This curriculum vitae summarizes Jacqueline Vassallo's professional experience and qualifications. She has over 15 years of experience as a clinical research coordinator at the University of Miami Miller School of Medicine, where she has assisted in numerous clinical trials related to kidney disease and hypertension. Her responsibilities have included regulatory tasks, patient recruitment and evaluation, data management, and coordinating activities between research teams and sponsors.

1. CURRICULUM VITAE
Date: January 26, 2016
Name: Jacqueline Vassallo, CCRP
Home Address: 58 N.W. 57 Street,
Miami, Florida 33127
Cell phone: (305) 302-1694
Work Address: University of Miami Miller School of Medicine
Clinical Research/Division of Nephrology & Hypertension
Nephrology Clinical Studies Laboratory/Office
1600 N.W. 10th Avenue, RMSB 7172ª/7171A
Miami, Florida, 33136
Office Phone: (305) 243-4691
Fax: (305) 243-3040
Email address: jvassall@med.miami.edu
PROFESSIONAL PROFILE
Dedicated and patient-focused Clinical Research Coordinator that provides support, coordination, and leadership
for drug studies that may involve industry sponsored Phase I, II, III, and IV clinical trials.
RELEVANT EXPERIENCE:
Assist PI in the conduct of all aspects of clinical trials including regulatory tasks in the initiation of Federal
and/or industry sponsored research studies:
• Assists the PI in developing, reviewing and submitting required documentation to the HSRO to ensure
successful approval of research protocols
• Assist PI in site selection, initiation visits and is available during all monitoring visits.
• Develops and maintains reporting needs and/or other requirements as established by the IRB and the
HIPAA office
• Reviews and administers informed consent forms to candidates for drug or device studies
• Maintains any reports and other requirements as required by the HSRO
• Maintains all study protocol regulatory binders
• Interacts with various sponsoring agencies and their representatives on issues regarding future and on-
going protocols requiring occasional visits to supporting agencies and national meetings
• Obtains necessary medical records and schedules patients for any research related visits
• Maintains a study patient list as required per protocol
• Coordinates research related activities between departments to accomplish goals of studies
• Interacts with other Departments within the University in providing study visit reports to aid in
invoicing/reconciling sponsor payments
• Keeps track of payments of stipends to study participants and submits all forms for
reimbursements/Petty Cash Custodian
• Submits purchase requisitions using ARIBA (UMenet) for payments to outside vendors/agencies
Develops and manages the following procedures as they pertain to studies and patients:
• Completes patient case report forms (eCRFs) and Maintains case report form binders as needed
• Collects results from outside laboratories and enters data into case report forms
Page 1 of 7

2. • Contacts patients as required by the PI for clinical follow-up of requirements and adherence to research
protocols
• Reviews the medical chart for any other data required on the case report form
• Coordinates the necessary patient evaluations per physician’s orders and/or study protocol requirements
• Assists PI in conducting participant visits in completing all study related procedures: vital signs,
phlebotomy, recording adverse events, reviewing concomitant medications per protocol.
• Other duties as assigned
RESEARCH AND PROFESSIONAL EXPERIENCE
February 2010 – Research Support Specialist/Clinical Research Coordinator
Present University of Miami Miller School of Medicine
Clinical Research, Division of Nephrology and Hypertension
Miami, Florida
August 2008 – Research Support Specialist/Assistant Study Coordinator
February 2010 University of Miami Miller School of Medicine
Clinical Research, Division of Nephrology and Hypertension
Miami, Florida
June 2008 – Sr. Administrative Assistant/Program Assistant/Research Support Coordinator
August 2008 University of Miami Miller School of Medicine
Clinical Research, Division of Nephrology and Hypertension
Miami, Florida
Dec 2006 – Program Assistant II/ Research Support Coordinator
May2008 University of Miami Miller School of Medicine
Clinical Research, Division of Nephrology and Hypertension
Miami, Florida
May 2000 – Program Assistant II/Regulatory Specialist
Dec 2006 University of Miami School of Medicine
Clinical Research, Division of Nephrology and Hypertension
RESEARCH STUDIES:
“An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil
(MMF) in Patients with Stable, Quiescent Systemic Lupus Erythematosus (SLE)” (ALE06).
Sponsored by the Division of Allergy, Immunology, and Transplantation (DAIT), National
Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.
Site Principal Investigator: Gabriel Contreras, MD, MPH. Project period 4/2014 – 4/2016.
A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and
Safety of BMS188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil
(MMF) and Corticosteroids in Subjects with Active Class III or IV Lupus Nephritis
(ALLURE) – Site Principal Investigator: Maria Fernanda Carpintero, MD. Project period
11/2013 – 6/2016
“A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and
Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult
Subjects with Active Lupus Nephritis” (BLISS Study); Study ID: HGS1006-C1121/GSK
Page 2 of 7

