Natalia Lisovoy
Toronto,Ontario
Summary
- Senior Clinical Research Associate with over 9 years extensive experience in managing clinical trials across various therapeutic areas and study phases, including early development studies.
- Proven track record of successfully conducting all aspects of study site monitoring visits, ensuring adherence to protocols, regulatory compliance, and data integrity.
- Proficient in overseeing site management activities, including electronic Trial Master File (eTMF) uploads, regulatory submissions, staff training, and data quality assurance.
- Strong background in risk identification and mitigation, issue escalation, and collaboration with cross-functional teams to implement Corrective and Preventative Actions (CAPAs).
- Skilled in site supply management, vendor liaison, and sponsor audit preparation.
- Recognized for exceptional performance with awards including the ICON Inspire Award and ICON Recognized Employee of the Year.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
ICON Strategic Solutions
03.2021 - Current
- Early Development team: multiple clinical research studies phases I - III, in the fields of Hematology, Multiple Myeloma (CAR T-cell therapy), Cardiology and Dermatology studies phases II-III.
- Managed multiple clinical research studies in various therapeutic areas, overseeing all aspects of site monitoring visits, including initiation and interim visits.
- Facilitated effective communication among study team members to ensure timely achievement of study deliverables.
- Conducted site management activities, including eTMF uploads, regulatory compliance, staff training, and data quality assurance.
- Proactively identified and addressed risks to data integrity, escalating issues and collaborating with quality and project teams on CAPAs.
- Managed site supply logistics and liaised with study vendors, contributing to overall study efficiency.
- Prepared for and participated in sponsor audits, demonstrating readiness and compliance.
- Provided internal staff training programs and mentored junior CRAs, contributing to team development and performance.
Clinical Research Associate II
IQVIA, Eli Lilly
2019 - 2021
- Vast Monitoring experience in multiple therapeutic areas, Phases II to III studies : Diabetes Mellitus type 2, Cardiovascular Diseases, Rheumatoid arthritis, Atopic dermatitis and pediatric studies.
- Performed site initiation, site monitoring (onsite/remote) ,and site close-out visits
- Managed and monitored 15-20 sites simultaneously
- Performed all ongoing monitoring responsibilities (tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data query generation and resolution, creating and maintaining appropriate documentation regarding site management
Clinical Research Associate
Biomedical Research Design Ltd
2016 - 2018
- Phase II and III studies in Neurology and Dermatology fields
- Performed site selection, initiation, interim and close-out visits
- Performed site management, recruitment, routine monitoring activities
- Assisted in preparation of trial-related documentation such as study protocols, case report forms, consent documents, study logs and forms including submission packages
- Local EC audit preparation
Study coordinator
Barzilai Medical Center, Nephrology Department
2015 - 2016
- Study Coordination of over 12 clinical trials phase II-III nephrology studies
- Responsible for submissions and reports to Ethics Committee
- Performed recruiting, screening, and scheduling of subjects, performing study assessments according to protocol requirements
- Completed case report forms (e-CRF), Adverse Event Reporting, handling and distribution of samples
- Maintained communication with subjects, sponsors, monitors, and other site personnel
Clinical Nutritionist
B-well
2014 - 2015
- Provided lectures and consultations on healthy lifestyle in organizations and companies in fields of nutrition and fitness
- Conducted personal nutrition consultations
Nutritionist and Fitness Instructor
Holmes Place International
2012 - 2015
- Head of nutrition department
- Provided nutrition consultations
- Administered workshops for weight loss and healthy lifestyle
- Conducted personal and team fitness training
Education
Master of Public Health -
University of Tel Aviv
2015
Bachelor of Science - Nutrition
The Robert H.Smith Faculty, Hebrew University of Jerusalem
2011
Skills
- Critical thinking
- Leadership
- Problem-solving
- Self-Motivated
- Time management
- Planning
- Teamwork
- Mentoring
- Fast Learning
THERAPEUTIC AREAS
Hematology: Multiple Myeloma
Cardiology: Hypertrophic Cardiomyopathy, CVD (Coronary Heart Disease, Stroke and TIA, Peripheral Arterial Disease, Aortic Disease)
Neurology: Multiple Sclerosis
Endocrinology: Diabetes Mellitus Type 2,Dyslipidemia
Genitourinary: Polycistic Kidney Disease, Acute/Chronic Kidney Disease, Nephrotic Syndromes
Autoimmune: Rheumatoid Arthritis, Psoriasis
Dermatology: Atopic Dermatitis
Infectious Diseases: Herpes Simplex
Other: Pediatric clinical trial
Certification
2017 - Regulatory Strategies and Compliance in the Development of Drugs & Biotechnology- Derived Products by the United States (FDA) and European Union (EMA) Course, BRD- Bio - medical research design, Ness- Ziona.
2015 - Good Clinical Practice ICH GCP for Clinical Research and Clinical Research Associate certificate - Pharma Job
2013 - Cognitive Behavioral Therapy - Neuro-linguistic Programming & coaching academy.
2013 - Sports Nutrition, Hadassah Optimal Medical Center and The Academic College at Wingate.
2011 - Physical Fitness Instructor, including training for children. The Academic College at Wingate.
Languages
English: Proficient
Hebrew, Russian, Ukrainian: Native
COMPUTER AND CLINICAL SYSTEMS EXPERTISE
- MS Office (Word, Excel, PowerPoint) • CTMS • eTMF • EDC (Inform, Rave EDC, iMedidata, VeevaVault) • ERT (eDiries) • IWRS • Covance – LabCorp, LabLinks+
Timeline
Senior Clinical Research Associate
ICON Strategic Solutions
03.2021 - Current
Clinical Research Associate II
IQVIA, Eli Lilly
2019 - 2021
Clinical Research Associate
Biomedical Research Design Ltd
2016 - 2018
Study coordinator
Barzilai Medical Center, Nephrology Department
2015 - 2016
Clinical Nutritionist
B-well
2014 - 2015
Nutritionist and Fitness Instructor
Holmes Place International
2012 - 2015
Master of Public Health -
University of Tel Aviv
Bachelor of Science - Nutrition
The Robert H.Smith Faculty, Hebrew University of Jerusalem
2017 - Regulatory Strategies and Compliance in the Development of Drugs & Biotechnology- Derived Products by the United States (FDA) and European Union (EMA) Course, BRD- Bio - medical research design, Ness- Ziona.
2015 - Good Clinical Practice ICH GCP for Clinical Research and Clinical Research Associate certificate - Pharma Job
2013 - Cognitive Behavioral Therapy - Neuro-linguistic Programming & coaching academy.
2013 - Sports Nutrition, Hadassah Optimal Medical Center and The Academic College at Wingate.
2011 - Physical Fitness Instructor, including training for children. The Academic College at Wingate.
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