CARE E R SUMM ARY
Enthusiast research professional with over 25 years of clinical trials experience that includes pharmaceutical, NIH
funded studies, as well as Investigator initiated studies; who has worked as a Clinical Research Coordinator (CRC),
Monitor, Associate Clinical Trials Manager and Project Manager; with experience conducting and managing multi-
million, global multicenter trials in North America, Latin America, Western and Eastern Europe.
EXPE RIE NCE
November 2014 - Present The Icahn school of Medicine at Mount Sinai Hospital New York, NY
Clinical Trials Manager
Responsible for supporting the cardiology department’s Cath Lab Research
Supervise the overall performance of staff in the different areas:
- Regulatory…. Maintenance of regulatory binder, IRB submissions
- CRF completion…. Including source documentation verification and Electronic data capturing.
Conduct Quality Assurance through internal audits to ensure protocol adherence.
Responsible for the finances… Account reconciliation, contract negotiations and payments
Analyze, report, give recommendations and develop strategies on how to improve the quality of the trial-
identifying problems, creating choices and providing alternative course of action
Main contact person for the Clinical Research Organizations / Sponsors.
Hiring of employees…. selection and training
October 2005 - September 2014 Columbia University Medical Center New York, NY
Project Manager 2010-2014
Associate Clinical Trials Manager 2005 –2010
Responsible for supporting the Clinical Coordinating Center (CCC) of a large scale international clinical trial-
WARCEF Study– in the management of US and international based sites
Supervise the overall performance of staff in the different areas:
- Country Coordination (US, Canada, Argentina, India and Europe)
- Regulatory…. IRB submissions, FWA, collection of site documentation
- Quality Assurance….. Protocol adherence, QA measures, conference calls
- Finance… contract negotiations and payments
- Development and revision of study manual, protocol and training materials
- Monitoring
Analyze, report, give recommendations and develop strategies on how to improve the quality of the trial-
identifying problems, creating choices and providing alternative course of action
Main contact person for the Clinical Research Organizations involved in the trial- Clinsys, STAT, Verum, Charite,
QED, Avemedica (FGK) / FARMA
Organize and plan Annual Investigators Meetings
Newsletter and Journal Editor
Involved in employee selection and training
VILMA MEJIA
152 Edgar Street, Carteret, NJ 07008
Tel: 732-969-0922 (H), 646-369-8269(C)
Email: vmejia2181@gmail.com
February 2005 - July 2005 ZLB Behring Pharmaceuticals Newark, NJ
Clinical Research Associate (Monitor)
Contract: Five to eight months at St. Michaels Medical Center in Newark, NJ.
Monitored a Phase IV clinical trials on Von Willebrand’s Disease.
Reviewed all regulatory documents: IRB submissions, Serious Adverse Events reporting, completion of case
report form and source document verification.
Ensured compliance to protocol, GCPs, and ICH guidelines.
Communicated with hospital staff to discuss study progress and issues and obtain resolution to problems.
Reported site’s progress to ZLB Behring.
November 2001 - August 2004 NY Headache Center New York, NY
Clinical Research Coordinator
Conducted Phase II and III clinical trials for pharmaceutical companies.
Responsible for all aspects of patient care including: recruitment, consenting, data collection, accountability and
dispensing of investigational medication, ECG, vital signs, and venipuncture.
Prepared research materials and regulatory documents: IRB submissions, Serious Adverse Events reporting.
Interacted with Clinical Research Associates and attended national investigator meetings.
Administrative responsibilities included: Interviewing future employees and grant proposals.
April 1996 – November 2001
Homemaker
June 1989 - April 1996 Eastside Comprehensive Medical Services New York, NY
Senior Clinical Research Coordinator
Conducted Phase II, III, IV and Post-marketing clinical trials for pharmaceutical companies in the following
areas: Depression, Anxiety, Panic, Alzheimer, Chronic Fatigue, Chronic Pain, Migraine, IBS, Ulcer, Pneumonia,
Bronchitis, Cardiovascular and Allergic Conjunctivitis.
Responsible for all aspects of patient care including: recruitment, consenting, data collection, accountability and
dispensing of investigational medication, ECG, vital signs, and venipuncture.
Prepared research materials and regulatory documents: IRB submissions, Serious Adverse Events reporting.
Interacted with Clinical Research Associates and attended national investigator’s meetings.
Administrative responsibilities included: Interviewing, training and supervising other research coordinators, grant
proposals, billing and bookkeeping.
1987 - 1988 Kettering Medical Center Kettering, OH
Student Medical Technologist
Worked in hematology, urinalysis and immunology departments. Performed routine laboratory work.
Involved in phlebotomy and blood bank. Responsibilities included daily morning rounds for blood draw, blood
typing and blood compatibility testing.
EDUCAT IO N
1984 - 1989 Bachelors of Science in Biology, Minor in Chemistry
Southern Adventist University, Collegedale, TN
1987 - 1988 Student of Medical Technology
School of Medical Technology, Kettering, Ohio
Related Courses: Microbiology I & II, Hematology I & II, Phlebotomy, Immunology and Blood Bank.
