Objective:

Position: Contract or permanent hire with a pharmaceutical, device or biotech company as a Clinical Project Manager, Lead/Senior Clinical Research Associate, Sponsor/CRO Oversight Monitor or CRO/Sponsor CRA Manager/Trainer.

Qualifications: Employing 20+ years of hospital and medical office based clinical medicine experience (Respiratory Care and Cardiopulmonary Technology) and 30+ years of clinical research monitoring, coordination, training, and project management experience

Therapeutic Experience in Research:

Site Coordinated Trials, Monitored and Managed Phases: Pre-Clinical/Early Phase and Phases I, 1b, II, IIa, IIb, III and IV clinical trials in the following therapeutic diseases:

•Antibiotic Therapy: Intravenous, Oral and Inhaled - Critical Care & Community acquired Infections as a Study Coordinator, Sepsis as a CRA

•Arthritis: Osteoarthritis & Rheumatoid Arthritis (Scheduled and Non-Opioids/NSAIDs, Cox- 2 inhibitors for Pain Control)

•Cardiology: Heart Failure & Pulmonary Arterial Hypertension (Right Side Heart Failure), Hypertension, Cardiac Stent Placement

•Central Nervous System/Neurology: Schizophrenia (scheduled/controlled substances and non-scheduled compounds), Alzheimer’s Disease for cognitive response, Prophylaxis of Migraine and generalized Migraine, adult and pediatric Epilepsy (simple partial seizures), Pediatric and Adult ADHD, PTSD, generalized pain control/management, drugs for addiction.

•Critical Care: Multiple Organ Failure/Sepsis and hospital acquired infections (see antibiotic therapy)

•Dermatology: Atopic Dermatitis (Eczema), Psoriasis

•Device: Cardiology – ICD (Implant determination); Cystic Fibrosis (Aerosol Delivery System); Ophthalmology (surgical implant for Uveitis; Diabetes (Injectable Delivery System)

•Endocrinology/Metabolism: Type I & Type II Diabetes (injectables), Sexual Dysfunction (testosterone), Obesity (weight control)

•Early Phase/Phase I & IIa Trials – Phase I Renal Micro-Dose Trial - Compounding; Laboratory specimen monitoring, Adverse Event Monitoring; Phase 1b - Para-Thyroid Compound; Phase I – Tobacco (Moist Pouch)

•Immunology: Hereditary Angioedema, Allergy (asthma, sinusitis & rhinitis), Tumor Necrosis Factor (TNF) Anti-bodies/Immunotherapy

•Gastroenterology: Irritable Bowel Syndrome (IBS), Gastrointestinal Reflux (GERD) & Crohn’s Disease

•Investigator Academic Studies at University of Pennsylvania: Curcuminoid’s effect on cellular proliferation, apoptosis and COX-2 expression and activity in the colorectal mucosa

•Hematology: Recombinant Hemoglobin –Post Trauma Surgery, Anti-Platelet Therapy post Cardiac Stent Placement, Oncologic

•Neonatology (pre-term newborn babies) – (see rare disease) Necrotizing Entero-Colitis, Bronchopulmonary Dysplasia

•Neuromuscular: Amyotrophic Lateral Sclerosis (ALS), Pediatric Duchenne Muscular Dystrophy (DMD)

•Nuclear Medicine Radiopharmaceuticals: Cardiology (Heart Failure/HM Ratio calculation determination for ICD implant) and Oncology (Malignant Melanoma)

•Oncology/Hematology (Phase I through Phase IV): Chemotherapy and Immunotherapy treatment for Solid Tumor, Lymphoma, Brain (Glioblastoma), Lung (Non-Small Cell Lung Cancer), Bladder Cancer and Pancreatic Cancer (Adjunctive Monoclonal Antibodies Therapy/Immunotherapy) and Antiemetic, Cutaneous T-Cell Lymphoma)

•Ophthalmology: Pharmaceutical & surgical Implant Device for Uveitis

•Rare Diseases: pre-term babies - Necrotizing Entero-Colitis and Bronchopulmonary Dysplasia; Adult Oncology - Cutaneous T-Cell Lymphoma; Adult Neuromuscular - Amyotrophic Lateral Sclerosis (ALS); Pediatric Neuromuscular - Duchenne Muscular Dystrophy (DMD); Ocular – Uveitis; Pediatric & Adolescent - Cystic Fibrosis; Pediatric & Adult – Epilepsy (seizure control); Pediatric (4/5-year-old) - ADHD, Adult Male - Pyronine’s Disease; Immunologic: Hereditary Angioedema

