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Personal Data:
Surname, First Name: MARTE ALCANTARA, JOSE GIOVANNY
Address Ave. Jacobo Majluta. Res. Ciudad Bonita
Manz C, Edif 9, Apto 402, Santo Domingo. Dominican Republic
Phone Contact: 1809-852-1491 / 1829-846-0209
E-mail: josegiovanny@hotmail.com
Languages:
English
Native Read Written
Spoken
Native Read Written
Spoken
Education at College/University/Medical School Level:
Qualification: Year:
2008
Institution/Country:
Informatic Universidad del Caribe (UNICARIBE)
Details of Employment:
Current Position: From Institution Name and Address:
Research Assistant
Coordinator / DEA
Coordinator / Quality
Control / Regulatory
Affairs.
2006 Hospital de Maternidad Nuestra Señora de la Altagracia (Investigational
Site)
Fundacion Dominicana de Perinatología
Calle Pedro Henríquez Ureña No. 49, Gazcue, Santo Domingo,
Dominican Republic
Experience in Clinical Trials (Phase, Therapeutic area(s) and Responsibility (ies):
DEN – 301, Takeda. Phase III, Double-Blind, Randomized, Placebo-Controlled, Trial to Investigate the
Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in
Healthy Children Aged 4 – 16 Years Old. Research Assistant / Quality Control
T2-ABMG (FIDEC) A Phase 4 study to evaluate the safety and immunogenicity of trivalent oral polio vaccine
in healthy polio vaccinated children 1 to 5 years old and in healthy unvaccinated infants at 6 weeks of age in
the Dominican Republic. Quality Control / Data Entry General Coordinator
VIPV-05, Serum Statend Intitut SSI Immunogenicity and safety of 3 adjuvanted reduced dose inactivated
polio vaccines (IPV-Al SSI) and non-adjuvanted full dose IPV SSI, given as primary vaccinations to infants at
6, 10 and 14 weeks of age. Quality Control / Data Entry General Coordinator
DEN – 204, Takeda. A Phase II, double-blind, controlled trial to assess the Safety and Immunogenicity of
different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged
between 2 and 18 years and living in dengue endemic countries in Asia and Latin America. Quality Control /
Data Entry General Coordinator
IPV001ABMG, FIDEC. A Phase 4, Randomized Study to Evaluate the Safety and the Humoral and Intestinal
Immunogenicity of One or Two Additional Doses of Licensed Inactivated Polio Vaccines (IPVs) in Latin
American Infants Previously Vaccinated with Bivalent Oral Polio Vaccines (bOPVs) Quality Control / Data
Entry General Coordinator
113823 (MenACWY-TT-054), GSK. A Phase III, open, randomized, controlled, multicentre study to assess
the immunogenicity and reactogenicity of GSK Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus
toxoid conjugate vaccine (MenACWY-TT) administered alone as compared to MenACWY-TT co-
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administered with GSK Biologicals’ HPV vaccine Cervarix or co-administered with Cervarix and GSK
Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap)
(Boostrix) in female adolescents and young adults at 9-25 years of age. Quality Control / Data Entry
General Coordinator
V98_15OB, NOVARTIS. A multicentre, observational study to identify factors that influence access of
pregnant women and their infants to their local healthcare systems. Quality Control / Data Entry General
Coordinator
116705 (MenACWY-TT-098), GSK. A Phase III, randomised, partially-blind, controlled, multi-centric, multi-
country study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ MenACWY-TT
conjugate vaccine co-administered with Boostrix® administered intramuscularly versus MenACWY-TT alone
administered intramuscularly, in healthy adolescents and young adults between 11 and 25 years of age.
Quality Control / Data Entry General Coordinator
116926 (FLU Q-QIV-013), GSK. A Phase III, observer-blind, randomised study to evaluate the
immunogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine candidate, GSK2282512A (FLU
Q-QIV), compared to GSK Biologicals’ trivalent influenza vaccine Fluarix®, administered intramuscularly to
children 6 to 35 months of age. Quality Control / Data Entry General Coordinator
115345 FLU D-QIV-004, (Cohort 2, 4 and 6) GSK. A phase III, observer-blind, randomized, multi-country,
non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline
Biologicals’ quadrivalent seasonal influenza candidate vaccine GSK2321138A (FLU D-QIV), administered
intramuscularly in children 6 to 35 months of age. Quality Control / Data Entry General Coordinator
V98_09, NOVARTIS. Multicenter Evaluation of the Burden of Invasive Neonatal Group B Streptococcal
Disease: Incidence and Serotype Distribution. Quality Control
113948 (DTPa/HBV/IPV-124), GSK. A phase I/II, double-blind, randomized, multicentre study to evaluate the
safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine
when administered to healthy infants as a primary vaccination course at 2, 3 and 4 months of age.
Quality Control / Data Entry General Coordinator
114843 (DTPa/HBV/IPV-125 BST:124), GSK. A phase II, double-blind, multicentre study to evaluate the
safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals’ combined
DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in
study 113948 (DTPA-HBV PRI). Quality Control / Data Entry General Coordinator
114541 (FLU Q-QIV-006), GSK. A Phase III, observer blind, randomized, non-influenza vaccine comparator-
controlled, multi-country and multi-centre study of the efficacy of GSK Biologicals’ quadrivalent, inactivated,
split virion, seasonal influenza vaccine candidate, GSK2282512A (FLU QQIV), administered intramuscularly
in healthy children 3 to 8 years of age. Quality Control / Data Entry General Coordinator
V111_03, NOVARTIS. A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity,
Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Egg-derived, Inactivated
Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects from 6 Months
to 17 Years of Age. Data Capture
V110_04, NOVARTIS. A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity,
Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Cell-derived, Inactivated
Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects from 6 Months
to 17 Years of Age. Data Capture
V71P6, NOVARTIS. A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate
the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in
Embryonated Hen Eggs in Healthy Subjects
Aged 18 to 49 Years. Data Capture
106260 (ROTA 052), GSK. A phase IIIb, randomized, double-blind, placebo-controlled study to explore the
existence of horizontal transmission of the RIX4414 vaccine strain between twins within a family. Data Entry
Assistant
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Type of GCP training (e.g. GCP Course, Investigator meeting): Date of Last GCP Training:
ICH Good Clinical Practice for Clinical Trial Sites, LONGBOAT
ICH Good Clinical Practice for Clinical Trial Sites, NIDA
ICH Good Clinical Practice for Clinical Trial Sites, QUINTILES
ICH GCP training, Latin America Bioethics Consultants
ICH Good Clinical Practice training, IMR Isthman Med.
Research
September, 2016
March, 2014
August, 2013
November, 2009
October, 2008
Signature: MARTE A., JOSE G. Date FEB 06, 2017