Vilma Mejia - Page 2
CE RT IF ICAT IO N
SAF-T-PAK - Shipping of Infectious Substances Training- 2003
EDC - Continuing certification in Electronic Data Capturing - since 2002
GCP - Continuing certifications in GCP, ICH guidelines and Human Subjects Protection- since 2007
HIPPA– Continuing certifications since 2007
SE M INARS ATT E NDE D
International Stroke Conference: New Orleans, Louisiana. February 2012
IRB Seminars: Columbia University- Since 2007—2014
IRB Seminars: Mount Sinai– Since 2014
PUBL ICAT IO NS
Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF): Shunichi Homma, John Thompson, Pat-
rick Pullicino, Bruce Levin, Ron Freudenberger, John Teerlink, Susan Ammon, Susan Graham, Ralph Sacco, Douglas
Mann, J. P. Morh, Barry Massie Arthur Labovitz, Stefan Anker, Dirk Lok, Piotr Ponikowski, Conrado Estol, Gregory
Lip, Marco DiTullio, Vilma Mejia, Andre Gabriel, Mirna del Valle, Richard Buchsbaum, Alexandra Sanford and
Claudia Moy. May 2012. New England Journal of Medicine. PMID 22551105
EXT RACURRICUL AR ACT IVIT IE S
2001 - Present Youth Director for the Seventh Day Adventist Church.
2005 - 2009 Pathfinders Club Sub-director
1999 - 2005 Adventurers Club Sub-director.
1992 - 1993 Pathfinders Club Director
SKIL L S
Bilingual– English/Spanish
Computer Literate - Word, Excel, PowerPoint, Publishers.
Vilma Mejia - Page 3
Vilma Mejia- Page 4
Clinical Research Trials
Migraine Studies:
1. A multi-center, Double-blind, Randomized, Placebo-controlled Study of Eletriptan (20 and 40 mg)
versus Placebo in Early Treatment of Migraine.
2. A 20-week, Open-label Study to Evaluate the Efficacy of Levetiracetam in Migraine Prophylaxis.
3. Program to Assess Treatment Strategies: A Botox Observational Program.
4. A 20-week, Multi-center, Randomized, Double-blind Comparison of the Efficacy and Safety of
Aricept versus Inderal LA in Migraine Prophylaxis.
5. A Phase III, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multi-center Evaluation
of Civamide (Zucapsaicin) Nasal Solution in the treatment of Episodic Cluster Headache.
6. Escitalopram Effects on Quality of Life.
7. A Multi-center, Safety and Efficacy Study of Vagus Nerve Stimulation (VNS) using the NeuroCyber-
netic Prothesis (NCP) System in Patients with Migraine and Chronic Daily Headache.
8. A Multi-center, Randomized, Open-label Comparison of the Effects of Zomig-ZMT (Zolmitriptan) and
Usual Migraine Care on Work Loss, Productivity, and Patient Preference.
9. Double-blind, Randomized, Placebo-controlled, Crossover Trial of Intravenous Magnesium Sulfate
for the Prevention of Menstrual Migraine.
10. A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the
Safety and Efficacy of Botox Purified Neurotoxin Complex for the Prophylactic Treatment of Mi-
graine Headaches in the Chronic Migraine Population.
11. A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the
Safety and Efficacy of Botox Purified Neurotoxin Complex for the Prophylactic Treatment of Mi-
graine Headaches in the Episodic Migraine Population.
12. A single-dose, Double-blind, Placebo-controlled, Randomized, Parallel-design Oral Dose (1.2mg,
0.8mg, 0,4mg and 0.2mg) Response Study of PG-118415 in the Treatment of Acute Migraine
Headache With or Without Aura.
13. Advil Migraine vs. Imitrex Migraine Headache Study.
14. A Multi-center, Randomized, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Ear-
ly Efficacy and Tolerability of Zolmitriptan (Zomig) Nasal Spray in the Acute Treatment of Adult
Subjects with Migraine.
Depression Studies:
15. A 3 year Open-label Safety Evaluation of Adinazolam in Depressed Outpatients who
Responded to Adinazolam.
16. Double-blind Flexible Dose Comparison of the Efficacy and Safety of Deracyn SR Tablets,
Deracyn CT Tablets, and Placebo in Depressed Outpatients.
17. A Multi-center, Placebo-Controlled, Double-blind Study of ICI 170, 809 in Non-
hospitalized Patients with Depression.
18. Fluvoxamine in the Treatment of Depression. A Single-center, Double-blind, Placebo-
controlled Comparison with Imipramine in Outpatients.
19. Multi-center-Randomized, Double-blind, Placebo-controlled Comparison of Paroxatine
and Fluoxetine in the Treatment of Major Depression.
20. A Double-blind, Randomized Study to Provide Safety Information on Switching Fluoxetine-
treated Patients to Paroxetine Without an Intervening Washout Period.
21. A Multi-center Dose Response Evaluation of the Safety and Efficacy of Bupropion HCL SR vs.
Placebo in Depressed Outpatients.
22. Double-blind, PPO-controlled, Parallel Group Dosage Comparison Study of Fixed B/D Dosing of
Venlafaxine in Outpatients with Major Depression.
