Clinical Quality Assurance Auditor

Our client, a large international pharmaceutical company is expanding their operation to the US and will be centrally located in Fort Lee, NJ. They are currently seeking an experienced Clinical Quality Assurance Auditor to join their growing team.  This is an excellent opportunity for the candidate that wants to be close enough to enjoy the city lifestyle without the stress and cost of living in the city.   

PRIMARY RESPONSIBILITIES:
Provide comprehensive Quality Assurance (QA) and Quality Control (QC) activities for all Clinical Affairs activities. Audit investigational sites as well as other clinical trial vendors. Review internal Clinical Affairs processes to assure compliance with FDNICH/OCP regulations and guidelines. QC of all documents or other deliverables produced by Clinical Affairs department. Maintain master Clinical Affairs SOP list. Work with Clinical Affairs department heads to assure necessary SOPs are in place. Provide departmental training on FDNICH/OCP regulations and guidelines.

Education/Experience
-Minimum of 3 years as a Clinical Research Auditor for a CRO, pharmaceutical or biotech
company
-Bachelor's degree in a relevant discipline (life sciences, nursing, pharmacy, etc.) 
-Computer proficient including experience with MS Office suite of programs


We provide a comprehensive benefits package including a 401(k) health vision and dental. We offer competitive salaries and bonus.