Post Job Free

Resume

Sign in

Research Associate

Location:
Tustin, CA
Posted:
November 16, 2022

Contact this candidate

Resume:

APRIL C. SORIANO *

LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA, Torrance, California Research Associate IV (2017-present)

Data extraction and analysis of investor initiated and multi-center research protocols that involve Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Asthma, Heart Failure, Pulmonary Hypertension and Exercise Physiology.

Conduct and manage clinical trials through budgeting, protocol review, Institutional Review Board (IRB) tasks (creation of source documents, preparation of submission materials for IRB review, completion of continuing IRB review, and serious adverse event submission, and study closures). Creates trial protocols, verifies data, presents results, and writes reports.

Tests devices and drugs prior to release onto market, collaborates with ethics committees. Develops TMFs, eTMFs, CRFs, for clinical trials; responds to audits and data queries. Updates and maintains ISFs, EDCs, and CTMS.

Assists with supporting oversight of vendors/CROs, including invoice processing. Manages site activities (pre-study, initiation, routine, and close-out visits) and on-time execution of clinical tasks, while ensuring the trial is conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements including FDA.

Assists with Site Feasibility for investigators for participation in clinical trials.

Supports Clinical Trial Manager/Clinical Director in scheduling of internal and external team meetings, investigator meetings, and other trial specific meetings as required.

ROBERTSON CARDIOVASCULAR CENTER, Beverly Hills, California Manager (2011-2017)

Clinical Exercise Physiologist (2005-2011)

Responsible for managing day-to-day center operations for Nuclear Cardiology and Diagnostic departments including payroll, billing, vendor negotiations, and updating national and regional accreditations such as ICANL and RAML.

Worked directly with Medical Director and CFO. Monitor staffing levels, licensure/certification, training, and evaluation performances. Implement Quality Control projects. Conducted forecasting, risk management, and workflow analytics, that minimized overhead and maximized patient satisfaction. Has managed smooth, efficient, and cost-effective facility operations. Spearhead department meetings.

Prepare patients for testing procedures, assisting physicians and technologists with exercise and pharmacological nuclear stress testing, performing data quality control, interpreting test results, patient relations, and handling a wide variety of special projects. Worked extensively on unique projects that are internationally recognized (Biggest Losers, Weight for Love, and The Clinic).

CEDARS-SINAI MEDICAL CENTER, Los Angeles, California Clinical Exercise Physiologist (2005-2011)

Responsible for test preparation and monitoring of patients, obtaining, and performing data quality control, and submitting results for final interpretation. Worked on various multi-centered grant research projects and generated teaching materials and lessons for staff and students. Lead Clinical Exercise Physiologists for 2009-2010 Phase two, open-label, multi-center study for the development of one-day rest/stress cardiac Positron Emission Tomography (PET) perfusion exercise and pharmacological imaging protocols. Lead Clinical Exercise Physiologist in projects for medical research involving protocol development and phase implementation for the following: Positron Emission Tomography/ Computed Tomography (PET/CT) Rubidium, pharmacological cardiac Magnetic Resonance Imaging (MRI), Spectrum Dynamics’ D-Spect, Astellas’ Lexiscan, and treadmill-only stress testing. ROBERT KOBLIN, M.D. - A MEDICAL CORPORATION, Beverly Hills, California Assistant Manager (2004-2005)

Responsible for assisting with day-to-day facility operations, office administration, scheduling patients, preparing medical documents, letters, and reports; patient check-in, processing payments, answering phones, and patient relations. Provided the highest levels of administrative support to physicians and other medical personnel. CALIFORNIA STATE UNIVERSITY LONG BEACH (Department of Kinesiology-Laboratory of Applied Physiology) Laboratory Assistant (2002)

Responsible for preparing and observing subjects for various tests, calculated, and analyzed laboratory test values, evaluated, and finalized documents.

Student Research Assistant (2001-2002)

Worked on various mini-grant research projects. Calibrated equipment and collected and analyzed data. PROFESSIONAL EXPERIENCE

APRIL C. SORIANO

951-***-**** adtj8k@r.postjobfree.com 14702 Plaza Dr. Tustin, CA 92780 APRIL C. SORIANO 2

KAHAKAI OUTRIGGER CANOE CLUB, Long Beach, California Board of Directors, Secretary (2016-2017)

Volunteer (2013-2017)

Provides essential support that is critical to the successful operation of Kahakai Outrigger Canoe Club’s non-profit mission. Performs tasks related to Kahakai Outrigger Canoe Clubs Development and Marketing Programs, including maintaining and coordinating public relations needs, sending member e-mails and press releases, overseeing staffing events, and assisting with event planning.

