EXPERIENCE:
March 2003--Present
Managing Director
Burke Pharmaceutical Research, Inc.
3633 Central Avenue, Suite I
Hot Springs, AR 71913
(501) 620-4449
Market research site to pharmaceutical companies and clinical research organizations.
Negotiate contracts and budgets.
Efficiently coordinate and conduct clinical activities, including participant recruitment and screening, data specimen collection and study medication dispensation, according to protocol.
Develop and maintain complete and accurate federal regulatory document files and study patient case histories.
Oversee study coordinators in daily activities.
Protocol Development for Investigator Initiated Studies.
March 2002- March 2003:
Regional Director of Clinical Operations
Research Solutions, LLC
900 South Shackleford, Suite 210
Little Rock, AR 72211
Responsible for management of clinical trials at the site level. Duties include oversight of the assigned clinical research coordinator, ensuring the submission of the initial and all subsequent regulatory documents, overseeing the IRB approval process, attending sponsor pre-study and initiation visits, assisting the investigator with various recruiting tools and techniques, and acting as the liaison between the sponsor and the investigator.
January 2002-March 2003
Contract CRA
Beardsworth Consulting
70 Church Street, Suite 200
Flemington, NJ 08822
Work on a contract basis after hours and on weekends to assist other monitors on clean up jobs.
July 2000 to March 2002:
Clinical Research Coordinator - Director of Business Development
Physicians Group Research Clinic, LLC
500 S. University, Suite 515
Little Rock, AR 72205
Efficiently coordinate and conduct clinical activities, including participant recruitment and screening, data specimen collection and study medication dispensation, according to protocol.
Develop and maintain complete and accurate federal regulatory document files and study patient case histories.
Market research site to pharmaceutical companies and clinical research organizations.
Negotiate budgets and head the feasibility committee.
August 1999 to July 2000:
Clinical Research Coordinator/Project Manager
Clinical Investigation Specialists, Inc.
Little Rock, AR /Gurnee, IL
Screened physician-investigator sites for participation in clinical trials prepared, collected, and maintained federal regulatory and Institutional Review Board documents for sites and sponsor during trial initiations, ensuring quality document submissions.
Monitored recruitment activities and provided consultation to physicians and
coordinators to enhance participant recruitment, coordinated clinical studies; indications psoriasis and pharmacokinetic.
EDUCATION
December 1998: B.S. Biology, University of Arkansas at Little Rock - Minor in Fish and Wildlife Management
MEMBERSHIPS
2004-Present Drug Information Association
1998-Present Association of Clinical Research Professionals
PROFESSIONAL TRAINING
May 2005:Clinical Research Contract Professional Certified (CRCP) – Model Agreement Group Initative and Strategic Research Institute, Philadelphia, PA
March 2004:Safe-T-Pak, Dangerous Goods Shipping Procedure Training – Burke Pharmaceutical, Hot Springs, AR
November 2003:Recertification, Certified Clinical Research Coordinator, Association of Clinical Research Professionals
October 2003:Clinical Research Site Management Training - The University of Wisconsin Medical School
November 2001:Certified Clinical Research Coordinator - CRC Certification Examination, Association of Clinical Research Professiona1s
July 2001: Blood Born Pathogen and Tuberculosis Training for Offices and Clinics - PGRC, LLC, Little Rock, AR
July 2001: Safe-T-Pak, Dangerous Goods Shipping Procedure Training - CBT, PGRC, LLC, Little Rock, AR
May 2001: Blood Pressure Standardization Shared Care, PGRC, LLC, Little Rock, AR
