• Ensures timely and accurate study-related communication to clinical personnel (i.e., internal and external study teams, consultants and investigative site personnel): prepares and disseminates clinical trial correspondence, newsletters, etc. (working with project clinician), and assists with creating study-specific manuals, tools, and templates, along with providing training (as needed)• Participate in selection and management/oversight of external vendors or sites and develop vendor specifications; review vendor reports, budgets, and metrics; acts as liaison between vendors and sites (e.g., assists site with laboratory sample queries)• Coordinate specified clinical trial meetings (e.g., investigator meetings, Study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes• Set-up, track, and maintain audit-ready clinical trial documentation and study status in clinical trial management system: manage and track regulatory/IRB/EC documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents; generate, review and distribute reports; assist with quality assurance audits and resolution of audit findings• Participate in study design and execution by contributing operational experience and expertise: provide input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; participate in site monitoring visits, as appropriate; post and maintain study-related information on external websites when applicable• Ensure that necessary study supplies are available as per study timelines: source clinical trial supplies through external vendors (such as Case Report Forms, Study Manuals, lab kits, etc.);• Serve as a liaison and resource for investigational sites

• Collaborate with project team in the clinical study development process• Assist in the development and editing of study-related materials• Assist with planning, coordination and presentation of information at Investigators’ meetings• Assists with site management at the direction of other clinical personnel• Assists the Clinical Team in providing support to the clinical sites and the clinical team members during the conduct of clinical trials• Assists with the management and tracking of study projects through the use of the CTMS or other electronic means• Independently produces meeting minutes• Assists with management of investigational drug and study supplies by preparing and ensuring the accuracy of shipments of study-related materials (e.g., drug orders, study binders, clinical documents and spreadsheets)• May participate in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned CRA or designee• Assists the CRA with the flow of data, including but not limited to facilitating CRF retrieval and query resolution under guidance of CRA or designee• Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 forms)• Assists with data query resolution process• May assume a specialized administrative role (e.g., SOP Administrator, CTMS Administrator, TMF Administrator, etc…)

Tasks include:• Collaborate with project team in the clinical study development process• Assist in the development and editing of study-related materials• Assist with planning, coordination, and presentation of information at Investigators’ meetings• Assist with daily site management; both independently and at the direction of other clinical personnel• Assist the Clinical Team in providing support to the clinical sites, clinical vendors, and other clinical team members during clinical trials• Assist with the management and tracking of study projects through the use of excel, Medidata CTMS, and Montrium• Independently produce meeting minutes• Calculate subject visit costs• Assist with management of investigational drug and study supplies by preparing and ensuring the accuracy of shipments of study-related materials (e.g., drug orders, study binders, clinical documents and spreadsheets)• Assist with planning, coordination, and presentation of information at internal and external meetings (e.g., cross-functionally, at vendor meetings)• May participate in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned CRA or designee• Assist the CRA with the flow of data, including but not limited to facilitating CRF and other document retrieval and query resolution under guidance of CRA or designee• Assist with the collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 forms)• Assist with data query resolution process• Assist with lab sample shipments and lab sample reconciliation• Assist with vendor management; both independently and at the direction of other clinical personnel• May assume a specialized administrative role (e.g., SOP Administrator, CTMS Administrator, TMF Administrator, etc.)

Clinical Administrative Assistant to the VP of Clinical Development.Tasks included:• Provide all around clerical support functions for clinical department• Handle special projects and execute research and data analysis tasks• Analyze problems, compile and analyze data and prepare reports• Coordinate activities internally and externally• Interact with company employees at all organizational levels to gather information• Track clinical finances and reconcile with Finance department• Schedule meetings and manage executive calendars• Manage filing system for executives and clinical trials

Summer and Winter Breaks 2010-2013 while in college.Tasks included:• Process and track essential documents (monitoring reports, 1572’s, IRB documents, IP shipment records, study correspondence), invoices, site payments and supply requests• Document editing and quality control (Protocols, Investigator Brochures, SIV slides, Organizational Charts, CSR’s and NDA modules)• Maintain/create tracking tools (RFP responses, potential investigators, reference lists, essential document lists)• Data handling including CRF review, data entry, quality control auditing and activity reporting• Perform remote drug accountability• Provide front desk break/vacation coverage by handling corporate wide incoming calls and special projects as requested

Part-time job while in high school.Tasks included:• Filing and miscellaneous projects