Violeta Soriano Matsuda CRC

acrw9g@r.postjobfree.com 619-***-****

Highly Talented and accomplished Certified Clinical Research Coordinator with extensive skills and experience

OBJECTIVE

Over 18 years of experience as Clinical Research Coordinator. Proven ability to manage multiple studies simultaneously, from inception to completion. Superior ability of digesting protocols in order to conduct the trial in compliance with Good Clinical Practice Guidelines. Thorough understanding of regulations implemented by Institutional Review Board for subject’s safety. Ability to liaison with fellow coordinators as well as with CRA, excellent communicator. Exceptional Organizational skills.

As a Clinical Research professional aspiring to a higher level of opportunity to work in another area of clinical research-Quality Control- detailed review coupled with cross-tracking of clinical research data in various types of source documents.

Given a medical background and was trained initially in a dedicated clinical research environment in Metabolic Endocrinology, Rheumatology, Vaccine trials. Trained to handle regulatory documents from study inception to completion. Most recently handled Hematology/Oncology trials in a hospital setting then Hepatology clinical trials both outpatient & inpatient settings.

Actively searching for a permanent, full time work.

PROFESSIONAL BACKGROUND

6/3/2015 – present UC San Diego Clinical & Translational Research Institute La Jolla CA

Clinical Research Coordinator, Temporary position

Maintain a high level of knowledge and understanding on how to execute assigned protocols.

Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with protocol.

Responsible for completion of all study documentation forms, including case report forms and other study specific documents.

Conducts clinical research in compliance with all applicable regulations.

Communicate closely and timely with representatives from GlaxoSmithKlne, Merck, PRA International, Novum, Novartis, Sanofi-Pasteur and other research partners

Responsible for completion of required regulatory document submission to various Central Institutional Review Boards for study start-up and maintenance of regulatory master file

2/28/2011- 6/2/2015 Veterans Medical Research Foundation San Diego CA

CERTIFIED CLINICAL RESEARCH COORDINATOR

Maintain a high level of knowledge and understanding on how to execute assigned protocols.

Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with protocol.

Responsible for completion of all study documentation forms, including case report forms and other study specific documents.

Conducts clinical research in compliance with all applicable regulations.

Communicate closely and timely with representatives from GlaxoSmithKlne, Merck, PRA International, Novum, Novartis, Sanofi-Pasteur and other research partners

Responsible for completion of required regulatory document submission to various Central Institutional Review Boards for study start-up and maintenance of regulatory master file

6/2006 – 12/17/2010 ACCELOVANCE SAN DIEGO, CA

CERTIFIED CLINICAL RESEARCH COORDINATOR

Maintain a high level of knowledge and understanding on how to execute assigned protocols.

Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with protocol.

Responsible for completion of all study documentation forms, including case report forms and other study specific documents.

Conducts clinical research in compliance with all applicable regulations.

Communicate closely and timely with representatives from GlaxoSmithKlne, Merck, PRA International, Novum, Novartis, Sanofi-Pasteur and other research partners

Responsible for completion of required regulatory document submission to various Central Institutional Review Boards for study start-up and maintenance of regulatory master file

11/199*-**-**** RADIANT RESEARCH SAN DIEGO, CA

CLINICAL RESEARCH COORDINATOR

Maintain a high level of knowledge and understanding on how to execute assigned protocols.

Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with protocol.

Responsible for completion of all study documentation forms, including case report forms and other study specific documents.

Conducts clinical research in compliance with all applicable regulations.

Communicate closely and timely with representatives from GlaxoSmithKlne, Merck, PRA International, Novum, Novartis, Sanofi-Pasteur and other research partners

Responsible for completion of required regulatory document submission to various Central Institutional Review Boards for study start-up and maintenance of regulatory master file

1996-1997 GUAM MEMORIAL HOSPITAL TAMUNING, GUAM

QUALITY ASSURANCE COORDINATOR

1995-1996 GUAM EYE CLINIC TAMUNING, GUAM

OPHTHALMOLOGIC ASSISTANT

1990-1994 BENGUET CORPORATION Mandaluyong City, PHILIPPINES

RESIDENT PHYSICIAN/SECTION MANAGER

1987-1990 SANTO NINO MEDICAL CLINIC Olongapo City, PHILIPPiNES

PRIVATE MEDICAL PRACTITIONER

EDUCATION

1981 Far Eastern University Manila, PHILIPPINES

DOCTOR OF MEDICINE

1977 Far Eastern University Manila, PHILIPPINES

BACHELOR OF SCIENCE IN ZOOLOGY

CERTIFICATION

Association of Clinical Research Professionals

Certified Clinical Research Coordinator, 09/08/2007

State of California, Department of Health Services

Certified Phlebotomy Technician I, 11/10/2008

American Heart Association

BLS Lifesaver, 05/01/2007

RESEARCH EXPERIENCE

An Evaluation of the safety and Efficacy of XXXX (a Combination Tablet of Niacin Extended Release/XXXX Immediate Release): A Dose-Ranging Study.

