steven harvey cra resume 2016-january

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Steven C. Harvey 1113 Oakcrest Drive Providence Village, Texas 76227 Phone: 214-675-2386 E-mail: [email protected] Objective Seeking a position as a CRA with a results oriented company that requires an ambitious career conscious person, who has Clinical trials experience. Bachelor of Science degree and Masters of Education with over 2 years of Clinical Monitoring. Education – Bachelor of Science 1/15/2000 – 5/15/2003 University of Houston, BS. Information Systems Masters of Education 1/20/2014 - 12/4/2015 Grand Canyon University, Master of Education, Educational Leadership The Bracane Company 10/20/2014 Present Plano, TX Contract Research Organization specializing in clinical trial site management. Regional Clinical Research Associate Supervise the progress of the clinical study in accordance with GCP guidelines, sponsor’s SOPs and the study protocol. Complete site initiations, interim monitoring visits, and close-out visits. Maintain regulatory and IRB requirements, ensure proper Informed Consent process. Assure inclusion/exclusion criteria are properly met. Monitor case report forms, laboratory procedures, adverse event reporting and query resolution. Monitor investigational drug shipments/storage, maintain accurate records, and perform accountability. Develop and maintain rapport/relationship, communicate via letters, phone and email. Prepare monitoring reports. Clinical Study Monitoring Dermatology -Teva Acne Study- Phase II Dermatology -Novum Acne Study Phase II & III Infectious Disease GSK-Sinusitis Phase III Cardiovascular Novartis-Hypertension- Phase II & III Endocrinology Novo- Diabetes (Type II)Phase II & III Site Visits = 218 Protocols = 6 Designated sites = 25 Site initiations visits (SIV) = 4 Co-Monitor Routine monitoring visits (RMV) = over 185 Training Basics of Clinical Research Principles December 2014 (8hrs)

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Page 1: Steven Harvey CRA Resume 2016-January

Steven C. Harvey 1113 Oakcrest Drive Providence Village, Texas 76227 Phone: 214-675-2386 E-mail: [email protected]

Objective Seeking a position as a CRA with a results oriented company that requires an ambitious career conscious person, who has Clinical trials experience. Bachelor of Science degree and Masters of Education with over 2 years of Clinical Monitoring.

Education – Bachelor of Science 1/15/2000 – 5/15/2003 University of Houston, BS. Information Systems

Masters of Education 1/20/2014 - 12/4/2015

Grand Canyon University, Master of Education, Educational Leadership

The Bracane Company 10/20/2014 – Present

Plano, TX

Contract Research Organization specializing in clinical trial site management.

Regional Clinical Research Associate Supervise the progress of the clinical study in accordance with GCP guidelines, sponsor’s SOPs

and the study protocol. Complete site initiations, interim monitoring visits, and close-out visits. Maintain regulatory and IRB requirements, ensure proper Informed Consent process. Assure

inclusion/exclusion criteria are properly met. Monitor case report forms, laboratory procedures, adverse event reporting and query resolution. Monitor investigational drug shipments/storage, maintain accurate records, and perform

accountability. Develop and maintain rapport/relationship, communicate via letters, phone and email. Prepare

monitoring reports.

Clinical Study Monitoring

Dermatology -Teva Acne Study- Phase II

Dermatology -Novum Acne Study – Phase II & III

Infectious Disease –GSK-Sinusitis – Phase III

Cardiovascular –Novartis-Hypertension- Phase II & III

Endocrinology –Novo- Diabetes (Type II)– Phase II & III

Site Visits = 218

Protocols = 6 Designated sites = 25

Site initiations visits (SIV) = 4 Co-Monitor

Routine monitoring visits (RMV) = over 185

Training Basics of Clinical Research Principles – December 2014 (8hrs)

Page 2: Steven Harvey CRA Resume 2016-January

ICH/GCP Training EDC Training

Children First Academy of Dallas 8/20/2012 – 8/8/2014 Elementary School Teacher Educated an average of 23 students in Kindergarten and received “Best Teacher Award” Provided tutoring support and designed individualized learning plans for English Language Learners, students with learning difficulties, and gifted learners.

Off the Bone Barbeque Restaurant 6/15/2008 – 8/1/2012 Marketing Director / Operational Manager Opened and operated my new family business in the highly competitive downtown Dallas. Received rave reviews from Dallas Morning News to celebrity catered events as the hottest new food establishment of Dallas eateries.

Grand Homes 2/1/2006 - 6/15/2008 New Home Sales Consultant / Community Manager Managed and executed the opening of New and Future Phases of the community subdivision. Developed selling techniques to acquire higher % of full priced sales at Builders asking price and increased upgrades added on a per sale basis. Expedited marketing strategies, managed overall appeal and maintenance of a $60 Million dollar subdivision.

Awards and Professional Designations Salesperson of the Year - 2004 McSAM 2006 Award nominee - Top New Home Sales Consultant (250K—300K) Teacher of the Year - 2014

References Business, Client and Personal available upon request