July 2000: Phlebotomy Training - St. Vincent Health Education, Little Rock, AR
RESEARCH EXPERIENCE
Phase I – Nasal Spray Treatment for Pediatric (6-11) Allergic Rhinitis
Phase I – I.V. Treatment for Moderate to Severe Plaque Psoriasis
Phase I/II – Topical Treatment for Onychomycosis
Phase II – Topical Treatment for Actinic Keratosis
Phase II – Topical Treatment for Acne Vulgaris
Phase II – Adrenal Suppression Study of Tropical Treatment for Pediatric Atopic Dermatitis
Phase II – Injection study for Severe Psoriasis
Phase III – Topical Treatment for Acne Vulgaris
Phase III – Oral Treatment for Acne Vulgaris
Phase III – Follow up Treatment for Acne Vulgaris
Phase III – Topical Treatment for Seborrheic Dermatitis
Phase III – Topical Treatment for Facial Seborrheic Dermatitis
Phase III – Topical Treatment of Plaque-Type Psoriasis
Phase III – Topical Treatment for Rosacea
Phase III – I.V. Treatment for Moderate to Severe Plaque Psoriasis
Phase III – Oral Treatment for Acne Vulgaris
Phase III – Topical Treatment for Atopic Dermatitis
Phase III – Topical Treatment for Mild to Moderate Acne Vulgar
Phase III – Topical Treatment for Plaque-Type Psoriasis
Phase III – Subcutaneous Treatment for Psoriatic Arthritis
Phase III – Topical Treatment for Acne Vulgaris
Phase III – Oral Treatment for Acute Exacerbation of Chronic Bronchitis
Phase III – Oral Treatment for Acute Symptomatic Deep Venous Thrombosis
Phase III – Topical Treatment for Atopic Dermatitis
Phase III – I.V. Treatment for active Crohn’s Disease
Phase III – Vaccine for Rotavirus in Healthy Infacts
Phase III – Oral Treatment for Irritable Bowl Syndrome
Phase III – Oral Treatment for Irritable Bowl Syndrome
Phase III – Oral Treatment for Hypercholesterolemic
Phase III – Oral Treatment for Type II Diabetes
Phase IIIB – Oral Treatment for Herpes Labialis
Phase IIIB – Oral Treatment for Hypercholesterolemia
Phase IV – Topical Treatment for Actinic Keratosis
Phase IV – Oral Treatment for Genital Herpes
Phase IV – Oral Treatment for Herpes Labialis
Phase IV – Pharmacokinetic Study for Oral Cold and Sinus Medication
PROTOCOL DEVELOPMENT
Allergan Twin Study: an evaluation of the safety and efficacy of Tazorac 0.1% Cream (qd) versus placebo in the treatment of identical twin subjects with mild to moderate photodamage.
GlaxoSmithKline Twin Study: an eighteen month placebo controlled study to determine the effects of oral Dutasteride 0.5 mg once a day in identical male twins with male pattern hair loss.
An open-label study of the effects of Solagè™ (2% Mequinol/ 0.01% Tretinoin) combined with cryotherapy for the treatment of solar lentigines on the dorsum of the hands.
THE CLINICAL TRIALS LISTED ABOVE WERE CONDUCTED BY THE FOLLOWING COMPANIES:
Abbott
Alcon
Allergan
Altana
Amgen
Astra Zenaca
Aventis
Barrier Therapeutics, Inc.
Bayer
Biogen
Bristol Myers Squibb
Centocor
Clay Park Labs
Connetics
Covance
Dermik Pharmaceuticals
DermTech
Discovery
Dow Pharmaceuticals
Ferndale
Forrest Laboratories
Fujisawa
Galderma Laboratories
Genomics
Glaxo/SmithKline
HealthPoint
Icon
Isis
3M Pharmaceuticals
MDS
MacroChem
Medicis
Merck Pharmaceuticals
NanoBio
Novartis Pharmaceuticals
OmniCare
Paddock
Pfizer
PharmaNet
PRA International
Pracs
QUATRx Pharmaceuticals
Quintiles, Inc.
Serono
Schering/Plough Pharmaceuticals
Solvay
Symbio
Synta Pharmaceuticals, Corp
Takada
Target Research Associates
Teva Pharmaceuticals
Therapeutics
TKL
TolerRx Inc.
Topical Solutions
Versicor
Watson Labs
White Hall Robbins
Xoma
INDICATIONS
Acne
Actinic Keratosis
Allergic Rhinitis
Alopecia
Atopic Dermatitis (Adult)
Atopic Dermatitis (Pediatric)
Crohn’s Disease
Chronic Bronchitis
Deep Venous Thrombosis
Genital Herpes
Herpes Labialis
Hypertension
Hypercholesterolemia
Irritable Bowel Syndrome
Onychomycosis
Photo Damaged Skin
Psoriasis
Rosacea
Rotavirus Vaccine
Seborrheic Dermatitis
Skin Infection
Solar Lentigines
Tinea Pedis
Tinea Versicolor
Type II Diabetes