Manager Project

Marina Papuashvili

Email: abp16i@r.postjobfree.com

Address: *** ****** **** *****

City: Gaithersburg

State: MD

Zip: 20877

Country: USA

Phone: 240-***-****

Skill Level: Senior

Salary Range: $85,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Marina N. Papuashvili

E-mail; abp16i@r.postjobfree.com

Immunologist /head of department and Head of lab,

Professor, with over 15 years of experience working on clinical trials:

Protocol designs, Data reviews and interpretation, conducting patient-based research on a wide range of infectious diseases relevant to the broader medical communities,

studying morphological and physiological specificities of HIV- strains in culture.

Skills Summary:

* Over 15 years of experience working on clinical trials of antiviral, immunmodulators, citostatic and other group of treatment against herpes simplex, CMV, HIV and Sarcoma Kaposi

* 18 years of experience working in Clinical Immunology and allergy.

* Possess a background serving as the Head of a Clinical Department of Immunodeficiency at the Institute of Immunology and as the Head of the Retroviral Lab at the Sechenov's Moscow Medical Academy and Program Manager.

* Possess a background working as a Senior Executor/Principal Investigator (PI) of many clinical trials

(PAREXEL-USA, ASGL-European, "Brintzalov", "Vero-Pharma", "Biopharma", "Polidan" and several other Russian companies)

* Experienced managing up to 25 scientists, medical residents, postgraduates and technicians staff in a lab and clinical department environment

* Experienced in using Oracle Clinical to enter and Query data in a clinical database, knowledgeable of EMEA and ICH regulations, CDISC and FDA guidance in applying GCP to a work environment

* Knowledgeable in current technological developments/trends in data management, database construction, management and retrieval methods

* Possess a background in developing and organizing the unique clinical monitoring database of more than 2,000 HIV-infected patients (1991-2005)

* Developed effective program for Monitoring and Evaluation (M&E) of TB, HCV and HIV infections.

* Established and approved scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.

* As a scientific chief of lab had collected blood samples, sperms, saliva and other biological materials, and had established the unique data base of different types and subtypes of HIV, circulating in former Soviet Union's territory.

* In order of performing the diverse Clinical research she has developed protocols, including the study objectives, subject safety specificity of clinical symptoms and consequences. Monitoring clinical protocols, safety monitor plans, adverse event reports. She has forming data base, studying advisory recommendation documents and diversity of scientific literatures, permanently updating Work products and processing documents for providing clinical expertise in areas related Sexually Transmitted Diseases (STD), infectious respiratory or other infectious diseases. Prepared and performed methodical recommendations on these issues. Based on the findings, she has generalized the concept of safety, the role of climate or geographical specificities in terms of manifestation of causal agents of infectious diseases.

* Collected about 3,000 HIV isolates and generated strain libraries from cultures.

* Sequenced and published in Los Alamos HIV Sequence Data Base, Full length genomes of all subtypes of HIV (subtype A,B,C, AB), circulated in former SU territory.

Professional Experience:

* Department of Defense,

Military Vaccine Agency

Clinical Project Manager September 11- up to now

* Consulting work with Clinical Research Data ancillary services experts to correctly analyze feasibility. Identify protocol required procedures and to schedule study subjects with vaccination

* Managing the Data Management processes with CRO partners.

Presenting at CRT meetings on Data Management issues, Protocol and CRF review and database setup through database lock activities.

* Providing oversight management of several CROs based upon existing studies outsourced to CRO partners.

* Perform the activities associated with the evaluation, initiation, monitoring and collection of data, and closeout of clinical trial sites in the geographic area assigned.

* Ensure adequate protection of the rights of human subjects and the safety of all subjects involved in vaccine- sponsored clinical trials. Ensure the quality and integrity of the data collected within vaccination clinical trials, in compliance with GCP and regulations governing the conduct of clinical research.

* Developing the regulatory monitoring plans, conducting Federally Funded studies and Department of Health and Human Services (DHHS) Regulations. Performing documents according FDA IDE/IND regulations, submission processes and contracts.

