Quality Assurance Coordinator

NONNA STEPANOV

**** ******* ***** • Johnson City, TN • *********@*****.*** • 614-***-****

CLINICAL, RESEARCH, MANAGEMENT

SUMMARY OF QUALIFICATIONS

•Foreign graduate Medical Doctor with more than 20 years of clinical and research experience. US citizen. Fluent in English and Russian.

•Experienced in Phase 2,3,4 protocols in oncology, neurology, gynecology, cardiology, trauma/orthopeadic, rheumatology fields.

•Effectively able to communicate complicated concepts in an understandable manner, matching the message to the audience.

•Solid management and supervisory skills. Experienced in hiring, training, motivation and evaluation.

•Adept and experienced in problem solving and providing solutions. Excellent qualifications in leadership and interpersonal communications.

•Persuasive, with ability to communicate effectively with culturally diverse audience.

•Exceptional education with knowledge of study protocols, work in accordance with Federal Regulations, Good Clinical Practices, ICH Guidelines and Standard Operating Procedures and guidance documents, excellent work ethic, strong commitment to quality patient care and a proven desire for achievement and continued professional growth.

•Secured many professional contacts in the pharmaceutical research field; skilled in staff developmental training and knowledge of regulatory laws. Nine years experience as a Medical Doctor; three years experience as a nurse, seven years as Clinical Research Coordinator in neurology and oncology fields; three years as Clinical Research Manager at OB/GYN Clinical trial Office, CCRC; Corporate Director of multi-specialty research site( cardiology, orthopaedic, rheumatology, oncology)

•RDC, InForm and Oncore data base trained; skilled in managing clinical trials data, formulating source documents, IRB protocol submissions IRB phases and IND Safety Reporting.

•Monitor research activities at the site. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements

•Excellent organizational and problem-solving skills. In depth therapeutic and protocol knowledge as provided in research training.

•Extended experience of conducting the internal audits and assisting sponsors in completion of site monitoring visits.

•Extended experience with obtaining and monitoring different type of funds

PROFESSIONAL EXPERIENCE

CORPORATE DIRECTOR, DEPARTMENT OF RESEARCH

MOUNTAIN STATE HEALTH ALLIANCE

June 2011- Current

•Planned, organized and coordinated research activities at the Research Department within MSHA

•Collaborated with sponsoring agencies; served as liaison with the IRB, ETSU,FDA, drug companies

•Overseen research staff, assisted with hiring, training and development of new employees

•Completed internal audits for open studies

•Participated in monitoring visits with sponsors

•Conducted Implementation meetings, research staff meeting

•Served as a liaison between different departments and clinics within MSHA

•Assisted in developing plans to meet requirements of new studies/protocols; prepared for external quality assurance and review

•Developed Procedural Manual and Standard Operation Procedures

•Managed research staff

•Managed department and research budget, set up billing procedures

•Reviewed and developed research contracts

•Participated in study-specific activities including conducting internal audits

•Participated in IRB meetings

•Completed study visits

•Reported study data, developed source documents, responded to queries

•Maintained research charts

•Distributed Investigational Product(s)

CLINICAL RESEARCH MANAGER,

GENERAL DIVISION OF DEPARTMENT OF OBSTETRICS AND GYNECOLOGY

June 2008- June 2011

THE OHIO STATE UNIVERSITY, MEDICAL CENTER

•Planned, organized and coordinated research activities at CTO

•Collaborated with sponsoring agencies; served as liaison with the IRB, FDA, drug companies

•Responsible for compliance with all state and federal regulations; assisted with writing for and securing continued and additional funding; participated in writing manuscripts

•Conducted Implementation meetings

•Responsible for all start-up activities, drug distribution, enrollment. Identified, assessed eligibility, and recruited patients for assigned protocols; assessed risk/benefit ratios; ensured informed consent; educated patients regarding assigned protocol; evaluated patients for clinical complications related to protocol; provided collection and distribution of biologic samples. Monitored care of study participants and insured proper follow-up visits are scheduled and conducted

•Collected and summarized research data

•Assisted in developing plans to meet requirements of new studies/protocols; prepared for external quality assurance and review

•Developed Standard Operation Procedures

•Assisted with site visit preparations; attended training conferences, seminars, and study-related meetings; organized investigator, expert, and safety monitoring meetings

