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

Feel free to forward my email to your friends/colleagues who might be available

• 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

Ron Sharma

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 &- 2013 (7th Year)

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

Direct No. :- 732-429-1649

Tel: (732) 549 2030 Ext. - 230

Fax: (732) 549 5549