Certified Clinical Research Coordinator

• 2011 - Present

Collection of data to complete Case report Form Monitor drug dispensing and accountability Resolve data queries Review source documents to confirm subject eligibility for the clinical trial Identify any serious adverse events and ensure that these are appropriate reported. Prepare new project documentation for IRB review Prepare and modify informed consent for IRB approval Document and report adverse events and serious adverse event to IRB Monitor clinical trials phase I,II,III,IV Monitor cardiovascular device and drug protocol Obtain informed consent and HIPPA authorization, conduct intake interview, and enroll subjects Monitor health and safety of subjects and ensure subject compliance with study protocol. Maintain database of subject information and generate reports and shipments of data to coordinating centers, as needed. Identify any serious adverse events and ensure that these are appropriate reported.