• Assist in the preparation of Quality Control Plans• Attend project team meetings concerning QC activities• Generate QC listings• Monitor compliance with SOPs, Policies and Operating Guides• Perform Data Management QC of the following:o Study-specific documentation, e.g., Data Management Plans, Guidelines, approval formso Database design and associated set-up activitieso Data entry and verificationo Laboratory normal ranges• Perform IVRS QC of the following:o Study-specific documentation, e.g., Project Requirements, Project Design, Validation Test Plan, IVRS File Transfers, Test Script, approval forms o Database design and associated set-up activities• Develop and oversee completion of corrective action plans• Assist in development of QC for studies utilizing RAVE and INFORM• Assist in performing QC of Computer System Validation (CSV) documentation• Assist in preparation for sponsor or regulatory audits• Perform rolling, interim and final QC Inspections of the Clinical Study Database• Coordinate the work of Quality Control Associates I for assigned projects• Train QC and additional DM personnel on project-specific QC requirements• Train QC on IVRS specific documents and QC processes required to review IVRS binders• Coordinate QC activities conducted by others in the department• Prepare documentation of QC findings

• Answer IVRS help calls from system users, resolve issues and track resolutions• Resolve issues/problems relating to client and investigator requests and supply shipments• Document validation plans and other required materials for IVRS projects• Assist manager with data modifications/loads for IVRS projects• Monitor and re-submit failed confirmation reports to ensure receipt• Provide administrative support to management

• Answer IVRS help calls from system users, resolve issues and track resolutions• Resolve issues/problems relating to client and investigator requests and supply shipments• Document validation plans and other required materials for IVRS projects• Assist manager with data modifications/loads for IVRS projects• Monitor and re-submit failed confirmation reports to ensure receipt• Provide administrative support to management• Train support staff

• Entered data from Case Report Forms (CRFs) into the database with a high degree of accuracy and speed• Verified data previously entered into the clinical database by performing second entry and resolving discrepancies• As a primary Data Technician for one or more project(s):• Tracked the progress of CRF receipt and entry• Coordinated CRF workflow with the Data Technicians entering the data• Performed data entry testing of the database• Reviewed and tested data entry guidelines• Identified issues which may affect the quality and timeliness of project completion and implement solutions • Trained other staff on data entry guidelines and other study-specific issues• Trained other data entry staff on data entry procedures and systems• Undertook quality control inspection of data entry• Participated in quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor • Identified achievement of milestones to the other clinical data management staff, e.g., approval of database testing for data entry and completion of data entry for a study

• Entered data from Case Report Forms (CRFs) into the database with a high degree of accuracy and speed• Tracked the progress of CRF receipt and entry• Coordinated CRF workflow with the Data Technicians entering the data• Identified issues which may affect the quality and timeliness of project completion and implement solutions • Undertook quality control inspection of data entry• Participated in quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor • Identified achievement of milestones to the other clinical data management staff, e.g., approval of database testing for data entry and completion of data entry for a study

• Provided clerical and administrative support to project team• Set-up and maintain project files• Set-up and maintain investigator files• Faxed, photocopied, and distributed study-related documents• Contacted study personnel at sites regarding administrative issues• Generated and maintained study-specific tracking spreadsheets (e.g., patient enrollment, regulatory documents, site visits, investigator payments)• Shipped/mailed supplies and documents to clients, investigator sites, and IRBs• Assisted in preparing and assembling materials for Investigators‘ Meetings• Prepared regulatory binders (Study File Notebooks) for study sites• Maintained investigator payment documentation • Trained Technical Assistants on job functions

• Provided clerical and administrative support to project team• Set-up and maintain project files• Set-up and maintain investigator files• Faxed, photocopied, and distributed study-related documents• Contacted study personnel at sites regarding administrative issues• Generated and maintained study-specific tracking spreadsheets (e.g., patient enrollment, regulatory documents, site visits, investigator payments)• Shipped/mailed supplies and documents to clients, investigator sites, and IRBs• Assisted in preparing and assembling materials for Investigators‘ Meetings• Prepared regulatory binders (Study File Notebooks) for study sites• Maintained investigator payment documentation

• Responsible for billing, data entry, new customer set-ups, accounts receivable, cash handling, and processing orders• Liaised to customers for problem solving issues and satisfaction• Dispatcher for service calls and deliveries

• Supervised eight sales associates and scheduled duties• Assisted cashiers with purchases, returns, and exchanges• Financial duties included bank deposits and accounting of registers• Created store floor plans and designs• Supervised daily and monthly inventory loss prevention reports

• Organized orders, and assisted customers with purchases, returns, and exchanges • Assisted in daily and monthly inventory and floor designs• Organized sales and specials