•Radiopharmaceuticals: (see Investigator/Academic Studies at University of Pennsylvania) (Academic Diagnostic) Nuclear Medicine tracers for Neurodegenerative disorders: Brain Bio-distribution in Alzheimer’s Disease: Selective Serotonin Reuptake site imaging agents: (GE Healthcare Cardiology) Heart/Mediastinum Ratio calculations for ICD placement; (Diatide) Post excision of Melanoma for cancer cell tracer

•Renal Disease: Phase I renal disease evaluations of Phase I Micro-Dosing trial

•Pulmonary/Respiratory: (Study Coordinator) Pediatric and Adult Asthma, Chronic Obstructive/Restrictive Pulmonary Disease, Chronic Bronchitis, Nosocomial & Community Acquired Pneumonia, Obstructive Sleep Apnea

(Clinical Research Monitor -CRA) Phase II Asthma, Non-Small Cell Lung Cancer Pulmonary Arterial Hypertension, Phase II/III Cystic Fibrosis - aerosol devices and antibiotic therapy

•Urogenital: Pyronine’s Disease, Erectile Dysfunction, Hypogonadism

•Vaccines: (QA/Data Reviewer for Adult and Pediatric vaccines trials) Rabies and Lyme’s Disease

Clinical Research Experience

CRA (I, II, III, Senior & Trainer, Project Management/Lead CRA, Study Oversight & Site Management:

•Recruit Investigators for clinical trials/Feasibility

•Evaluate investigational sites for ability to effectively conduct a clinical trial (feasibility review and selection)

•Liaison between the protocol sponsor and CRO with the investigational sites during clinical trials. (forge site relationships with PI and research staff for study compliance)

•Initiate investigational sites and train the study staff to a study protocol.

•Train site staff to specific protocols and procedures during specific studies (Site Management)

•Review screening and recruitment during the clinical trial.

•Monitor CRFs (paper and Remote Data Capture) against source documentation for quality, accuracy, and adherence to the protocol.

•Review patient medical records (paper and electronic medical records/EMR) for source documentation.

•Evaluate and report Serious, and Non-Serious Adverse events, Adverse Drug Reactions and Important Medical Events during and post clinical trials.

•Review laboratory values for Important Clinical Events during clinical trials.

•Review laboratory values for hematological responses of liquid oncology Phase I, II & III trials.

•Pharmacokinetic samples laboratory monitoring (Phase I, II & III)

•Perform and maintain clinical test article accountability. (Trained for controlled substance/ scheduled compounds shipping return using DEA 222 form)

•Obtain, review, and audit regulatory documents at the site and at the sponsor location.

•Maintain study documentation during and post-trial as per the protocol and/or ICH/GCP and FDA requirements.

•Review study data remotely. (Risk Based Monitoring)

•Ensure GCP/ICH and FDA requirements and guidelines are followed by sites and monitoring.

•Review imaging documentation for tumor size and calculation for solid tumor responses in Oncology trials Phases I, II, III (CR, SD, PR).

•Perform GCP/Quality Assurance Audits, post QA audit review and responses.

•Work with study data vendors to maintain accurate data and data transfer. (Data Management)

•Closeout the site after the clinical trial is completed.

•Reported the investigational site's activities to the protocol sponsor and/or Clinical Research Organization (CRO) via Telephone Contacts and Monitoring Visit Reports (MVR).

•Train and manage study monitors for United States and Global clinical trials, adherence to protocol requirements and study timelines (In-house and remote as Lead CRA and Global Lead CRA)

•Mentor/Train Clinical Research Associates

•Assist development and write protocol procedures for protocol development.

•Case Report Form development. (Paper & EDC)

•Create protocol consent forms templates and review for prior to IRB submission/approval.

•Review and develop financial budgets for the clinical trial.

•Develop sample source documentation from the protocol for site use.

•Review reports for accuracy and completeness (study management)

•Monitor the sites for adherence of study procedures, enrollment and adherence to Federal, State and Local regulatory procedures throughout the course of the clinical trial.

•Assist the sponsor with submission of the IND and NDA to the FDA.

•Academia monitoring of Investigator Trials

Computerized Clinical Trial Systems:

Electronic Data Capture (EDC)

Medidata Rave

Medrio

InForm (Versions 4.2 and 5.5)

TrialMaster

Electronic Source Documentation

CRIO

Verisci (Electronic CNS/Psychologic Rating System)

RealTime

Clinical Trial Management Systems (CTMS)

Oracle (Seible)

Medidata

Informat

Bioclinica

SureClinical

Trial Management Files (eTMF)

Veeva Vault

Wingspan

Trial Interactive

SureClinical

Clinical Trial Experience (Permanent Positions & Consulting)

March 2022 to Present

ImmunityBio Inc. (Pharmaceutical Division of Nantwest Inc.)

