► Team member on a global Phase III study, providing support to CTMs, PMs, and CRAs.► Recipient of three ICON “Exceeding Expectations” Inspire Awards in 2016 and one in 2017▪️▪️ Project Management Support ▪️▪️ Producing and distributing minutes (internal and sponsor); generating and distributing CTMS reports; tracking of document receipt and site IRB submissions; training/mentoring of study members; assisting with study newsletter; providing back-up support for ROW staff; responding to sponsor requests in a courteous and timely manner.▪️▪️ Site Interaction ▪️▪️ Distributing study materials to sites; communicating with sites about staff changes and study documents; drafting and sending electronic mass communications to sites; following up on data entry as instructed by CTMs during data locks. ▪️▪️ System Access Facilitation and Maintenance ▪️▪️ Maintaining information in Clinical Trial Management System (CTMS); Facilitating Electronic Data Capture (EDC) and Interactive Voice Response System (IVRS) access and troubleshooting reported issues.▪️▪️ Maintaining Clinical Study Documentation in eTMF ▪️▪️ Submitting documents to eTMF; coordinating document translation services; providing eTMF updates during weekly CRA meetings; training study team members as needed and serving as a resource; distributing Coming and Past Due and Rework reports and preparing Study Statistics; following-up with team members on outstanding documents and issues that need correction; preparing for sponsor audits and performing QC; participating in biweekly eTMF study team meetings and global eTMF Q&A meetings; troubleshooting larger system issues impacting completeness and timeliness metrics and providing feedback to study team, TMF Lead and eTMF Changes Team.▪️▪️ CTA Group Development ▪️▪️ Mentoring of new CTAs, designated SME in two areas and contributor to global CTA handbook, and nominated member of the Super User TMF-CTA Working Group.

▪️▪️ IRB and Related Regulatory Requirements ▪️▪️ Tracking TRI IRB, Philadelphia Department of Health IRB, Data Safety Monitoring Board, funder and other project deadlines; preparing submissions and ensuring their timely submission.▪️▪️ Literature Reviews ▪️▪️ Conducting literature reviews, imputing and organizing references in EndNote, and preparing first drafts of federal and local grant submissions, peer-reviewed journal articles, conference presentations, and white papers.▪️▪️ External Advisory Boards Coordination ▪️▪️ Coordinating Scientific Advisory Board, Parent Advisory Board and Expert Panels; recruiting consultants, preparing materials for meetings, compiling, synthesizing, and disseminating meeting-related data; developing sampling frame for recruitment of nation-wide clinical and research experts, compiling data for analysis and creating relevant charts/graphs.▪️▪️ Database Design and Management ▪️▪️ Creating data collection protocols, collaborating with the University of Pennsylvania’s Data Management Unit to develop online forms for data entry and a project-specific online participant tracking system; organizing and overseeing data collection, monitoring and cleaning; training data entry personnel. ▪️▪️ Software Beta Testing ▪️▪️ Testing of software programs, data entry forms, survey systems, and a project-specific website; developing end-user surveys for website, monitoring key informant processes and creating guidelines for revising the website. ▪️▪️ Instrument Development ▪️▪️ Assisting with instrument development, refining Key Elements of quality treatment framework, audit procedures, and design of web-based Consumer Guide.▪️▪️ Project Implementation ▪️▪️ Recruiting, consenting and interviewing project participants; identifying potential study sites; developing multiple site assessment schedules to facilitate recruitment goals and maximize data collection efforts; completing chart reviews, program audits, and documenting AEs/SAEs.

Worked with various psychology labs utilizing a wide range of my skill set.▪️▪️ Responsibilities included ▪️▪️ Implementing research protocols; assisting with development of study design and laboratory manuals, data entry and QC; training and monitoring of research staff team members to ensure data reliability; coding of behaviors/speech via taped interaction; performing literature reviews; conducting, transcribing, and coding semi-structured interviews; preparing APA-style manuscripts.