Served as the main point of contact and escalation for the study, coordinated regular meetings with sponsor, internal team and vendors to review open issues and action items, interact cross functionally to identify issues and risks related to study activity, manage governance activities to review risks and provide updates to sponsors, develop and work within budget and scope of project, raise invoices monthly and work with finance to develop change orders to adjust the scope of the project as… Show more Served as the main point of contact and escalation for the study, coordinated regular meetings with sponsor, internal team and vendors to review open issues and action items, interact cross functionally to identify issues and risks related to study activity, manage governance activities to review risks and provide updates to sponsors, develop and work within budget and scope of project, raise invoices monthly and work with finance to develop change orders to adjust the scope of the project as needed Show less

Site management, data management, vendor management, oversight of clinical monitoring activity, review of monitoring reports, responsible for tracking and overseeing enrollment of study, supply management, responsible for establishing and maintaining TMF and eISF files, study and protocol training for sites as well as staff, NIH Toolbox and Audiometer training and tracking, travel to sites for monitoring, SIV and COV visits, and site budgets and contracts.

Regulatory and IRB experience, responsible for supply management, site payments, updating and filing of TMF and eISF files, responsible for tracking study enrollment, data management.

Maintain calendars for several VPs, Directors and Assistant Directors, arrange domestic and international travel, shipping needs, processing expenses and credit card reconciliation, acting clinical trial coordinator responsible for IRB submissions, maintaining patient data from clinical trials, updating Clinicaltrials.gov, shipping supplies for various studies, processing site payments for assessments, and tracking all regulatory documents. Acting Medical Operations coordinator responsible for… Show more Maintain calendars for several VPs, Directors and Assistant Directors, arrange domestic and international travel, shipping needs, processing expenses and credit card reconciliation, acting clinical trial coordinator responsible for IRB submissions, maintaining patient data from clinical trials, updating Clinicaltrials.gov, shipping supplies for various studies, processing site payments for assessments, and tracking all regulatory documents. Acting Medical Operations coordinator responsible for tracking clinical training for all sites and processing training certificates. Responsible for maintaining and processing payments for maintenance fees and annuity payments for all patents. Responsible for obtaining safety articles and maintaining article database. Responsible for reviewing and maintaining all applications for enrollment in the Patient Assistance Program including obtaining all necessary documentation and shipping supplies. Show less