Leads multiple project teams (CRAs, other project support staff) and coordinates with cross functional groups to ensure delivery of multiple clinical programs according to established measures for timelines, budget and quality. Serves as Program Lead for multiple observational research studies, responsible for delivering programs according to established timelines, budget, and quality standards Oversees study team, reviews project site budgets and expenses including site and vendor invoices Leads or assigns development of study protocols and informed consent templates Supports cross-functional team collaboration and guides risk-based monitoring activities associated with other departmental teams to ensure project-specific data quality procedures are achievedVendor management, including functional area contribution to contract/budget/scope of work development, invoice review and budget management, and adherence to contract parameters Creates and implements project plans and guidance documents including monitoring plan, trial management plan, risk plan, study reference manual, and training materials for US and Ex-USDevelops site activation and enrollment projections; track monthly progress and implement mitigation efforts as neededDevelopment, management, mitigation and reporting of program-specific Key Performance Metrics (KPI)Assists with the identification of PRO measures, as well as licensing, translations, and packet preparation for US and Ex-USOrganizes and provides program training for the study teamOversees all aspects of the clinical operations of the study including site identification, study start up, activation, and enrollmentLine Management of CRAs and Data Quality Specialists or other assigned direct reportsAssure compliance with and project team application of best practices of GCP/relevant regulations, SOPs, and project metrics across multiple study types

• Added responsibility in 2020: Cross functional team leadership and project management responsibilities to ensure efficient resource allocation and timely completion of deliverables • Mentored and trained new CRA team members• Developed standard operating procedures, monitoring plans, and study reference materials • Significant experience in risk-based monitoring approaches• Responsible for the co-management of and communication with up to 65 research sites in the U.S., Canada, and the EU across multiple protocols • Site management and monitoring activities including IP reconciliation, review of informed consent, review for protocol compliance, verification of proper staff training and qualifications, and regulatory binder review/ reconciliation (on site and remote experience)• Responsible for developing training content and delivering training/ re-training of site staff and study team on study procedures and per protocol requirements • Supported clinical team and industry partners on protocol development and customized EDC forms to ensure necessary data was captured and functional for the analytic plan• Managed planning and timelines for data cleaning; clinical data listings review; and, coordinated process for reviewing data listings with leadership and clinical team• Responsibilities to review and distribute program-wide and project-specific metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) for external/internal collaborators/clients/vendors• Advisor on clinical safety review & data management• Monitored AEs and SAEs and assuring that they were reported in accordance with the protocol • Evaluated compliance with protocols, SOPs, GCP, and applicable regulatory requirements, and communicated deviations, escalating issues as needed • Responsible to draft reports documenting on-site and remote monitoring activities• Liaison between data management team and manuscript lead authors

In addition to Research Associate responsibilities:• Assist with on-site monitoring and co-monitoring activities including IP reconciliation, review of informed consent, inclusion exclusion criteria review, review for protocol compliance, regulatory binder review• Assist in reviewing AEs/SAEs• Assist Lead CRAs with investigative site recruitment/feasibility for study-start up, in-house site management activities, as well as study close-out activities in accordance with the Sponsor, protocol, standard operating procedures, ICH/GCP guidelines, and all applicable regulatory requirements• Follow up with sites to help address outstanding queries and resolve data issues in EDC• Data listings review and support for database lock activates• Responsible for both the collection and review of all essential documents from investigative sites and performed frequent quality control checks to assess quality and overall health of trial master files• Assist investigators and investigative site staff with regulatory submissions, protocol questions, and vendor support• Ensure that all site and sponsor interactions are performed and documented in a professional, accurate, and timely manner• Complete Central IRB submissions and support sites through local IRB submissions• Assist with the creation of Informed Consents (ICF), evaluate and review ICFs as well as study material requiring sponsor and IRB approval• Create study templates, plans, and site manuals• Facilitate communication between internal project team and sites as well as sponsor and sites• Create and maintain trackers for various aspects of clinical projects• Mentor and train new Research Associates and DMC Coordinators

Assist project managers in day-to-day operations of either federally-funded or commercial studies.• Act as a liaison with investigational sites, project personnel, vendors and/orSponsors; functioning as a central contact point for studies• Collect, review, approve and track all site regulatory documents• Maintain the clinical trials management system (CTMS) and other project tracking tools• Initiate, maintain and reconcile the Trial Master File• Support audit preparation activities• Create and maintain project website • Complete and track site payments, invoicing, and budget reconciliations • Write internal and external correspondence such as emails, memos, letters, meeting minutes, and reports• Create, order, and coordinate shipment of clinical trial materials to sites.• Coordinate project meetings with the internal team, sponsor, vendors, and/or investigators• Support Data Monitoring Committee (DMC) activities and coordinate communication between the DMC members and the sponsor, Schedule, organize, and facilitate DMC meetings, Package and deliver DMC reports and meeting materials• Assist with development and creation of study materials including study protocols, consent forms, Data Monitoring Committee (DMC) Charters and recruitment materials• Assist in creating slide presentations for internal and external trainings• Provide assistance to data management for the following: Manual data entry, Manual query resolution, Meditata RAVE Database building, User Acceptance Testing• Provide assistance to business development for the following: Grants Manager Estimates for RFPs, feasibility assessment for RFPs.

• Administrative work as Assistant to the VP of Business Operations. • Make travel arrangements, and act as the liaison between Rho, Inc. and the travel company • Manage the Integrated Product Development Course series• Provide administrative support for all departments• Work at the front desk as a backup, answer and screen telephone calls on a multi-line system• Arrange overnight shipments and mailings• Maintain office supplies• Interact with vendors• Complete special assigned projects

I managed a crew of 3-5 members to ensure top quality customer service. I maintained store inventory, kept up with cashflow and deposits. I assisted in new hire training. Additonally I was in charge of making and decorating cakes.

I worked at the circulation desk to help check out books, answer patron questions, and assist in other areas as needed. I also helped to shelve and sort books. Additonally I was trained in how to recgonize and take care of damaged books.