Clinical Research Management
Resume:
Olga Ajipa
** ********* *****, *** * ? Hackensack, NJ 07601 ? H: 201-***-****
? C: 267-***-**** ? ******@*******.***
Motivated biomedical and clinical research professional with
unique combination of scientific background and clinical research
experience. Strong analytical and technical skills, essential
working knowledge in conducting clinical research will allow me to
achieve my career goals in the area of planning, implementation,
management and reporting clinical trials.
PROFESSIONAL EXPERIENCE
Clinical Research Associate
09/2008-01/2010
Plenum Scientific Research, Inc., Hackensack, NJ
Involved in collaboration with Clinical Trial Team in the development
and execution of clinical trials
Developed Protocols, Case Report Forms (CRF), Informed Consents
Documents (ICD), CRF instructions, and SOPs
Reviewed and evaluated scientific literature necessary for protocol
development
Participated in coordinating clinical trial activities within the
studies agreed timelines including:
Site selection
process; Essential documents collection (e.g, Confidentiality
agreement, ICD, Clinical trial agreements); Maintaining clinical
study files; Planning/coordinating investigator meetings
Assisted and conducted site monitoring (e.g., study initiation,
routine). Acquired knowledge of close-out visits. Monitored study
progress to ensure compliance with the Protocol requirements, FDA
regulations, ICH/GCP and SOP standards. Traveled 20-30% for site
monitoring. Prepared study monitoring reports.
Collected and documented clinical data as required; Reviewed
completed CRFs for consistency
Maintained drug accountability, handled lab specimens
Developed strong time management skills in handling multiple projects
and adherence to deadlines
Research Associate/Coordinator
05/2007-09/2008
Montefiore Medical Center, Bronx, NY
Department of Oncology
Eastern
Cooperative Oncology Group clinical trials (ECOG)
Participated in eligibility verification of the patients undergoing
Leukemia/Lymphoma clinical trials
Handled patient database, patient files, lab specimens
Coordinated lab specimens submission for Pathology Review
Analyzed and reported clinical data; compiled, reviewed and archived
all original CRFs
Coordinated required regulatory documentations: Study protocols,
HIPAA agreements, Informed consents, pathology material submission
documents
Communicated with other investigational sites for regulatory
documents tracking and queries resolution
Reviewed study protocols for compliance; Ensured adherence to
ICH/GCP and FDA regulations
Experienced in clinical trials through exposure to a variety of
protocols in oncology therapeutic area
Research Associate
03/2005-04/2007
Hackensack University Medical Center, Hackensack, NJ
Department of Clinical Cancer Research
Studied immune system reconstitution in patients with
hematological malignancies after allogeneic
Hematopoietic Stem Cell Transplantation (translational
studies)
Handled patient database and patient files
Developed CRF specific for the study, developed and maintained
laboratory specific SOPs
Designed study relevant to hypothesis; statistically collected,
processed, analyzed, and reported data
Reviewed and evaluated literature relevant to the study protocol
Coordinated and prepared study results for reporting; scientific
writing and presentations
Data Coordinator experience
Reviewed documentation for study subjects (i.e. research nurse's
note, adverse events documentation, CRFs)
Assisted in the preparation for a monitoring visits
Reviewed documentation utilized within the division for completing
IRB continuing reviews, 1572 forms,
financial disclosures, study update reports
Participated in completion of e-CRF completion logs
QUALIFICATIONS
Applied knowledge GCP/ICH guidelines and FDA regulations
In-depth knowledge of overall drug development process
Knowledge and experience in Osteoarthritis, Cardiovascular and Oncology
therapeutic areas
Preclinical expertise in Oncology, Immunology and Transplant Immunology
therapeutic areas
Knowledge of scientific approaches, strong analytical skills gained
though experience in clinical research and basic biomedical research
Team-based work experience
Applied knowledge of Windows-based computer applications
PROFESSIONAL EXPERIENCE (PRECLINICAL)
Visiting Scientist
01/2004-03/2005
University of Pennsylvania, Philadelphia, PA
Department of Pharmacology
Studied complement's participation in acquired immunity
Research Associate
09/2000-01/2004
University of Pittsburgh, Pittsburgh, PA
Thomas E. Starzl Transplant Institute, Department of Surgery
Studied roles of donor passenger leukocyte in solid allograft
acceptance
Research Associate
01/1998-08/2000
University of Pittsburgh
Department of Pediatrics
Studied hematopoietic cell signaling
Postdoctoral Fellow
06/1995-05/1997
University of Southern California, Los Angeles, CA
Department of Molecular Microbiology & Immunology
Studied: Extracellular enzymes in T cell regulation; and Effects of
HIV Tat protein on immune responses
Staff Scientist
09/1990-05/1995
Cancer Research Center, Moscow, Russia
Laboratory of Immunoregulation Mechanisms
Studied cytotoxic T lymphocytes differentiation
EDUCATION and CERTIFICATIONS
NIH web-based training in certification on PHRP (Protection of Human
Research Participants)
4 Certificate, Clinical Research Associate - American Institute of
Pharmaceutical Technology. Hackensack, NJ
Certificate in Clinical Trial Management - Temple University, School of
Pharmacy. Philadelphia, PA.
