KARINE THOMAS-MATTHEWS
Port Charlotte,FL
Summary
An experienced, ambitious, and results-oriented Standards Support Specialist with considerable experience in design standards. Highly driven, dedicated, and hardworking professional who gets the job done correctly with excellent communication skills.
Overview
22
22
years of professional experience
Work History
Database Developer
Premier Research
11.2023 - Current
- Creates electronic Case Report Forms (eCRFs) according to finalized protocols for EDC studies
- Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
- Designs, builds and tests clinical databases according to Premier Research standard operating procedures
- Writes procedures, validation and data extraction programs
- Produces database documentation including an annotated CRF
- Performs system testing and assists with Quality Control (QC) of specified deliverables
Senior Standards Support Specialist
Premier Research
03.2015 - 11.2023
- Populates the Metadata Repository based on approved impact assessments and/or Case Report Form (CRF) specifications and annotations
- Creates specifications and annotations based on impact assessments and documented decisions
- Populates the metadata in the global library of the clinical data management system (CDMS)
- Creates new graphic CRF modules based on approved impact assessments
- Posts Data File Specifications, Statistical Guidance Documents, and other related documents to the Metadata Repository
- Manages the Standards work flow change control process via the change control system
- Trains and follows sponsor’s standard operating procedures as applicable
- Mentor and train Standards Support Specialist
Standards Support Specialist
Premier Research
06.2010 - 03.2015
- Completes metadata in Oracle Clinical based on impact assessments that are completed by the client
- Populates the Data Standards Catalog with new metadata that gets created in Oracle Clinical/Teleform
- Creates new CRF modules in Teleform based on approved impact assessments
- Creates new graphic layouts in the global library of Oracle Clinical based on approved impact assessments
- Trains and follows sponsor’s standard operating procedures as applicable
Scanning Technician
Children’s Hospital
03.2010 - 05.2011
- Perform Quality Control on scanned documents
- Scans patient’s records in hospital computer system
- Corrects errors and strives for accuracy in patient’s records.
Associate Database Developer
Premier Research
03.2008 - 05.2010
- Develop clinical trial databases using Oracle Clinical
- Program validation and derivation consistency checks using Oracle Clinical
- Develop Case Report Forms for clinical trials using Teleform
- Perform quality testing on database builds, consistency checks, and Case Report Forms
- Provide support to study team members to test and resolve database issues
- Train on, and follow, sponsor’s Standard Operating Procedures as applicable.
Data Co-ordinator
Children’s Hospital
07.2007 - 02.2010
- Monitors and maintains accuracy of Master Patient Index database
- Performs in-errors of scanned documents residing in the Electronic Medical Record
- Corrects demographic information on hospital computer system
- Verifies duplicate medical records and performs merges
- Strives for accuracy in work performance.
File Section Leader
Children’s Hospital
09.2001 - 06.2007
- File and purge medical records
- Assist with general administrative duties.
Education
Bachelors of Science in Computer Engineering Technology -
Wentworth Institute of Technology
Boston, MA2006
Skills
- Metadata Repository
- Nurocor (NCP)
- Oracle Clinical
- CDISC
- Medidata Rave
- Critical thinking skills
- Attention to detail
- Flexibility
- Verbal Communication
Languages
English
Full Professional
Timeline
Database Developer
Premier Research
11.2023 - Current
Senior Standards Support Specialist
Premier Research
03.2015 - 11.2023
Standards Support Specialist
Premier Research
06.2010 - 03.2015
Scanning Technician
Children’s Hospital
03.2010 - 05.2011
Associate Database Developer
Premier Research
03.2008 - 05.2010
Data Co-ordinator
Children’s Hospital
07.2007 - 02.2010
File Section Leader
Children’s Hospital
09.2001 - 06.2007
Bachelors of Science in Computer Engineering Technology -
Wentworth Institute of Technology
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