Clinical Documentation Specialist

Clinical Documentation Specialist

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.

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

Qualifications

• 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

Additional Information

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