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
Job details are sourced from the employer's original posting.
Open job postingAbout the company
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.