23. A Multi-center, Placebo-controlled, Fixed-dose Range Study of Org.4428 in outpatients with
Major Depression.
Vilma Mejia- Page 5
24. Evaluation of Bupropion (Wellbutrin) in Depressed Elderly Outpatients Who Failed to Tolerate or
Respond to Fluoxetine.
25. A double-blind, Parallel-comparison of Sertraline and Fluoxetine in Outpatients with Major Depres-
sion.
26. A Double-blind, Fixed-dose, Multi-center Study of Citalopram vs. Placebo in Outpatients with Mod-
erate to Severe Depression.
27. A Double-blind, Randomized Trial of Paroxetine vs. Placebo in Patients with Depression Accompa-
nied by Anxiety.
28. Ritanserin vs. Placebo in the Treatment of Dysthymia (Depressive Neurosis).
29. A phase III, Double-blind, Multi-center Comparison of Sertraline and Amitriptaline in the Treatment of
Geriatric Patients with Major Depression or Bipolar Disorder.
30. Double-blind Parallel Comparison of Sertraline, Desipramine and Placebo in Depressed Geriatric
Outpatients.
31. A 70 day, Double-blind Efficacy and Safety Study Comparing Adinazolam and Desipramine in 45
Depressed Geriatric Outpatients.
32. An Open-label Evaluation of the Long-term Safety of Oral Venlafaxine tablets in Depressed Geriat-
ric Outpatients.
33. Fluvoxetine v. Placebo in Geriatric Patients with Major Depression.
34. Evaluation of Bupropion in Depressed Elderly Outpatients Who Failed to Tolerate or Respond to
Fluoxetine.
Anxiety Studies:
35. Double-blind, Placebo-controlled Comparative Study of Alpidem and Lorazepam in Pa
tients with Non-psychotic Anxiety.
36. Open Long-term Extension Study of Alpidem in Patients with Non-psychotic Anxiety.
37. Double-blind, Placebo-controlled, Parallel-group Dose Determination Study of Enciprazine
Tablets in Outpatients with Generalized Anxiety Disorder.
38. A Pilot Study of SQ29,852 in Patients with Generalized Anxiety Disorder.
39. Evaluation of the Effects of SQ29,852 in Patients with Generalized Anxiety Disorder.
40. A Second Multi-center, Double-blind Dose Response Study of Zacopride and Placebo in Anxious
Outpatients.
41. A Double-blind, Multi-center Trial of 2 doses of Extended Release Buspirone ER Compared to
Buspirone IR in the Treatment of Anxious Outpatients.
42. Prospective Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Groups Compari
son of the Efficacy and Safety of Abecarnil and Alprozolam in Outpatients with Generalized
Anxiety Disorder.
43. Prospective, Multi-center, Open-label Study of the Safety of Abercarnil in Outpatients with
Generalized Anxiety Disorder.
44. LY237733 in Outpatients with Generalized Anxiety Disorder.
45. A Double-blind, Placebo-controlled, Multi-center Trial Comparing 30mg of Buspar Given 2 BID vs.
TID in Patients with Generalized Anxiety Disorder.
46. A Flexible Dose, Placebo-controlled Study of Deracyn SR Tablets in the Treatment of Generalized
Anxiety Disorder.
47. Flexible Dose, Double-blind Study Comparing Efficacy and Safety of Deracyn SR Tablets and
Xanax CT in the Treatment of Geriatric Outpatients with Clinical Anxiety.
Panic Studies:
48. Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Com
parison of the Efficacy and Safety of Abercanil and Lorazepam in Elderly Outpatients with
Anxiety Symptoms.
49. Short and Long-term Discontinuation of Alprazolam in Patients with Panic Disorder with
Agoraphobia.
Vilma Mejia- Page 6
50. A Double-blind Safety Tolerability and Pilot Efficacy Study Comparing L-365,260 to Placebo in
Outpatients with Panic Disorder.
Alzheimer Studies:
51. Clinical Evaluation of Sabaluzole in the Treatment of Patients with Dementia of the Alzheimer Type.
52. Clinical Evaluation of Phisostigmine in the Treatment of Alzheimer Dementia.
Pain Studies:
53. Long-term Safety of Transnasal Butorphanol in Patients with Chronic Pain of Non-malignant Origin.
Gastro-Intestinal Studies:
54. A Symptomatic Treatment of Irritable Bowel Syndrome: A Double-blind Comparison of Clidinium
Bromide with Placebo in 12 Patients.
55. Multi-center, Randomized, Double-blind, Placebo-controlled Evaluation of Healing and Relapse
Rates Following Oral GR122311x Compared with GR8850x, Ranitidine and Placebo in Patients
with Duodenal Ulcer.
56. Multi-center, Randomized, Double-blind Study Comparing Ranitidine and Placebo in Patients with
Gastric Ulcer.
Respiratory Studies:
57. LY163829 vs. Cefaclor in Bronchitis.
58. LY163829 vs. Augmentin in Pneumonia.
59. Loracarbef vs. Ceftin in Acute Exacerbation of Chronic Bronchitis.
60. Double-blind, Randomized, Comparative, Multi-center Study of RP-64206 (Sparfloxacin) vs.
Cefaclor in the Treatment of Community Acquired Pneumonia.