3. BEL114054. Sponsored by Human Genome Science, Inc./GlaxoSmithKline group. Site
Principal Investigator: Gabriel Contreras, MD, MPH. Project period 4/2013 – 4/2017.
“The Systolic Blood Pressure Intervention Trial” (SPRINT). Study sponsored by the National
Institutes of Health (NHLBI, NIDDK, NIA and NINDS) through Wake Forest University.
Site Principal Investigator: Gabriel Contreras, MD, MPH. Project period 09/14/2009 through
7/2015
“SPRINT MIND BRAIN MRI STUDY” (SPRINT MIND) Study sponsored by the National
Institutes of Health (NHLBI, NIDDK, NIA and NINDS) through Wake Forest University.
Role: Recruitment. Site Principal Investigator: Gabriel Contreras, MD, MPH. Project period
09/14/2009 through 7/2015
“The NEPhrotic Syndrome STUtudy NEetwork” (NEPTUNE) (1U54 DK083912). Study
sponsored by the Office of Rare Disease and NIDDK/NIH, Department of Health and Human
Services (DHHS),The University of Michigan and The NephCure Foundation. Site Principal
Investigator: Gabriel Contreras, MD, MPH. Project period 09/08/2009 – 01/2013
“Randomized, Double-Blind, Controlled, Phase II Multicenter Trial of CTLA4Ig (Abatacept)
Plus Cyclophosphamide vs. Cyclophosphamide Alone in the Treatment of Lupus Nephritis.
Study funded by National Institutes of Health – NIAID throughout The University of
California; N01-AI-15416; Site Principal Investigator: Gabriel Contreras, MD, MPH. Project
period 12/01/2008 through 04/30/2014
“The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in
Subjects with Chronic Kidney Disease Stage 3B/4; Abbott Laboratories - Protocol #M10-
030. Site Principal Investigator: Gabriel Contreras, MD, MPH. Project period 1/ 2008 –
02/2012
“The AASK Nocturnal Ambulatory Blood Pressure pilot study: The effects of Ramipril-Based
Antihypertensive Therapies on Nocturnal BP funded by National Institutes of Health;
extension of grant number DK048652. Role: Regulatory Specialist. Site Principal
Investigator: Gabriel Contreras, MD, MPH. Project period 11/2007 – 10/2009
“A Randomized, double-blind, placebo-controlled, multicenter, phase III study to evaluate the
efficacy and safety of rituximab in subjects with ISN/RPS 2003 class III or IC lupus
nephritis” funded by Genentech Inc. Protocol number U2970g. Role: Regulatory Specialist/
Study Coordinator; Site Principal Investigator: Oliver Lenz, MD. Project period 3/2006 – Dec
2010
“Cardiovascular outcome in renal atherosclerotic lesions CORAL Study”. Medical University of
Ohio/ NIH NHLBI Collaborative Agreement; Grant #1 U01 HL071556-02. Role: Study
coordinator; Site Principal Investigator: Gabriel Contreras, MD, MPH. Project period
02/01/2006 – 6/30/2014
“A prospective, randomized, double-blind, active controlled, parallel group, multi-center trial to
assess the efficacy and safety of mycophenolate mofetil (MMF) in maintaining remission and
renal function in subjects with lupus nephritis who underwent successful induction therapy
with either MMF or cyclophosphamide”. Aspreva Pharmaceuticals, Inc., Protocol WX17801.
Page 3 of 7

