Clinical Documentation Specialist

Title: Clinical Documentation Specialist 

Location: Lexington, MA

Duration: 6 months (possible extension)

JOB SUMMARY:

• Manages the Trial Master Files (all of the documents that support the clinical trials-everything that the FDA and regulatory agencies review) 

• Support group for clinical, data managing, medical writing, safety, clinical supplies (Global Clinical Development Operations) 

JOB REQUIREMENTS:

• Processing, filing and tracking of Trial Master File (TMF) documents (paper and/or electronic) in accordance with study-specific TMF Roadmaps 

• Performing quality checks of TMF documents as needed 

• Providing oversight of TMF quality checks performed by functional areas and/or CRO’s 

• Assisting with audit and inspection preparation as applicable

MUST HAVE:

• 2 years minimum experience doing anything associated with TMF (Trial Master Files) or Clinical Documentation

• GCP Experience preferred

• clinical experience

• CTA/CRA experience OK

• Experience with using an electronic document management system and proficient in excel necessary

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