Allergy Studies:
61. Efficacy and Safety of Ocymetazoline HCL 0.025% vs. Placebo in Subjects with Allergic
Conjunctivitis.
Blood Disorder Studies:
62. Study of Safety and Efficacy of Antihemophilic Factor/ Von Willebrand Factor Complex (Humate-
P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects with Von Willebrand’s
Disease.
Cardiac Studies:
63. Reducing Recurrence of Symptomatic Atrial Fibrillation/Flutter and PST.
64. WARCEF: Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction.
Cath Lab Research:
65. A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared with Standard Care
in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory
66. Chemometric Observations of Lipid Core Containing Plaques of Interest in Native Coronary
Arteries Registry- COLOR
67. Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid
Lowering- YELLOW II
68. A Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety and Effectiveness
of the Tryton Side Branch Stent™ used in Conjunction with a Drug-Eluting Stent Compared to Side
Branch Balloon Angioplasty in Conjunction with a Drug-Eluting Stent in the Treatment of de novo Bi
furcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation
-TRYTON
Vilma Mejia- Page 7
68. AVERT Trial– Assesses the AVERT System device for CM volume reduction and incidence of CIN
69. ABSORB III- A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular
Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
70. HARMONEE- Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich’s
Combo Stent (Japan-USA HARMONEE): Assessment of a Novel DES Platform For Percutaneous Coronary
Revascularization in Patients with Ischemic Coronary Disease and NSTEMI Acute Coronary Syndrome
71. PIONEER-An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment
Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment
Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
72. COBRA- COBRA PZF™ coronary stent system in native coronary arteries for early healing, thrombus
inhibition, endothelialization and avoiding long-tern dual an-platelet therapy.
73. PARACHUTE- Percutaneous Ventricular RestorAtion in Chronic Heart Failure due to Ischemic Heart
Disease
74. ISCHEMIA- International Study of Comparative Health Effectiveness with Medical and Invasive
Approaches
75. BIOHELIX- The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium,
Bare-Metal Stent
76. COAST- Coronary Orbital Atherectomy System Study
77. EVOLVE II- A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety
and Effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System
(SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion (s)
78. EXPERT CTO- Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic
Total Occlusions
79. ABSORB IV- A clinical Evaluation of the ABSORB BVS, the Everolimus Eluting Bioresorbable Vascular
Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
80. The Asahi Intecc PTCA Chronic Total Occlusion Study
81. MACE- Multi-center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified
Coronary Lesions (MACE)
82. RESOLUTE INTEGRITY -A Post approval Study of the Medtronic Resolute™ Integrity Zotarolimus-
Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a
Reference Vessel Diameter of 2.25 mm to 4.2 mm
83. TWILIGHT- Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
84. AVIATOR 2- Antithrombotic Strategy Variability In Atrial Fibrillation and Obstructive Coronary Disease
Revascularized with PCI
85. BIOFLOW-V- A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the
Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo
or Restenotic Coronary Artery Lesions – V
86. ENDOMAX - ENDOvascular Interventions with AngioMAX
87. ILLUMENATE - Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of
Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel PacliTaxel-Coated Percutane-
ous Angioplasty Balloon
88. PIVOTAL- Medtronic CoreValve® U.S. Pivotal Trial (High Risk Surgical Patients)
89. SURTAVI- Surgical Replacement and Transcatheter Aortic Valve Implantation
90. SENTINEL- Cerebral Protection in Transcatheter Aortic Valve Replacement
91. SPYRAL OFF-Global Clinical Study of Renal Denervation with the Simplicity Spyral™i multi-electrode
renal denervation system in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive
Medications
84. SPYRAL ON- Global Clinical Study of Renal Denervation with the Simplicity Spyral™i multi-electrode
renal denervation system in Patients with Uncontrolled Hypertension on Standard Medical Therapy.
85. EXCEL- Evaluation of XIENCE PRIME™ or XIENCE V® versus Coronary Artery Bypass Surgery for Effec-
tiveness of Left Main Revascularization
Vilma Mejia- Page 8
86. SYMPLICITY HTN-3- Renal Denervation in Patients with Uncontrolled Hypertension
87. SHIELD II- Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular
Support Device
86. A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System RESOLUTE ONYX
Core (2.25 mm – 4.0 mm)
86. A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
RESOLUTE ONYX 2.0 mm
90. PLATINUM Diversity: Outcomes with the Promus PREMIER™ Stent in Women and Minorities
91. ORBID- Three–dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch V
vessel After Provisional Main Vessel Stenting In Coronary Artery Disease
92. GALILEO- Global multicenter, open-label, randomized, event-driven, active-controlled study comparing
a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter
aortic valve replacement (TAVR) to Optimize clinical outcomes
93. EXPANDED USE- Medtronic CoreValve® U.S. Expanded Use Study
94. CAS-Medtronic CoreValve® Continued Access Study (High Risk and Extreme Risk Patients)
95. EVOLUT R- The Medtronic CoreValve™ Evolut™ R US Clinical Study
96. A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy™ Drug
Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
97. PROTECTED PCI STUDY: A prospective clinical trial for patients undergoing protected percutaneous
coronary intervention with IMPELLA® 2.5 SYSTEM
98. TRIAGE Patients Undergoing Percutaneous Coronary Interventions To Improve Clinical Outcomes Through
Optimal Platelet Inhibition
99. FREEDOM- Long-term outcomes in patients who underwent revascularization
100. COBRA REDUCED– Randomized trial of Cobra PZF stenting to reduce duration of triple therapy.

Vilma-'s resume-1(4) copy

  • 1.
