Elizabeth Gallardo

**** ***** ** ******, **** *

Oceanside, CA 92056

Phone: 201-***-****

E-mail: abm6l1@r.postjobfree.com

OBJECTIVE

To obtain a position utilizing my education and accumulated skills and

where there is an opportunity for continued learning, professional growth,

and advancement

SUMMARY

. Clinical Research experience in Phase I and III studies with both Pharma

and CRO companies

. Trained to conduct field monitoring of clinical trials; working knowledge

of GCP, GMP and GLP

. Prior experience to clinical trials included 7 years of GMP QC lab

experience in the disciplines of microbiology, analytical chemistry, and

molecular biology

. Ability to learn new skills quickly and accurately; attention to detail;

strong interpersonal skills; bilingual (English / Spanish)

SKILLS

Provide excellent customer service, gather and generate data, prepare

reports, medical terminology, QC/QA, EDC, IVRS, MS Word, Excel and Outlook

PROFESSIONAL EXPERIENCE

CHILTERN INTERNATIONAL, INC. Carlsbad, CA

Clinical Research Associate January 2009 -

September 2009

Therapeutic Area Indication

Phase

Autoimmune Diseases Rheumatoid Arthritis

III

Cardiovascular Orthostatic Hypotension

III

Co-Monitored multiple on-site Phase III clinical trials via site

evaluation, interim and close-out visits, while

assuring adherence to GCP and ICH guidelines, while in compliance

with study procedures

. Conducted comprehensive audits of Trial Master

Files and worked with sites and CRAs to obtain

the

required information to bring the files into full compliance with

GCP and FDA regulations

. Assisted in the feasibility assessment of sites

. Worked with sites to identify and resolve data

discrepancies to ensure all data was submitted

in a timely

fashion for an interim analysis

. Tracked investigator payments and performed

payment reconciliation of previous payments

. Updated and maintained clinical project related

trackers and systems within project timelines

VALEANT PHARMACEUTICALS Aliso Viejo, CA

Clinical Project Assistant October 2007 -

November 2008

Therapeutic Area - CNS Indication - Epilepsy

Phase - I & III

. Central support to the clinical project team for various designated

operational activities, including generation, compilation, organization,

distribution, file maintenance, tracking, and review of study documents

. Coordinated and maintained the collection of essential clinical

documents, identified documentation noncompliance, and ensured updated

versions were received in a timely manner as applicable to local

regulatory requirements, ICH guidelines and company requirements

. Engaged in frequent correspondence with investigational sites and vendors

regarding study-related matters and inquiries

. Reviewed monitoring reports on site issues and report findings

. Reviewed ICFs and HIPAA language for submission to IRBs; reviewed CRFs

for completeness, clarity, legibility, and adherence to protocol

requirements

. End of study Trial Master File quality control review and reconciliation

in preparation for FDA audits; designated point person for the

interpretation and review of Latin American study files, as well as the

main contact person for follow-up inquiries related to TMF reconciliation

findings

. Provided support with data base lock activities including review of

multiple line listings for clinical relevancy/data accuracy and

interaction with data management for resolution of discrepancies

. Assisted with periodic data review of tables, listings and figures in

preparation of NDA submission

GEN-PROBE, INC. San Diego, CA

QC Analyst II June

2007 - August 2007

. Temporary employee for a leader in DNA probe technology products used for

the clinical diagnosis of human diseases, and for the screening of

donated human blood

. Performed quality control release testing on in-process and final

products (component and kit testing) using a variety of manual and

automated molecular genetic assays involving Transcription-Mediated

Amplification and Hybridization Protection Assay methods

. Kept accurate records and documentation according to cGMP

. Performed review of test data and release functions in SAP

. Conducted investigations for OOS test results and wrote event reports

. Performed laboratory maintenance per written protocols and monitored

inventories

ROCHE MOLECULAR SYSTEMS (A subsidiary of Hoffman La Roche, Inc.)

Branchburg, NJ Scientist/Environmental Monitoring

May 2004 - April 2007

. Conducted microbiological testing and evaluation of environmental samples

from clean rooms, purified waters and various stages of in-vitro

diagnostic products, in accordance with USP, FDA regulations and

internal guidelines.

. Performed basic microbiological techniques to culture, isolate/identify,

microorganisms and validate microbiological media

. Accurately documented all work according to cGMP and entered

environmental monitoring data into a LIMS

. Calibrated, operated and maintained laboratory instrumentation (Vitek 2

Compact, Vitek Legacy and Biolog Identification Systems, RCS Plus Air

Sampler, MetOne Particle Counter and TOC Analyzer)

. Performed qualification and validation of new laboratory equipment

. Assisted with project improvements; developed and executed validation

protocols; produced final reports

. Authored and revised Standard Operating Procedures

. Trained technicians in laboratory techniques and environmental monitoring

procedures

ANDEROL, INC., East Hanover, NJ

Analytical Laboratory Technician

April 2000 - April 2004

. Provided customer technical service by analyzing synthetic and petroleum-

based lubricating oils, greases and other organic compounds submitted by

customers. Some of the routine tests performed included viscosity, total

acid number, water, elemental analysis by ICP-AES, and FTIR. All tests

were done in accordance with ASTM, federal specifications, and other in-

house methods.

. Wrote and issued product technical service reports to customers and sales

staff containing recommendations based on test results.

. Other laboratory duties included trouble shooting lab instruments, non-

routine testing such as product compatibility analysis, and analyzing

QA/QC batch samples

PROFESSIONAL TRAINING

Clinical Research Associate Education and Training Program Conducted by

Medical Research Management, Inc, an accredited provider through ACPE

"Fundamentals of Clinical Research" March 2007

140 hour Training Program included the following topics:

. The drug research and development process, identifying and reporting of

non-serious and serious adverse events, principles of data management and

query resolution, protocol development, case report form design, and

informed consent writing.

. Good clinical practices 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54 Financial

Disclosure by Clinical Investigators. International Conference of

Harmonization (E6) GCP Consolidated Guideline and (E2A) Clinical Safety

Data Management.

. Monitoring method and responsibilities: Systematic approach to

monitoring, managing essential documents and clinical trial materials.

Selecting investigators and conducting pre-evaluation, study initiation,

interim and close out visits. Writing pre-visit letters, follow-up letters

and site visit reports. Performed five mock site visits utilizing case

studies.

EDUCATION

Seton Hall University, South Orange, NJ

Bachelor of Science in Biology, December 1999

References Available Upon Request

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