•Overviewed necessary billing, and stayed within budget guidelines of study; verified any expenditures charges to the study

•Reviewed case report forms for completeness, clarity, legibility, to available source documentation, and adherence to protocol requirements

•Conducted query resolution, track clinical trial supplies and patient recruitment

•Performed drug accountability and reported adverse events promptly

•Submit essential regulatory documents to IRB

•Overseen research staff, assisted with hiring, training and development of new employees

CLINICAL RESEARCH COORDINATOR, ONCOLOGY

2005-2008

ARTHUR G. JAMES CANCER HOSPITAL AND RICHARD J.SOLOVE RESEARCH INSTITUTE. COMPREHENSIVE CANCER CENTER AT THE OHIO STATE UNIVERSITY

•Managed research subjects in complicated long term medicated treatments as part of research studies for breast cancer ( physician-initiated, ECOG and CALGB studies)

•Obtained patient consent, patient registration/randomization, recruitment, follow/up, case report form completion and collaborated with regional CRA. Performed SAE reporting, handled investigator files, prepared site for attending audits

•Participated in collection and distribution of biologic samples

•Evaluated and interpreted collected clinical data; prepared oral presentations and written reports, analyzed progress, trends and recommendations/conclusions

•Assisted with comprehensive regulatory submission processes to provide quality regulatory documentation for IRB

•Conducted research studies that are compliant with protocol, Federal regulations and Good Clinical Practice, ICH Guidelines, internal instructional policies and regulations

•Participated in establishment of start-up gene-specific treatment/chemotherapy

•Coordinated large number of patients during the long term follow up trials

COORDINATOR CLINICAL STUDIES /LABORATORY MANAGER, NEUROLOGY

2002-2005

MOVEMENT DISORDER CENTER, THE OHIO STATE UNIVERSITY, MEDICAL CENTER

•Managed daily activities of research study and conduct studies that is compliant with the protocol, FDA regulations and Good Clinical Practice, instructional policies

•Managed trial documentation and reports, IRB, WIRB submissions.

•Screened hospital records

•Supervised laboratory activities including handling radioactive materials, splitting the cells, ELISA test

•Collected blood samples for genetic test for Huntington’s disease

•Served as Sub-Investigator on non-pharmaceutical trials

•Participated in development of new informed consent forms, writing manuscripts

•Communicate with Principal Investigators at site and clinical trial sponsors (pharmaceutical companies) on regular bases. Utilize knowledge gained as a Medical Doctor to perform job at highest level

Additional Employment

ADJUNCT FACULTY/LAB ASSISTANCE

1999-2007

COLUMBUS STATE COMMUNITY COLLEGE, OH

Biological & Physical Science Department

1999-2004 Laboratory Assistant ( same department)

RESEARCH ASSISTANT

1995-1997

KYRGYZ SCIENTIFIC RESEARCH ACADEMY

M.D., NEUROLOGIST

1989-1997

CHILDREN’S HOSPITAL #3, BISHKEK, KYRGYZSTAN

NEUROLOGY DEPARTMENT

•Worked as Medical Doctor

NURSE

1986-1989

CHILDREN’S HOSPITAL #3, BISHKEK, KYRGYZSTAN

NEUROLOGY DEPARTMENT

EDUCATION AND TRAINING

DOCTOR OF MEDICINE 1989

KYRGYZ STATE MEDICAL UNIVERSITY Bishkek, Kyrgyzstan

CERTIFICATE OF CLINICAL RESEARCH COORDINATOR 2005

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS USA

status active

PROFESSIONAL AFFILIATIONS

Ex-officio member of the ETSU IRB Standing Committee

Huntington’s Disease Society of America

Association of Clinical Professionals Cancer and Leukemia Group B

Cancer Trial Support Unit

Cancer Committee, Regional Cancer Center, JCMC

Site Solution Summit participant, 2011

NCI

Southeast Cancer Control Consortium

Major Extremity Trauma Research Consortium (METRC)

__________________________________________________________________________________

PUBLICATIONS

Stepanov NV. Risk of development of hydrocephaly in early neonatal period in group of children who were born by women employed in tobacco industry. Mectep, Kyrgysztan, 1995

Stepanov NV. Using of Y-aminobutyric acid(GABA) in group with a high risk of the development of movement disorders.

