Clinical Research Coordinator
Resume:
Marcia D. Smith, CCRC
Tyler Cardiovascular Consultants
Tyler, Texas 75701
1-903-***-**** (Fax)
EDUCATION Attended Tyler Junior College
CERTIFICATION Certified Clinical Research Coordinator 2006
Board Certified in Phlebotomy since 1991
PROFESSIONAL EXPERIENCE
2000-Present Tyler Cardiovascular Consultants; Tyler, Texas
Certified Clinical Research Coordinator –
Research Lab Director In charge of various protocols and special testing and handling of research specimens. Responsible for study startups in accordance to Sponsor and FDA regulations. Screens patients for various protocols, completes study specific case report forms, starts IV’s, conducts Cardio Pulmonary exercise treadmill tests, performs Halter hook-ups and ECG’s, organizes paperwork as appropriate for protocols, works closely with study doctors monitors and sponsor representatives for accurate data compliance.
1994-1998 Trinity Mother Frances Hospital; Tyler, Texas
Phlebotomist – Lab Supervisor in charge of all lab and lab processing at North Park Laboratory.
1990-1994 Stewart Blood Center; Tyler, Texas
Phlebotomist – Donor services-Team Leader, Responsible for filling in at all Satellite stations.
Tyler Hematology; Tyler, Texas
Phlebotomist – PRN
RESEARCH EXPERIENCE
© WIZARD – A Randomized, Double-blind, Placebo-controlled Trial of the Effects of Weekly Azithromycin on the Incidence of Coronary Artery Disease in Subjects with Evidence of Exposure to C. Pneumoniae
© SPORTIF V – Efficacy and Safety Study of the Oral Direct Thrombin Inhibitor H376/95 Compared with Dose-adjusted Warfarin (Coumadinâ) in the Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation
© CHESS (Comparative HDL Efficacy and Safety Study) – A Multi-center, Double-blind, Randomized, Parallel, 28-Week Study to Evaluate the Efficacy and Safety of Simvastatin 80 mg/day Versus Atorvastatin 80 mg/day in Patients with Hypercholesterolemia
© VALIANT – (Valsartan In Acute Myocardial Infarction) – A Multi-national, Multi-center, Double-blind, Randomized, Active-controlled, Parallel Group Study Comparing the Efficacy and Safety of Long-term Treatment with Valsartan, Captopril, and Their Combination in High-risk Patients After Myocardial Infarction
© CHARM – (Candesartan Cilexetil in Heart Failure: Assessment of Reduction in Mortality and Morbidity) – Studies of Candesartan in Patients with Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function (0003), Who Are Treated with ACE Inhibitors and Have Depressed left Ventricular Systolic Function (0006), and Patients with Heart Failure and Preserved Left Ventricular Function (0007)
© THRIVE V – A Double-blind, Efficacy and Safety Study of the Oral Direct Thrombin Inhibitor, H376/95 versus Standard Therapy [Enoxaparin and Warfarin (Coumadinâ)] in Patients with Acute, Symptomatic Deep Venous Thrombosis with or without Pulmonary Embolism
© STELLAR – Statin Therapies for Elevated Lipid Levels Compared Across Rosuvastatin – A 6-Week, Open-label, Dose-comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Cerivastatin, Pravastatin, and Simvastatin in Subjects with Hypercholesterolemia
© REVERT – Reversal of Ventricular Remodeling with Toprol-XL – A Multi-center, Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Effect of Extended Release Metoprolol Succinate (Toprol-XLâ) on Cardiac Remodeling in Asymptomatic Heart Failure Patients (NYHA Class I) with Left Ventricular Dysfunction
© ARIFLO – A Randomized, 12-Week, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Ariflo 15 mg Twice Daily in Patients with Chronic Obstructive Pulmonary Disease (COPD)
© REPLACE - Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events
© WYETH AMI – A Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Safety and Efficacy Study of Recombinant P-selectin Glycoprotein Ligand-Ig in Combination with Acute Myocardial Infarction
© MERCURY – An Open-label, Randomized, Multi-center, Phase IIb, Parallel Group Switching Study to Compare Atorvastatin and Simvastatin with Rosuvastatin in High Risk Patients with Type IIa and IIb Hypercholesterolemia
© NOET – A Phase III, Open-label, Single-crossover Study to Confirm the Diagnostic Potential of Intravenously-Administered 99mTcN-NOET to Identify Coronary Artery Disease During Exercise and Resting Conditions by Using Gated Myocardial SPECT Imaging
© IMPACT – The Impact of Medical Subspecialty on Patient compliance to Treatment
© VICC - Visipaque (Iodixanol) vs. Isovue (Iopamidol) in Cardiac Catheterization
© MCC-135 - A 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
© SELECT – A Multi-center Prospective, Randomized, Double-blinded, Parallel Group Study Comparing the Effects of Lotrel® (5/20mg) and Benazepril (20mg) on Systolic Blood Pressure and Pulse Pressure in Patients with Systolic Hypertension
© VERIFIED Pacemaker Registry – Value of Electronically Recorded and Interrogated Follow-up via IPG Exported Data
© ETC-588 - A Phase II, Randomized, Double-blind, Placebo-controlled Multiple-center Pilot Study of ETC-588 in Patients with Acute Coronary Syndromes (ACS)
© CRESTOR - A 48-Week, Open-label, Non-comparative, Multi-center, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-regulating Agent Rosuvastatin in the Treatment of Subjects with Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia (Protocol # 45221L/0091)
© TROPIC – The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication – a Matrix Design
© PROTECT-TIMI 30 – A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-platelet and Anti-thrombotic Agents
© VERITAS-1 – Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients with Acute Heart Failure
© Michelangelo-OASIS 5 – An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-Segment Elevation MI Acute Coronary Syndromes
© TIMI 26 JUMBO – A Double-blind, Randomized, Multi-center, Dose-ranging Trial of CS-747 (LY640315) Compared with Clopidogrel in Patients Undergoing Percutaneous Coronary
© ASSESS – Assessment of Unipolar vs Bipolar Pacing Threshold Registry
© ETC-642 - Dose-Ranging, Double-Blind, Placebo-Controlled, Multicenter, Pharmacokinetic, Pharmacodynamic and Tolerability Study of ETC-642 in Patients with Stable Atherosclerosis
© Impulse Dynamics – Evaluation of the Safety and Efficacy of the OPTIMIZER system with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction FIX-HF-5
© RE-LY – Randomized Evaluation of Long Term Anticoagulant Therapy Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate with Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation
© Longitude – Non-randomized, Multi-center, Clinical Study Designed to Collect Patient Device Data from Implanted Guidant Pulse Generators
© IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) – A Multi-center, Double-blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting with Acute Coronary Syndrome
© EXACT – Examination of Arrhythmia Classification and Therapy
© TOPCAT – Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist
© LSR – Longitudinal Surveillance Registry
© RELY-ABLE - Longterm Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomized Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes
© ARISTOTLE – A Phase 3 Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation
© RESET – Restoration of Chronotropic Competance in Heart Failure Patients with Normal Ejection Fraction (Boston Scientific)
© SMART AV – SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy
© LSR-ASL – Longitudinal Surveillance Registry of the Acuity Spiral Lead
© APPROPRIATE – Assessment of Proper Physiologic Response with Tate Adaptive
Pacing Driven by Minute Ventilation or Accelerometer.
© MADIT-RIT – Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy (University of Rochester and Boston Scientific)
© FIX-HF-5B - Evaluation and Efficacy of the OPTIMIZER System in Subject with heart failure and EF between 25%-35% and NYHA Class III Symptoms.(Impulse Dynamics)
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Marcia Smith, CCRC Date
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