Profiles

Michele D. Vanover

Research Coordinator

TRAININGS & QUALIFICATIONS

  • Electronic Diaries: sponsor/vendor training (4-6 months)
  • Electronic consent: sponsor/vendor training (6 yrs)
  • Electronic source documents: sponsor/vendor training (6 yrs)
  • CSSR-S: sponsor/national training; certificate available (4-6 months)
  • PK Centrifuge: in-house training, sponsor/lab training (10 yrs)
  • Centrifuge: training by site, including cup size, RPMs, & calibrations (10 yrs)
  • EKG acquisition: site training per cardiologist; lead placement per sponsor recommendations; conducting for 10 years
  • EKG Transmission: sponsor/vendor training; both computer/phone line (10 yrs)
  • CPR: BLS certificate
  • Vitals: include temp, wt, ht, BP, HR; site training; manual/automatic BP; oral, temporal, auricle temp (10 yrs)
  • Pacemaker/ICD Interrogation (10 yrs)
  • GCP CITI: computer training; current certificate holder
  • EDC Experience: includes Medidata Rave, MedNet Solutions, PhaseForward, InForm System, Oracle (10 yrs)
  • IXRS: sponsor training; includes ClinPhone RTSM, Cenduit, and Almac (10 yrs)
  • IATA: current certificate holder
  • Questionnaires: MIDAS; sponsor/national training (4-6 months)
  • ABI/TBI: sponsor/national training (4 yrs)
  • Lab Sample Processing: sponsor, central lab specific, local lab & site training (10 yrs)

CLINICAL RESEARCH

  • VITALITY: A randomized, parallel-group, placebo-controlled, double blind, multi-center trial to evaluate the efficacy and safety of the oral SGC stimulator vericiguat to improve physical functioning in activities of daily living in patients with heart failure and preserves ejection fraction.  BAY1021189/19334
  • EVALUATE-HF: A multicenter, randomized, double-blind, double-dummy, parallel group, active-controlled, forced-titration, 12-week comparison of combined angiotensin-neprilysin inhibition with sacubitril and valsartan versus enalapril on changes in central aortic stiffness in patients with heart failure and reduced ejection fraction.  CLCZ696BUS08
  • TRAVERSE: Testosterone Replacement therapy for assessment of Long-Term Vascular events and efficacy response in Hypogonadal men.  ABBVIE M16-100
  • AMPLITUDE: A randomized, Double-Blind, Placebo-Controlled, parallel-group, multicenter study to evaluate the effect of Efpeglenatide on cardiovascular outcomes in Type 2 Diabetes patients at high Cardiovascular risk.  SANOFI RFC 14828
  • CREDO 2: A randomized, double-blind, parallel-group, placebo and active controlled, multicenter phase 3 study to the efficacy and safety of Olokizumab in subjects with moderately to severely active Rheumatoid Arthritis inadequately controlled by Methortrexate therapy.
  • CREDO 3: A randomized, double-blind, parallel-group, multicenter, Phase 3 stud y to the efficacy and safety of Olokizumab in subjects with moderately to severely active Rheumatoid Arthritis inadequately controlled by tumor necrosis factor alpha (TNA-a) inhibitor therapy.
  • CREDO 4: A Multicenter, open-label, Phase 3 study of the Safety and efficacy of Olokizumab in subjects with moderately to severely active Rheumatoid Arthritis.
  • PROVE: A 52 week, open label evaluation of the effects of sacubitril/valsartan (LCZ696) therapy on biomarkers, myocardial remodeling and patient – reported outcomes in heart failures with reduced left ventricular ejection fraction.
  • COL MIG-302:  A Study of Three Doses of Lasmiditan (50 mg, 100 mg, and 200 mg) Compared to Placebo in the Acute Treatment of Migraine:  A randomized, double-blind, placebo-controlled parallel group study (SPARTAN).
  • COL MIG-305:  An Open-label, Long-term, Saftey Study of Lasmiditan (100 mg and 200 mg) in the Acute Treatment of Migraine (GLADIATOR).
  • Protego:  Protego DF4 Post-Approval Registry.
  • Voyager PAD:  An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of Rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures.
  • Celestial: Post approval Registry (Corox, OTW, Endocardial, Left Ventricular Steroid Lead.  Bipolar Post Approve Registry)
  • Galaxy: Registry (Long-term evaluation of the Linox family ICD Leads Registry).
  • Rocket: A Prospective, Randomized, Double-Blind, Parallel-Group, Multi-Center, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban with Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects with Non-Valvular Atrial Fibrillation.
  • Real AF: Registry to Evaluate Anticoagulation in Atrial Fibrillation
  • Gilead 0133: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects with Chronic Stable Angina and Coronary Artery Disease with a History of Type 2 Diabetes Mellitus.
  • Drone_L04316: A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Multaq 400 mg BID for 12 weeks on Atrial Fibrillation Burden in Subjects with Permanent Pacemakers.
  • Drone_L04315: A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400 mg BID on Cardiac Geometry and Function in Patients with Atrial Fibrillation and Left Atrial Enlargement
  • Pallas: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400 mg BID in Patients with Permanent Atrial Fibrillation and Additional Risk Factors, Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy.
  • Endeavor: Evaluation of Pharmacokinetics and Safety of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System in De Nevo Native Coronary Artery Lesions
  • Respect: Reducing Episodes by Septal Pacing Efficacy Confirmation Trial
  • Impact: A Multi-Center, Single-Blinded, and Randomized Clinical Trial of Biotronik Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices.
  • BioG: Long Term Evaluation of the Linox Family ICD Leads Registry.
  • BioC: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
  • Provide: Programming Implantable Cardioverter Defibrillation in Patients with Primary Prevention Indication t Prolong Time to First Shock
  • Rate: Registry of AT/AF Episodes in the CRM Device Population
  • Orbit: Outcomes Registry for Better Informed Treatment Atrial Fibrillation.
  • Gloria AF: Global Registry on Long-term Oral Anti-Thrombotic Treatment in Patients with Atrial Fibrillation.
  • Pozen 301: A 6-Month, Phase 3, Randomized, Double-Blind, Parallel Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers.
  • Pozen 303: A 12-Month, Phase 3, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers.
  • Euclid: A Randomized, Double-Blind, Parallel Group, Multi-Center Phase IIIb Study to Compare Ticagrelor with Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischaemic Stroke in Patients with established Peripheral Artery Disease (EUCLID-Examining Use of tiCagreLor in paD.
  • Entracte: A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade with Tociizumab (TCZ) in Comparison with etanercept (ETA) on the rate of Cardiovascular Events in Patients with Moderate to Severe Rheumatoid Arthritis (RA).