Clinical Research Professional with over 18 years experience. Diverse roles include study coordinator, regulatory specialist, in-house and regional CRA, and clinical trials manager. Successful implementation of global phase II and III clinical trials from study start up through FDA approval. Diligent and detail oriented problem solver with proven ability to multitask and execute projects independently according to established timelines.Demonstrated abilities include:- Operational Planning, Oversight and Execution of Projects- CRO, Vendor, and Site Management - Investigator Meeting Planning and Presentation- Clinical Research Associate Training and Co-Monitoring- Informed Consent Development, Review and Negotiation- Case Report Form (CRF) Development and Completion- Study Document Development (Tools, Templates, and Guidelines)- Site Monitoring Visits (Site Qualification, Initiation, Monitoring, Close-out)- Regulatory Document Management and Review- Local and Central IRB submission- Audit Preparation, Completion and Follow-up