San Diego, California (Remote)

Senior Clinical Research Associate/Monitor

General Oncology Research – Specializing in Lung Cancer (NSCLC, Small Cell Lung Cancer)

December 2020 to March 2022

Clinilabs Research (CRO – Fulltime) (resigned to work on Lung Trials for sponsor company)

New York City, New York (Remote)

Senior Clinical Research Associate/Site Monitor

CNS – Alzheimer’s Disease and Obstructive Sleep Apnea (Adult & Elderly with/without COPD)

September 2020 to December 2020

Paidion Research (CRO) – Fulltime (Laid off due to Covid-19)

Durham, North Carolina (Remote)

Senior Clinical Research Associate/Site Monitor (Pediatric & Neonatal Rare Diseases)

Premature Infant - NICU (Bronchopulmonary Dysplasia)

October 2018 to March 2020

Premier Research (CRO) – Fulltime (Laid off due to Covid-19)

Research Triangle Park, North Carolina (Remote)

Senior Clinical Research Associate/Site Monitor (Rare Diseases)

Premature Infant - NICU (Necrotizing Endo-Colitis), CNS (Schizophrenia, Pediatric and Adult ADHD, PTSD), Oncology Phase II (Cutaneous T-Cell Lymphoma)

January 2018 to October 2018

Celerion (CRO) – Fulltime

Lincoln, Nebraska

Senior Clinical Research Associate Phase I & IIa - Early Phase Clinical Trials

(Merck Phase I (Micro-Dosing Renal Trial) & Altria Tobacco (MST Pouch) Study)

June 2017 to August 2017

Rho Inc. (CRO) – Contract (Short Term contract completed)

Durham, North Carolina

Senior Clinical Research Associate (Contract CRA to assist with data management/collection) (Heredity Angioedema)

Contracted through Talentmine

November 2016 to April 2017

Topstone Research (CRO) – Contract (Short Term contract completed)

Toronto, ON, Canada

Senior Clinical Research Associate/Site Monitor (Atopic Dermatitis)

Contracted through ClinLinks

September 2015 to November 2016

TFS International (CRO) – Fulltime

Princeton, NJ and Lund, Sweden

Lead Clinical Research Associate

Senior Clinical Research Associate/Monitor (Global Lead CRA for Global Cardiac Heart Failure Study, Field CRA/Monitor for Pulmonary Arterial Hypertension (PAH) study (Rare Disease), Phase I Monitor for Para-Thyroid safety study, Field CRA/Monitor for Pyronine’s Disease (Rare Disease)

October 2008 to June 2015

Quintiles Transnational (Lilly GFR Program) (CRO) – Fulltime (SWAT Monitor)

Research Triangle Park, NC

Senior Clinical Research Associate III in collaboration with Lilly Integrated Clinical Operations

(Quintiles Field Monitoring Group - SWAT Monitor) – Endocrinology/Metabolism (Type II Diabetes) (dulaglutide Marketed as Trulicity®), Women’s Health (osteoporosis fractures)teriparatide marketed as Forteo, Men’s Health (low testosterone) transdermal testosterone marketed as Axiron®, Neuroscience/CNS (Pain Management, Schizophrenia), Neuromuscular(DMD), Oncology Trials (Solid Tumor – NSCLC (Phase III), Glioblastoma (Phase II), Pancreatic (Phase I) and Prostate (Phase I), Critical Care (C Reactive Protein, Infectious Diseases), Bio-Meds (OA and RA)

Clinical Research Consulting Projects:

Galex Clinical Consulting, Inc. - April 1996 to October 2008

Direct Contracts

July 2008 to September 2008

Eisai Pharmaceuticals (Sponsor) (Short Term contract completed)

Ridgefield Park, NJ.

Regional Sr. CRA – Pre-Study Visits for Hematology/Oncology (Phase II Pediatric & Phase IV Adult Study) (Site Qualification Visits only)

June 2008 to July 2008

Orexigen Therapeutics (Sponsor) (Short Term contract completed)

San Diego, CA.

Regional Sr. CRA/Co-Monitor for Phase III Obesity study (Co-Monitor/oversight Monitor for Data Collection only) Contracted through CRO

April 2008 to June 2008

Morphotek, Inc. (Sponsor) (Short Term contract completed)

Exton, PA.

