MD

CURRENT ADDRESS:

**** ******* **. # ***

Valley Village, CA 91607

818-***-**** (home)

*******@******.****.***

Keywords: CRA, Investigator Brochure, Investigator Meeting, Adverse Events, Recruit, Screen, Enroll subjects, Informed Consent, CRF, Source documents, regulatory documents, IRB, Clinical database, GCP, ICH, FDA and HIPAA regulations Hematology-Oncology, Endocrinology

EDUCATION

1990 – 1996 M.D. Titu Maiorescu University from Bucharest, ROMANIA, Faculty of General Medicine.

2001-2003 Computer System Programming at the Advanced Computing Institute, Inc., Los Angeles, CA, USA.

2007-2008 CRA Professional Development Program, Kriger Research Center, Inc. ICH GCP Training, Clinical Site Monitoring (site selection, initiation, monitoring and close out), Adverse Event Reporting, Pharmacology for Clinical Research Professionals.

HIGHLIGHTS OF QUALIFICATIONS

July 2007 - present. Staff Research Associate II, Department of Medicine, Hematology-Oncology Division, Geffen School of Medicine at UCLA, CA, USA.

2006 – 2007. Clinical Coordinator (Trainee), Department of Endocrinology, Charles R. Drew University, Los Angeles, CA, USA.

2004 - 2007. Senior Research Associate, Department of Endocrinology, Charles R. Drew University, Los Angeles, CA, USA.

1999 - 2007. External consultant with BRAND INSTITUTE Inc., the premier full service brand identity consultancy dedicated to the strategic and innovative development of brand nomenclature and identity solutions for major US Pharmaceutical Companies. Miami, FL, USA.

1998 – 2001. Research Assistant Molecular Endocrinology & Oncology Department from CHUL Research Center, LAVAL University, Quebec, CANADA.

1998. Internship as physician, the Department of Internal Medicine at the "Judetean" University Hospital, Brasov, Romania.

1996 - 1997. Clinical Research Monitor in the Pharmaceutical Division of the "First Monitor Pharma" Company in Bucharest, ROMANIA.

RELEVANT EXPERIENCE

CLINICAL TRIALS I participated:

Kriger Research Center Inc. (CRO)

Clinical Research Associate,

Projects:

1. 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.

2. Phase I Study the safety and Dose determination of Immuno - Stimulatory Therapy Agent for Bladder cancer, melanoma and colon cancer.

3. Phase II Study the Efficacy of the healing effect of recombinant human epidermal growth factor (rhEGF) on diabetic foot ulcers.

4. 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.

Charles R Drew University - Clinical Center

Trainee Clinical Coordinator, Physiologic Testosterone Replacement in Women with Hypopituitarism, outpatient, double blind, and safety trial profile.30 patients enrolled. Ongoing study. Los Angeles, CA

Trainee Clinical Coordinator, 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, 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.

First Monitor Pharma (Sponsor)

Clinical Research Monitor, 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:

2009 – UCLA M261 Ethics in Patient-Oriented Research: certificate of proficiency in clinical research

2009 - UCLA K30 Graduate Training Program in Translational Investigation: Safety and Regulatory Issues in Patient- Oriented Research. Safety and Regulatory Issues in Patient- Oriented Research.

2008-2009 “Principles of Clinical Pharmacology” NIH Clinical Center sponsored course. Diploma is available.

2007-2008 “Introduction to the Principles and Practice of Clinical Research.” NIH Clinical Center sponsored course. Diploma is available.

PRECLINICAL STUDIES AND NEW ANTI-CANCER DRUG TESTING

-Cell proliferation viability assays;

-Cell survival assays;

-Large-scale human cancer cell culture;

-Pharmacokinetic and pharmacodynamic analysis studies.

NEW DRUGS BRANDING

- Nomenclature Development,

- Market Research and Design for new drugs from Major US Pharmaceutical Companies.

RELATED SKILLS

- Operating Systems – WINDOWS, UNIX, LINUX and MacOS.

- Microsoft Office - Excel, Word, Access, PowerPoint.

- Statistics – SPSS, SigmaStat, SigmaPlot, GraphPad InStat.

- Database - basic understanding of relational database concepts

- Graphics – Adobe Photoshop, Corel Draw, Harvard Graphics.

- Programming: working knowledge of HTML; some knowledge of IDL, C++, Visual Basic and Java

LANGUAGE: Besides I am fluent in English, I have fair level knowledge in French.

PUBLICATIONS

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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