Experience

WORLDWIDE CLINICAL TRIALS EARLY PHASE SERVICES

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Lead Clinical Research Associate

  • Sep 2015 - Present

  Sr CRA, Sep 2015 - current date - Worldwide Clinical Trials Ukraine.• Therapy, Phase III, Diabetes Mellitus II, adult patient,• Therapy, Phase III, Heart failure, adult patient• Therapy, Phase III, Ischemic Heart diseases, adult patient• Therapy, Phase IV, Bronchial asthma, adult patients• Therapy, Phase IV, Bronchial asthma, adolescents• Rheumatology Phase II b, Rheumatology arthritis, adult patient• Small Cell Lung Cancer, phase II:• Chemotherapy-induced nausea and vomiting (Pediatrics), phase II:• Relapsing-remitting multiple sclerosis, III phase:• Complicated intra-abdominal infections1. Co-monitoring, Audit preparation/participation2. Start-Up activities (numerous projects):3. Feasibility (urinary tract infection, multiple sclerosis)4. Budget negotiation, Site/Investigator Agreement preparation5. Site’s Packages preparation for RA (MoH) submission6. Review essential document packages for IP Release (Clinical team review)Tools/database/services:eCRF (Medidata, Oracle), IWRS (Cenduit, Endpoint, Medidate RTSM, Suvoda), TMF (Veeva), Temperature monitoring (SmartView, ELPRO), Other (Bioclinica for Cardiac Safety/Medical imaging, NeuroRx, Banook for Cardiac monitoring)



Arterium

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• CRA II, May 2012 – Sep 2015 Arterium, Ukraine.

  • May 2012 - Sep 2015

  • Participate in oncology and therapeutic studies ( IIb, III phases).• Have an experience in different types of visits (SQVs, SIVs, IMVs, Close out visits).Obtain and maintain essential documentation in compliance with ICH-GCP, Sponsors Procedural. • Documents and local regulations both in the office and at site.• Train, support and advice Investigators and site staff in study related matters.• Contribute to national Investigators meetings.• Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.• Update IMPACT and other systems with data from centers as per required timelines.Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.• Perform source data verification according to SDV plan.• Ensure data query resolution.• Ensure accurate and timely reporting of Serious Adverse Events.• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and CA&A.• Provide the required monitoring visit reports within required timelines.

• CTA, May 2010 – Sep 2012 Arterium, Ukraine.

  • May 2010 - Sep 2012

  CTA