4. Role: Study coordinator; Site Principal Investigator: Gabriel Contreras, MD, MPH. Project
period 7/2005 – Dec 2010
Page 4 of 7

5. Program Assistant/Regulatory Specialist:
“A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate
Efficacy of StaphVAX®
, a Bivalent Staphylococcus aureus Glycoconjugate Vaccine in
Adults on Hemodialysis. Sponsored by Nabi®
Biopharmaceuticals. Site Principal
Investigator: Jorge Diego, MD. Project period 4/2004 – 12/2005
“A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder versus
Calcium-Based Phosphate Binders in Hemodialysis Patients” – Genzyme (Formerly Geltex
Pharmaceuticals) - Protocol #GTC-68-401. Site Principal Investigator: Phillip J. Pennell,
MD Project period 12/2003 – 12/2004.
“Intensive vs Conventional renal support in acute renal failure, funded by Veterans Affairs
cooperative study #530/National Institutes of Health, Site Principal Investigator: Gabriel
Contreras, MD, MPH. project period 8/15/2003 – 02/14/2007
“An Open Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered “On
Demand” to Men of Various Populations with Erectile Dysfunction” SPONSOR: Lilly ICOS
LLC - Protocol: H6D-MC-LVFN(b). Site Principal Investigator: Arif Asif, MD. Project
period 8/2003 – 7/2004
“Randomized Controlled Trial Of The Benefits Of Oral Essential Amino Acids In Recently
Hospitalized Hemodialysis Patients” GAMBRO Healthcare Inc./NIH/NIDDK/ Recip AB,
Aminess N - Protocol #CT 00-AMI-003” Site Principal Investigator: Phillip J. Pennell, MD.
Project period 12/2002 – 2/2006
“A Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of an Oral
Calcimimetic Agent (AMG 073) When Two Different Vitamin D Regimens Are Used In
Subjects with Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)” Amgen
Inc. Protocol Number: AMG 073 20020158. Site Principal Investigator: Jorge Diego, MD.
Project period 12/2002 – 6/2005
“A Placebo-Controlled, Double-Blind, Extension Study To Assess The Long-Term Safety Of An
Oral Calcimimetic Agent (AMG 073) In Secondary Hyperparathyroidism Of End-Stage
Renal Disease” Amgen Inc., Protocol No. AMG 073 20010240. Project period 10/2002 –
11/2003
“African American Study of Kidney Disease and Hypertension (AASK) Cohort Study”, at
University of Miami funded by National Institutes of Health; extension of grant number
DK048652; NIH/NIDDK DK-03-500 & King Pharmaceuticals. Site Principal Investigator:
Gabriel Contreras, MD, MPH. Project period 7/2002 – 6/2007
“A Study to Evaluate the Efficacy and Safety Of 7.5% Icodextrin Peritoneal Dialysis Solution As
Compared To Dianeal®
PD-2 Peritoneal Dialysis Solution With 4.25% Dextrose, For the
Long Dwell in Patients Treated With Automated Peritoneal Dialysis (APD)” Baxter
Healthcare Corporation Protocol No.: RD-00-CA-050 Project period 7/2002 – 3/2003
“Correction of Hemoglobin & Outcomes in Renal Insufficiency (Choir)” Ortho Biotech Products,
L.P., Protocol #PR00-06-014. Project period 1/2002 – 5/2005
Page 5 of 7

