Summary
Overview
Work History
Education
Skills
Current Position
Past Positions
Hospital Affiliations
Papers
Research
Timeline
Generic

Paige Brown

O'Fallon,MO

Summary

Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities with positive attitude. Willingness to take care of added responsibilities to meet team goals.

Overview

16
16
years of professional experience

Work History

Medic

Cetero Research
  • Accurately perform ECG’s on patients
  • Collect vital signs and record data
  • Explain and answer any questions regarding the study consent form.

Clinical Assistant

  • Assists in preparation for future studies including wrapping blood shippers and Vacutainer blood collection tubes
  • Make reminder calls for subjects enrolled in an upcoming study, reminding subjects of their dietary restrictions, and to inform subjects what clinic to report to
  • Assist in bagging and shipping of blood tubes
  • Adequately can read and understand study protocol.

Manager, Clinical Trial Operations

St. Louis Heart and Vascular P.C.
06.2017 - Current
  • Oversight and management of large department
  • Conflict Resolution and problem solving
  • Creation and implementation of workflows
  • Budget and contract negotiation
  • Leading meetings with outside clients, staff and physicians
  • Extensive knowledge of ICH GCP and FDA regulations
  • Experienced in audits and inspections
  • Conduct quality control at site level
  • Study payments and invoicing
  • Data Entry
  • Conducting Patient Visits
  • Consenting study patients
  • Performing Vital Signs, EKG, ABI/TBI
  • Obtaining blood samples
  • Obtaining medical history and medication history
  • Processing Labs
  • Patient Recruitment
  • Regulatory, study start-up, interim reports, end-of-study reports
  • IRB Correspondence
  • Creating and Updating Spreadsheets
  • Creating Source Documents
  • Catheterization Lab Experience
  • GCP and IATA Training
  • Drug and device trial experience.

Regulatory Specialist/Clinical Research Coordinator

St. Louis Heart and Vascular, P.C
01.2012 - 06.2017
  • Study start-up
  • Study close out
  • Local and central IRB communication
  • Investigational Product management
  • Conduct informed consent
  • Conduct Patient Visits
  • Data Entry
  • Lab collection and processing.

PLCO

Washington University
06.2012 - 10.2012
  • Lost funding 09/30/2012
  • HIPAA Certified
  • Data Entry
  • Phone Calls
  • Answering participants’ questions regarding study and consent forms
  • Assisting in pathology
  • Pulling and filing charts
  • Updating medical charts.

Study Enrollment Specialist

Cetero Research
01.2008 - 01.2012
  • Represented Cetero Research by providing excellent customer service for those inquiring information about the company or upcoming studies
  • Accurately verified participants’ medical history and updated volunteers’ electronic chart
  • Provided information about current studies that fit the participants’ schedules and study qualifications
  • Recruitment of potential subjects into available studies
  • Scheduled screening and physical appointments
  • Answered incoming calls and utilized call list to contact qualified subjects for upcoming studies
  • Notified any currently enrolled participants of any changes or cancellations that have been made to their study
  • Proficient in MS Word, Excel, Powerpoint, and Outlook
  • Familiar with office equipment such as printers, fax machine, phones, etc.

Patient Safety Assistant

DePaul Health Center
04.2011 - 09.2011
  • Training in basic first aid
  • Observed and reported high-risk patients' status according to the time of day, mood, and activities
  • Work with other staff to make patients more comfortable
  • Create a safe environment for patients eliminating the opportunity for self-injury or fall.

Education

High School Diploma -

Francis Howell High School
Saint Charles, MO
06.2010

Skills

  • Clinical trial management
  • Patient recruitment
  • Investigator relations
  • Clinical Data Management
  • Training and mentoring
  • Audit preparation
  • Document Management
  • Good Clinical Practices
  • Research SOPs understanding
  • Incident Management
  • Multi-tasking Efficiency

Current Position

Manager, Clinical Trial Operations, St. Louis Heart and Vascular P.C., St. Louis, Missouri, 2012, Present, Oversight and management of large department, Conflict Resolution and problem solving, Creation and implementation of workflows, Budget and contract negotiation, Leading meetings with outside clients, staff and physicians, Extensive knowledge of ICH GCP and FDA regulations, Experienced in audits and inspections, Conduct quality control at site level, Study payments and invoicing, Data Entry, Conducting Patient Visits, Consenting study patients, Performing Vital Signs, EKG, ABI/TBI, Obtaining blood samples, Obtaining medical history and medication history, Processing Labs, Patient Recruitment, Regulatory, study start-up, interim reports, end-of-study reports, IRB Correspondence, Creating and Updating Spreadsheets, Creating Source Documents, Catheterization Lab Experience, GCP and IATA Training, Drug and device trial experience

Past Positions

  • Regulatory Specialist/Clinical Research Coordinator, St. Louis Heart and Vascular, P.C, St. Louis, Missouri, 2012, 06/2017, Study start-up, Study close out, Local and central IRB communication, Investigational Product management, Conduct informed consent, Conduct Patient Visits, Data Entry, Lab collection and processing
  • Study Enrollment Specialist, Cetero Research, 2008, 2012, Represented Cetero Research by providing excellent customer service for those inquiring information about the company or upcoming studies, Accurately verified participants’ medical history and updated volunteers’ electronic chart, Provided information about current studies that fit the participants’ schedules and study qualifications, Recruitment of potential subjects into available studies, Scheduled screening and physical appointments, Answered incoming calls and utilized call list to contact qualified subjects for upcoming studies, Notified any currently enrolled participants of any changes or cancellations that have been made to their study, Proficient in MS Word, Excel, Powerpoint, and Outlook, Familiar with office equipment such as printers, fax machine, phones, etc.
  • Medic, Cetero Research, Accurately perform ECG’s on patients, Collect vital signs and record data, Explain and answer any questions regarding the study consent form
  • Clinical Assistant, Assists in preparation for future studies including wrapping blood shippers and Vacutainer blood collection tubes, Make reminder calls for subjects enrolled in an upcoming study, reminding subjects of their dietary restrictions, and to inform subjects what clinic to report to, Assist in bagging and shipping of blood tubes, Adequately can read and understand study protocol
  • PLCO, Washington University, 06/2012, 10/2012, Lost funding 09/30/2012, HIPAA Certified, Data Entry, Phone Calls, Answering participants’ questions regarding study and consent forms, Assisting in pathology, Pulling and filing charts, Updating medical charts
  • Patient Safety Assistant, DePaul Health Center, 04/2011, 09/2011, Training in basic first aid, Observed and reported high-risk patients' status according to the time of day, mood, and activities, Work with other staff to make patients more comfortable, Create a safe environment for patients eliminating the opportunity for self-injury or fall.

Hospital Affiliations

  • Christian Hospital Northeast, St. Louis, Missouri
  • Missouri Baptist Medical Center, St. Louis, Missouri
  • Barnes St. Peters, St. Peter’s, Missouri
  • Progress West Hospital, O’Fallon, Missouri
  • Gateway Regional Medical Center, Granite City, Illinois
  • Des Peres Hospital, St. Louis, Missouri

