Sara Bailey Email & Phone Number

Saratoga Springs, NY, US

Denver, Colorado, US

Denver, Colorado, US

Denver, Colorado, US

• Manage all phases of clinical trials form regulatory start-up to study close-out.
• Experience in the conduct of clinical research including ICH-GCP requirements.
• Working knowledge of medical terminology, FDA regulations and ICH guidelines.
• Provide extensive in-service training and supervision of research staff.
• Maintain all study documentation including source documentation, electronic case report forms, study and regulatory binders and patient charts.
• Facilitate timely completion of electronic case report forms and reporting of severe adverse event reports to the sponsor and IRB

• Accelerated the growth of the research department
• Acted as liaison between principle and sub-investigators and pharmaceutical companies for study-related correspondence
• Facilitated sponsor and/or CRO site visits, correspondence and follow-up
• Managed subject visit scheduling, subject visits and clinical trial data, formulating source documents and data collection charts and severe adverse event reporting.
• Enhanced internal monitoring and quality improvement plan.
• Recognized by physicians for attention to detail, patient advocacy and decision-making abilities in critical situations.

• Designed custom artwork for clients.
• Facilitated pre press file preparation for color separation, working with all major desktop publishing, design and layout applications, to a direct-to-plate process.
• Implemented Variable Data and Cross Media Marketing.