The Protocol Review and Regulatory Affairs Department is looking for a Regulatory Specialist II.  

Position Highlights:

• Support research activities through the critical evaluation and completion of protocol specific documents and standardized reports for effective and compliant protocol activity from activation through closure.   
• Focus on regulatory document completion, submission, proper filing and reporting to achieve and maintain compliance with internal policy, external sponsors and federal regulations pertinent to research involving human subjects. 

Responsibilities:

• Extract all required data from protocols, investigators brochure, and any other pertinent source documentation to complete the application process, including drafting the informed consents.
• Reconcile all IRB queries to ensure study approval.
• Gather required documentation for internal/external audits collaborating with the research staff and draft regulatory responses.
• Independently process Biosafety applications  as necessary.
• Electronically file all correspondence for future retrieval and upload all IRB approvals to e-binders and CTMS accordingly.

Credentials and Qualifications:

• High School diploma with 4 (four) years of clinical regulatory experience required OR Associate’s/Bachelor’s degree with 2 (two) years of clinical research regulatory experience OR Master’s Degree with 1 (one) year of regulatory experience.
• CCRA, CCRC, CCRP, CIP or CIM certification preferred.
• Previous experience in a medically related field or an understanding of medical terminology required