IRENE KLEPACKI

• Interpret conversations consecutively to help both parties conduct business, handle medical needs or manage personal concerns
• Demonstrate ability to adapt quickly to new and changing technologies
• Participate in ongoing quality assurance and call monitoring programs
• Provide cultural input to speakers to help parties who do not speak similar languages communicate with and understand one another
• Maintain message content, tone, and emotion as closely as possible
• Develop and maintain glossary of technical terms

• Interpret conversations consecutively to help both parties conduct business, handle medical needs or manage personal concerns
• Maintain message content, tone, and emotion as closely as possible
• Research specialized vocabulary and terminology

• Trained other data entry personnel
• Tracked completed case report forms and generated tracking reports; performed initial case report form review
• Created, updated, filed and distributed project-specific database documents
• Created edit check specifications in SAS
• Compared, resolved and updated data entry discrepancies

• Insured overall integrity of project databases for analysis and reporting
• Designed databases according to sponsor/internal specifications
• Created data entry screens; provided for transfer of data to and from external sources
• Closed/produced listings for database cleaning and locked databases for analysis
• Served as primary contact for data management phase of operations as appropriate
• Interacted with programmers and statisticians

• Created data validation programs using SAS
• Designed and created data listings as defined by the clinical study team
• Administered corrections to clinical study databases
• Validated clinical data by ensuring consistency between data listings and case report forms

• Developed, tested and implemented data entry packages; liaised with Therapeutic Units and Data Operations groups to implement and maintain screens
• Created and maintained codelists in accordance with database standards
• Assisted in resolution of data errors and inconsistencies highlighted by reasonability check programs to provide clean and validated databases for analysis and reporting
• Interacted with Programmers, Statisticians, and Data Operations Personnel to ensure high quality of data and efficient data access
• Reviewed protocols and case report forms to ensure data is collected in a consistent manner across the drug database
• Performed basic SQL programming

• Reviewed and verified integrity of incoming data
• Generated discrepancies and clarifications
• Identified and tracked data discrepancies and resolutions by establishing a DRF tracking system
• Updated discrepancy resolution form tracking system when necessary
• Processed outstanding and resolved discrepancy resolution forms and clarifications and updated database
• Revised case report forms
• Entered lab normal ranges
• Entered, verified, validated and merged data
• Performed military audits
• Encoded medications and adverse events

Computer Experience:

• Used ALL-IN-1
• WordPerfect and Clintrial via a VAX/VMS system and clinical software
• Ran edit checks
• Ran simple programs using SQL and SQL (plus) 4