Papers

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease 2017 NEJM 27Aug2017

Research

  • Good Clinical Practice Training: 11/2023
  • The aim of the study is to assess the safety and efficacy of the Eximo's B-LaserTM hybrid catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).
  • Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy
  • Tack Optimized Balloon Angioplasy Study of the Tack Endovascula System in Below the Knee Arteries
  • Bard UltraScore Focused Force PTA balloon (without stent) for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries).
  • Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
  • Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
  • Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
  • A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
  • Outcomes With the Promus PREMIER Stent in Women and Minorities
  • Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
  • Patient and Provider Assessment of Lipid Management Registry
  • Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction
  • Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
  • Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
  • An Open-labelm, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Intervention
  • Cardiovascular Multi-dimensional Observational Investigation
  • Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
  • A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
  • Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
  • Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation
  • A multi-center prospective observational study of newly diagnosed Heart Failure patients to test the hypothesis that additional Ejection Fraction recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy is achieved.
  • A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
  • Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
  • Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation
  • Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source
  • Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
  • A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
  • A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
  • EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction
  • EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction
  • A randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the InterAtrial Shunt Device System II in symptomatic heart failure patients with an LV ejection fraction ≥40%, and elevated left-sided filling pressures despite standard GDMT
  • Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
  • Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
  • Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
  • Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure
  • Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
  • Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
  • Benefits of Microcor in Ambulatory Decompensated Heart Failure
  • Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
  • Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients
  • Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction
  • Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
  • A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
  • A Double Blind Placebo Controlled Study to Evaluate the Effects of Bexagliflozin on Hemoglobin A1c in Patients With Type 2 Diabetes and Increased Risk of Cardiovascular Adverse Events
  • Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
  • Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
  • Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
  • A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria
  • Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
  • Effect of Efpeglenatide on Cardiovascular Outcomes
  • A Long Term, Randomised, 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
  • A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
  • Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
  • INcrease Of VAgal TonE in CHF
  • A Randomized Study to Establish the Safety and Efficacy of CardioFit for the Treatment of Subjects With Heart Failure and Left Ventricular Dysfunction
  • Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
  • Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia
  • Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin
  • Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia
  • Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins
  • Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia
  • Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment
  • Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments
  • Open Label Study of Long Term Safety Evaluation of Alirocumab
  • Baroreflex Activation Therapy for Heart Failure
  • Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
  • A streamlined; multicentre, randomised, parallel group, double-blind placebo-controlled superiority trial to evaluate the effect of EMPAglifozin on hospitalisation for heart failure and mortality in patients with aCuTe Myocardial Infarction
  • A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 with Dapagliflozin Treatment in Patients with Heart Failure with Left Ventricular Ejection Fraction (LVEF) Below 55% and Chronic Kidny Disease
  • A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure
  • Effect of semaglutide 2.4mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction
  • Effect of semaglutide 2.4mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction and type 2 diabetes
  • Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
  • A Double-Blind, Placebo-Controlled, Randomized, Tolerability and Efficacy of IONIS-AGT-LRX, an Antisense inhibitor if Angiotensinogen Production, Administered Subcutaneously over 12 Weeks in Patients with Chronic Heart Failure with Reduced Ejection Fraction
  • A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Heart Failure with Preserved Ejection Fraction and Obesity
  • Cardiovascular and Renal Treatment in Heart Failure Patients with Hyperkalaemia or at High Risk of Hyperkalaemia
  • A randomized controlled, multicenter, open-label trial comparing a hospital post-discharge care pathway involving aggressive LDL-C management that includes inclisiran with usual care versus usual care alone in patients with a recent acute coronary syndrome
  • A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat (VERQUVO) in Adults With Chronic Heart Failure With Reduced Ejection Fraction
  • Assessment of Implantable CCM in the Heart FaIlure Group with Higher Ejection FRaction
  • A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies
  • A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes
  • A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease
  • A Study of the Prevalence of Apolipoprotein L1 (APOL1) Alleles Among Individuals With Proteinuric Kidney Disease Who Are of Recent African Ancestry or Geographic Origin
  • A Phase 2/3 Adaptive, Double-blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 12 Years and Older With APOL1-mediated Proteinuric Kidney Disease
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease
  • A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke
  • A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD4831 with Dapagliflozin Treatment in Patients with Heart Failure with Left Ventricular Ejection Fraction > 40%
  • DORAYA-HF Early Feasibility Study
  • The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease
  • Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.
  • A Double-Blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a)
  • A randomized double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease

Timeline

Manager, Clinical Trial Operations

St. Louis Heart and Vascular P.C.
06.2017 - Current

PLCO

Washington University
06.2012 - 10.2012

Regulatory Specialist/Clinical Research Coordinator

St. Louis Heart and Vascular, P.C
01.2012 - 06.2017

Patient Safety Assistant

DePaul Health Center
04.2011 - 09.2011

Study Enrollment Specialist

Cetero Research
01.2008 - 01.2012

Medic

Cetero Research

Clinical Assistant

High School Diploma -

Francis Howell High School
Paige Brown