Clinical Research Medical Assistant

GREY SANCHEZ

Pembroke Pines, FL *****

954-***-****

***********@*******.***

PROFESSIONAL WORK EXPERIENCE:

CLINICAL RESEARCH ASSOCIATE

**/**** – Present HOLY CROSS HOSPITAL FT. LAUDERDALE, FL

Conduct clinical trials using good clinical practice, monitor and assure protocol compliance, recruitment of research participants, Identify eligible study participants, (IRB) submissions, managed clinic procedures, coordinate clinical treatment, patient care and follow-up care, prepare case report forms (CRF), submit CRFs and other data to the sponsor as necessary, assist the investigator in evaluating, documenting and reporting adverse events, review and supervise all research documents before submission, QA/QC, regulatory readiness and compliance before audits or sponsor review, maintain and review of SOP, trainings and GCP/ICH guidelines, conduct study close-out, oversee regulatory compliance within required regulations and guidelines, as well as policies and procedures such as FDA, OHRP, IRB, ICH-GCP, HIPAA, Assure all procedures are conducted in compliance with the sponsors and hospital SOP.

CLINICAL RESEARCH SUPERVISOR (Contract)

11/2015 – 06/2016 GALIZ RESEARCH MIAMI, FL

Supervised all aspects of the clinical research department and employees (CNS Studies), conducted clinical trials using good clinical practice, prepared (IRB) submissions, revised informed consent documents, worked with the institutional official in contract negotiations, developed detailed cost analysis, negotiated budget with the Sponsor (i.e. pharmaceutical company or granting agency), performed contract review and negotiation, handled project budgeting, managed clinic procedures, conducted in house quality assurance, QA/QC, regulatory compliance review, supervise SOP/GCP/ICH trainings, responsible for subject recruitment and patient care, provided adverse event reporting, prepared case report forms (CRF), submitted CRFs and other data to the Sponsor as necessary, conducted study close-out, recruited and screened study participants, coordinated clinical treatment and follow-up care, conducted patient care visits, quality control/assurance and regulatory compliance oversight, assured all procedures were conducted in compliance with the protocol.

CLINICAL OPERATIONS MANAGER (Contract)

08– 10/2015 SUNCOAST RESEARCH GROUP MIAMI, FL

Train, develop, coach, evaluate and monitor staff to promote personal and corporate growth, recruit new staff as needed, ensure that research staff obtain and maintain applicable licensure and certification, oversee and actively participate in the implementation of corrective and preventive actions, conduct regular staff meetings and in-services to promote companionship, interaction, education, exchange of ideas and information, update on activities and challenges, recruit, develop, retain and supervise coordinators and other clinical research staff, support to Faculty/Principal Investigators, provide guidance with regulatory requirements and advice in study planning and design, meet regularly with Faculty/Principal Investigators to review study progress, quality control/assurance and regulatory compliance oversight, oversee internal and external monitoring and auditing processes, oversee day-to-day research related operations including protocol review, regulatory affairs, patient recruitment, data management and quality control, discuss with staff on adverse events, protocol deviations, etc., develop, implement and train on standard operational procedures, provide oversight of electronic data base(s) to ensure proper updates, regulatory compliance and system accuracy, perform periodically quality control of ongoing studies for adherence to protocol, assure that subjects are enrolled in accordance with specified inclusion/exclusion criteria, encourage, facilitate and empower clinical coordinators to obtain ACRP/SOCRA certification within 2 years of their employment or as soon as the coordinator meets the criteria for examination, oversee regulatory compliance within required regulations and guidelines, as well as policies and procedures such as FDA, OHRP, IRB, ICH-GCP, HIPAA.

CLINICAL RESEARCH DIRECTOR

09/2012 – 08/2016 GSA MEDICAL RESEARCH COOPER CITY, FL

Oversee day-to-day research related operations including protocol review, regulatory affairs, patient recruitment, data management and quality control, responsible for supervision and training of staff, oversee regulatory compliance within required regulations and guidelines, provide oversight of electronic data base(s) to ensure proper updates, regulatory compliance and system accuracy, perform periodically quality control of ongoing studies for adherence to protocol, as well as policies and procedures such as FDA, OHRP, IRB, ICH-GCP, HIPAA.

CLINICAL RESEARCH SUPERVISOR

02/2010 – 09/2012 DEERFIELD BEACH CARDIOLOGY DEERFIELD BEACH, FL

Supervised all aspects of the clinical research department and employees, conducted clinical trials using good clinical practice, prepared (IRB) submission, revised informed consent documents, worked with the institutional official in contract negotiations, developed detailed cost analysis, negotiated budget with the Sponsor (i.e. pharmaceutical company or granting agency), performed contract review and negotiation, handled project budgeting

Managed clinic procedures, conducted in house monitoring, responsible for subject recruitment and patient care

provided adverse event reporting, prepared case report forms (CRF), submitted CRFs and other data to the Sponsor as necessary, conducted study close-out, recruited and screened study participants, coordinated clinical treatment and follow-up care, conducted patient care visits, assured all procedures were conducted in compliance with the protocol, provide oversight of electronic data base(s) to ensure proper updates, regulatory compliance and system accuracy, perform periodically quality control of ongoing studies for adherence to protocol.

CLINICAL RESEARCH COORDINATOR

01/2009 – 07/2009 SKIN AND CANCER ASSOCIATES AVENTURA, FL

Conducted investigator initiated and pharmaceutical clinical trials using good clinical practice, prepared the (IRB) submissions, wrote protocols and informed consent documents, worked with the institutional official in contract negotiations, developed a detailed cost analysis and negotiated budget with the Sponsor (i.e. pharmaceutical company or granting agency), performed contract review and negotiation, responsible for subject recruitment and patient care, provided adverse event reporting, prepared the case report form (CRF), submitted CRFs and other data to the Sponsor as necessary, handled study close-out, recruited and screened study participants, coordinated clinical treatment and follow-up care, conducted patient care visits, assured all procedures were conducted in compliance with the protocol, monitored other coordinator’s work to maintain accuracy, collected, submitted and maintained study data and regulatory documents, developed and ensured compliance with study protocols, responsible for all lab procedures and shipping management as well as patient testing and monitoring visits.

CLINICAL RESEARCH COORDINATOR

05/2006 – 07/2008 SUNRISE MEDICAL RESEARCH PLANTATION, FL

Conducted investigator initiated and pharmaceutical clinical trials using good clinical practice, prepared the (IRB) submissions, revised protocols and informed consent documents, worked with the institutional official in contract negotiations, developed a detailed cost analysis and negotiated budget with the Sponsor (i.e. pharmaceutical company or granting agency), performed contract review and negotiation, responsible for subject recruitment and patient care, provided adverse event reporting, prepared the case report form (CRF), submitted CRFs and other data to the Sponsor as necessary, handled study close-out, recruited and screened study participants, coordinated clinical treatment and follow-up care, conducted patient care visits, assured all procedures were conducted in compliance with the protocol, monitored other coordinator’s work to maintain accuracy, collected, submitted and maintained study data and regulatory documents, developed and ensured compliance with study protocols.

CLINIC COORDINATOR

09/2005 – 04/2006 EPILEPSY FOUNDATION FT. LAUDERDALE, FL

Supervised Epilepsy clinics and provided services to children and adults with Epilepsy, provided initial neurological evaluation and ongoing medical follow ups, performed test monitoring: Blood, EEG, MRI, CT Scan and others

provided telephonic follow up, administered anticonvulsant drug programs: Department of Health, Epilepsy Control program, regular program and Expansion Pilot Project, implemented Patient Assistance Programs from drug companies and retail Pharmacies, processed referrals, scheduled appointments, provided Medical Reports

conducted periodic review of policies and procedures with medical providers to ensure high quality services, implementing HIPAA guidelines, monthly and annual statistics, conducted meetings with case managers and staff members to ensure the highest level of medical care.

RESEARCH ASSISTANT

12/1996 – 12/1998 COLUMBIA UNIVERSITY NEW YORK, NY

Conducted investigator initiated clinical trials using good clinical practice in diabetes research, conducted telephone interviews, recruitment of participants, obtained informed consents, prepared visits for patients, performed halter monitoring, administered clinical questionnaires, obtained clinical measurements, performed data analysis and data entry, organized and maintained filing systems, handled travel and expense reports as well as petty cash, Inventory.

BIO-MEDICAL TECHNICIAN

09/1994 – 11/1996 UPTOWN HEALTHCARE MNGT. NEW YORK, NY

Assisted Physicians in all patient Care Activities, medical assistant, performed bone density testing, motor nerve conduction (NCV) and somatosensory evoked potential (SSEP), assisted Neurologist with EMG testing, EKG, halter monitoring, manual muscle testing (MMT), joint test (ROM), phlebotomy, maintained inventory of medication and clinical supplies, provided patient reports.

EDUCATION / CERTIFICATIONS:

2019 Association of Clinical Research Professionals ACRP – Boca Raton, Florida

Certified Clinical Research Coordinator (CCRC)

2012 - 2019 Collaborative Institutional Training Initiative (CITI) WIRB/University of Florida Affiliations.

