Clinical Research Coordinator
Resume:
NESTOR GARCIA. CRC., MD
Miami, Fl 33135
Ph # 786-***-****
EDUCATION:
COLLEGE: Instituto Superior de Ciencias Medicas de la Hababa Cuba
Julio Trigo Hospital
DEGREE: Doctor of Medicine
LANGUAGES: English, Spanish
COMPUTER EXPERIENCE/SYSTEMS
Proficient in Microsoft Office/Windows, Excel, Power Point,
Oracle Clinical Remote Data Capture
Inform Remote Data Capture
MS Outlook
PHT Electronic Diaries
License and Certification
IATA Certified 2012
GCP Training 2012
Phlebotomy; 2011
Infusion: 2011
PROFESSIONAL EXPERIENCE:
October 2011 to July 2012- Ocean Blue Medical Research. Clinical Research Coordinator. Business Development
March 2011 to Sept 2011- South Miami Clinical Research. Clinical Research Coordinator. Business Development
May 2010 to Feb 2011- ADA Medical Ltd. Clinical Research Coordinator
Dec 2003 to April 2010- Experience Clinical Research. Orlando Rangel, M.D.,P.A
July 1, 2004 to July 1, 2005 - Clinical Research Coordinator
Medical Evaluation Centers, Inc. - 3801 Corporex Park Drive, Suite 110A, Tampa, FL 3619
Medical Centers of Tampa Bay - 2802 W. Waters Avenue, Tampa, FL 33614
Medical Centers of Tampa Bay - 5200 16th Street N., St. Petersburg, FL 33703
2002 to 2004 Causeway Medical Clinic - Independent Clinical Research Coordinator
2000 to 2002 Pediatric Epilepsy and Neurology Specialist - Clinical Research Coordinator
1997 to 2000 Gambro Health Care, Dialysis - Patient Care Technician
1993 - 1995 V I Lenin Hospital, Cuba - Medical Doctor
THERAPEUTIC EXPERIENCE: PHASE II, III, IV
Nephrology: CKD.
Obgyn : Vulvo-vaginal Candidiasis, Utérine Bleading, Vulvar and Vaginal Atrophy
CNS; Neurology, Epilepsy, Migraine Headaches, ADHD, Parkinson ‘s Disease
Endocrinology; Diabetes, Obesity,
Cardiovascular : Hyperlipidemia, Hypertension.
Musculosketal : Back Pain, Osteoarthritis, RA
Urology: Urinary Incontinence
Respiratory: Asthma, COPD, CAP
CLINICAL TRIAL EXPERIENCE:
A Double-blind Placebo-Controlled Add-on Clinical Trial Multicenter Study To Assess Safety and Efficacy of Levetiracetam in refractory Pediatric Patients with Partial onset seizures. Protocol N159. UCB Pharma. Clinical Research Coordinator
A Multicenter, Open-Label, Long Term Follow-up Study of the Safety and Efficacy of Levetiracetam in Children with Epilepsy. Protocol N 157. UCB Pharma. Clinical Research Coordinator
A Double-blind, Placebo-Controlled, Add-on Clinical Trial on the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric aged Subject (1-24 months). GlaxoSmith Kline. Protocol: 200006 .Sub- Inv. Clinical Research Coordinator.
An Open-Label, Uncontrolled, Long-term Study to Assess the Safety af Lamictal in Pediatrics Subjects Previous Enrolled in Protocol ( LAM 2006) and in Lamictal naive subjects (1-24 months of age). Protocol LAM 2007.GlaxoSmith Kline. Sub-Investigator. Clinical Research Coordinator.
Open Label Long-Term Safety of Zonisamide Administered to Children with Epilepsy. Protocol: AN46046-354 Sub-Investigator, Clinical Research Coordinator
An Open-Label, Multi-center Trial to Evaluate the Effect of Concomitant Antiepileptic Drugs on the Tolerability of Topamax in Subjects with Partial Seizures. Clinical Research Coordinator
Lamictal in Combination with newer and Older Antiepileptic Drugs as Monotherapy, A practical clinical assessment of Tolerability and Clinical Effectiveness (The TARGET STUDY) Trial to Assess and Refine Global Epilepsy Treatment. Clinical Research Coordinator. Glaxo-Smith Kline
Keppra Epilepsy Evaluation of Patients Time Response. (keeper Trial) Clinical Research
Coordinator
Topamax: Action of Co-Therapy on Tolerability in the Clinical Setting.
Clinical Research Coordinator
Tiagabine and Treatment of Infantive Spasms. (A Pilot Study) Clinical Research Coordinator
An Open-Label, Multicenter, Randomized Study to Assess Tolerability, Effectiveness and Quality of Life associated with the use of SLI381(Adderall XR) in Children with Attention Deficit Hyperactive Disorder (ADHD) in a Community Practice Setting( A Phase III Study) Protocol LADD-CAT,Clinical Research Coordinator.
