CARLOS MARTINEZ2303 Ranch Rd. 620 South Suite 135-121

Lakeway, Texas 78734512 293-4733 - carlosaustin@att.net

Experience

1997-Present Clinical Research Consultant

· Responsible for independently monitoring Phase I-IV clinical trials in accordance with Good Clinical Practice, ICH guidelines and federal regulations· Participate in identification an evaluation of Investigators· Manage and report study site and overall program progress· Monitor and or audit clinical studies to ensure data quality and integrity · Verify investigational drug accountability and storage equipment · PK sampling experience · Conduct ongoing review of regulatory files and study supplies are maintained during the assigned project  · Resolve issues regarding enrollment· Maintain relationships with Principal Investigators and study staff · Ensure quality and deliverables are met across assigned clinical research institutions · Trial Master File reconciliation· Understanding of the assigned protocol(s) and trial specific manuals/plans to ensure quality

PPD/Pharmaco Inc. / Clinical Trials Management North America

1995-1997 Clinical Research Associate· Independently monitored Phase II to IV clinical studies · Conducted pre-study site selection, initiation, interim, and close-out visits · Documented all findings, outcomes, and agreements reached during site visits · Resolved discrepancies with EDC data · Ensured proper maintenance of site's regulatory binder · Verification of study drug accountability · Contributed to the preparation and finalization of clinical study protocols and final reports · Completion of Interim Analysis

1994-1995 Project Administrator· Responsible for the management of multiple domestic and global projects · Performed day to day tasks associated with the overall management of clinical research trials· Tracked and managed fiscal aspects of studies, including yearly budget projections, actuals and study specific expenses· Evaluated, selected, and implemented new clinical research technology according to GCPs, GLPs, cGMPs, FDA, DEA

and international guidelines· Organized and scheduled multiple projects concurrently to meet deadlines

1991-1994 Clinical Research Coordinator· Worked directly with physicians in the conduct of various in-patient and out-patient clinical trials · Managed Schedule II and III controlled-substance studies· Maintained accurate patient records, medication compliance and monitored for adverse events· Presented protocols before research councils within hospitals for local IRB approvals· Acted as liaison between pharmaceutical companies and clinical research institutions

Skills Computer – MAC OS X, XP 2011, Windows 8, ORACLE, CTMS, InForm, RAGE, IRT - Fluent in Spanish

Education May 1990 University of Texas at Austin - Austin, Texas Biology, Minor in Chemistry and Spanish

CLINICAL TRIAL EXPERIENCEPhase I

Pharmacokinetic and Pharmacodynamic Interactions of an Antiarrythmic and a Calcium Channel Antagonist.

The Oral Bioavailability /Bioequivalence of a New Beta Blocker Administered as 3 x 200mg Tablets and 600mg Tablets Manufactured at different sites

Rising Dose Study to Determine the Tolerability and Pharmacokinetics of a New Antiarrhythmic Agent Using Continuous Infusions in Normal Healthy Subjects

A Pharmacokinetic Comparison of a Calcium Channel Antagonist in Fed and Fasted Conditions

Multiple Dose Safety and Tolerance of a Cholesterol Absorption Inhibitor Administered in Ascending Doses and Effect on Cholesterol Absorption in Volunteers with Mild to Moderate Hypercholesterolemia

Single Dose Safety and Tolerance of a Unique Cholesterol Lowering Agent in Man

A Randomized Four-Way Crossover Study to Evaluate the Pharmacokinetics, Dose Proportionality and Bioavailability of an Anti-gout Agent Following Single Intravenous and Oral Administration in Healthy Male Volunteers

At Risk for HIV Clinical Specimen Collection Study

Evaluation of the Pharmacokinetics of AMG 073 When Concomitantly Administered with Pantoprazole

Evaluation of the Pharmacokinetics of AMG 073 When Concomitantly Administered with Renagel

An Open-label, Single-dose Study of the Pharmacokinetics of AMG 073 Administered to Subjects with End Stage Renal Disease Receiving Continuous Ambulatory Peritoneal Dialysis

Randomized, Double-blind, Placebo-controlled, Ascending, Single Oral Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BAG972 in Healthy Volunteers

PHASE II-IV

Preventive Relapse in Erosive or Ulcerative Gastroesophageal Reflux Disease

A Study of the Patient-Activated Reservoir in the Intrathecal Delivery of Morphine Sulfate as Management of Pain due to Cancer and its Therapies

Long-Term Comparison on Growth Velocity and Tolerance of a Norditropin Human Growth Hormone