Choncherek”, Kyrgyztan, 1996

Publications as part of clinical research groups.

At Risk for Huntington Disease: The PHAROS (Prospective Huntington At Risk Observational Study) Cohort Enrolled. Arch Neurol 63:991-998, 2006.American Medical Association

Huntington’s Study Group, Baseline Characteristics of the Prospective Huntington At Risk Observational Study (PHAROS) Cohort. Amer. Neuro. Assoc. Abst. 2004.

Tetrabenazine as anti-chorea therapy in Huntington’s disease: A Randomized control trial. M/S # 2005/100453.

Amer.Neuro.Assoc. 2005

At risk for Huntington’s Disease: The PHAROS COHORT Enrolled.

The Huntington’s Study Group. Archives of Neurology,Oct.31,2005

Living at Risk: Concealing Risk and Preserving Hope in Huntington’s Disease. Journal of Genetic Counseling. Springer Netherlands. Febr,2008.Vol 17, N 1, 1059-7700.

PROFESSIONAL ACTIVITIES

Co-Investigator, Huntington’s Study Group (HSG) Unified Huntington’s Rating Scale (UHDRS’99) Database 2003-2005.

The Huntington Study Group

Co-Investigator, Qualitative Interviews for the Prospective Huntington At Risk Observational Study (Pharos). 2004- 2005

Co-Investigator, The Immune system and neurodegeneration in basal ganglia disorders. Central Ohio Parkinson Society 2002-2005

Coordinator, A Multi-Center, Double-Blind, Randomized, parallel Group, placebo-Controlled Trial of ethyl-EPA (Miraxon) in Subjects with Mild to Moderate Huntington’s disease (HD),TREND-HD.2005-2005.

Coordinator, Prospective Huntington At Risk Observational Study (PHAROS). Huntington’s Study Group. 2002-2005

Coordinator, A Randomized, Double-Blind, Placebo-Controlled, Study of Tetrabenazine for the Treatment of Huntington’s Chorea (TETRA). Huntington’s Study Group and Prestwick Pharmaceuticals . 2003-2004.

Coordinator, Open-Label, 48 Week Extension Study of Tetrabenazine for the Treatment of Huntington’s Chorea. Huntington’s Study Group and Prestwick Pharmaceuticals. 2004-2005

Coordinator,COHORT-Cooperative Huntington’s Observational Research Trial, HSG, High Q Foundation, 2005-2005

Coordinator,Trend-HD-A Multi-Center, Double-Blind, Randomized,Parallel Group, Placebo-Controled Trial of Ethyl-EPA (Miraxion) in Subjects with Mild to Moderate Huntington’s Disease (HD), HSG, Amarin Neuroscience Ltd, 2005

Coordinator,CALGB 9343: Evaluation of Lumpectomy, Tamoxifen, and Irradiation of the Breast Compared with Lumpectomy Plus Tamoxifen in Women 70 Years of Age or Older Who Have Carcinoma of the Breast That is Less Than or Equal to 2 cm and Clinically Negative Axillary Nodes. 2005-2008

Coordinator, CALGB 9494: (INT-0142, E3193) Phase III Comparison of Tamoxifen versus Tamoxifen with Ovarian Ablation in Premenopausal Women with Axillary Node-Negative Receptor-Positive Breast Cancer <3 cm, Intergroup. 2005-2008

Coordinator, CALGB 9661: A Pilot Study of Low-Dose Interleukin-2 Plus Recombinant Human Anti-HER2 Monoclonal Antibody in Solid Tumors. 2005-2008

Coordinator, CALGB 9840: A Phase III Study of Paclitaxel via Weekly 1 Hour Infusion vs. Standard 3 Hour Infusion Every 3 Weeks with Herceptin (Trastuzumab) (NSC #688097) in the Treatment of Patients with/without HER-2/Neu-Overexpressing Metastatic Breast Cancer, 2005-2008

Coordinator, CALGB 49801: Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast, 2005-2008

Coordinator, CALGB 49802: Phase III Study of Adriamycin/Taxotere vs. Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer.2005-2008

Coordinator, CALGB 49805: A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen. 2005-2008

Coordinator, CALGB 49906: A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed By Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive Breast Cancer. 2005-2008

Coordinator, CALGB 40105: Evaluation of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast cancer: An Innovative Randomized Phase II Trial Design. 2005-2008