A Randomized, Double-Blind, Parallel Group Evaluation of XXXX 0.8 mg Compared to XXXX 0.4 mg and Placebo/XXXX 20 mg Once Daily in Patients with Hypercholesterolemia.

A Multicenter, Randomized, Dose Response Study to Compare the Efficacy and Tolerability of XXXX and XXXX in Patients with Type II Diabetes Mellitus and Hypercholesterolemia.

A 24 week, Double-Blind Study of XXXX in combination with Sulfonylurea or in combination with Sulfonylurea plus XXXX in Type II Diabetes patient inadequately controlled on Sulfonylurea plus XXXX.

Safety and Efficacy of XXXX/ XXXX combination products in NIDDM who have failed glycemic control with diet, exercise and maximum doses of Sulfonyurea therapy.

An Open-Label extension study evaluating the Safety and Efficacy of XXXX (a combination tablet of Niacin extended release/XXXX immediate release).

An Open-Label, Randomized study of the relative Efficacy of XXXX (a combination tablet of Niacin extended release/XXXX compared to XXXX and XXXX).

An 18-Month, Double-Blind, Placebo-Controlled, Phase III Trial with a 12-Month Analysis of the effect of XXXX on Fracture incidence in Women with Post-Menopausal Osteoporosis.

A Multi-Center, Randomized Parallel Group, Open-Label, XXXX-Controlled Cardiac Safety Study of Oral XXXX Sodium tablets (7.5 mg) or micronized XXXX (maximum 12 mg) administered for twelve months to subject with Type II Diabetes Mellitus.

A Phase 3 Study on analgesic efficacy and safety of XXXXX: A Randomized Double-Blind 13-week placebo and Naproxen-Controlled, multicenter efficacy study of XXXXX (375 mg bid and 750 mg bid) in patients with osteoarthritis of the knee. (PRA082) 2006

A Multicenter, Randomized, Double-Blind, Prospective, Placebo-Controlled Study Comparing the Safety and Efficacy of XXXXX and FDA Approved Statin Combination Therapy to XXXXX and FDA Approved Monotherapy in Subjects with Mixed Dyslipidemia. (COV104) 2006

A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of XXXX or XXXX Versus XXXX 5 in Subjects with Moderate to Severe Osteoarthritis (OA) Pain.

A phase IIIb, prospective, double-blind, randomized, controlled multicenter study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [XXXXX®] compared to Sanofi Pasteur's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [XXXXX®], when administered as a booster vaccination in adults aged 19 to 64 years of age. (GSK068)

Phase I/II, Randomized Study to Evaluate the Safety and Immunogenicity of Transcutaneous Trivalent Influenza Vaccination with Different Doses of Heat-Labile Enterotoxin of Escherichia coli in Healthy Adults (IOM001)

A parallel randomized, open-label, multicenter study of [XXXXX (375 mg bid and 750 mg bid)] in subjects with osteoarthritis of the knee (follow-up of the 13- week, double-blind, parallel, randomized, placebo- and Naproxen-Controlled XXXXX-X-301 efficacy and safety study.(PRA082)

A Placebo Controlled, Randomized, Double Blind Study to Compare Antioxidant Levels in Normal Subjects with Elevated Waist Circumference When Administered 1 or 2 XXXXXX Dietary Supplement Capsules for 4 Weeks.(POM001)

Multi-center, Randomized, Double-Blind, Randomized, Parallel group, Placebo-Controlled, study to investigate the safety and efficacy of an oral medication once daily, in preventing heartburn with a 1-week placebo-run-in period, and a 2-week placebo or study drug treatment period.(PPD252)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of XXXXX in Subjects with Mild to Moderate Uncomplicated Essential Hypertension. (MDS013)

A Multicenter, Randomized, double-Blind, parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of [XXXXX] Versus XXXXX in Patients with Mixed Hyperlipidemia. (MCK049)

