TMF Documentation Coordinator

Job Summary:

• 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.

Qualifications:

• Related Document Processing experience with Associate s degree

• 2+ yrs. with Bachelor’s degree 

• Quality control experience preferred.

Warm Regards,

Sneha Shrivastava

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 549 2030 

Fax: (732) 549 5549

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70