Posted to MedZilla on 10/27/2017


DOCS Global, Inc.

US-MA, Sr. CRA AS-004537-MZ


 
 

DOGS Global is looking for a Sr. CRA or Project Manager with previous monitoring experience!

Interested candidates may submit their resume for review to [click here]">[click here] with the subject line “IVD Sr. CRA”

Requirements:

· IVD (In-Vitro Diagnostic) experience is an absolute requirement.

· Current monitoring experience

Job Description:

· Responsible for clinical trials oversight in North America (US and Canada) for in-vitro diagnostics to support 510(k) submissions to FDA or registration with Health Canada

· Support global R&D and clinical research teams.

· Responsible for all activities involved in clinical trials establishment and execution

· Collaboration with clinical and regulatory teams providing submission to FDA and other agencies.

· Hands on clinical monitoring needed

· Must have experience in clinical trials resulting in FDA clearance of IVD products

· Must be experienced in looking at output reports that are run at the laboratories and clinical sites

· 5-7 years involved in pharmaceutical or Biotech industry

· PT CRA needed – 20 Hours a week through end of August with extension possibly FT based on performance.

· Need to start as soon as possible.


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