SHEILA KAR HEALTH FOUNDATION, Beverly Hills, California Volunteer (2004-2017)

Promotes organization and community activities on a variety of media platforms. Assists in building organizational partnerships to expand visibility, outreach, and political impact. Performs other essential functions based on the needs of the organization. GEORGE WASHINGTON UNIVERSITY, Washington, DC

Master of Business Administration

Certificate in Regulatory Affairs

Graduation date: 2024 Spring

CALIFORNIA STATE UNIVERSITY LONG BEACH, Long Beach, California Bachelor of Science in Kinesiology, with concentration in Exercise Science Minors in Biology and Chemistry

Cornell University, Ithaca, New York

Project Management Certificate

Anticipated completion date: 2022 December

Collaborative Institutional Trading Initiative

Biomedical Responsible Conduct of Research

Good Clinical Practice

Information Privacy Security Health Privacy

Conflicts of Interest

Export Control

Biomedical Research- Basic/Refresher

Conflicts of Interest

Export Control

Biomedical Research- Basic/Refresher

GDPR

Saf-T-Pak (ICAO & IATA training)

General Familiarization

Safety and Security

Overview of Dangerous Goods Shipping

Classification of Infectious Substances

Exempt Patient Specimens

Category B Infectious Substances

Dry Ice with Infectious Substances

Preservatives with infectious Substances

Basic Life Support

Advanced Cardiac Life Support

Computer knowledge: Microsoft Office, SharePoint, PowerPoint, Visio, Quickbooks, SigmaPlot, Medidata RAVE, ORACLE RDC Onsight (Boehringer Ingelheim Remote Trials Portal), Perceptive Informatics ClinPhone RTSM, Perceptive MyTrials (Data Labs- EDC), ERT Dashboard iCardiac, RAMOS NG, Ambra, Salesforce, Connexus, SigmaPlot, IGOR, RedCap, IBM Clinical Development. PROFESSIONAL DEVELOPMENT

TECHNICAL EXPERTISE

EDUCATION

PROFESSIONAL CERTIFICATIONS

COMMUNITY SERVICE

APRIL C. SORIANO 1

LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA, Torrance, California Research Associate IV (2017-present)

Data extraction and analysis of investor initiated and multi-center research protocols that involve Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Asthma, Heart Failure, Pulmonary Hypertension and Exercise Physiology.

Conduct and manage clinical trials through budgeting, protocol review, Institutional Review Board (IRB) tasks (creation of source documents, preparation of submission materials for IRB review, completion of continuing IRB review, and serious adverse event submission, and study closures). Creates trial protocols, verifies data, presents results, and writes reports.

Tests devices and drugs prior to release onto market, collaborates with ethics committees. Develops TMFs, eTMFs, CRFs, for clinical trials; responds to audits and data queries. Updates and maintains ISFs, EDCs, and CTMS.

Assists with supporting oversight of vendors/CROs, including invoice processing. Manages site activities (pre-study, initiation, routine, and close-out visits) and on-time execution of clinical tasks, while ensuring the trial is conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements including FDA.

Assists with Site Feasibility for investigators for participation in clinical trials.

Supports Clinical Trial Manager/Clinical Director in scheduling of internal and external team meetings, investigator meetings, and other trial specific meetings as required.

ROBERTSON CARDIOVASCULAR CENTER, Beverly Hills, California Manager (2011-2017)

Clinical Exercise Physiologist (2005-2011)

Responsible for managing day-to-day center operations for Nuclear Cardiology and Diagnostic departments including payroll, billing, vendor negotiations, and updating national and regional accreditations such as ICANL and RAML.

Worked directly with Medical Director and CFO. Monitor staffing levels, licensure/certification, training, and evaluation performances. Implement Quality Control projects. Conducted forecasting, risk management, and workflow analytics, that minimized overhead and maximized patient satisfaction. Has managed smooth, efficient, and cost-effective facility operations. Spearhead department meetings.

Prepare patients for testing procedures, assisting physicians and technologists with exercise and pharmacological nuclear stress testing, performing data quality control, interpreting test results, patient relations, and handling a wide variety of special projects. Worked extensively on unique projects that are internationally recognized (Biggest Losers, Weight for Love, and The Clinic).

CEDARS-SINAI MEDICAL CENTER, Los Angeles, California Clinical Exercise Physiologist (2005-2011)

Responsible for test preparation and monitoring of patients, obtaining, and performing data quality control, and submitting results for final interpretation. Worked on various multi-centered grant research projects and generated teaching materials and lessons for staff and students. Lead Clinical Exercise Physiologists for 2009-2010 Phase two, open-label, multi-center study for the development of one-day rest/stress cardiac Positron Emission Tomography (PET) perfusion exercise and pharmacological imaging protocols. Lead Clinical Exercise Physiologist in projects for medical research involving protocol development and phase implementation for the following: Positron Emission Tomography/ Computed Tomography (PET/CT) Rubidium, pharmacological cardiac Magnetic Resonance Imaging (MRI), Spectrum Dynamics’ D-Spect, Astellas’ Lexiscan, and treadmill-only stress testing. ROBERT KOBLIN, M.D. - A MEDICAL CORPORATION, Beverly Hills, California Assistant Manager (2004-2005)

Responsible for assisting with day-to-day facility operations, office administration, scheduling patients, preparing medical documents, letters, and reports; patient check-in, processing payments, answering phones, and patient relations. Provided the highest levels of administrative support to physicians and other medical personnel. CALIFORNIA STATE UNIVERSITY LONG BEACH (Department of Kinesiology-Laboratory of Applied Physiology) Laboratory Assistant (2002)

Responsible for preparing and observing subjects for various tests, calculated, and analyzed laboratory test values, evaluated, and finalized documents.

Student Research Assistant (2001-2002)

Worked on various mini-grant research projects. Calibrated equipment and collected and analyzed data. PROFESSIONAL EXPERIENCE

APRIL C. SORIANO

951-***-**** adtj8k@r.postjobfree.com 6277 Chadbourne Avenue, Riverside, CA 92505 APRIL C. SORIANO 2

KAHAKAI OUTRIGGER CANOE CLUB, Long Beach, California Board of Directors, Secretary (2016-2017)

Volunteer (2013-2017)

Provides essential support that is critical to the successful operation of Kahakai Outrigger Canoe Club’s non-profit mission. Performs tasks related to Kahakai Outrigger Canoe Clubs Development and Marketing Programs, including maintaining and coordinating public relations needs, sending member e-mails and press releases, overseeing staffing events, and assisting with event planning.

SHEILA KAR HEALTH FOUNDATION, Beverly Hills, California Volunteer (2004-2017)

Promotes organization and community activities on a variety of media platforms. Assists in building organizational partnerships to expand visibility, outreach, and political impact. Performs other essential functions based on the needs of the organization. GEORGE WASHINGTON UNIVERSITY, Washington, DC

Master of Business Administration

Certificate in Regulatory Affairs

Graduation date: 2024 Spring

CALIFORNIA STATE UNIVERSITY LONG BEACH, Long Beach, California Bachelor of Science in Kinesiology, with concentration in Exercise Science Minors in Biology and Chemistry

Cornell University, Ithaca, New York

Project Management Certificate

Anticipated completion date: 2022 December

Collaborative Institutional Trading Initiative

Biomedical Responsible Conduct of Research

Good Clinical Practice

Information Privacy Security Health Privacy

Conflicts of Interest

Export Control

Biomedical Research- Basic/Refresher

Conflicts of Interest

Export Control

Biomedical Research- Basic/Refresher

GDPR

Saf-T-Pak (ICAO & IATA training)

General Familiarization

Safety and Security

Overview of Dangerous Goods Shipping

Classification of Infectious Substances

Exempt Patient Specimens

Category B Infectious Substances

Dry Ice with Infectious Substances

Preservatives with infectious Substances

Basic Life Support

Advanced Cardiac Life Support

Computer knowledge: Microsoft Office, SharePoint, PowerPoint, Visio, Quickbooks, SigmaPlot, Medidata RAVE, ORACLE RDC Onsight (Boehringer Ingelheim Remote Trials Portal), Perceptive Informatics ClinPhone RTSM, Perceptive MyTrials (Data Labs- EDC), ERT Dashboard iCardiac, RAMOS NG, Ambra, Salesforce, Connexus, SigmaPlot, IGOR, RedCap, IBM Clinical Development. PROFESSIONAL DEVELOPMENT

TECHNICAL EXPERTISE

EDUCATION

PROFESSIONAL CERTIFICATIONS

COMMUNITY SERVICE

APRIL SORIANO 1

1

Cardiopulmonary Exercise Testing Core Laboratory

Data Analysis

COPD cachexia: deciphering the impact of antioxidants, iron and mitochondrial function using ‘omics approaches. University of Alabama. (2021-present) Principal Investigator: Harry Rossiter, PhD. A Multicenter, Open-Label, Single-Arm Study to Assess the impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma. Genentech ML41645. (2020-2021) A Randomized, double blind, placebo controlled, parallel group study to evaluate the effect of dupilumab on exercise limitation in patients with moderate-to-severe asthma; Phase 4 study. Regeneron R668-AS-1903. (2020-present) A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy. United Therapeutics ROR-PH-302. (2020-Present)

