Quality Control Data
Resume:
Antoinette Edmondson, CCRC, CCRA
Raleigh, NC 27610
E-mail: ********@*****.***
** ***** ** ******** ****** experience within the Pharmaceutical and CRO
industries, 3 years of validation experience .
Professional Experience
Secretary of State, Raleigh, NC
Processing Assistant
October 13-Present
• Assist the Athlete Agent Team, which consists of Enforcement Attorneys, a Special
Agent and Investigator, and the Litigation Support Team in processing and
p reparing evidence in compliance with the North Carolina Criminal Law Rules of
D iscovery.
• Reviews 100,000+ pages of information in an electronic database looking for
personal identifiable information and other specific information as instructed.
• Creates inventory spreadsheets, including corresponding bates numbered ranges, of
documents processed by Litigation Support Team.
• Secure information by completing database backups.
• Assist in minimizing duplication of information to be processed by Litigation
Support Team by reviewing and comparing electronic and paper documents.
• Redacts personal identifiable information contained within records utilizing
electronic system.
• Reviews and updates 100,000+ pages of information in an electronic database
looking for personal identifiable information and other specific information as
i nstructed.
D ivision of Child Development, Raleigh, NC
Policy Consultant
M arch 13-September 13
• Develops policy training for the Subsidized Child Care Program and for local county
staff who administers the program.
• Resolves the allocation and expenditure of subsidized child care funds.
• Assists in the development of training materials and resource files for use by
regional staff and county department of social services staff.
Talecris/Grifols, RTP, NC
Validation Specialist
August 09-December 12
• Scheduled and performed validation studies to meet production and revalidation
requirements for the plant site.
Responsible for preparing, programming, maintaining the use of data acquisition systems
•
used for validation of plant equipment and processes.
Performed validation runs, analyzed data, assembled the final validation packets and
•
wrote reports and protocols.
• Assisted in revising Talecris Validation Procedures and the training of new validation
specialists.
• Assisted GMP, QA and production personnel during internal audits and made
accurate corrections to the database as requested by the center managers or regulatory
agencies.
• Interacted with program personnel to analyze and recommended solutions to complex
flow cytometric system workflows and donor issues.
• Performed accurate data entry of records, updated the database for all 69 centers.
•Used toolbox to create new templates for existing donors entering new centers.
•Extensive usage of Adobe Acrobat to create new pdf files for center managers .
•Collected and updated data through EDC for donors at the donor centers.
INC, Research Raleigh, NC
Data Entry Technichian
July 08-August 09
•Identified any data issues encountered during entry to Data Management in accordance with
relevant SOPs/WIs.
• Performed accurate and timely data tracking, entry, verification, and QC checks of
clinical data into the clinical database as governed by the Data Entry Instruction Manuals,
SOPs and communicated policies of the department and sponsor.
• Used multiple databases such as Oracle Clinical to enter data from case report forms
(CRFs) ensuring the fidelity between the CRF and the clinical database of record.
• Reviewed IRB approval documents, financial disclosure forms and medical licenses that
are required for site activation.
• Reviewed regulatory documents for accuracy, consistency and discrepancies.
• Processed, sent follow-up queries and entered clinical trial AE/SAE reports for adverse events.
•Ensured that all final electronic deliverables met current regulatory electronic document
requirements and guidance under general supervision of the Manager.
•Updated the database using EDC(Electronic Data Capture).
Kendle International RTP, NC
Clinical Data Associate I
May 07-July 08
• Tracked and reconciled data received for in-house review through use of CRF tracking
tools. Applied corrections an updated the Oracle Clinical database and documents
(original and working copies of CRFs) that are identified through query resolution, data
entry, text review, site request, computerized validation and/or data importing.
• Generated and/or reviews listings to check accuracy and completeness of coded clinical
data. Performed internal audits to the clinical database using EDC and CRFs.
• Maintained internal CDM QC documentation and produces QC audit report including
calculating accuracy rate.
• Conducted quality control review of regulatory documents, e.g. Clinical Study Reports.
• Archived regulatory documents (in both paper and electronic formats) in accordance with SOP’s .
•Maintained, organized, completed and updated study documentation for the project team.
• Operated computer software, such as lab and clinical databases, to review data, generate reports
and update data.
PPD Morrisville, NC
Clinical Data Associate I
August 05-February 07
• Responsible for set-up, logging, tracking and maintaining the project SAE tracking
database using Oracle Clinical.
• Responsible for compiling SAE case files and allocates to the appropriate clinical safety
team for review/processing.
• Issued CRF tracking status reports.
• Reviewed CRF’s for consistency in page numbering, identification and completeness.
•Participated in quality control measures for the finalization and transfer of the database and related
materials to the sponsor.
• Assisted in the collation of study metrics for the team and archival of project
documentation at study closeout.
•Published documents that worked with sponsors and/or regulatory agency software programs, and
met consistency and security issues.
•Archived regulatory documents (in both paper and electronic formats) in accordance with SOP’s.
•Updated/modified study/program specific forms using Adobe Acobrat .
Nabi BioPharmaceuticals Rockville,MD
Clinical Data Manager
January 05-August 05
• Performed data review activities such as generation of queries both programmed and manual,
query updating, resolving of data entry flag reports, run metrics reports, etc.
• Updated the Clintrial Database from Data Revision Forms and Data Verification Request Forms.
• Performed Clinical Data Review and Query Maintenance.
• Updated SAS listings and Adhoc listings.
• Ensured that Standing Operating Procedures were being followed.
• Trained and mentored new data review employees.
• Analyzed, reviewed and generated queries based on coding reports.
• Maintained study documentation both electronically and in study documentation binder.
Quintiles RTP, NC
Clinical Data Coordinator I
June 03-January 05
• Collated, encoded and logged in Case Report Forms.
• Entered changes/updates to the database from Error Correction Reports, Data Clarification
Forms, Updated Request Forms and Adverse Events.
• Performed quality control over clinical data and clinical data review.
• Prepared Case Report Forms and peripheral study data for data entry.
• Performed 1st and 2nd checks on audits for various studies.
•Scanned and published electronically case report forms and regulatory documents.
Bertek Pharmaceuticals, RTP, NC
Clinical Data Specialist
March 00-May 03
• Performed updates to queries produced by management and audited in all stages of the project
(Protocol audit, Trial master file audit, Investigator site audit, Database audit and Report audit).
• Served in a support-level capacity on a CDM team to provide efficient, quality data management
products that met the client's needs.
• Managed multiple trials on different platforms, performed audits to assess adherence and
compliance with Standard Operating Procedures (SOPs), Good Clinical Practice Guidelines
(GCP), regulatory requirements governing the trial protocol, client instructions and contractual
obligations.
Skills and Qualifications
Therapeutic Experience
• Oncology
• Infectious Diseases
• Respiratory
• Phase I, II, III, IV
Microsoft Office Suite, Clintrial 4.2, 4.3, 4.4, Oracle Clinical, EDC, Access, Donor Management
System, Learning Management System, Trackwise, Microsoft Office 2003, Knowledge of SQL,
Lotus Notes and Adobe Acrobat.
Education
Southeast Halifax High
High School Diploma, 1993
Durham Technical Community College
Associate Degree in Biology 2012
Certificate of Achievement for Clinical Data Management Quality Control, 2005
Certificate of Completion for Clinical Research Associate and Clinical Research
Coordinator, 2003
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