Served as a Project Manager and QA Auditor handling multiple clinical trials. Acted as liaison between the Investigators Sites, Project Team Members, Sponsors, CROs and their affiliates. Led, directed, supported and guided the Trial Team Members to ensure study delivery on time, on budget and in appropriate quality.Supervised correspondence with pharmaceutical companies/sponsors and their affiliates.Monitored quality and timelines of data submissions.Performed Internal Audits.Prepared presentations for Investigator Meetings. Updated Company brochure and website.Wrote/Designed Protocol, CRF and other study related documents. Developed company's SOPs.Handled numerous projects reporting directly to the CEO and President of the company.

Supported the Trial Team Members to ensure study delivery on time, on budget and in appropriate qualitySupervised correspondence with pharmaceutical companies/sponsors and their affiliatesActed as liaison between the Investigators Site, Project Team Members, Sponsors, CROs and their affiliatesMonitored quality and timelines of data submissions Prepared presentations for Investigator MeetingsUpdated Company brochure and websiteWrote/Designed Protocol, CRF and other study related documents Developed company's SOPs

Clinical trial coordination for multiple sites and projects including, but not limited to:Managed patient recruitment/retention Performed informed consent process, patients' visits, vital signs assessments, and phlebotomyManaged collection, documentation and maintenance of clinical data while ensuring compliance with study protocols Maintained of regulatory documentsReported adverse events in a timely mannerCorresponded with Sponsor, IRB, and InvestigatorsManaged specimen handling and shippingPerformed other administrative tasks in support of conducted clinical studies

Clinical trial coordination at one site including, but not limited to:Managed patient recruitment/retention Performed vital signs assessments and phlebotomyManaged collection, documentation and maintenance of clinical data while ensuring compliance with study protocols Maintained regulatory documents Reported Adverse Events in a timely mannerCorresponded with Sponsors, IRB, and InvestigatorsManaged specimen handling and shipping Performed other administrative tasks in support of clinical studies conducted