Noel Smith Email & Phone Number

Santa Rosa, Ca

Project lead for fast-track protocol study. Responsible for driving start-up activities. Works closely with 35+ sites to answer study start-up related questions that arise. Facilitates negotiations of CSAs and budgets. Responsible for maintaining a tracker for all aspects of the study including documents received, IRB approvals, and enrollments, that is distributed to the leadership team. Works closely with the sales team to get sites up and running as quickly and efficiently as possible. Taking on responsibilities of a CRA to conduct Site Initiation Visits, implementing a risk-based monitoring approach and remotely monitoring data as well as conducting on-site monitoring visits. Attends live cases to give clinical study support when needed. Responsible for maintaining the Trial Master File (TMF). Aids in the creation of source documents and maintains version control. Proficient at using Merge eClinical OS. Harmonizes our SOPs to be more in line with our current clinical practices. Assists with creating and editing monitoring plan and eCRF Guidelines. Plans and executes Investigator Meetings. Member of the audit preparedness team with FDA back room audit experience. Works closely with our graphic designer to create marketing materials for patients and physicians regarding the study. Leads study coordinator update calls bi-monthly and distributes a newsletter with updates on study progress bi-monthly.

Continued in all of the aspects mentioned under clinical research coordinator below while expanding knowledge in different indications including cardiovascular disease, Parkinson’s disease, Alzheimer’s disease, peripheral vascular disease, obesity, diabetes, hypercholesterolemia, cardiac device studies, nutritional supplement studies, vaccine studies, and consumer product testing. Broadened understanding of FDA, ICH, and GCP regulations, guidelines, policies, and practices for conducting clinical research. Ensured that IRB approved protocols were implemented and followed. Executed informed consent process and monitored patient status and safety. Conducted study specific training and site in-services to study related staff on new and amended protocols. Educated patients about treatments and possible side effects. Recruited potential patients and expanded database. Documented adverse events according to protocol guidelines. Completed case report forms and ensured accuracy of data and reporting of adverse events to sponsors. Became familiar with several eCRF programs including Inform and Oracle. Completed IRB initial submission forms, continuing review forms, close- outs and SAE reporting. Maintained clinical trial files for each study. Dispensed investigational product and instructed subjects on usage and potential drug interactions. Established a rapport with sponsors and maintained frequent face-to-face, written, and telephone contact with various persons involved in study, including patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of our company. Helped participate in outreach talks around the community to enhance public knowledge of research. Managed a high profile, high volume vaccine study for its second year (enrolled over 140 patients each year).