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Regulatory Affairs Coordinator - United States  

Celerion (company)


Posted on : 21 June 2017

Project Description

  • Our company is a leader in Early Stage Clinical Research, has an excellent opportunity for a Regulatory Affairs Coordinator at our fast-paced facility. 
  • Every member of our company is involved in making a distinctive contribution to the health and well-being of people around the world. 
  • That's the sense of purpose shared by our employees. We are a performance-driven drug research company, operating in robust and growing markets. 
  • We have an exciting future and offer a strong development environment for our great employees.

  • Organize and maintain all Study Binders including set up, archival and creation of templates. 
  • Organize and maintain the Investigator Site File including set up, archival and creation 
  • Maintain and ensure completion of financial disclosure forms including obtaining signatures and submitting the forms. 
  • Maintain and ensure completion of essential study documents in compliance with Good Clinical Practice. 
  • May maintain all current and historical copies of laboratory accreditations, reference ranges, staff Curriculum Vitae (CVs), medical licensures, and related forms. Request updates when necessary.   
  • Responsible for assisting in on-site and off-site storage including vendor budget as well as obtaining records for audits or as needed. 
  • Ensure all protocol and protocol amendments are signed accordingly 
  • Responsible for all study and non-study specific IRB approvals 
  • Responsible for assisting study management with responding to queries with regard to regulatory binders during study monitoring visits. 
  • Coordinate and oversee activities of On-site and off-site study archives. 
  • Shall archive and/or work closely with all other departments to archive, off-site, all studies approximately six months after study is closed out by the IRB.
  • 2 years after study is closed out by the IRB
  • Responsible for scanning, uploading and filing all study documents to Celexus. 

  • Associate's degree in life sciences or equivalent preferred 
  • Two or more years of regulatory experience 
  • Strongly prefer experience with IRB/FDA and/or other regulatory bodies and guidelines 
  • Must have strong organizational, attention to detail, multi-tasking, and time management skills 
  • Excellent oral and written communication skills 

Additional Information:  
  • Hours will be during normal business hours. M-F 
  • Overtime may be required