System One Services Clinical Documentation Specialist in Boston, Massachusetts02133

Clinical Documentation SpecialistBoston, Massachusetts

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:117932

Date Posted:06/02/2017

Clinical Documentation Specialist

Location:Boston, MA

Duration:Direct Hire

Hours:Mon-Fri/8am-5pm (In-House role, no travel required)

  • BA/BS degree required

Experience:

  • 1-2 yrs. of Clinical Trial experience

"Must Haves":

  • TMF experience is required

  • Ability to learn new software programs

  • Excellent Microsoft Office experience

Duties/Responsibilities:

  • Maintain clinical trial files in electronic Trial Master File

  • Perform QC checks on documents supporting global clinical trials to ensure complete

  • Prepare documents for publishing process (including ensuring headings are correct, hyperlinking, updating and maintaining EndNote library)

  • Draft documents for IRB submissions, including manuals of operations, schema, ICFs, protocol summaries

  • Prepares and ensure documentation is complete for Sponsor audits

  • Update documents for distribution in clinical trial management system including creation of source documents for Investigator Site Files

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