Clinical Data Entry temp-3 month assignment

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NxStage Medical is a medical device company in Lawrence, MA that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease and acute kidney failure.  NxStage’s primary product, the NxStage System One, is a small, portable, easy-to-use hemodialysis system designed to provide physicians and patients improved flexibility in how hemodialysis therapy is prescribed and delivered.  Given its design, the System One is particularly well-suited for home hemodialysis and more frequent, or “dailyâ€� dialysis, which clinical literature suggests provides patients better clinical outcomes and improved quality of life.  The System One is specifically cleared by the US FDA for home hemodialysis as well as hospital and clinical-based dialysis.  We believe the largest market opportunity for our product is the home hemodialysis market for end-stage renal disease.  Come join us during this exciting time in our growth as a company!

 

NxStage Medical is an Equal Opportunity Employer

 

Summary: The Clinical Data Entry position works under the direction of the Director of Clinical and Regulatory Affairs and is responsible for entering data into a Clinical Research Database. The position includes receiving Case Report Forms, verifying completion of the Case Report Forms, entering the data into a database and assisting in any related administrative duties, e.g. filing, preparing study related materials, and generating reports.

Specific Duties:
oEnters data into databases
oReviews data discrepancies resolutions provided by the investigative site and enters corrections in the database as appropriate
oAssists in generating automated and manual Data Clarification Forms (DCF) for corrections to illegible, inconsistent and/or missing data
oAssists in the review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports
oAs required, conduct database audits according to established DMP and is familiar with the implementation of GCP's
oGenerate standard reports from database for internal/external review
oWhen required, administrative support for clinical and regulatory projects, including: maintain central files for each clinical study, assemble and distribute study documentation, etc.

Requirements:

College Graduate preferred. Science/Biology degree a plus
Attention to detail
Strong organizational skills
Ability to work well independently or as a member of the team
Database experience (preferred)


 

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