TRIIM-X is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. Intervene Immune, Inc. (2020-present) Characterization of Progressive Airflow Limitation during Incremental Cycle Ergometry in Patients with Moderate to Severe COPD using Breath by Breath Analysis of the Spontaneous Expiratory Flow-Volume Curves and Impulse Oscillometry (IOS). (2018-2021) Investigator initiated. Principal Investigator: Janos Porszasz, M.D., Ph.D. The immunologic, metabolic and exosome response to exercise in chronic obstructive pulmonary disease. Investigator Initiated 31265-01. (2019-present) Principal Investigator: Harry Rossiter, Ph.D. An Investigator Initiated, Randomized, Double Blind, Placebo Controlled, Two Period, Crossover Study to Assess the Effect of BEVESPI AREOSHERE™ Therapy (Glycopyrrolate/Formeterol) on Exercise Tolerance and Dynamic Hyperinflation in Patients with Chronic Obstructive Pulmonary Disease. AstraZeneca Investigator initiated 21752-01. (2017-2019) Principal Investigator: William Stringer, M.D.

A Randomized, Crossover, Placebo Controlled, Double-Blind Phase IV Trial of the Effect of on STIOLTO™ RESPIMAT® on Central and Peripheral Components of Fatigue During Exercise in Chronic Obstructive Pulmonary Disease. Boehringer-Ingelheim Investigator Initiated 1237.55. (2017-2018). Principal Investigator: Richard Casaburi, PhD, M.D. Exercise Physiologist

Technical Assessments

A Phase 2, MulticEnter, Double Blind, Three Arm, Placebo and Active Control Efficacy and safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction. AstraZeneca. (2020-2022) Principal Investigator: Matthew Buddoff, M.D.

A Double-blind, Randomized, Placebo controlled, Multicenter Study to Assess the Effect of Omecamtiy Mecarbil on Exercise Capacity in Subjects with Heart with Reduced Ejection Fraction and Decreased Exercise Tolerance. Amgen: METEORIC- HF CY 1031. (2019-2021). Principal Investigator: William French, M.D. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 weeks in Patients with Heart Failure with Preserved Ejection Fraction (CAPACITY HFpEF). Ironwood C1973-204. (2017-2019). Principal Investigator: William Stringer, M.D. Beta-Blockers for the Prevention of Acute Exacerbations of COPD. Department of Defense DoD Award: W81XWH-15-1-0705 Protocol 30477-01. (2017- 2019). Principal Investigator: William Stringer, M.D. RESEARCH AND PRESENTATIONS

APRIL SORIANO 2

2

COPD Research Subject Database for the Chronic Disease Clinical Research Center (CDCRC). Registry 31005-01. (2017-Present). Principal Investigator: William Stringer, M.D.

Redefining Early THerapy IN COPD (RETHINC). Pulmonary Trials Cooperative. (2017-2021). Principal Investigator: William Stringer, M.D.

Genetic Epidemiology of Chronic Obstructive Pulmonary Disease: the COPDGene® Study: Phase 3 Short Term Follow Up. United States National Heart, Lung and Blood Institute of the National Institutes of Health through a grant to the National Jewish Health Research Center in Denver and the COPD Foundation. (2017- Present). Principal Investigator: Richard Casaburi, M.D. A Phase 2a, Randomized, Double-blind, Placebo-controlled, Two Period, Crossover Study to Assess the Effect of CK-2127107 on Physical Function in Subjects with Chronic Obstructive Pulmonary Disease. Astellas 3318 CL-3002. (2017-2018). Principal Investigator: Harry Rossiter, Ph.D.

Development of a One-Day Rest/Stress Cardiac Positron Emission Tomography (PET) Perfusion Imaging Protocols of BMS747158. Lantheus Medical Imaging. (08/06/2009-03/20/2010). Principal Investigator: Daniel Berman, MD. 123I-Altropane Reference Image Acquisition in Subjects with Diagnostically Uncertain Tremor. Alseres Pharmaceuticals, Inc.

(07/02/2008-7/2009). Principal Investigator: Alan Waxman, MD. Evaluation of 99Tc-NC100697 Imaging in the Detection of Parkinson’s Disease. GE Healthcare Ltd. (12/05/2006- 05/31/2007). Principal Investigator: Alan Waxman, MD.