    CARE E RSUMM ARY Enthusiast research professional with over 25 years of clinical trials experience that includes pharmaceutical, NIH funded studies, as well as Investigator initiated studies; who has worked as a Clinical Research Coordinator (CRC), Monitor, Associate Clinical Trials Manager and Project Manager; with experience conducting and managing multi- million, global multicenter trials in North America, Latin America, Western and Eastern Europe. EXPE RIE NCE November 2014 - Present The Icahn school of Medicine at Mount Sinai Hospital New York, NY Clinical Trials Manager Responsible for supporting the cardiology department’s Cath Lab Research Supervise the overall performance of staff in the different areas: - Regulatory…. Maintenance of regulatory binder, IRB submissions - CRF completion…. Including source documentation verification and Electronic data capturing. Conduct Quality Assurance through internal audits to ensure protocol adherence. Responsible for the finances… Account reconciliation, contract negotiations and payments Analyze, report, give recommendations and develop strategies on how to improve the quality of the trial- identifying problems, creating choices and providing alternative course of action Main contact person for the Clinical Research Organizations / Sponsors. Hiring of employees…. selection and training October 2005 - September 2014 Columbia University Medical Center New York, NY Project Manager 2010-2014 Associate Clinical Trials Manager 2005 –2010 Responsible for supporting the Clinical Coordinating Center (CCC) of a large scale international clinical trial- WARCEF Study– in the management of US and international based sites Supervise the overall performance of staff in the different areas: - Country Coordination (US, Canada, Argentina, India and Europe) - Regulatory…. IRB submissions, FWA, collection of site documentation - Quality Assurance….. Protocol adherence, QA measures, conference calls - Finance… contract negotiations and payments - Development and revision of study manual, protocol and training materials - Monitoring Analyze, report, give recommendations and develop strategies on how to improve the quality of the trial- identifying problems, creating choices and providing alternative course of action Main contact person for the Clinical Research Organizations involved in the trial- Clinsys, STAT, Verum, Charite, QED, Avemedica (FGK) / FARMA Organize and plan Annual Investigators Meetings Newsletter and Journal Editor Involved in employee selection and training VILMA MEJIA 152 Edgar Street, Carteret, NJ 07008 Tel: 732-969-0922 (H), 646-369-8269(C) Email: vmejia2181@gmail.com
  • 2.
    February 2005 -July 2005 ZLB Behring Pharmaceuticals Newark, NJ Clinical Research Associate (Monitor) Contract: Five to eight months at St. Michaels Medical Center in Newark, NJ. Monitored a Phase IV clinical trials on Von Willebrand’s Disease. Reviewed all regulatory documents: IRB submissions, Serious Adverse Events reporting, completion of case report form and source document verification. Ensured compliance to protocol, GCPs, and ICH guidelines. Communicated with hospital staff to discuss study progress and issues and obtain resolution to problems. Reported site’s progress to ZLB Behring. November 2001 - August 2004 NY Headache Center New York, NY Clinical Research Coordinator Conducted Phase II and III clinical trials for pharmaceutical companies. Responsible for all aspects of patient care including: recruitment, consenting, data collection, accountability and dispensing of investigational medication, ECG, vital signs, and venipuncture. Prepared research materials and regulatory documents: IRB submissions, Serious Adverse Events reporting. Interacted with Clinical Research Associates and attended national investigator meetings. Administrative responsibilities included: Interviewing future employees and grant proposals. April 1996 – November 2001 Homemaker June 1989 - April 1996 Eastside Comprehensive Medical Services New York, NY Senior Clinical Research Coordinator Conducted Phase II, III, IV and Post-marketing clinical trials for pharmaceutical companies in the following areas: Depression, Anxiety, Panic, Alzheimer, Chronic Fatigue, Chronic Pain, Migraine, IBS, Ulcer, Pneumonia, Bronchitis, Cardiovascular and Allergic Conjunctivitis. Responsible for all aspects of patient care including: recruitment, consenting, data collection, accountability and dispensing of investigational medication, ECG, vital signs, and venipuncture. Prepared research materials and regulatory documents: IRB submissions, Serious Adverse Events reporting. Interacted with Clinical Research Associates and attended national investigator’s meetings. Administrative responsibilities included: Interviewing, training and supervising other research coordinators, grant proposals, billing and bookkeeping. 1987 - 1988 Kettering Medical Center Kettering, OH Student Medical Technologist Worked in hematology, urinalysis and immunology departments. Performed routine laboratory work. Involved in phlebotomy and blood bank. Responsibilities included daily morning rounds for blood draw, blood typing and blood compatibility testing. EDUCAT IO N 1984 - 1989 Bachelors of Science in Biology, Minor in Chemistry Southern Adventist University, Collegedale, TN 1987 - 1988 Student of Medical Technology School of Medical Technology, Kettering, Ohio Related Courses: Microbiology I & II, Hematology I & II, Phlebotomy, Immunology and Blood Bank. Vilma Mejia - Page 2
  • 3.
