Irina Mikhaylova

I’m Irina Mikhailova. For 7 years I worked as a Senior Clinical Research Assurance where I was conducting site visits, including pre-study, initiation, monitoring and termination, confirming adherence to all FDA, ICH-GCP and local regulations, ensuring the completion and collection of regulatory documents, performing data verification of source documents, ensuring implementation and complience with FDA, ICH-GCP Guidelines, participating in budget negotiation and follow-up where applicable, assisting with data validation and query resolution, mentoring junior team members as required. Through these experiences I learned to built rapport quickly with customers and worked in a fast-paced environment that required me to collaborate with my colleagues. During my annual evaluation my supervisor complimented me on my strong work ethic, organization and time management skills. I look forward to contributing my skills and experience in a new position and hope to have the opportunity to speak with you further about how I can be an asset to your team.