2006 - 2019 NIH Certification: Protecting Human Research Participants, GCP Course

2011 - 2019 Mayo Clinic Training for the Shipping of Category A Infectious Substance Affecting Humans and Category B, Biological Substance

2006 - 2019 Certification of training with SAF-T-Pak for shipping Infectious substances

2007-2010 Broward College – Bachelor of Arts in Health Administration

2005 Miami Children’s Hospital

Certification: Education in Pediatrics

2005 International Geriatric Epilepsy Conference - Miami, Florida

1997 Columbia University - New York, New York

Certification: GCP Course/Phlebotomy Validation

1996 Norland Medical Systems - New York, New York

Certification: Bone Density Testing

1996 Empire Careers Inc. - New York, New York

Certifications: Medical Assistant, Ultrasound Technician

1995 Empire Careers Inc. - New York, New York

Certification: MA/Phlebotomy/EKG

SKILLS: Bilingual (English/Spanish), Windows, MS Word and Excel, Internet, Research Development, Research Regulatory, Allscripts, MEDTRONIC, Hospital EMR MEDITECH, REVEAL, Touchworks.

CLINICAL RESEARCH EXPERIENCE:

Clinical Research Coordinator

ANNEXA - A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET

ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR. Protocol 18-513. 03/2019 to Present

AEGIS - A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group

Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

Study Number: CSL112_3001 Study Product: CSL112 (apolipoprotein A-I [human]). 11/2018 to Present.

METEORIC - Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure (METEORIC-HF) 03/2019 to Present.

SPIRRIT - Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved

Ejection Fraction, Protocol: SPIRRIT-HFpEF. 02-2019 to Present.

CORVIA REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD®

System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure. 10/2018 to Present

ARTESIA - Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial fibrillation. 10/2018 to Present

ZOLL BMAD – Protocol 90D0182: Benefits of Microcor (uCor) in ambulatory decompensated heart failure. 10/2018 to Present

ESPERION – Protocol 1002-043: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at High Risk for Cardiovascular Disease who are Statin Intolerant – ESPERION 1002-043, 11/2017 to Present.

CAMELLIA - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Long-Term Treatment with BELVIQ (lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors, (Eisai Camellia Study APD356-G000-401).

CANTOS - A randomized, double-blind, placebo-controlled, event- driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP, (Novartis Cantos Study CACZ885M2301).

COMPASS - A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS – Cardiovascular OutcoMes for People using Anticoagulation StrategieS) Rivaroxaban for the prevention of major cardiovascular events in CAD or PAD

(COMPASS) (BAYER BAY 59-7939/15786).

DECLARE - A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes. (AstraZeneca Declare-Timi 58 Study D1693C00001).

THEMIS - A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus [THEMIS - effect of Ticagrelor on Health outcomes in diabEtes Mellitus patients Intervention Study]. (AstraZeneca D513BC00001).

ORBIT AF - Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II ORBIT-AF II RIVAROXAFL4002. The Duke Clinical Research Institute and Janssen Scientific Affairs, LLC.

GUIDE-IT - GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT)GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT) ECHO Substudy

HARMONY - A long term, randomized, double-blind, placebo-controlled study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus. Harmony Outcomes Trial. GlaxoSmithKline GLP116174.

AMARANTH - A 24-Month, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The Amaranth Study D5010C00009).

GRIFOLS - A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis with Infusion of Human Albumin, Combined with Intravenous Immunoglobulin in Patients with Mild-Moderate Alzheimer's Disease. (Grifols IG1002)

EPOCH - A Randomize, Placebo Controlled, Parallel-Group, Double Blind Efficacy and Safety Trial of MK-8931 with a Long Term Double-Blind Extension in Subjects with Mild to Moderate Alzheimer's Disease. (Merck MK-8931 017).

APECS - A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal AD), (Merck MK-8931 019).

STEADFAST - Randomized, Double-Blind, Placebo Controlled, Multi-Center Registration Trial to evaluate the Efficacy and Safety of TTP488 in Patients with Mild Alzheimer's Disease Receiving Acetyl cholinesterase Inhibitors and/or Memantine. (TransTech Pharma TTP488-301).

FORWARD 2 - Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AE58054 in Patients With Mild to Moderate Alzheimer's Disease Treated With an Acetyl cholinesterase Inhibitor, (Lundbeck 14863A)

A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults who Have an Inadequate Response to Antidepressant Therapy (The FORWARD-2 Study).

EXPEDITION - Continued Efficacy and Safety Monitoring of Solanezumab an Anti-Amyloid Antibody in Patients with Alzheimer's Disease (H8A-MC-LZAO).

EISAI E2609-G000-202 - A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Proof-of-Concept, Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease, (Eisai E2609-G000-202).

