Objective:
 

The ideal desired position is telecommuting.


Work Desired:Part Time
Citizenship:US Citizen
Resident Of:State: Pennsylvania - Area Code: 610
Willing To Relocate:No
Posted By Candidate:1+ Year Ago
Experience:More than 3 years of work-experience
Technical Skills:Clintrial, SAS, MS Word, Polish Translation, Database Design
Work Experience:
IRENE KLEPACKI
406 Cedar Court
Schwenksville, Pennsylvania 19473
 [Send email to request phone number] 87-4305 
														

OBJECTIVE
A telecommuting position utilizing my computer skills and knowledge of
biology/biochemistry.  Special interest in SAS programming and clinical data. 
         
EXPERIENCE IN TRANSLATION
        Telelanguage Services, Inc., Portland, Oregon                           
                                        May 2004-Present
        Polish Interpreter
        •     Converts spoken statements from Polish into English and vice
versa. 
        •     Interprets by listening to, understanding and memorizing content,
then reproducing statements, questions and speeches. 
        •     Interprets usually from the English language into the Polish
language, but may be on a two-way basis. 
        •     Researches specialized vocabulary and terminology as part of the
role.

EXPERIENCE IN CRO/PHARMACEUTICAL COMPANY
Genaera Corporation, Plymouth Meeting, Pennsylvania     
Data Manager, Biostatistics Department	                                         
       January 2002 – August 2002
       •      Trained data entry personnel.
       •      Tracked completed CRFs.
       •      Generated CRF tracking and other reports.
       •      Performed initial CRF review.
       •      Created, updated, filed and distributed project-specific database
documents.      
       •      Created edit check specifications in SAS.
       •      Compared, resolved and updated data entry discrepancies.
                   	      	      
Medex Clinical Trial Services, Inc., Essington, Pennsylvania
Database Manager, Data Management Department                                    
                             July 2000 – July 2001  
       •      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 database
for analysis.   
       •      Served as primary contact for data management phase of operations
as appropriate.
       •      Interacted with programmers and statisticians.
       •      Performed other duties as assigned.
       
Rhone-Poulenc Rorer Research and Development, Collegeville, Pennsylvania
Employed by Strategic Software Solutions under contract to Rhone-Poulenc Rorer
Research and Development.
GDM Consultant, Data Management Department	May 1997 – May 2000
       •        Created data validation programs using SAS.
       •     	Administered corrections to clinical study databases.
       •	Designed and created data listings as defined by the clinical study
team.
       •	Validated clinical data by ensuring consistency between data listings
and patient case report forms and documented   pertinent issues in an audit
report.
       •	Provided ad hoc support to the clinical study team.

SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania
Employed by Aerotek under contract to SmithKline Beecham Pharmaceuticals.
Global Database Manager, Biometrics Department	November 1994 - October 1996
       •	Developed, tested and implemented data entry packages, liaised with
Therapeutic Units and Data Operations groups to implement and maintain the
screens.
       •	Created and maintained codelists in accordance with database standards.

       •	Assisted in the resolution of data errors and inconsistencies
highlighted by the 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 CRF’s to ensure data is collected in a
consistent manner across the drug database.
       •	Performed basic SQL programming.

Sterling Winthrop Pharmaceuticals, Collegeville, Pennsylvania
Employed by Scientific Staffing, Inc. under contract to Sterling Winthrop
Pharmaceuticals. 
Clinical Data Coordinator, Clinical Data Management Department	February 1993 -
November 1994
       •	Reviewed and verified the integrity of incoming data.
       •	Generated discrepancies and clarifications.
       •	Identified and tracked data discrepancies and resolutions by
establishing a DRF tracking system. 
       •	Updated the DRF tracking system when necessary.
       •	Processed outstanding and resolved DRF’s and clarifications and updated
the 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).

EXPERIENCE IN BIOCHEMICAL LAB	June 1990 - March 1991
Drexel University, Philadelphia, Pennsylvania 

Biochemistry
        •	Isolation of Total RNA and Poly (A)+ RNA From the Yeast
Schizosaccharomyces pombe
Separated the poly (A)+ RNA fractions from the poly (A)- RNA fractions utilizing
oligo (dt) cellulose chromatography.  Found poly (A)+ RNA represented 5% of the
total RNA isolated from Schizosaccharomyces pombe.	

         •	Isolation of Genomic and Plasmid PBR322 DNA From Escherichia coli and
Resolution by Agarose Electrophoresis 
Researched genomic and plasmid DNA molecules utilizing restriction
endonucleases.  Analyzed the fragments utilizing agarose electrophoresis.  Found
that molecules of lower molecular weight migrate through an agarose
electrophoresis gel faster than molecules of higher molecular weight.	

         •	Gel Filtration Chromatography	
Determined the total protein concentrations from eluted fractions of Mucor
racemosus.  Utilized Bradford protein assay.  Found protein concentration
increased relative to absorbance.	

        •	Fractionation, Centrifugation, and Colorimetric Determination of
Proteins	
Analyzed a protein mixture from the yeast, Schizosaccharomyces pombe.  Found
that higher concentrations of proteins were “salted out” as the percent
saturation of ammonium sulfate increased producing a linear plot.	

        •	Sequence It	
Determined the length, isoelectric point, and sequence of two peptides utilizing
a Macintosh computer.	

       •	Peptide Characterization: Thin Layer Chromatography	
Spotted a precoated cellulose sheet with asparagine, aspartic acid, glutamic
acid, and valine.  Compared it with an unknown peptide mixture.  Concluded
unknown amino acids were aspartic acid, valine, and phenylalanine, respectively,
based on Rf values.	

OTHER EXPERIENCE
       •	Biosciences Information Service, Philadelphia, Pennsylvania

Medical Editor	September 1987 - April 1989

Indexed abstracts according to concepts discussed.  Added keywords to supplement
author's title.	

       •	St. Anne's Senior Citizen's Center, Philadelphia, Pennsylvania

Social Work Technician	June 1985 - August 1987
	
Administered service management to 60+ geriatric population of English and
Polish speaking clients.  Performed home visits to assess client need and
arranged for in-home services via phone contact with formal providers.

        •	Community Interactions of Bucks County, Feasterville, Pennsylvania
	
Residential Program Trainee (Intern)	Summer 1984
	
Administered to physical and psychological needs of three mentally retarded
clients in community living arrangement.  Dispensed medications.  Wrote medical
reports.

EDUCATION
Drexel University, Philadelphia, Pennsylvania
M.S. Biological Sciences, March 1992	GPA 3.4

Holy Family College, Philadelphia, Pennsylvania
B.A. Psychobiology, May 1985                                                    
                                                                      GPA 3.4				

 

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