Clinical Data
Resume:
**** ***** **** **, ******* NC ***** 919-***-****
***********@*****.***
LADAWN J. HALL
SR. CLINICAL DATA ASSOCIATE
EDUCATION
BS, Biology, 1998
Elizabeth City State University, Elizabeth City
Penn Foster (currently enrolled)- obtaining medical coding certificate
THERAPEUTIC EXPERIENCE
Virology/Infectious Disease: HIV/AIDS, Hepatitis C
Psychiatry: Sleep Disorders
Genitourinary: Urinary Incontinence
Cardiovascular: CHF, MI, Stroke,
Respiratory: Asthma, COPD, Bronchitis, Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis, and Sinusitis
Digestive: Small Bowel Syndrome, Crohn’s Disease, Cystic Fibrosis, Ostomy/Stoma Care
Renal/Urology System: Renal Disease
PROFESSIONAL EXPERIENCE
Kendle International, Durham, NC
2008-April 2010
Sr. Clinical Data Associate
Identify the need for and generate data queries at any point during data processing, based on guidelines set forth in the Data Management Plan (DMP). Review study-specific documentation as part of the project team in order to obtain understanding of study-specific data processing conventions. Prepare data for entry through completion of transmittal verification, data tracking, and completion of manual review processes. Perform data entry in any clinical data management system used by Clinical Data Management. Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes. Investigate and resolve data anomalies. Also, i’m responsible for issuing and reviewing queries for completeness and forwarding to the project lead or designee. Conduct quality control including case report form to database review processes. Create test data, perform testing procedure of entry screens, and provide test results to the project lead or designee. Work concurrently and accurately on multiple protocols. Provide functional oversight of data processing activities including training of Data Entry and CDA I staff on project specific tasks. I report routine project status and data trends to project lead or departmental management as required. Create case report forms in accordance with the protocol and established standards when necessary. Serve as resource for project lead and departmental management. Perform all other related duties as assigned.
Kendle International, Durham, NC
August 2006- 2008
Clinical Data Associate II
Identify the need for and generate data queries at any point during data processing, based on guidelines set forth in the Data Management Plan (DMP). Review study-specific documentation as part of the project team in order to obtain understanding of study-specific data processing conventions. Prepare data for entry through completion of transmittal verification, data tracking, and completion of manual review processes. Perform data entry in any clinical data management system used by Clinical Data Management. Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes. Investigate and resolve data anomalies. Also, i’m responsible for issuing and reviewing queries for completeness and forwarding to the project lead or designee. Conduct quality control including case report form to database review processes. Create test data, perform testing procedure of entry screens, and provide test results to the project lead or designee. Work concurrently and accurately on multiple protocols. Provide functional oversight of data processing activities including training of Data Entry and CDA I staff on project specific tasks. I report routine project status and data trends to project lead or departmental management as required. Create case report forms in accordance with the protocol and established standards when necessary. Serve as resource for project lead and departmental management. Perform all other related duties as assigned.
Charles River Laboratory, Clinical Services Inc. Cary, NC
December 2004-August 2006
Clinical Data Associate II
Identify the need for and generate data queries at any point during data processing, based on guidelines set forth in the Data Management Plan (DMP). Review study-specific documentation as part of the project team in order to obtain understanding of study-specific data processing conventions. Prepare data for entry through completion of transmittal verification, data tracking, and completion of manual review processes. Perform data entry in any clinical data management system used by Clinical Data Management. Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes. Investigate and resolve data anomalies. Also, I’m responsible for issuing and reviewing queries for completeness and forwarding to the project lead or designee. Conduct quality control including case report form to database review processes. Create test data, perform testing procedure of entry screens, and provide test results to the project lead or designee. Work concurrently and accurately on multiple protocols. Provide functional oversight of data processing activities including training of Data Entry and CDA I staff on project specific tasks. I Report routine project status and data trends to project lead or departmental management as required. Create case report forms in accordance with the protocol and established standards when necessary. Serve as resource for project lead and departmental management. Perform all other related duties as assigned.
Pharma Research Inc. (merged, Inveresk, Cary, NC)
February 2003-December 2004
Clinical Data Management Associate II
Perform data entry in any clinical data management system used by Charles River. Prepared and forwarded data for entry processing. Reconciled project files, reports, listings, and other documents generated in data management against a database for accuracy and completeness of data management processes. Generated data queries as created at any point during CRF processing and to forward queries as required to a project lead or clinical designee. Conducted quality control processes. Worked concurrently on multiple protocols as directed. Assisted in developing project specific data management plans (DMPs) and other related documentation. Made review reports, listings, and other documents generated in data management for distribution to sponsor, investigators and their study support staff, or to review project files for accuracy and completeness. Also, reviewed study-specific documentation as part of a project team. Respond to employee requests and questions in a professional, timely, and thorough manner. Keeps abreast of GCP guidelines, GMP regulations and SOPs related to data management and interactions in other project assigned.
PHARMA-RESEARCH CORP., RTP, NC
April 2001-Feburary 2003
Data Management Associate I
Review case report forms and other critical documents for completeness, clarity, legibility, and conformity to available source documentation and adherence to protocol requirements. (1/2 entry, audits, pre-entry review, compares, queries, tracking, updates, SAE entry/tracking, tracking patient enrollment) Clintrial 3.3
PHARMA-RESEARCH CORP., RTP, NC
October 2000-Feburary 2001
Data Entry Associate
Review case report forms and other critical documents for completeness, clarity, legibility, and conformity to available source documentation and adherence to protocol requirements. Clinical data entry 1 and 2, used pharmatrace, auditing, initial tracking of first arrival. Clintrial 3.3
PHARMA-RESEARCH CORP., RTP, NC
June 2000-October 2000
Temp Assignment (Data Entry Associate)
Review case report forms and other critical documents for completeness, clarity, legibility, and conformity to available source documentation and adherence to protocol requirements. Clinical data entry 1 and 2, used pharmatrace, auditing, initial tracking of first arrival. Clintrial 3.3
(DRS) RC-Enterprise, Ahoskie, NC
August 1999-May 2000
Microfilm Specialist
I was responsible for the preparation of medical records for the assurance and quality of being reviewed. Filmed and reviewed fetal monitors to be sent off to the correct hospital or agency. Also performed data entry on the patient involved with the study.
Rhone Poulenc (Belcan Temp), RTP, NC
August 1998-July 1999
Advanced Research Assistant
Performed soil and moisture determination, calibrate and use of scale to weigh soil and vegetables, performed extractions, and mix solutions using universal precautions. Also kept up lab and kept a recorded of procedures performed. Also I was responsible for maintaining a daily record of PH levels.
COMPUTER EXPERIENCE
Microsoft Excel, Word, Clintrial 3.3.3, 4.0, 4.4, Oracle Clinical, EDC
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