Clinical Research Associate

Shelly de Guzman

Phone 303-***-****

*******@**********.***

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Education

****-**** ********** ** ********** at San Diego

B.S. Microbiology; Minor Psychology

**** *********ern Community College

Emergency Medical Technician EMT-IA Certificate

1998 Association of Clinical Research Professionals

Certified Clinical Research Associate (CCRA) Recertified

2000, 2002, 2004

1996 Learning Tree University

Medical Transcription Certification

Professional Experience

Apr 2004- Sky Ridge Medical Center/HealthOne/HCA Hospital

2013 10101 RidgeGate Parkway, Lone Tree, CO 80124

Nursing Education Department - Learning/eLearning

Coordinator

Management, tracking, and coordinating of all training

programs. Maintained records and assured JCAHO and other

regulatory body compliance. Nursing student placement,

CEU and LMS (Healthstream) for entire hospital. As sole

author, builder, and administrator, I elevated HLC

utilization from a single annual course to over 200

courses and/or assignments annually. Constantly enhanced

HLC functionalities with new authoring skills, software

and tools such as HTML, Captivate.

Apr 2005- Romo, Inc

April 2006 26675 Strafford, Mission Viejo, CA 92692

Clinical Research Associate - Regional (Contract)

Therapeutic areas: Bariatric Surgery

Site management of outpatient multi center study in

bariatric surgery. Performing regulatory document

tracking, drug accountability, and patient data auditing.

Dec 2004- The Medicines Company

Apr 2005 8 Campus Dr, Parsippany, NJ

Clinical Research Associate - Regional (Contract)

Therapeutic area: interventional cardiology

Site management of inpatient multi-center Phase III

study. Performing regulatory document tracking, drug

accountability, and monitoring of eCRFs and hospital

charts. Developed close relationship with cath lab

physicians and staff to optimize screening and

enrollment. Regulatory document tracking, SAE

reporting/tracking, remote data entry, drug

accountability, and monitoring of source documents.

Oct 2004- Children's Hospital of Philadelphia

Oct 2005 Novartis Pharmaceuticals

Clinical Research Associate - Regional (Contract)

Therapeutic area: dermatology

Site management for inpatient, multi-center, Phase III,

study. Duties include regulatory document tracking, drug

accountability, and data auditing.

Oct 2004- Children's Clinical Research Institute

May 2005 3535 Market St, Philadelphia, PA

Clinical Research Associate - Regional (Contract)

Therapeutic areas: oncology, respiratory

Site management for two inpatient and one outpatient

multi-center Phase II and III pediatric pharmaceutical

and device studies. Performing regulatory document

tracking, drug accountability, and patient data auditing.

Aug 2002- PPD Development

Sept 2004 4009 Banister Lane, Austin, TX

Senior Clinical Research Associate - Regional

Therapeutic areas: HIV, CNS Site management for

outpatient multi-center Phase III pharmaceutical studies.

Performed regulatory document tracking, drug

accountability, and patient data auditing. As Lead CRA

responsibilities included reviewing monitoring and

expense reports, evaluations, personnel and site

allocation.

Oct 1998 - The PHOENIX

200 Valley Rd, Mt Arlington, NJ

June 2000 Senior Clinical Research Associate - Regional

Therapeutic areas: dermatology, infectious disease,

nephrology, urology

Site management of concurrent multi-center outpatient

Phase II and III pharmaceutical studies. Performed

regulatory document tracking, drug accountability, and

patient data auditing. Designed company Training

Manual, study summaries, and presentations.

May 1995 - Baxter Healthcare Corporation / Edwards LifeSciences

Cardiovascular Division, Irvine, CA

Oct 1998 Clinical Research Associate

Therapeutic area: cardiovascular

Site and study management including design and drafting

of CRFs, clinical protocols, annual reports, and study

results for sales, marketing, and product development

teams. Managed site contracts and agreements, and site

recruitment for multi-center international IDE and post

market inpatient Class III device studies.

Sep 1993 - Neocrin Company

31 Technology Drive, Irvine, CA

May 1995 Research Associate

Supervisor of three pancreatic islet research programs:

culture, cryopreservation, and microencapsulation.

Assisted with rodent, canine, and primate studies.

Aug 1991 - The Scripps Research Institute

10499 Torrey Pines Road, La Jolla, CA

Sep 1993 Research Associate

Performed culturing and cryopreservation of multiple

human melanoma cell lines. Performed rodent surgeries

and utilized ELISA, FACS, electrophoresis, and

spectrophotometry as research tools.

Publications

1998 Perchinsky, M., et al Quality of Life in Patients With

Bioprostheses and Mechanical Prostheses - Evaluation of

1993 Cohorts of Patients 51-65 at Implantation. Circulation.

1998: 98.

Montgomery, A, et al "Production and Regulation of

Gelatinase B by Human T-cells" B&B Acta. 1176(3):265-268,

1993.

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