A randomized, double-Blind Study Evaluating the Safety and Tolerability of a 600-mg QD Dose and a 600-mg BID Dose of Oral XXXXX Versus Oral Placebo for 14 Days in Volunteers.(SAL001)

A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of XXXXX Concentrate (XXXXX Flu and Cold Formula) for the Prevention of Cold and Influenza (POM005)

A Parallel randomized, open-label, multicenter study of [XXXXX (375 mg bid and 750 mg bid)] in subjects with osteoarthritis of the knee (follow-up of the 13- week, double-blind, parallel, randomized, placebo- and Naproxen-Controlled XXXXX-X-301 efficacy and safety study.(PRA084)

A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Extended Cycle Oral Contraceptive Regimens (DR-1031) Compared to Seasonale Oral Contraceptive Regime.(DMP003)

Gastrointestinal Randomized Event and Safety Open Label NSAID Study: A Randomized, Open-Label Blinded-Endpoint, Parallel-Group Trial of GI Safety of Celecoxib Compared with Non-Selective Nonsteroidal Anti-inflammatory Drugs (NSAIDS) in Osteoarthritis Subjects. (BBA007)

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral dose Typhoid Fever Vaccine (XXXX) in Healthy Adult Subjects.(AVA001)

A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial to Evaluate the Safety and Efficacy of a Marketed Medical Food Containing GanedenXXX (bacillus coagulans) on Symptoms of Lactose Intolerance. (GAN001)

A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenecity of Pandemic Influenza Plasmid DNA Vaccines. (VIC001)

A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenecity of Pandemic Influenza Plasmid DNA Vaccines Administered with the Biojector® 2000 Needle-free System.(VIC001)

A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Efficacy of a Marketed Medical Food Containing GanedenXXX (bacillus coagulans) on Symptoms of Diarrhea Predominant Irritable Bowel Syndrome. (GAN004)

Audrey Project Consumer Focus Group Study.10/4 person focus groups to review a feminine care product. (GNX001)

A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients with Moderate to Severe Atopic Dermatitis. (NVM014)

A prospective, multi-center, paired data, cohort screening trial comparing SCOUT DS to the fasting Plasma glucose Test in Subjects at Risk for Diabetes (VLT003)

A Randomized, Double-Blind, Multiple Site, Placebo Controlled, Parallel Design, Clinical Study to Evaluate the BioEquivalence of XXXXX (Strides Arcolab Limited) Compared to XXXXX (3M pharmaceuticals) in Patients with Actinic Keratosis (NVM 015)

A Phase II, Muticenter, Randomized, Observer-Blind, Placebo Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL’s 2009 H1N1 Influenza Vaccine (CSL 425) in Healthy Adults Aged 18 Years of Age and Older (CSL 003)

An Observer Blinded, Randomized, Parallel Group, Multicenter Study Comparing the Safety and Immunogenicity of Heplisav to Licensed Vaccine (Engerix B) among Healthy Subjects 40 to 70 Years of Age (DYN 001)

A Phase 1 Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Plasmid DNA Vaccine (VCL SM01) Against Novel H1N1 Influenza Virus in Healthy Adults (VIC002)

A Phase 3, Randomized, Double Blind, Placebo-Controlled Study of Pegfilgrastim Administered to Subjects with Newly-diagnosed, Locally advanced or Metastatic Colorectal Cancer treated with Bevacizumab and Either 5-Fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)

A Phase 3, Prospective, Open-Label, Multicenter Study of LYMPHOSEEK-Identified Sentinel Lymph Nodes (SLNs) Relative to the Pathological Status of Non-Sentinel Lymph Nodes in an Elective Neck Dissection (END) in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma

A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

The Men’s Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer patients on Active Surveillance

Registration Phase III Study of XXX (Belagenpumatucel-L) in Advanced Non-small cell Lung Cancer: An International Multicenter Randomized, Double-Blind, Placebo-Controlled Study of XXX Maintenance Therapy for Stages III/IV NSCLC Subjects who have responded to or have Stable Disease following One Regimen of Front-Line platinum-based Combination Chemotherapy

A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) patients to Assess the Relationship between Patient Outcomes, Treatment Regimens and Molecular Profiles

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the long-Term Safety and Efficacy of Darbepoetin Alfa Administered at 500ug Once Every 3 Weeks in Anemic Subjects with Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy

Training Certificates/Records will be provided upon request.

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