A Double-Blind, Randomized, Placebo-Controlled Study of Dose vs. Placebo in Sjogren's Syndrome Patients with Xerostomia and Keratoconjunctivitis Sicca

An Open-Label Chronic Safety Study of a Dose in Sjogren's Syndrome Patients with Xerostomia and Keratoconjunctivitis Sicca

A Comparison of the Onset of Action of Claritin-D and Semprex-D in Patients with Moderate to Severe Seasonal Allergic Rhinitis

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging study of CS-866 using Ambulatory Blood Pressure Monitoring in Hypertensive Patients

A Phase II, Double-Blind, Double-Dummy, Optional Dose Titration, Cross-Over Comparison of Methylphenidate Modified Release Formulation in Attention-Deficit Hyperactive Disorder Subjects Effectively Treated with B.I.D. Immediate Release Methylphenidate

A Multicenter, Double-Blind, Parallel Group study comparing the Incidence of Gastroduodenal Ulcer associated with SC-58635 bid with that of Diclofenac 75mg bid and lbuprofen 800mg tid, taken for 12 weeks in patients with Osteoarthritis or Rheumatoid Arthritis

A Study of Long-Term Safety of SC-58635 in Treating and Signs and Symptoms of Osteoarthritis and Rheumatoid Arthritis

A Comparative Study of the Efficacy and Safety of Clarithromycin Extended-Release Tablets and Loracarbef Pulvules for the Treatment of Subjects with Secondary Bacterial Infectious of Acute Bronchitis

A Comparative Study of the Efficacy and Safety of Clarithromycin Extended-Release Tablets and Clarithromycin Immediate Release Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis

A Double-blind, Randomized, Stratified, Placebo-controlled Study of Ro64-0796 (also known as GS4104) in the Treatment of Influenza

A Double-blind, Randomized, Stratified, Placebo-controlled Study of Ro64-0796 (also known as GS4104) in the Treatment of Influenza in Children with Chronic Asthma

A Randomized, Double-blind, Placebo-Controlled Multicenter Study Measuring the Effects of Troglitazone in Latino Patients with Type 2 Diabetes Mellitus

A Comparative Study of the Safety, Efficacy and Effectiveness of Clarithromycin Extended-Release Tablets and Augmentin Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis

A Comparative Study of the Safety, Efficacy and Effectiveness of Clarithromycin Extended-Release Tablets and Augmentin Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis

A Phase II Double-Blind, Multi-Center, Vehicle-Controlled Feasibility Study of the Safety and Efficacy of Intranasal Doxepin in the Prophylactic Treatment of Chronic Daily Headache

A Phase II Double-Blind, Multi-Center, Vehicle-Controlled, Dose Escalating Trial of the Safety and Efficacy of Intranasal Doxepin in the Prophylactic Treatment of Chronic Daily Headache

A Multinational, Randomized, Double-Blinded, Active-Controlled, Study for Evaluation of the Efficacy and Safety of Oral HMR 3647 800mg Once a Day for 5 Days vs. Cefuroxime Axetil 250mg Twice a Day for 10 Days in the Treatment of Acute Maxillary Sinusitis in Adults

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of the Hormone Replacement Therapy Combination Drug Product Drospirenone/Estradiol in Postmenopausal Women With Concomitant Disease and Medication Known to Potentiate the Risk of Hyperkalemia

A Randomized, Open Label, Parallel Design Study of Renagel Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled And Open-label Evaluation of the Safety and Efficacy of Dual Therapy With Atorvastatin Plus Amlodipine When Compared To Either Therapy Alone in the Treatment of Patients With Simultaneous Hyperlipidemia and Hypertension

Clinical Utility of Amlodipine/Atorvastatin To Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia

A Phase 3, Double-Blind, Multicenter, Multinational Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Pulmonary P. aeruginosa (AIR-CF1)

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial with Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Pulmonary P. aeruginosa Requiring Frequent Antibiotics (AIR-CF2)

A Phase 3, Open-label, Follow-on Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)A study of the irritation potential of 10% terbinafine hydrochloride nail solution for onychomycosis (NSO) during repeated applications on the skin of healthy subjects

An open-label proof-of-concept study to assess the effects of two AIN457 doses (on Day 1 and Day 22) in patients with noninfectious uveitis

A Randomized, Double-Blind, Placebo-Controlled, Two Dose-Arm, Parallel study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer’s DiseaseA Phase 2B Double Blind, Randomized, Placebo-Controlled, Parallel group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of PF-04950615 Following Monthly and Twice Monthly Subcutaneous Dosing for Six Months in Hypercholesterolemic Subjects on a Statin

