The Protocol Review and Regulatory Affairs department is looking for a Regulatory Startup Project Coordinator

Essential Job Functions: 

• Responsible for shepherding clinical research projects through the study start up process and oversees the development of study regulatory documents
• Primary liaison for regulatory protocol activation issues for internal and external customers; meets with team(s) regularly to provide progress update 
• Work on quality metrics for the study activation processes 
•  Work with Clinical Trials Office training staff to provide new and ongoing education to clinical research staff on Study Activation Procedures

Credentials and Qualifications: 

• Bachelor's degree required (Master's degree preferred)
• Five (5) years' experience in clinical research (2 of the 5 years must be in a research study start up or regulatory position)
• CCRP/CCRC or equivalent certification preferred
• Working knowledge of Food and Drug Administration and other regulatory requirements
• Strong scientific /research knowledge and organizational skills
• Oncology experience preferred (2 years)