    CE RT IFICAT IO N SAF-T-PAK - Shipping of Infectious Substances Training- 2003 EDC - Continuing certification in Electronic Data Capturing - since 2002 GCP - Continuing certifications in GCP, ICH guidelines and Human Subjects Protection- since 2007 HIPPA– Continuing certifications since 2007 SE M INARS ATT E NDE D International Stroke Conference: New Orleans, Louisiana. February 2012 IRB Seminars: Columbia University- Since 2007—2014 IRB Seminars: Mount Sinai– Since 2014 PUBL ICAT IO NS Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF): Shunichi Homma, John Thompson, Pat- rick Pullicino, Bruce Levin, Ron Freudenberger, John Teerlink, Susan Ammon, Susan Graham, Ralph Sacco, Douglas Mann, J. P. Morh, Barry Massie Arthur Labovitz, Stefan Anker, Dirk Lok, Piotr Ponikowski, Conrado Estol, Gregory Lip, Marco DiTullio, Vilma Mejia, Andre Gabriel, Mirna del Valle, Richard Buchsbaum, Alexandra Sanford and Claudia Moy. May 2012. New England Journal of Medicine. PMID 22551105 EXT RACURRICUL AR ACT IVIT IE S 2001 - Present Youth Director for the Seventh Day Adventist Church. 2005 - 2009 Pathfinders Club Sub-director 1999 - 2005 Adventurers Club Sub-director. 1992 - 1993 Pathfinders Club Director SKIL L S Bilingual– English/Spanish Computer Literate - Word, Excel, PowerPoint, Publishers. Vilma Mejia - Page 3
  • 4.
    Vilma Mejia- Page4 Clinical Research Trials Migraine Studies: 1. A multi-center, Double-blind, Randomized, Placebo-controlled Study of Eletriptan (20 and 40 mg) versus Placebo in Early Treatment of Migraine. 2. A 20-week, Open-label Study to Evaluate the Efficacy of Levetiracetam in Migraine Prophylaxis. 3. Program to Assess Treatment Strategies: A Botox Observational Program. 4. A 20-week, Multi-center, Randomized, Double-blind Comparison of the Efficacy and Safety of Aricept versus Inderal LA in Migraine Prophylaxis. 5. A Phase III, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multi-center Evaluation of Civamide (Zucapsaicin) Nasal Solution in the treatment of Episodic Cluster Headache. 6. Escitalopram Effects on Quality of Life. 7. A Multi-center, Safety and Efficacy Study of Vagus Nerve Stimulation (VNS) using the NeuroCyber- netic Prothesis (NCP) System in Patients with Migraine and Chronic Daily Headache. 8. A Multi-center, Randomized, Open-label Comparison of the Effects of Zomig-ZMT (Zolmitriptan) and Usual Migraine Care on Work Loss, Productivity, and Patient Preference. 9. Double-blind, Randomized, Placebo-controlled, Crossover Trial of Intravenous Magnesium Sulfate for the Prevention of Menstrual Migraine. 10. A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Botox Purified Neurotoxin Complex for the Prophylactic Treatment of Mi- graine Headaches in the Chronic Migraine Population. 11. A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Botox Purified Neurotoxin Complex for the Prophylactic Treatment of Mi- graine Headaches in the Episodic Migraine Population. 12. A single-dose, Double-blind, Placebo-controlled, Randomized, Parallel-design Oral Dose (1.2mg, 0.8mg, 0,4mg and 0.2mg) Response Study of PG-118415 in the Treatment of Acute Migraine Headache With or Without Aura. 13. Advil Migraine vs. Imitrex Migraine Headache Study. 14. A Multi-center, Randomized, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Ear- ly Efficacy and Tolerability of Zolmitriptan (Zomig) Nasal Spray in the Acute Treatment of Adult Subjects with Migraine. Depression Studies: 15. A 3 year Open-label Safety Evaluation of Adinazolam in Depressed Outpatients who Responded to Adinazolam. 16. Double-blind Flexible Dose Comparison of the Efficacy and Safety of Deracyn SR Tablets, Deracyn CT Tablets, and Placebo in Depressed Outpatients. 17. A Multi-center, Placebo-Controlled, Double-blind Study of ICI 170, 809 in Non- hospitalized Patients with Depression. 18. Fluvoxamine in the Treatment of Depression. A Single-center, Double-blind, Placebo- controlled Comparison with Imipramine in Outpatients. 19. Multi-center-Randomized, Double-blind, Placebo-controlled Comparison of Paroxatine and Fluoxetine in the Treatment of Major Depression. 20. A Double-blind, Randomized Study to Provide Safety Information on Switching Fluoxetine- treated Patients to Paroxetine Without an Intervening Washout Period. 21. A Multi-center Dose Response Evaluation of the Safety and Efficacy of Bupropion HCL SR vs. Placebo in Depressed Outpatients. 22. Double-blind, PPO-controlled, Parallel Group Dosage Comparison Study of Fixed B/D Dosing of Venlafaxine in Outpatients with Major Depression. 23. A Multi-center, Placebo-controlled, Fixed-dose Range Study of Org.4428 in outpatients with Major Depression.