An Open-Lable Safety Study of Gabapentin (CI945) as Adjunctive Therapy in Children Aged 1 month through 4 years with Seizures Uncontrolled by Current AED Therapy (Protocol: 945-301).Pfizer. Sub-Investigator, Clinical Research Coordinator. Pfizer Pharmaceutical
A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial Comparing the Safety and Efficacy of Rufinamide as Adjunctive Therapy Relative to Placebo in Patients with Inadequately Controlled Lennoz Gastau Syndrome; A long Term Follow-up Protocol Rufinamide 022. Novartis. Clinical Research Coordinator. Novartis Pharmaceutical
An Open, Randomized, Parallel-Group, Multi-Center trial to Compare a Stratified Care Treatment Regimen base on Migraine Disability (MIDAS Grade) Vs. Standard Therapy for the Treatment of Migraine Headache. Clinical Research Coordinator
A Multicenter, Rater-blind, Randomized, Age Stratified, Parallel-Group Study Comparing two doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients with Inadequately Controlled
Partial Seizures. Protocol CTR 1476E2340. Sub-Investigator, Clinical Research Coordinator.
A Multicenter, Rater-Blind, Randomized, Age-Stratified, Parallel-Group Study Comparing two doses of Oxcarbazepine as Monotherapy in Pediatric Patients with Inadequately-Controlled Partial Seizures .( CTR1476E-2339).Sub-Investigator. Clinical ResearchCoordinator.
A Comparison of the Efficacy and Safety of Topiramide Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects. Protocol CAPSS-122. Novartis. Clinical Research. Coordinator.
A Placebo Controlled Comparison of the Efficacy and safety of the Current US Version of Pulmicort (Budesonide)Turbohaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated with Inhaled Steroids. Clinical Research Coordinator.
Impact of Point-of-Care Vs. Laboratory testing of Hemoglobin A1c (HbA1C), and Intense vs Standard monitoring ot Titration algorithm adherence on Glycemic control in type 2 Diabetes Subjects, who are Inadequately Controlled on Oral anti-hyperglycemic therapy, and starting Lantus ( Insulin Glagrin ( rDNA origin) injection a 2X2 randomized, open-label trial. Clinical Research Coordinator.
Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-morbidities with Stress Urinary Incontinence: Evaluation of Efficacy and Safety. Protocol: F1J-US-SBCD Clinical Research Coordinator.
A phase II, Dose-Escalating, Randomized, Single blind study of PLD-118 in the treatment of Vulvovaginal Candidiasis in comparison with fluconazole. Protocol:118-AD-04-03-US- 1
.Clinical Research Coordinator.
A Double- Blind, Randomized, Placebo controlled, Phase III Safety Study of Tramadol 300 MG, taken once-daily for the relief of signs and symptoms of Osteoarthritis of the Hip and Knee. Protocol: TRAMCT.02.04. Clinical Research Coordinator. Cipher Pharmaceutical
A Randomized, Multicenter, Double- Blinded, Placebo- Controlled, Pilot Study to Assess the Safety and Efficacy of FS-67 in Patients with Muscle Strain. Protocol FS-67-E02. Clinical Research Coordinator.
A Randomized, Double-Blinded, Active- Controlled, Parallel-Group Study To Evaluate the Safety of Etoricoxib in Patients with Osteoarthritis or Rheumatoid Arthritis. Protocol: 066. MK 0663.Clinical Research Coordinator.
A Randomized, Double- Blind, Placebo-Controlled, Parallel- Group Study Comparing Clindamycin Phosphate 2 % Butoconazole Nitrate 2% Combination Vaginal Cream with Clindesse, Glynazole-1, and Placebo in Treatment of Subject with Mixed Bacterial Vaginosis/ Vulvovaginal Candidiasis Infections. Protocol: KV05-601-622467. Research Coordinator
A 12- week, randomized, double-blind, multicenter, vehicle-controlled, parallel group study to assess the efficacy and safety of Diclofenac Sodium Gel 1% for the relief of signs and symptoms in patients with osteoarthritis of the knee. Protocol: VOSG-PN-304. Clinical Research Coordinator. Novartis Phramaceutical
An Uncontrolled Long-Term Safety Trial of Diclofenac Na Gel, 1% in Patients with Osteoarthritis of the Knee.Protocol VOSG-PN-309. Clinical Research Coordinator. Novartis Pharmaceutical
An 8-week, multicenter, randomized, double-blind, placebo-controlled, parallel group trial of Diclofenac Sodium Gel 1% in patients with primary osteoarthritis of the hand. Protocol: VOSG-PE-315. Clinical Research Coordinator. Novartis Pharmaceutical
A Fourteen-week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease of a Triple Reuptake Inhibitor. Protocol NS2330. Clinical Research Coordinator.
Comparison of the Safety and Efficacy of a Unique Intravenous Iron Preparation ( VIT-45) versus Oral Iron Iron in the Treatment of Iron Deficiency Anemia Secondary to Heavy Uterine Bleeding. Protocol:1VIT04002. Clinical Research Coordinator.
