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Clinical Research Associate

SUMMARY OF QUALIFICATIONS • Foreign graduate Medical Doctor and licensed RN with more than 22 years of clinical and research experience. US citizen. Fluent in English, Russian and Romanian • Extensive training in Good Clinical Practices, ICH Guidelines, SOPs through various Sponsors • In depth therapeutic and protocol knowledge as per Sponsor’s assignment. Excellent organizational and problem-solving skills.

Ideal Companies: Biotech companies

Tags for this Online Resume: research associate, biotech, CRA, Las Vegas, pharmaceutical, health

You shouldn't have to read my entire resume to know I'm the one!

I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...

Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies

Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder