Michelle Garcia-Barbón, BS, MT (ASCP)

**** ***** **. *** 4-301-***-****

Alexandria, VA, 22312 gl8ewr@r.postjobfree.com

MEDICAL TECHNOLOGIST/ SENIOR RESEARCH ASSOCIATE/

LABORATORY SPECIALIST/CLINICAL REVIEWER

Clinical Laboratory ● Contract Research Organization ● GLP/GCP● Compliance

SUMMARY

A sharp minded and efficient Medical Technologist committed to excellence; ASCP certified and over ten

years of laboratory related experience. Strong skills in clinical and non-clinical environments including

pharmaceutical, contract research organizations (CRO), reference laboratories, and hospital settings.

Experienced, knowledgeable and dependable on oversight of experimental and database design, GLPs,

GCPs and FDA compliance. Works well under pressure and time constraints within high-volume, fast

paced environments.

Core Competencies

• Laboratory Analyses • GLP/GCP • SOP Development and

Implementation

• FDA, CLIA Compliance • Process Improvement (Six • Specialized Clinical Testing

Sigma)

• Project Management • Data Management • Microsoft Office 2003, 2007

PROFESSIONAL EXPERIENCE

Human Genome Sciences, Inc./MedFocus, Rockville, MD January 2011-October 2012

Clinical Reviewer-Contractor January 2011-October 2012

Represents clinical review in the development of study-specific CRFs, development

of study-specific CRF Completion Guidelines, development of clinical review edit

checks, review of clinical data for consistency and completeness not captured in

the automated edit checks and identifies potential issues with protocol compliance.

In addition the Clinical CRF reviewer may provide support and guidance to the

associate clinical reviewer.

• Functions as the primary reviewer for multiple projects in phases 1 through 4 of clinical trials

(including all clinical review functions from study development through database lock) in

therapeutic areas of Oncology and Immunology.

• Provides training to other HGS personnel or CRO employees on clinical review processes,

edit checks and data trends.

• Generates Data Clarification Forms (DCFs) in accordance with the protocol specific edit

checks and reviews site responses for accuracy.

• Assesses site/investigator/CRA compliance with protocol requirements as defined by the

protocol specific edit checks.

• Works with the Clinical Data Manager and Programmer to develop clinical review data

listings for new projects.

• Uses electronic data capture systems such as DSG (eCaselink® EDC) and Perceptive

Informatics (DataLabs® EDC) to review subject data for protocol compliance.

Covance Laboratories, Inc., Vienna,VA October 2006- January 2011

Senior Research Associate October 2006-January

2011

Successfully conducted GLP and non-GLP experiments using genetic based and molecular

biology techniques by starting human, CHO (Chinese Hamster Ovary) and TK6 cell cultures,

utilizing sterile technique and following assay protocols, SOPs and related directives to ensure

data integrity and compliance. Ensured studies were conducted error free by demonstrating

excellent communication skills with study directors, clients and colleagues.

• Consistently assisted in the design of non-clinical protocols and prepared reports to meet

deadlines for completed study data books with no errors or protocol deviations resulting in

increased client satisfaction and improved data quality.

• Managed multiple tasks efficiently and error free. Influenced laboratory staff by setting an

example of keeping a professional attitude under stressful every-day unexpected situations.

• Demonstrated leadership skills, instrument operation and scientific expertise by being

appointed technical lead in Non-Human Primate Immunophenotyping validation study using

Flow Cytometry methodologies.

• Assisted laboratory operations supervisor in the performance of quality assurance procedures

and application of good housekeeping principles.

Medical Technologist II October 2006-January 2011

Received and prepared specimens to perform manual and automated laboratory procedures used

in the Clinical Pathology area for mammalian toxicology studies in the early development stages

of drug development. Verified, recorded and reported laboratory results on all performed tests.

• Consistently commended for the timely, high quality and error free completion of studies.

• Streamlined the chemistry sample disposal procedure by creating a new procedure utilizing

Six Sigma practices.

• Created a Value Stream Map of all the areas of the laboratory (hematology, clinical

chemistry, special chemistry, urinalysis and coagulation) using Microsoft Visio and

coordinated data collection on a project designed to harmonize procedures in Clinical

Pathology departments globally.

• Demonstrated excellent data management/analysis skills by answering Quality Assurance

data audits.

• Organized workload efficiently by prioritizing tests required by studies and operated multiple

instruments simultaneously to provide results in a timely manner when facing staff shortage.

Washington Hospital Center, Washington, DC February 2004- October 2006

Medical Technologist II

Received and analyzed blood samples and confirmed that the appropriate paperwork was

submitted in the pathology laboratory of a 900 bed hospital that also served as a reference

clinical laboratory for clinics and other health care providers in the Washington, DC area.

Demonstrated extensive operational knowledge of clinical chemistry, coagulation, arterial blood

gases, hematology and special chemistry analyzers; including routine maintenance and

troubleshooting procedures.

• Improved Quality Control procedures by monitoring laboratory wide quality control results

daily and addressing any outlier or unacceptable results immediately.

• Assisted laboratory personnel by demonstrating outstanding skills in instrument operation,

maintenance and troubleshooting.

• Demonstrated the ability to communicate and discuss test results effectively with physicians,

pathologist and nursing staff as a member of an interdisciplinary team focused on providing

exemplary quality of patient care.

American Red Cross, National HLA Laboratory, Baltimore, MD May 2002-February 2004

Clinical Laboratory Scientist

Performed complex histocompatibility testing in specialized CLIA certified clinical laboratory

using molecular biology technique in the work involved with organ transplantation. Received

and prepared human biological material for cross match testing using serologic, genetic,

molecular and flow cytometric analysis; gained experience in ELISA and other procedures used

to perform HLA typing.

• Monitored reagent inventory and assisted in the preparation of reagents on a weekly basis.

• Adapted to work “on call” to perform laboratory work associated with tissue compatibility

testing on cadaver donors and potential recipients within the time limits.

• Commended for completing training effectively in a limited time frame.

• Received whole blood samples and performed DNA extraction using manual methods and

automated instruments.

• Performed polymerase chain reactions (PCR) to analyze DNA by capillary electrophoresis to

find HLA genotype for cross matching.

EDUCATION / TRAINING

Bachelor of Science, Biology

Antillean Adventist University, Mayaguez, Puerto Rico

Professional Certificate, Medical Technology

Interamerican University, San Germán, Puerto Rico

Master of Public Health (projected completion fall 2013)

Grand Canyon University, Phoenix, Arizona

CERTIFICATIONS/TRAINING

Medical Technologist

American Society for Clinical Pathology, Chicago, Illinois

Pre-Leadership Development

Covance Laboratories, Vienna, Virginia

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