A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Fixed Dose Response Study Comparing the Efficacy and Safety of Sumanirole versus Placebo in Patients with Early Parkinson's Disease. Protocol: DA2APD-0075-031. Clinical Research Coordinator.
A phase III, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of fourteen day treatment with lansoprazole 15mg or 30mg once a day in frequent nighttime heartburn. Clinical Research Coordinator
A Randomized, Open-Label, Study to Assess the Safety of Epoetin Alfa Manufactured by Deep Tank Technology and Epoetin Alfa Manufacture by Roller Bottle Technology in Subjects with Chronic Kidney Disease Not on Dialysis. P rotocol 20040259. Clinical Research Coordinator. Amgen Pharmaceuticals.
Randomized, Double-Blind Trial of Carisoprodol 250 mg Tablets Compared to Placebo in Patients With Acute Painful Musculoskeletal Spasm of the Lower Back. Protocol MP505. Clinical Research Coordinator. MedPointe Pharmaceutical
Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Woman: A 12 -week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 mg and 60 mg Daily Doses with Placebo. Clinical Research Coordinator .
A Phase IV, Stratified, Randomized, Prospective, Unblinded, Active-Controlled Trial of Factive Versus Biaxin XL for the Treatment of Community Acquired Pneumonia and Versus Amoxicillin/ clavulanate for the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis. Force Study. Clinical Research Coordinator.
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects with Mixed Dyslipidemia. Protocol M05-748. Clinical Research Coordinator. Abbot Laboratories.
A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects with Mixed Dyslipidemia. Protocol M05-758. Clinical Research Coordinator
Gilead : A Phase 3 Randomized, Double-Blind, Placebo-and Active-Controlled,
Multi-center, Parallel Group Study to Evaluate the safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo. Protocol DORADO-AC. DAR312. Clinical Research Coordinator
Gilead : A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of
Optimized Doses of Darusentan in Subjects with Resistant Hypertension Despite Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including A Diuretic, Compared to Guanfacine. Protocol DAR 312-E. Clinical Research Coordinator
Randomized, Double-Blind, Double-Dummy Trial of Two Sustained Release Formulations of Carisoprodol Compared to Placebo in Patients with Acute, Painful, Musculoskeletal Spasm of the Lower Back. Protocol MP511. Clinical Research Coordinator
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination with Atorvastatin and Ezetimibe to Atorvastatin in Combination with Ezetimibe in Subjects with Combined (Atherogenic) Dyslipidemia
Protocol M10-275. Clinical Research Coordinator
An 8-Week, Multicenter, Randomized, Double-Blind, Four-arm, Parallel-Group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects with
Hypercholesterolemia. Protocol M 10-667. Clinical Research Coordinator
The Efficacy and Safety of 5 Days Oral XXXXX( 800 MG QD) Versus 10 Days
Oral XXXXX (500 MD BID) in the treatment of Acute Exacerbation of Chronic Bronchitis.
Clinical Research Coordinator
Evalutation of Choline Fenofibrate(ABT-335) on Carotid Intima-Media Thickness (Cimt) in
Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy
(First) Trial. Protocol M10-158 Clinical Research Coordinator
A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome. Protocol APPRAISE-2. Clinical Research Coordinator
A Phase III, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillation. Protocol DU176b-C-U301. Clinical Research Coordinator
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type II Diabetes and Acute Coronary Syndrome.
Protocol SYR-322_402. Clinical Research Coordinator
An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV to Licensed Vaccine (Engerix-B) among Adults(18 to 70 years of Age) with Chronic Kidney Disease(CKD). Protocol DV2-HBV-17. Clinical Research Coordinator
A randomized, double-blin, placebo-controlled, parallel-group study of the efficacy and safety of Welchol as monotherapy for type 2 diabetes mellitus. Protocol WEL-A-U305. Clinical Research Coordinator
A randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of Welchol as add-on to pioglitazone therapy for type 2 diabetes mellitus.
Protocol WEL-A-U306. Clinical Research Coordinator
A randomized, Double-Blind, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Saferty of CEM-101 Compared to Levofloxacin in the Treatment of Patientys with Community-Acquired Bacterial Pneumonia. Protocol CE01-200. Clinical Research Coordinator
A 12- Month, Open-Label Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets( CEP-33237) at 15 to 90 mg Every 12 Hours in Patients Who Requiered Opiod Treatment for an Extended Period of Time. Protocol C33237/3080. Clinical Research Coordinator
A Long-Term, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsule in Opiod- experienced Subjects With Moderate to Severe CLBP. Protocol ZX002-0801. Clinical Research Coordinator
A Long-Term, Randomized, Double-Blind, Pralel-Group, Placebo-Controlled, Radiographic Study to Investigate the Safety and Efficacy of Orally Administered SD-6010 in Subjects with Symptomatic Osteoarthritis of the Knee. Protocol A 6171016. Clinical Research Coordinator
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