  • 5.
    Vilma Mejia- Page5 24. Evaluation of Bupropion (Wellbutrin) in Depressed Elderly Outpatients Who Failed to Tolerate or Respond to Fluoxetine. 25. A double-blind, Parallel-comparison of Sertraline and Fluoxetine in Outpatients with Major Depres- sion. 26. A Double-blind, Fixed-dose, Multi-center Study of Citalopram vs. Placebo in Outpatients with Mod- erate to Severe Depression. 27. A Double-blind, Randomized Trial of Paroxetine vs. Placebo in Patients with Depression Accompa- nied by Anxiety. 28. Ritanserin vs. Placebo in the Treatment of Dysthymia (Depressive Neurosis). 29. A phase III, Double-blind, Multi-center Comparison of Sertraline and Amitriptaline in the Treatment of Geriatric Patients with Major Depression or Bipolar Disorder. 30. Double-blind Parallel Comparison of Sertraline, Desipramine and Placebo in Depressed Geriatric Outpatients. 31. A 70 day, Double-blind Efficacy and Safety Study Comparing Adinazolam and Desipramine in 45 Depressed Geriatric Outpatients. 32. An Open-label Evaluation of the Long-term Safety of Oral Venlafaxine tablets in Depressed Geriat- ric Outpatients. 33. Fluvoxetine v. Placebo in Geriatric Patients with Major Depression. 34. Evaluation of Bupropion in Depressed Elderly Outpatients Who Failed to Tolerate or Respond to Fluoxetine. Anxiety Studies: 35. Double-blind, Placebo-controlled Comparative Study of Alpidem and Lorazepam in Pa tients with Non-psychotic Anxiety. 36. Open Long-term Extension Study of Alpidem in Patients with Non-psychotic Anxiety. 37. Double-blind, Placebo-controlled, Parallel-group Dose Determination Study of Enciprazine Tablets in Outpatients with Generalized Anxiety Disorder. 38. A Pilot Study of SQ29,852 in Patients with Generalized Anxiety Disorder. 39. Evaluation of the Effects of SQ29,852 in Patients with Generalized Anxiety Disorder. 40. A Second Multi-center, Double-blind Dose Response Study of Zacopride and Placebo in Anxious Outpatients. 41. A Double-blind, Multi-center Trial of 2 doses of Extended Release Buspirone ER Compared to Buspirone IR in the Treatment of Anxious Outpatients. 42. Prospective Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Groups Compari son of the Efficacy and Safety of Abecarnil and Alprozolam in Outpatients with Generalized Anxiety Disorder. 43. Prospective, Multi-center, Open-label Study of the Safety of Abercarnil in Outpatients with Generalized Anxiety Disorder. 44. LY237733 in Outpatients with Generalized Anxiety Disorder. 45. A Double-blind, Placebo-controlled, Multi-center Trial Comparing 30mg of Buspar Given 2 BID vs. TID in Patients with Generalized Anxiety Disorder. 46. A Flexible Dose, Placebo-controlled Study of Deracyn SR Tablets in the Treatment of Generalized Anxiety Disorder. 47. Flexible Dose, Double-blind Study Comparing Efficacy and Safety of Deracyn SR Tablets and Xanax CT in the Treatment of Geriatric Outpatients with Clinical Anxiety. Panic Studies: 48. Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Com parison of the Efficacy and Safety of Abercanil and Lorazepam in Elderly Outpatients with Anxiety Symptoms. 49. Short and Long-term Discontinuation of Alprazolam in Patients with Panic Disorder with Agoraphobia.
  • 6.
    Vilma Mejia- Page6 50. A Double-blind Safety Tolerability and Pilot Efficacy Study Comparing L-365,260 to Placebo in Outpatients with Panic Disorder. Alzheimer Studies: 51. Clinical Evaluation of Sabaluzole in the Treatment of Patients with Dementia of the Alzheimer Type. 52. Clinical Evaluation of Phisostigmine in the Treatment of Alzheimer Dementia. Pain Studies: 53. Long-term Safety of Transnasal Butorphanol in Patients with Chronic Pain of Non-malignant Origin. Gastro-Intestinal Studies: 54. A Symptomatic Treatment of Irritable Bowel Syndrome: A Double-blind Comparison of Clidinium Bromide with Placebo in 12 Patients. 55. Multi-center, Randomized, Double-blind, Placebo-controlled Evaluation of Healing and Relapse Rates Following Oral GR122311x Compared with GR8850x, Ranitidine and Placebo in Patients with Duodenal Ulcer. 56. Multi-center, Randomized, Double-blind Study Comparing Ranitidine and Placebo in Patients with Gastric Ulcer. Respiratory Studies: 57. LY163829 vs. Cefaclor in Bronchitis. 58. LY163829 vs. Augmentin in Pneumonia. 59. Loracarbef vs. Ceftin in Acute Exacerbation of Chronic Bronchitis. 60. Double-blind, Randomized, Comparative, Multi-center Study of RP-64206 (Sparfloxacin) vs. Cefaclor in the Treatment of Community Acquired Pneumonia. Allergy Studies: 61. Efficacy and Safety of Ocymetazoline HCL 0.025% vs. Placebo in Subjects with Allergic Conjunctivitis. Blood Disorder Studies: 62. Study of Safety and Efficacy of Antihemophilic Factor/ Von Willebrand Factor Complex (Humate- P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects with Von Willebrand’s Disease. Cardiac Studies: 63. Reducing Recurrence of Symptomatic Atrial Fibrillation/Flutter and PST. 64. WARCEF: Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction. Cath Lab Research: 65. A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared with Standard Care in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory 66. Chemometric Observations of Lipid Core Containing Plaques of Interest in Native Coronary Arteries Registry- COLOR 67. Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering- YELLOW II 68. A Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Tryton Side Branch Stent™ used in Conjunction with a Drug-Eluting Stent Compared to Side Branch Balloon Angioplasty in Conjunction with a Drug-Eluting Stent in the Treatment of de novo Bi furcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation -TRYTON
  • 7.