FOURIER - Amgen Inc. Fourier Study (Protocol # 20110118) A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy in Patients with Clinically Evident Cardiovascular Disease FOURIER Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk

ENGAGE - Daiichi Sankyo Engage Study (Protocol # DU176b-C-U301) Principal Investigator. A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of DU-176b Versus Warfarin in Subjects with Atrial Fibrillation – Effective Anticoagulation with Factor xA Next Generation in Atrial Fibrillation.

HARMONY - GlaxoSmithKline Harmony Study (Protocol # 1127757) A Randomized, Double-Blind, Placebo-and Active Controlled, Parallel Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination with Metformin and Glimepiride Compared with Metformin Plus Glimepiride and Placebo and with Metformin Plus Glimepiride and Pioglitazone in Subjects with Type 2 Diabetes Mellitus.

HARMONY - GlaxoSmithKline Harmony Study (Protocol # 1127754) A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of Albiglutide Compared with Insulin in subjects with Type 2 Diabetes Mellitus.

SAVOR - AstraZeneca Savor Study (Protocol # D1680C00003) A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes.

Bayer Distinct Study (Protocol # 14725) A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo Controlled Dose-Finding Study of Nifedipine GITS and Candersarts Combination Compared to Monotherapy in Adult Patients with Essential Hypertension.

ORBIT - Ortho-McNeil Janssen Orbit Study (Protocol # Rivaroxafl 4001) Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (Orbit-AF)

TRILOGY - Eli Lilly Trilogy ACS Study (Protocol # H7T-MC-TABY) A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed.

Huffman La-Roche ACS Study (Protocol # NC20971) A Phase III, Double-Blind, Randomized Placebo-Controlled Study, to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in Stable CHD Patients, with a Documented Recent Acute Coronary Syndrome (ACS).

PRECISION - Pfizer Precision Study (Protocol # A3191172) A Randomized, Double-Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen.

Bayer Rocket-AF Study (Protocol # 39039039-AFL 3001) A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) with Adjusted Dose, Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systematic Embolism in Subjects with Non-Valvular Atrial Fibrillation.

Sanofi Pasteur Flu Study (FIM07) A Phase IV Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared with Fluzone Vaccine in Adults >65 Years of Age.

ATI (Protocol ATI-5923-CLN-504) Aryx Therapeutics. An Open Label Multi- Center Study of ATI-5923 for Anticoagulation in Patients with atrial Fibrillation.

Novartis Ageless Trial (Protocol CSPP100A2344) A 36 Week Randomized, Double=Blinded, Parallel Group, Multi-Center, Active-Controlled, Optional Titration Study Comparing and Aliskiren-Based Regimen to a Ramipril-Based Regimen in Patients >65 Years Old with Systolic essential Hypertension.

Kendle Vildagliptin Study (Protocol DAR 311/DAR311E) A Phase III Randomized, Double-Blind, Placebo Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Fixed dose of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four or more Antihypertensive Drugs, Including a Diuretic.

Sanofi Aventis Crescendo Study (Protocol EFC-5826) A Multinational, Multi-Center, Double-Blind, Placebo Controlled, two-arm Parallel Group Trial of Rimonabant 20mg daily for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients with Clustering Risk Factors for Cardiovascular Events.

Daiichi Sankyo Benicar Study (Protocol 866-451) A Randomized, Double-Blind, Placebo-Controlled, Titration study to Evaluate the Efficacy and Safety of Olmersartan Medoxomil based Treatment Regimen Compared to Placebo in Patients with Stage I or Stage II Hypertension.

Daiichi Sankyo (Protocol EFC-6911) A Multicenter, Randomized, Placebo-Controlled, Factorial Design, 12-Month Study to Evaluate the Efficacy and Safety of AVE5530 25mg/day and 50mg/day co-administered with all Registered Atorvastatin Strengths Ranging from 10mg to 80mg in Patients with Primary Hypercholesterolemia.

Daiichi Sankyo (Protocol EFC-6910) A Multicenter, Double-Blind, Randomized 12 Month Placebo-Controlled study to Evaluate the Lipid-Lowering Effect, Safety and Tolerability of AVE5530 25mg/day when Added to Ongoing Stable Stain Therapy (HMG=CoA reductase Inhibitors) in Patients with Primary Hypercholesterolemia.

Congentus (Protocol CG-104) A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase III Efficacy and Safety Study of CGT-2168 Compared with Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and symptomatic Ulcer Disease.

Takeda (Protocol TAK-491-CLD_302) A Phase III, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK-491 Plus Chlorthalidone Fixed-Dose Combination in Subjects with Moderate to Severe Hypertension.

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