HireDiversity

Job Summary:    The Regulatory Assistant is responsible for ensuring the accuracy and completeness of all regulatory files for clinical trials.  Working under the direction of the Clinical Trials Manager, the Assistant will serve as a resource for the clinical research team, maintaining regulatory documentation and supporting a wide variety of start-up and on-going activities integral to the successful implementation and conduct of clinical trials.

Required Education: BS or BA or 2years of related experience and/or training or equivalent combination of education and experience. Knowledge of Medical Terminology.

Preferred Education:  BS or BA.
 
Required License:  NC Driver’s License.  Must obtain and maintain certification in Human Subjects Protection as required by policy. CCRP certification required within 3 months of eligibility.
 
Preferred License: None
   
Required Experience:  Working knowledge of a significant body of federal regulations related to research. Must have the ability to analyze, synthesize and apply complex regulations and guidance in a variety of situations. Effective time management skills with the demonstrated ability to work on multiple projects within a defined period of time are required. Computer proficiency in Microsoft Word and Excel is essential. Excellent command of the English language and grammar skills are necessary.  An exceptional attention to detail is required. Must be able to work in a team environment and respond quickly to changing priorities with accuracy and efficiency. 
 
Preferred Experience:  Clinical Research and/or regulatory environment