Coordinator, CALGB 369901: Observational COHORT Study: Chemotherapy Decisions and Outcomes in Women age 65 or Older with Operable, Newly diagnosed Breast Cancer. 2005-2008

Coordinator, PACCT-1: Program for the Assessment of Clinical Cancer Test (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial, 2007-2008

Coordinator, CALGB 70305, Randomized Study of Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I-III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection, 2007-2008

Coordinator, ECOG 5103, A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer . 2007-2008

Coordinator :A multicenter, open label study to evaluate the efficacy, cycle control, and safety of a contraceptive vaginal ring delivering a daily dose of 150µg of Nestorone® and 15µg of Etinyl estradiol (150/15 NES/EE CVR), 2008-2010

Coordinator :A randomized, international, double-blind (with in-house blinding), controlled with Gardasil™, dose ranging, tolerability, immunogenicity, and efficacy study of a multivalent Human Papillomavirus (HPV) L1 virus-like particle (VLP) vaccine administered to 16-to-26 year old women, 2008-2010

Coordinator: A twelve month, open-label, safety trial of Flibanserin 50 milligrams to 100 milligrams daily in women with hypoactive sexual desire disorder, 2008-2010

Coordinator: A Multi-Center Prospective Clinical Study to Evaluate the Performance and Clinical Predictive Value of the Invader® HPV HR Molecular Assay and Invader® HPV 16/18 Molecular Assay for the Detection of the Human Pappillomavirus in Cervical Cytology Samples, 2008-2011

Coordinator: TASC/ Transatlantic Active Surveillance. International study. 2009-2010

Coordinator: Blood loss at the time of first trimester surgical abortion in anticoagulated women. 2008-2010

Coordinator: DR-103-301, A Multicenter, open-label study to evaluate the efficacy and safety of a combination oral contraceptive regimen for the prevention of pregnancy in women. 2009-2011

Coordinator: GOG # 215: A Phase II randomized Study of the effect of Zolendronic acid versus observation on bone mineral density of the lumbar spine in women who elect to undergo surgery that results in removal of both ovaries. 2008-current

Coordinator: GOG # 214: Phase II double blind randomized trial of evaluating the biological effect of levonogestrel on the ovarian epithelium in women at risk for ovarian cancer. 2008-2011

Coordinator: Telephone Counseling Intervention to Increase Highly Effective Contraceptive Method Use at Six Months Postpartum. ACOG/ Bayer Pharmaceutical Inc. 2010-2011

Coordinator: DR-103-301, A Multicenter, open-label study to evaluate the efficacy and safety of a combination oral contraceptive regimen for the prevention of pregnancy in women, 2009-2011

Coordinator: DSG-PPPS-303, A Multicenter, open-label study to evaluate the efficacy and safety of a combination oral contraceptive regimen (DR-102) for the prevention of pregnancy in women.

Coordinator: A Phase 3, Randomized, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System (20 mcg/day) and Mirena® for Long-Term, Reversible Contraception up to Five Years.

Sub-Investigator: Pregnancy immunomodulation impacts clinical outcomes in patients with history of eczema. 2009-2011

Independent Joint Accessor/Coordinator: CAIN457F2302, A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadeguate response to anti-TNF agents. Novartis Pharmaceuticals Corporation. 2011-current

Coordinator: A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) SOLID-TIMI 52, GlaxoSmithKline, 2011-current

Coordinator: A randomized, double-blind, placebo-controlled study ofAIN2206: efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate, AIN 2206. Novartis Pharmaceuticals Corporation. 2011-current

Coordinator: B3D-MC-GHDQ, Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing, Eli Lilly, 2011-current

Coordinator: 0311.13f-MSHA/BMS747158-301, Lantheus : A Phase 3, Open-Label, Multicenter Study for the Assessment of Myocardial Perfusion using Positron Emission Tomography(PET) Imaging of Flurpiridaz F18 Injection in Patients with Suspected of Known Coronary Artery Disease. Novartis Pharmaceuticals Corporation. 2011-current

Investigator: Cervical Ripening/Inducing Agents and Uterine Rupture: A case –Control Study. Premier Inc. 2011-current

ADDITIONAL TRAINING

SEPARATE DOCUMENT IS AVAILABLE UPON REQUEST

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