Ph.D. in Immunology - Research Center for Molecular Diagnostic &
Therapy. Moscow, Russia.
B.S/M.S. in Physiology - The Moscow State University. Moscow, Russia.
PROFESSIONAL MEMBERSHIPS
2007-2009 Association of Clinical Research Professionals
2000-2002 American Society for
Biochemistry and Molecular Biology
2000-2002 Genetic Society of America
1990-1995 Russian Society of Immunologists
HONORS AND AWARDS
1993-1995 International Science Foundation (ISF) individual research
grant award
1989 Patent -Strain of hybrid cells produced monoclonal
antibodies to poly-saccharide from Franciella tullarensis (co
investigators: E. Severin, E. Chernavskaya, P. Sveshnikov). Registered
in USSR: SU 1554364
SELECTED PUBLICATIONS (please note that my last name in
publications has different spelling)
1. O. Azhipa, S.D. Rowley, M.L. Donato, R. Korngold, and T. Friedman. T
cell repertoire of patients with chronic graft-versus host disease.
Manuscript in preparation.
T. Friedman, O. Azhipa, J. Zilberberg, et al. Reconstitution of T cell
subset repertoire diversity following multiple antigen-mismatched bone
marrow transplantation. Biol. Blood Marrow Transplant., 2006, v. 12:
1092-1095.
2. O. Azhipa, K. Kimizuka, A. Nakao, et al. Clinical Immunology,
2005, v.114, 199-209.
3. T. Okuda, T. Ishikawa, O. Azhipa, et al. Transplantation. 2002, v.
74(1), 103-111.
4. Z. Liu, O. Azhipa, S. Okamoto, et al. Journal of Immunology.2001,
v.167, 4942-4947.
5. Grishin, O. Azhipa, I. Semenov, and S.J. Corey. Proc. Natl. Acad.Sci.
USA, 2001, v.98, 101**-*****.
6. S. Okamoto, O. Azhipa, Y. Yu, et al. Journal of Immunology. 1998,
V.160, 4190- 4198.
7. O. Azhipa and B. Brondz. Immunology Letters, 1994, V.42, 117-122.
SELECTED MEETING PRESENTATIONS
O. Azhipa, S.D.Rowley et al. CD3 size spectratype analysis of patients
with chronic graft-versus host disease reveals complexity of the T
cell repertoire. BMT Tandem Meeting. Keystone, CO, 2007.
T. Friedman, J. Hsu, S. Rowly, S. Goldberg, O. Azhipa. Comprehensive
Immune reconstitution without development of GVHD using limited T cell
add back at the time of unrelated multi-antigen mismatched Pan T cell-
depleted transplant. 47th ASH Annual Meeting, Atlanta, GA, 2005.
1. O. Azhipa, T. Okuda, et al. Phenotype and function of donor MHC
class II+ cells involved in liver allograft acceptance under
tacrolimus immunosuppression. Presented at the 7th Conference for
Basic Sciences in Transplantation, Switzerland, 2001; at XIX
International Congress of the Transplantation Society, 2002, Miami,
FL; at American Transplant Congress, Washington, DC, 2002.
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