitor.

1986-1991 RN, Study Coordinator, Austin, Texas.

1980-1986 RN, Home Health-Clinic, Austin, Texas.

COMPUTER SKILLS

Windows 2000

Microsoft Office 2000

LICENSES & CERTIFICATES

Registered Nurse, license # 456005

AFFILIATIONS

ACRP Member

Research Practitioner Member

CLINICAL RESEARCH TRAINING

“Informed Consent Process- Past to Present,” KML Research-2000, Houston, Texas.

“What to Expect During an FDA Audit,” KML Research-1999, Houston, Texas.

“Medical Review- Manual Logic Checks in Clinical Research,” KML Research-1998, Houston, Texas.

“Basic Monitor Training,” KML Research-1996, Houston, Texas.

“Basic Monitor Training, “ Paragon Biomedical, INC. 1993, Indianapolis, Indiana.

EXPERIENCE DIAGNOSTICS AND DEVICE

1993- Alopecia Device trial

2004-2006 Roche Diagnostics: HCV/HIV diagnostic testing

2005-2006 Roche Diagnostics: HPV diagnostic testing

2006-2007 Tripath: abnormal pap

2004-2005 Medtronics: carotid stenting

2004-2005 Medtronics: coronary artery stenting

2006 Medtronics: abdominal artery/femoral artery aneurysm stents

REFERENCES

Available upon request.

08 Mar 2010

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