Regional Sr. CRA/Monitor for a Phase II Pancreatic Cancer study (Site Start up only)

Contracted through CRO

May 2006 to April 2008

GE Healthcare/Bio-imaging Systems (Sponsor) (2 year contract completed)

Princeton, NJ

In House and Lead Clinical Research Monitor for Phase III Heart Failure study for Nuclear Cardiology Imaging Iobenguane I 123 Injection marketed as AdreView

July 2005 to December 2006

University of Pennsylvania Hospital and Medical Center (Academia) (1 year contract completed)

Philadelphia, PA

External Monitor for Investigator Initiated Studies (CNS & GI imaging trials)

January 2005 to January 2006:

Corus Pharmaceuticals (Sponsor) (acquired by Gilead Sciences – October 2006) (2 year contract completed)

Seattle, WA

Clinical Research Monitor for pediatric and adult Cystic Fibrosis study (Inhaled Antibiotic and Delivery system) aztreonam inhaled marketed as Cayston®

December 2003 to February 2005:

Purdue Pharma, L.P. (Sponsor) (2 year contract cancelled due to Legal issues with sponsor)

Stamford, CT

Clinical Monitor for Addiction and Schedule 1 & 2 Pain Medication Studies (Buprenorphine, Naltrexone, Oxycodone)

May 2001 to December 2003:

Abbott Laboratories (Sponsor) (formally – Knoll Pharmaceuticals) (2 year contract completed)

Parsippany, NJ

Regional Monitor for Crohn’s Disease study and Psoriasis study. (Injectable Immunotherapy) adalimumab marketed as Humira®

December 2000 to April 2001:

Abvie (Sponsor) (formally - Forest Laboratories & Allergan) (2 year contract completed)

New York City, NY

Regional Field Monitor for Cardiovascular (Hypertension), CNS (Pain Management, Alzheimer’s disease memantine marketed as Namenda® and Gastrointestinal (IBS) studies.

June 2000 to December 2000:

Bausch & Lomb Pharmaceuticals, Inc. (Sponsor) (6 month contract completed)

Tampa, Florida

Regional Clinical Research Monitor for Ophthalmologic Infection (Uveitis) and implantable Device study. fluocinolone intravitreal marketed as Retisert®

May 2000 to June 2000:

Bayer Corporation (Sponsor) (Pharmaceutical Research & Development Division) (6 month

contract completed)

New Haven, Connecticut

Regional Clinical Research Monitor for site feasibility/qualification visits for asthma and complicated intra-abdominal infection studies.

August 1998 to November 2004:

Pfizer Global Research and Development (Sponsor) (formally – Parke-Davis Pharmaceuticals) (8 year renewable contract completed)

Ann Arbor, Michigan

Clinical Research Monitor for multiple CNS studies (Pediatric and Adult Epilepsy) pregabalin marketed as Lycria®

August 1998 to October 2002:

Aventis Pharmaceuticals ((Sponsor) Formally - Rhône-Poulenc Rorer Pharmaceuticals) (6 year renewable contract completed)

Bridgewater, New Jersey

Clinical Research Monitor for Oncology (Phase III Breast and Phase II & III Lung Cancer-NSCLC) studies docetaxel Marketed as Taxotere®

January 1998 to August 1998:

Anthra Pharmaceuticals Inc. (Sponsor) (1 year contract completed)

Princeton, New Jersey

Clinical Research Monitor for an Oncology study (Phase II - Non-invasive Muscle Bladder cancer)

November 1997 to January 1998:

Pfizer Global Research and Development (Sponsor) (formally – G.D. Searle & Company) (4 month contract completed)

Chicago, Illinois

Clinical Research Monitor for Arthritis (Osteoarthritis & Rheumatoid) and Post-Operative NSAID studies. celecoxib marketed as Celebrex®

January 1997 to October 1997:

Eli Lilly & Company (Sponsor) (1 year contract completed)

Indianapolis, Indiana

Mid-Atlantic Regional Clinical Research Monitor for; Oncology (Phase I, II, III - Ovarian, Pancreas, Soft-tissue sarcoma & Metastatic breast cancer) gemcitabine marketed as Gemzar, Sexual Dysfunction tadalafil marketed as Cialis

October 1996 to September 1997:

Diatide, Inc. (Sponsor) (1.5 year contract completed)

Londonderry, New Hampshire

Senior Clinical Research Monitor for a Radiopharmaceutical/ Oncology Nuclear Medicine (post excision Malignant Melanoma Tumor Tracer) trial.

September 1996 to February 1997:

GlaxoSmithKline (Sponsor) (formally - SmithKline Beacham Pharmaceuticals) (6 month contract completed)

Philadelphia, Pennsylvania

Clinical Research Monitor for an Allergic Rhinitis study.