* Working with AHLTA data base, and Case Report Forms (CRF), analyzing and interpretations of symptoms based on record events newly diagnosed prior to immunization and after. Post-licensure safety evaluation: active surveillance of adverse events after immunization with vaccine, among US military service personnel. Tier One and Tier Two adverse events.

* Determining concomitant diagnosis, recording relevant medical histories, diagnosed prior to immunization. Detecting, verifying and characterizing potential rare, serious adverse events, neurological, hypersensitivity reactions among 50 000 vaccinated military personnel. Identifying unexpected, unanticipated adverse events, possible associated with vaccination by performing data mining for events with significantly higher incidence in vaccinated personnel comparison with other analogue of vaccines. Characterizing medically significant events among the adverse events that had been identified by data mining. Describing pregnancy and infant health outcomes after delivery among females.

* Responsible for appropriate protection of electronic protected health information, based HIPAA, regarding the confidentiality of all records, protocols and patient's electronic data base.

* National Institutes of Health, May 09 - March 11

Center for Scientific Review

Scientific Review Officer (contractor)

* Worked with Federal staff in identifying and coordinating the recruiting and assignment of reviewers for NIH grant applications, performing the initial administrative and scientific review of the grant applications to ensure compliance with policies and procedures and the scientific feasibility of proposed activities.

* Identify and select reviewers by matching expertise with the specific science; innate and adaptive immunology, microbiology, virology, epidemiology, molecular biology, transplantation, and many infectious disease related areas.

* Assign applications to identified reviewers and Obtain written critiques.

* Clarify administrative and policy requirements associated with peer review.

* Provide recommendations for follow up by Federal Scientific Review Officer

* Organize and planning review meetings. Coordinating grant review committee sessions, including scheduling dates, conference rooms, and member attendance.

* Serve as a liaison between federal staff and reviewers.

* Use a variety of NIH databases and web-based applications including QVR, CRISP, IMPACII, IAR, eRA, and PubMed.

* Preparing a variety of reports and summaries.

* Establishing and maintaining effective working relationships with scientists to further the research goals and identify possible review committee members.

Florida International University College of Medicine (Miami, FL) Jun 08 - Dec.2008

HIV Researcher

* Worked on a project titled: "Gene Engineering Construction with siRNA's against HIV" (intending to present the product to NIH for grant eligibility)

* Worked involved preparing siRNA's against some special fragments of gene Tat, PBS of HIV

* Prepared cell culture, peripheral mononuclear blood cells, monocyte or lymphocytes and co-cultivation with different genes or proteins. Immunoassays analysis and PCR

Sechenov's Moscow Medical Academy (Moscow, Russia) Jun 06 - Feb 08

Head of Retroviral Lab & Leading HIV/HCV Researcher

* Served as the head of a newly established lab of retroviruses within the Moscow Medical Academy

* Investigated different proteins as a prognostic markers of disease (i.e. Urinary Trypsin inhibitor)

* Professor of Medicine, Moscow Medical Academy (Moscow Russia) 2006

Head of Laboratory Advance Medical Research (Moscow Russia) Nov 99 - Jul 05

Established by International Foundation, Vaduz, Lichtenstein

* Within 5 years, had been served as a head of Laboratory and Program Manager, simultaneously.

* Actively involved in Human experimentation that is intended to benefit the subjects on whom it is performed. Had served as a liaison between laboratory and The Lichtenstein Research Foundation.

* As a Program Manager In order to manage the process in lab and its proper functioning had served as Manager providing with necessary reagents and equipment.

* Planned, conducted, administered and closed procurement process. Prepared procurement statement of work, managing specifications, quality, performance data, collateral services required. Prepared Contract documentation, proprietary information, Bid document preparation, performance bonds and insurance needs, key milestones, integration with project, list of constraints and assumptions required.

State Research Center, Institute of Immunology (Moscow, Russia) Nov 91 - Sep 07

Doctor of Medical Science/Senior HIV Researcher, Biotechnology Dept. (2005-2007)

* Worked as a senior researcher in the Department of Biotechnology.

