Clinical Data Entry
Resume:
**** ********** **** ****, ******* NC *****
********@*****.***
Antoinette Edmondson
Experience
Aug 09-Sep 10 Talecris RTP, NC
Validation Specialist(Contractor)
• 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 audits conducted by internal groups or regulatory agencies.
• Performed accurate data entry of records and updated the database for all 69 centers.
• Interacted with program personnel to analyze and recommend solutions to complex flow cytometric system workflows and donor issues.
• Searched, located, obtained and distributed documents and records to be copied and filed.
Jul 08-Aug 09 INC, Research Raleigh, NC
Data Entry Technician
• Makes accurate corrections to the database as requested by the Senior Data Entry Technician, Group Manager, Lead Data Manager or internal auditor in accordance with relevant SOPs/WIs. Identifies any data issues encountered during entry to Data Management in accordance with relevant SOPs/WIs.
• Performs 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.
• Uses 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.
May 07-Jul 08 Kendle International RTP, NC
Clinical Data Associate I
• Tracked and reconciled data received for in-house review through use of CRF tracking tools. Applied corrections and/or updates to the Oracle Clinical database and appropriate documents (original and/or 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 CDM QC audits of the clinical database against the CRFs including query results.
• Maintained internal CDM QC documentation and produces QC audit report including calculating accuracy rate.
Aug 05- Feb 07 PPD Morrisville, NC
Clinical Data Associate I
• 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.
• Assisted in the collation of study metrics for the team and archival of project documentation at study closeout.
• Entered data from Case Report Forms (CRFs) into the database with a high degree of accuracy and speed
Feb 05-Jul 05 Nabi BioPharmaceuticals Rockville,MD
Clinical Data Manager
• Analyzed, reviewed and generated queries based on coding reports.
• Updated the Clintrial Database, SAS listings and Adhoc listings from Data Revision and Data Verification Request Forms.
• Trained and mentored new Data Entry employees.
• Performed Clinical Data Review and Query Maintenance.
Jan 03-Feb 05 Quintiles( CSG) RTP, NC
Clinical Data Coordinator(Contractor)
• Collated, encoded and logged in Case Report Forms.
• Entered changes/updates to the Oracle database from Error Correction Reports, Data Clarification Forms, Updated Request Forms and Adverse Events.
• Performed quality control over clinical data and clinical data review.
Education
Southeast Halifax High School 1989 – 1993
High School Diploma
Durham Technical College 2010-
Associates Degree
Skills and Qualifications
Therapeutic Experience: Oncology, Infectious Diseases, Respiratory and Phase I, II, III and IV. Microsoft Office Suite, Clintrial 4.2, 4.3, 4.4 and 4.5, Oracle Clinical, EDC, Access, Microsoft Office 2003, Donor Management System, Learning Management System, Trackwise, Lotus Notes and Adobe Acrobat.
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