CRA Professional Development Program, Kriger Research Center, Inc. (CRO)
ICH GCP Training, Clinical Site Monitoring (site selection, initiation,
monitoring and close out), Adverse Event Reporting, Pharmacology for
Clinical Research Professionals.
Main investigator
in the project entitled: “The role of hypothalamic and pituitary genes
in opiate dependency” supported by National Institute of Health.
Molecular biology techniques used:
- Microarrays (experiments design, data analysis, visualization and
integration);
- Real-Time RT-PCR (including primers design);
- In vitro
gene knockout; siRNA transfection;
- Protein expression: Western Blot, Immunoprecipitation;
- DNA cloning - DNA transfection methods;
- Mammalian Cell Cultures;
- In vivo: experience with mice, rats,
DNA genotyping, various surgery and behavioral procedures; maintain
colonies of transgenic
and KO mice;
- CT Scan in mice.
Main investigator
in the project entitled: “Transcriptional regulation of ICAM-1 gene by
CaMKII” supported by Canadian Research Council. Experienced with:
- DNA
cloning - DNA transfection methods;
- Vectors derived from plasmids;
- Fluorescences labeling/detection methods;
- Gel electrophoresis;
- Protein expression: Western Blot, Immunoprecipitation;
- Enzyme-Linked Immunosorbent Assay
(ELISA);
- Fluorescence-activated
cell-sorting (FACS);
- Electrophoretic Mobility Shift
Assay (EMSA);
- Kinases Activity
Assays (for CaMK II);
- Mammalian Cell Cultures
1. Transposition of 2D MRI Images in 3D Images; Applications in
Neurosurgery.
2. Computer assisted monitoring of anesthesia and automated anesthesia
record. Coordinator Prof. Dr. George Litarczek.
1991-1994
Summer Student
• Department of
Immunology, Genetics and Molecular Biology of the Titu Maiorescu
University, Bucharest, ROMANIA.
• Department of Surgery at the Iuliu Hatieganu Medical University,
Cluj-Napoca, ROMANIA.
TRAINING
Microarray Data Analysis
Software:
-R/Bioconductor Software Packages; dChip
-GenePix Pro 6, Acuity 4.0
2006 - GenePix/Acuity
Microarray Data Analysis Workshop, held at the
UCLA, Los Angeles, CA, USA.
MOLECULAR BIOLOGY &
GENETICS Experienced with the following:
Gene expression technology in mammalian cell (β-gal
and luciferase assay).
DNA cloning - DNA transfection methods.
DNA sequencing
Vectors derived from plasmids.
Gel electrophoresis.
Fluorescences labeling/detection methods.
Western Blot, Immunoprecipitation.
Kinases Activity Assays (CaMKII).
ELISA
FACS.
EMSA.
Microarrays (Experiments Design and Data Analysis).
Real-Time PCR (including primers design).
In vitro gene
knockout; siRNA transfection.
NEUROSCIENCE
1995
- Full fellowship at the Summerschool off The Max-Planck-Institute, Seewiesen,
Germany, entitled: “Gonadal hormone-depended control of sexual behavior.
From behavior to cellular mechanisms”. Coordinator Dr. Manfred Gahr.
Lab work the following
techniques:
•
Radioimmunoassay (RIA)
•
Immunocytochemistry (ICH)
• in-situ
hybridisation
•
tract-tracing.
IMMUNOGENETICS As summer student (1991-1994) I
participated in the following projects:
Q-, G- & C-banding of the chromosomes in leukaemia and lymphomas.
Allergens involved in bronchial asthma.
Immunologic aspects of small cell bronchial cancer.
c-fos possible role in megakaryocytic terminal
differentiation.
Experienced with the following:
- The Coombs' Test
- Passive Agglutination
- Precipitation Reactions in Gels and Solutions
- Radial Immunodiffusion
- Immunoelectrophoresis
- ELISA
- Direct and Indirect Immunofluorescence
- Production of antisera - Xenoantisera and
Alloantisera
Efficacy of the
lowering effect of PROLIPOSTAT® on Blood concentrations of low-density
lipoprotein cholesterol (LDL-C) in patients with normal and elevated blood
concentrations of LDL-C.
Phase I Study
the safety and Dose determination of Immuno - Stimulatory Therapy Agent for
Bladder cancer, melanoma and colon cancer.
Phase II Study
the Efficacy of the healing effect of recombinant human epidermal growth
factor (rhEGF) on diabetic foot ulcers.
Survey: Proper
Use and Cost Reduction strategies for prescription and non-prescription
drugs.
Responsibilities:
Member of
clinical development team.
Managed
assigned investigational study sites and performed on-site quality reviews
of case report form data.
Conducted
routine monitoring visits to ensure investigator and staff were in
compliance with protocol, TDP, FDA and ICH regulations, GCPs and pertinent
SOPs.