April 1996 to September 1996:

Aventis Pasteur (Sponsor) (formally Pasteur Mérieux Connaught) (6 month contract completed)

Swiftwater, Pennsylvania

Quality Assurance/Data Reviewer (In house) - Lyme’s Vaccine and Rabies Studies.

Clinical Research Early CRO positions:

December 1994 to April 1996:

Innovex Inc. (CRO) Direct Hire

Lenexa, Kansas

Clinical Lead Research Associate for a Phase II asthma study for Sanofi Pharmaceuticals (now Aventis Pharmaceuticals)

June 1993 to December 1994:

Pharmaceutical Product Development, Inc. (CRO) Direct Hire

Wilmington, North Carolina

Clinical Research Associate I for a Phase III GI OTC Ranitidine marketed as Zantac 75, OTC Phase IV Oncology antiemetic study granisetron marketed as Kytril Injectable

Study Coordinator/Clinical Research Experience:

June 1991 to June 1993:

Atlantic Clinical Research (division of Atlantic Pulmonary & Critical Care, PA.)

Absecon, New Jersey

Primary Clinical Trial Study Coordinator & Pulmonary Lab Director

Clinical Medicine Experience (Hospital):

1972 through 1991

Worked as a Respiratory Therapist/Cardiopulmonary Technologist in Pennsylvania, New Jersey and Florida. (general and critical care – NICU/pediatric and adult)

1977 through 1981 – Manager of ancillary services (Respiratory Care, Cardiac Stress & Echo Lab, Pulmonary Lab, Physical Therapy, Cardiology (ECG) and Neurology (EEG) Departments) at Elmer Community Hospital, Elmer New Jersey.

June 1991 to June 1993:

Atlantic Pulmonary & Critical Care, PA

Absecon, New Jersey

Pulmonary Laboratory (Clinical) Director

Duties: Complete Pulmonary Function Testing (spirometry, lung volumes, Vmax exercise testing)

Methacholine Challenge (Asthma Testing)

Blood Gas collection and testing

Sputum Induction and Gram Staining for eosinophil cell reading

Smoking cessation classes

Breathing Programs (COPD, Asthma, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis)

Medication instructional classes (proper inhaler and spacer usage)

Polysomnography (Sleep Study)

CPAP Set up

Consulting Business:

April 1996 to October 2008:

Galex Clinical Consulting, Inc.

Jamison, Pennsylvania

Clinical Research Consulting Services

President/CEO/Managing Director

Corporate Information:

•12 years as a Clinical Research Independent Consultant

•October 1996 – Incorporated in the State of Pennsylvania

• Galex Clinical Consulting, Inc. (Federal EIN#23-2865639)

Credentials:

May 1975: Certified Respiratory Therapy Technician by National Board of Respiratory Care

April 1998: Certified in clinical research by Association of Clinical Research Professionals #A98064

Certifications, Licenses, Affiliations and Recognitions:

Certifications:

1975 – Certified Respiratory Therapy Technician by National Board for Respiratory Care Certification Exam (NBRC)

1998 – Certified Senior Clinical Research Associate by Academy for Clinical Research Professionals (ACRP

Professional License:

1988 – 1991: Florida state DPR #TT0003405 Respiratory Care Practitioner (expired)

Professional Affiliations:

1995: Drug Information Association (DIA)

1994: Association of Clinical Research Professionals (ACRP)

1998: Academy for Clinical Research Professionals (ACRP)

1972: American Association for Respiratory Care (AARC)

1972: National Board for Respiratory Care (NBRC)

2006: Project Management Institute (PMI)

Education:

College/University:

2015 - 2016

Capella University (FlexPath Program)

Minneapolis, MN

Bachelor of Science Degree Program (online/incomplete)

Major: Healthcare Management (Project Management courses)

2009 - 2013

Kaplan University (Computerized Distance Learning Degree Program)

Phoenix, AZ

Bachelor of Science Degree Program (online/incomplete)

Major: Healthcare Management (Project Management courses)

1998 - 2002

Shaftesbury University (online)

London, UK

Bachelor of Science

Major: - Biology - Minor: Pharmacology

1972 -1972

Brookdale Community College

Lincroft, NJ

Major: Respiratory Therapy (Certification Program)

Leon Galex, RCP, CRT, CCRA

Senior, Certified Clinical Research Associate/Monitor

9780A Hydrangea Tree Way

Boynton Beach, Florida 33436

Cell/Text: 561-***-****

E-Mail: ad4l2m@r.postjobfree.com

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