Olga Bondareva
SrCRA
Academic
Russian National State Medical University
Russian Federation
Biography
Independently perform site evaluation, initiation, interim monitoring, and close-out visits for Phase II-III studies, as well as attend site audits for assigned studies. Independently perform studies feasibility in different fields of medicine. Perform monitoring responsibilities to support sponsor and investigator compliance with applicable country regulatory requirements, ICH/GCP guidelines Establish and maintain professional and mutually goal-oriented relationships with investigational sites and sponsors. Contribute to effective project management by pro-actively and positively supporting the study team; meeting study timelines and submitting deliverables as instructed. Communicate regularly with the Project Manager, Lead CRA, and Line Manager regarding study and monitoring issues. Participate in planning and execution of Investigator Meetings. Assist in identification of sites. Provide leadership and support for CTAs and CRAs. Conduct on-site training and evaluation of new CRA employees and CRAs in training. Assist the Country (or Training) Manager in performing co-monitoring visits as part of training when necessary. Participate in on-going clinical research training. Provided responses to corrective action plans from internal and Sponsor globalClinical Quality Assurance audits May negotiate study budgets with potential investigators and assist the legal department with statements of agreements. Cardiovascular: • Angina - Phase II,III • Coronary Artery Disease - Phase II, III Hypertension- Phase III Hyperlipidemia-Phase III Chronic Heart Failure-II, III Acute Myocardial Infarction-Phase II Hematology: • Antithrombotic agent (knee replacement) - Phase II Rheumatology: • Lupus Erythematosus - Phase IIIa • Rheumatoid Arthritis - Phase II Psychiatry • Major Depressive Disorder Schizophrenia Oncology Colorectal cancer-III CNS (epilepsy)II Pulmonology CAP, COPD-Phase III
Research Interest
Pulmonology