* Served as the responsible executor of the clinical trials of the first Russian HIV candidate vaccine VICHREPOL (phase 1) in which safety and tolerability of vaccine was proved.

Head of the Immunodeficiency Department (1999-2005)

* Served as the Head of Immunodeficiency Department at the State Research Center responsible for monitoring more than 2,000 HIV-infected patients in different stage of disease (Treatment).

* Performed physical examination of patients, completed case reports, prepared groups (or cohorts) for different phase of clinical trials.

* Collected Data for all clinical immunological investigations.

HIV Senior-Researcher (1993-1996)

* Worked in a research capacity responsible for testing a new test-system called "Peptoscrin-1-2" for detection of antibodies against HIV, monitoring of health donors.

* Performed more than 6,000 analysis of "Peptoscrin 1-2".

Previous Employment:

* Surgeon/Abdominal Surgeon Resident, CITY CLINICAL HOSPITAL N 1 (Moscow, Russia) 1990-1992.

Publications and Conferences:

* Published 45 papers and more than 100 abstracts, regarding HIV, HCV, HHV, prognostic markers of HIV.

* Lectured at more than 20 International Conferences such as:

Visiting Scientist of NIH-HIV Department. Presentation and discussion of project. "siRNA's against some special fragments of gene Tat, PBS of HIV". NIH Bethesda Maryland - USA, 2007.

Participant and speaker of "Round table" from "Stemedica" Company "Probable treatment of HIV patients by stem cells." San Diego, California - USA, 2007.

Participant and presenting of: "Gabriglobin - as a substitute immunotherapy". Russian National Conference "AIDS, Cancer and Related Problems." Saint Petersburg - Russia, 2006.

Participant and presenting of: "The serum and urinary Trypsin inhibitors level correlate with progression of HIV infection". 3rd IAS Conference of HIV pathogenesis and treatment. Rio De Janeiro, Brazil, 2005.

Participant and presenting of: "HIV-1 defective genomes in a cohort of HIV-1 infected individuals from Russian Federation". XV International AIDS Conference. Bangkok- Thailand, 2004.

Participant and presenting "The study of HAART's implication in accumulation of defective proviral genomes in peripheral blood mononuclear cells of HIV infected patients". 1st European symposium, Clinical Significance of Lipoprotein Disorders in HIV-positive Patients. Munich -Germany, 2003.

Presentation of project: "Low-level Alpha-1-anttrypsin in serum of HIV-infected patients demonstrates the progression of disease". X1V Int. Conference AIDS, Barcelona, Spain. 2002.

Participant of "Round Table" American International Health Alliance" Trainer of Training "Care of HIV positive pregnant women" Washington DC - USA, 2002.

Patents:

Holder of Four International Patents in USA, Canada, Japan and 15 other countries,

Prognostic Marker Proteins of HIV

Gene engineering constructions against HIV and HCV

Education:

2011. Master Certificate of Project Management, at Villanova University.

2011. Certificate (Practice of Clinical Research), Clinical Center at NIH.

2004. Certificate (Immunology - Allergy) 1466 "MEDBIOEKSTREM", Moscow, Russia.

2004. Certificate Doctor of the Highest Category DK 014240, Moscow, Russia.

2002. Diploma Doctor of Medical Science. 0828584. State Research Center, Moscow, Russia.

2001. Certificate (Infection Diseases) 1158/13, Moscow Medical University, Moscow, Russia.

2001. Certificate (Virology) 066419, Ivanovskiy's Institute of Virology, Moscow, Russia.

2000. Diploma, Master of Medical degree, No KT 025125, State Research Center. Moscow, Russia.

1999. Certificate (Immunology - Allergy) A 393742. State Research Center, Moscow, Russia.

1989. Diploma, Medical Doctor, MD. PB 445236. Pirogov's Moscow Medical University, Russia.

1980. Diploma, Medical Assistant, Laboratory Technician, Medical College, Obninsk, Russia

Awards;

In November, 2009 was awarded by Administration of CSR NIH as a "Star" for successful participation and contribution in realization of project "American Recovery and Reinvestment Act" (ARRA-2009)

January 2013

Contact this candidate