Verified case
report form information against source documents and reconciled data entry
queries.
Reviewed site
study files for completeness and up-to-date information, including IRB
related documents.
Ensured
informed consent was administered properly and advised site of any execution
issues.
Performed drug
accountability and reconciled counts with CRF, source data and dispensing
logs.
Oversaw and
evaluated subject enrollment, and compiled and reviewed patients’ status
tracking information.
Developed and implemented site initiation, routine monitoring and closure
checklists.
2005-2007. Charles R Drew University - Clinical Center
Trainee Clinical
Coordinator
1. Physiologic Testosterone Replacement in Women with Hypopituitarism, outpatient, double blind, and safety trial profile.30 patients
enrolled. Ongoing study. Los Angeles, CA
2. Baseline Sexual Function, Cognitive Function, Body Composition, and Muscle
Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women,
open-label. 50 patients enrolled. Ongoing study. Los Angeles, CA
Clinical
Coordinator,
1. Use of
Viagra (Sildenafil) to Alter Fatigue, Functional Status, and Impaired Cerebral
Blood Flow in Patients with Chronic Fatigue Syndrome, outpatient, double blind,
and safety trial profile. 31 patients enrolled. Ongoing study. Los Angeles, CA
Responsibilities:
- Recruit volunteer subjects. - Screen volunteers for study eligibility. - Explain and obtain Informed Consent from study participants. - Introduce data and maintain clinical database. - Clinical data, CRF and source documents. - Preparation and maintenance of IRB submissions, amendments and renewals.
1996-1997.First Monitor
Pharma (Sponsor)
Clinical Research Monitor,
1. Use of
Cyclospasmol (Cyclandelate) to improve the outcome of cerebral stroke patients,
inpatient, double blind. 250 patients enrolled. International, multisite,
finished study. Bucharest, Romania.
Responsibilities:
- CRF design, modification/creation of ICF, Investigator brochures, study
related forms/reports and source documents in collaboration with the CRO, Data
Management Group and Biostatistician. - Write and develop data and tracking forms, informed consent documents, and
updating/modifying operating procedures. - Prepare and track required documentation from clinical sites. - Provide technical assistance to study sites regarding the conduct of clinical
research. - Revise, as necessary, clinical trial documentation and standard operating
procedures, specifically SOPs for monitoring the clinical trial. - Travel to field sites to supervise and coordinate clinical studies. - Facilitate development and execution of Clinical Trials and Confidentiality
Agreements.
Clinical Research training:
2007-2008 “Introduction
to the Principles and Practice of Clinical Research.” NIH Clinical Center
sponsored course. Diploma is available.
2008-2009 In progress - “Principles of Clinical Pharmacology” NIH
Clinical Center sponsored course.
Outstanding problem solving skills. I am dependable and conscientious accurate at detail
work. I am a quality
oriented person on my results. I use my leadership with the
people around me for accomplishing goals and results. Under pressure, I respond to challenges and
problems in a flexible and fast way. I
normally use real facts for constructing my concepts. I
like to deduct practical applications from ideas. Easy to work with a cooperative and supportive
colleague.
LANGUAGE: Besides I am fluent in English, I have
beginner level knowledge in French and some knowledge
of German.
1996 -
Poster presenter
and full scholarship at the Advanced Course on "HLA
and Tumors", organized by the Ruggero Ceppellini School of
Immunology, Napoli, ITALY.
1996 -
Poster presenter
with full fellowship at the NATO ASI "Genome
Structure and Function" Course, held in Marciana Marina, Elba
Island, Italy.
Paez Espinosa V, Liu Y, Ferrini M,
Anghel A, Nie Y, Tripathi PV,Porche R, Jansen E, Stuart R, Nillni E, Lutfy K, Friedman TC.
Differential regulation of PC1/3, PC2 and phosphorylated CREB by short-term and
long-term morphine treatment: Implications for Understanding the “Switch” to
Opiate Addiction. Neuroscience.
2008 Oct 15; 156(3): 788-99.
Lutfy K, Brown MC, Nerio N, Aimiuwu O, Tran B, Anghel A, Friedman TC. Repeated Stress Alters the Ability
of Nicotine to Activate the HPA Axis.
Journal of Neurochemistry. 2006 Dec; 99(5):1321-7.
Liu Y, Yan C,
Wang Y, Nakagawa Y, Nerio N, Anghel A, Lutfy K, Friedman TC. Liver X
Receptor Agonist T0901317 Inhibition of Glucocorticoid Receptor Expression in
Hepatocytes May Contribute to the Amelioration of Diabetic Syndrome in db/db
Mice. Endocrinology. 2006 Nov; 147(11):5061-8.
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1-818-769-8743
.
- The Coombs' Test
Outstanding problem solving skills.