TMF Doc Coordinator

IntegratedResourcesINC

Cambridge, MA, United States contract

Posted: August 28, 2015

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Quick Summary

A few words about the job involves filing, QC, and remediating medical writing documentation required for trial.

Required Skills

Documentation Quality Control Trial Master File QC Case Review Remediation Documentation Reporting Medical Writing Patient Care HIPAA

Job Description

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

The primary purpose of this job is to file, QC, and remediate Medical Writing documentation required for Trial Master Files.

Uploads/files/performs quality control on documents to be submitted to the Trial Master File. Includes identification of missing documentation and follow-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation.

Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfilled documentation; performing periodic review and remediation of TMF.

Related Document Processing experience with Associate s degree

2+ yrs. with Bachelor’s degree

Quality control experience preferred

Trial Master File, Documentation

Anuj Mehta

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

(W) 732-429-1916 | (F) 732-549-5549

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