An Open-Label, Multicenter, Phase 3 Scinigraphy Study Assessing 123I-mIBG uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma. GE Healthcare Ltd. (07/07/2006– 05/30/2007). Principal Investigator: Alan Waxman, MD. Evaluation of the Efficiency and Safety of Altropane for Differentiating Parkinsonian Syndromes from Non-Parkinsonian Syndromes in Patients with Tremors. Boston Life Sciences, Inc. (3/10/2006-1/31/2007). Princip Investigator: Alan Waxman, MD. Study Coordinator

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the NuvairaTM Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-3). Nuvaira (2020-present). Principal Investigator: David Hsia, M.D.

A Clinical Evaluation of the The Ox Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD (RheSolve). Gala Therapeutics (2021-present). Principal Investigator: David Hsia, M.D. Effect of Using an In-line Filter on Cardiopulmonary Variables during Laboratory Exercise Testing. (2019-2020) Investigator Initiated. Principal Investigator: Janos Porszasz, M.D., Ph.D. Wearable Sensors to Monitor Exacerbation Risk In Chronic Obstructive Pulmonary Disease. (2021-present) Investigator Initiated. Principal Investigator: Harry B. Rossiter, Ph.D.

Determinants of 5 Year Progression of Muscle Dysfunction and Inactivity in COPDGene Participants. (2021- 2022) Investigator Initiated. Principal Investigator: Harry B. Rossiter, Ph.D. Respiratory Research Participant Database for the Rehabilitation Clinical Trials Center. (2017-present) Investigator Initiated. Principal Investigator: William Stringer, M.D.

A Randomized, Double-Blind (Sponsor Unblind), Placebo-Controlled, Multi-Centered Phase IIa Study to Evaluate the Safety and Efficacy of 13 Weeks of Once Daily Oral Dosing of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Older Men and Post-Menopausal Women with COPD and Muscle Weakness, Participating in Home Exercise. GlaxoSmithKline 200182. (2017-2021). Principle Investigator: Harry Rossiter, Ph.D. APRIL SORIANO 3

3

Observational study in healthy subjects and patients with COPD to assess the relationship between clinical, imaging and biomarker measurements, and progression of emphysema over three years. Boehringer Ingelheim 352.2069. (2017-Present). Principle Investigator: William Stringer, M.D.

Tiller NB, Cao M, Lin F, Yuan W, Wang C, Abbasi A, Calmelat R, Soriano AC, Rossiter HB, Casaburi R, Stringer W, Porszasz J. Dynamic airway function during exercise in COPD assessed via impulse oscillometry before and after inhaled bronchodilators. Journal of Applied Physiology. 2021 May.

Davis JA, Tyminski TA, Soriano AC, Dorado S, Costello KB, Sorrentino KM, Pham PH. Exercise test mode dependency for ventilatory efficiency in women but not men. Clinical Physiology and Functional Imaging. 2006 March; 26 (2): 72-8. Davis JA, Sorrentino KM, Soriano AC, Pham PH, Dorado S. Is ventilatory efficiency dependent on speed of the exercise test protocol in healthy men and women? Clinical Physiology and Functional Imaging. 2006 March; 26 (2) 67-71. Davis JA, Sorrentino KM, Soriano AC, Pham PH. Comparison of stroke volume estimation for non-steady-state and steady-state graded exercise testing. Clinical Physiology and Functional Imaging. 2005 January; 25 (1): 47-50. Stringer W, Porszasz J, Von Plato M, Khosrovi-Eghbal A, Zopey M, Cao M, Soriano AC, Calmelat R, Rossiter HB, Leyva A, Siddiqui S, Rennard S, Casaburi R. A randomized trial to determine the effect of glycopyprrolate/formoterol on exercise tolerance in COPD: influence of dynamic hyperinflation and dead space ventilation. ERS International Congress 2019 abstracts. 2019 September Cao M, Lin F, Stringer W, Khosrovi A, Calmelat R, Soriano AC, Wang CY, Rossiter HB, Siddiqui S, Rennard S, Casaburi R, Porszasz J. Bronchodilation increases exercise endurance in COPD patients with sustained concavity in the spontaneous expiratory flow volume loop. ERS International Congress 2019 abstracts. 2019 September Effect of Using an In-line Filter on Cardiopulmonary Variables during Laboratory Exercise Testing California Research Forum on Lung Health

Trudeau Society Virtual Program

2021

Can the Exercise Stroke Volume Be Validly Determined Using Standard Exercise Testing? 14th Annual Long Beach Research Symposium

Long Beach Memorial Medical Center

2004

Is There an Exercise Mode Dependency for the VO2 vs. VCO2 Slope? 13th Annual Long Beach Research Symposium

VA Long Beach Healthcare System

2003

PRESENTATIONS

CONFERENCE PAPERS

PUBLICATIONS



Contact this candidate