6. “A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal
Insufficiency (CRI) Subjects with Anemia” Amgen Inc. Protocol # 20010212. Project period
1/2002 – 5/2003
“A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073)
in Secondary Hyperparathyroidism of End Stage Renal Disease Treated with Hemodialysis”
Amgen Inc. Protocol # AMG073 20000172. Project period 12/2001 – 10/2003
“A Randomized Study to Compare the Safety of 200 mg vs. 100 mg Venofer® Administered to
Hemodialysis Patients” Luitpold Pharmaceuticals Protocol # 1VEN01015. Project period
11/2001 – 6/2003
“A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Effect of H5g1.1-Mab
on the Reduction of Proteinuria in Patients with Idiopathic Membranous Glomerulopathy”
Alexion Pharmaceuticals Inc., Protocol No. C99-004. Project period 10/2000 - 5/2005
“An Open-Label Study Of the Long-Term Safety of H5g1.1-Mab on the Reduction of
Proteinuria in Patients with Idiopathic Membranous Glomerulopathy” Alexion
Pharmaceuticals Inc. Protocol No.: E99-004. Project period 9/2000 – 12/2004
“An Open Label Study of the Safety of Venofer® (Iron Sucrose Injection), When Administered
without a Test Dose” Luitpold Pharmaceuticals Protocol # 1VEN99010. Project period
9/2000 – 3/2003
“A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel
Erythropoiesis Stimulating Protein (NESP) to Subjects with Chronic Renal Insufficiency
(CRI)” Amgen Inc. Protocol # NESP 990151-176. Project period 9/2000 – 8/2002
“Efficacy and Safety of Viagra in Black American Men with Erectile Dysfunction” Pfizer
Protocol #A1481006. Project period 9/2000 – 9/2001
“A Study Evaluating the Initiation and Titration of Fixed Doses of Novel Erythropoiesis
Stimulating Protein (NESP) Therapy in Subjects with Chronic Renal Insufficiency (CRI)”
Amgen Inc. Protocol #NESP 990788-176. Project period 8/2000 – 3/2002
“Open Label, Prospective, Multicenter Study to Evaluate the Rate of Adverse Events and Their
Relationship to Concomitant Administration of Angiotensin Converting Enzyme Inhibitor
Therapy Following Repeated Administration of Ferrlecit (Sodium Ferric Gluconate Complex
in Sucrose Injection) in Hemodialysis Patients Receiving Erythropoietin” R&D Laboratories
Inc. Protocol # FER9803. Project period 8/2000 – 1/2001
“Comparison of Oral Iron with Intravenous Iron in Patients with Anemia of Chronic Renal
Failure Not On Dialysis Luitpold Pharmaceuticals – Protocol # 1VEN99012. Project period
7/2000 – 3/2003
“Crossover, Randomized, Blinded, Prospective Multicenter Clinical Evaluation of the Rate of
Adverse Events to Ferrlecit in Hemodialysis Patients Compared to Placebo and Historical
Controls” R&D Laboratories Inc. Protocol # FER9806. Project Period 8/1999 – 10/2000
“Sequential Therapy for Severe Forms of Lupus Nephritis: Cyclophosphamide and Prednisone
followed by Maintenance Intravenous Cyclophosphamide-Prednisone, Azathioprine-
Page 6 of 7

7. Prednisone or Mycophenolate Mofetil-Prednisone” Roche Pharmaceuticals Protocol #
CEL059. Site Principal Investigator: Gabriel Contreras, MD, MPH. Project period 9/1996 –
8/2004
“The African American Study of Kidney Disease and Hypertension (AASK)” funded by
NIH/NIDDK – grant number DK48652. Site Principal Investigator: Jacques J. Bourgoignie,
MD. Project period 8/1994 – 6/30/2002
January 1996 – Secretary, African American Study of Kidney Disease and Hypertension (AASK),
June 2003 Division of Nephrology and Hypertension, Department of Medicine,
University of Miami, School of Medicine, Miami, FL
January 1996 – Sr. Secretary
May 2000 Division of Nephrology and Hypertension, Department of Medicine,
University of Miami, School of Medicine, Miami, FL
EDUCATION DEGREE YEAR FIELD OF STUDY
Miami Edison Sr. High School Diploma 1981 General Studies
Certifications & Training
June 2013 SOCRA Certified Clinical Research Professional
2002 - present CITI Clinical Research Coordinator (CRC); CITI certification in the Protection of Human
Subjects, Good Clinical Practice and ICH, Informed Consent, Health Information Privacy
and Security (HIPS), Research and Data Protection, Conflict of Interest, HIPAA Privacy
and Security (UM). Certification in Shipping of Dangerous Goods (Infectious
Substances) IATA certification, OSHA’s TB, Bloodborne Pathogens and Biomedical
Waste Training
Computer skills
Windows, Word, Excel
Language
English/Spanish
Page 7 of 7