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to ˂ 18 Years

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age

Planned Transition to Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients

An Open-label Extension Study of DS-5565 for 52 Weeks in Diabetic Peripheral Neuropathic Pain

A Randomized, Double-Blind, Placebo-Controlled, 13-Week Study of DS-5565 for Treatment of Diabetic Peripheral Neuropathic Pain

A Randomized, Double-Blind, Placebo- and Active-Controlled study OF DS-5565 in subjects with Pain Associated with Fibromyalgia

An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated with Fibromyalgia

A Phase III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of K-103-IP Compared With Placebo for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients with Parkinson’s Disease

A randomized, double-blind trial investigating the efficacy and safety of intravenous neridronic acid in subjects with complex regional pain syndrome type I (CRPS-I)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena)

AC-1204 26-Week Long Term Efficacy Response Trial with Optional Open-Label Extension (NOURISH AD) Alzheimer’s Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of Tofacitinib (CP-690,550) in Subjects with Active Psoriatic Arthritis and an Inadequate Response to at least One TNF Inhibitor

A Phase 3, Multi-Site, Open-Label Study of the Long Term Safety and Tolerability of 2 Doses of CP-690,550 in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Dermatology

Safety and efficacy of test article cream, 1% compared to it’s vehicle and test article #2, 0.75% compared to test article #3 in the treatment of Rosacea An adrenal suppression trial of test article lotion, 0.05%compared to test article #2, 0.05% in subjects with Psoriasis/Eczema. Bilateral tolerance comparison study in subjects with Acne Vulgaris

A study of the contact sensitization potential of a 10% terbinafine hydrochloride nail solution for onychomycosis (NSO) following repeated applications onto the skin of healthy subjects

Dental Study

A Randomized, Double-Blind, Placebo-Controlled Study to Compare the Analgesic Activity of RS138452,an IP Receptor Antagonist, with lbuprofen 400mg and Placebo in a Post Surgical Dental Pain Model in Male Patients, 18-40 Years of Age

In-Patient Studies

A Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging Study of Subcutaneous SR 90107A/Org 31540 with an assessor blind, comparative control group of Subcutaneous LMWH in the preventionof Deep Vein Thrombosis after Elective Total Hip Replacement

A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) with Children’s Peanut Allergy

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary, Unilateral, Inguinal Hernia Repair

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety, Efficacy, and Comparative Systemic Bioavailability of a Single Administration of SKY0402 via Local Infiltration for Prolonged Postoperative Analgesia in Subjects Undergoing Total Knee replacement

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 for Hemostasis in Subjects Undergoing Vascular Surgery

International Studies

Edinburgh, Scotland

Phase I Disposition and Metabolic Study of Orally Administered EPG Drug in Normal Healthy Male Volunteers

Ocho Rios, Jamaica & Guadalajara, Mexico

A Double-Blind, Randomized, Placebo-Controlled, Single Center, Multi-Site Study to Assess the Safety and Efficacy of SP-303 in the Symptomatic Treatment of Acute Diarrhea Syndrome among Adult Residents of Mexico Seeking Medical Care

A Double-Blind, Randomized, Placebo-Controlled, Multi-Site Study To Assess the Safety and Efficacy of SP-303 in the Symptomatic Treatment of Acute Diarrhea among Travelers to Mexico or Jamaica: Oral Administration of 125mg, or 500mg SP-303 Given Every 6 Hours for 48 Hours

Panama City, Panama

Pharmacokinetics of Telithromycin (HMR 3647) in Infants and Children Suffering from Bacterial Lower Respiratory Tract Infections after Single Oral Administration of 30mg/kg of a Telithromycin Suspension (50mg/ml)

San Jose, Costa Rica, Guatemala City, Guatemala & Panama City, Panama

Multi-center, Phase II, Open-Label Study of the Efficacy, Safety, Acceptability, and Pharmacokinetics of Telithromycin, after repeated oral administration of either of two doses, once daily, for 5 days or 7 to 10 days, in the treatment of respiratory tract infections in children of 6 months to 12 years.

Mexico City, Mexico

Clinical Protocol for A Third Party Blind, Placebo Controlled, Comparison of the Analgesic Activity of Bextra 20mg, Bextra 40mg, Arcoxia 120mg, and Placebo in a Postsurgical Dental Pain Model

Mexico City, Mexico

Phase II, Double-Blind, Randomized, Exploratory Placebo-Controlled Study of the Efficacy, Safety and Tolerability of MCC-135 Comparing QD vs. BID Doses in Subjects with Congestive Heart Failure, NYHA Class II/III