    Vilma Mejia- Page7 68. AVERT Trial– Assesses the AVERT System device for CM volume reduction and incidence of CIN 69. ABSORB III- A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions 70. HARMONEE- Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich’s Combo Stent (Japan-USA HARMONEE): Assessment of a Novel DES Platform For Percutaneous Coronary Revascularization in Patients with Ischemic Coronary Disease and NSTEMI Acute Coronary Syndrome 71. PIONEER-An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention 72. COBRA- COBRA PZF™ coronary stent system in native coronary arteries for early healing, thrombus inhibition, endothelialization and avoiding long-tern dual an-platelet therapy. 73. PARACHUTE- Percutaneous Ventricular RestorAtion in Chronic Heart Failure due to Ischemic Heart Disease 74. ISCHEMIA- International Study of Comparative Health Effectiveness with Medical and Invasive Approaches 75. BIOHELIX- The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent 76. COAST- Coronary Orbital Atherectomy System Study 77. EVOLVE II- A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion (s) 78. EXPERT CTO- Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions 79. ABSORB IV- A clinical Evaluation of the ABSORB BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions 80. The Asahi Intecc PTCA Chronic Total Occlusion Study 81. MACE- Multi-center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE) 82. RESOLUTE INTEGRITY -A Post approval Study of the Medtronic Resolute™ Integrity Zotarolimus- Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25 mm to 4.2 mm 83. TWILIGHT- Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention 84. AVIATOR 2- Antithrombotic Strategy Variability In Atrial Fibrillation and Obstructive Coronary Disease Revascularized with PCI 85. BIOFLOW-V- A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions – V 86. ENDOMAX - ENDOvascular Interventions with AngioMAX 87. ILLUMENATE - Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel PacliTaxel-Coated Percutane- ous Angioplasty Balloon 88. PIVOTAL- Medtronic CoreValve® U.S. Pivotal Trial (High Risk Surgical Patients) 89. SURTAVI- Surgical Replacement and Transcatheter Aortic Valve Implantation 90. SENTINEL- Cerebral Protection in Transcatheter Aortic Valve Replacement 91. SPYRAL OFF-Global Clinical Study of Renal Denervation with the Simplicity Spyral™i multi-electrode renal denervation system in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications 84. SPYRAL ON- Global Clinical Study of Renal Denervation with the Simplicity Spyral™i multi-electrode renal denervation system in Patients with Uncontrolled Hypertension on Standard Medical Therapy. 85. EXCEL- Evaluation of XIENCE PRIME™ or XIENCE V® versus Coronary Artery Bypass Surgery for Effec- tiveness of Left Main Revascularization
  • 8.
    Vilma Mejia- Page8 86. SYMPLICITY HTN-3- Renal Denervation in Patients with Uncontrolled Hypertension 87. SHIELD II- Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device 86. A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System RESOLUTE ONYX Core (2.25 mm – 4.0 mm) 86. A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent RESOLUTE ONYX 2.0 mm 90. PLATINUM Diversity: Outcomes with the Promus PREMIER™ Stent in Women and Minorities 91. ORBID- Three–dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch V vessel After Provisional Main Vessel Stenting In Coronary Artery Disease 92. GALILEO- Global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to Optimize clinical outcomes 93. EXPANDED USE- Medtronic CoreValve® U.S. Expanded Use Study 94. CAS-Medtronic CoreValve® Continued Access Study (High Risk and Extreme Risk Patients) 95. EVOLUT R- The Medtronic CoreValve™ Evolut™ R US Clinical Study 96. A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy™ Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries 97. PROTECTED PCI STUDY: A prospective clinical trial for patients undergoing protected percutaneous coronary intervention with IMPELLA® 2.5 SYSTEM 98. TRIAGE Patients Undergoing Percutaneous Coronary Interventions To Improve Clinical Outcomes Through Optimal Platelet Inhibition 99. FREEDOM- Long-term outcomes in patients who underwent revascularization 100. COBRA REDUCED– Randomized trial of Cobra PZF stenting to reduce duration of triple therapy.