Regulatory Specialist II

Job Summary

To support research regulatory activities, the full-time remote Regulatory Specialist II will manage protocol-specific documents and standardized reports to ensure compliance with internal policies and federal regulations throughout the study lifecycle.

Key responsibilities:

• Independently prioritize and evaluate regulatory requirements and submissions for assigned studies
• Create, maintain, and update informed consent forms and IRB/IBC applications while processing applications for Biosafety Committee review
• Mentor and train new regulatory staff, acting as the central contact for regulatory queries and collaborating with research staff during audits

Required qualifications:

• High School Diploma/GED required
• 4+ years of clinical research regulatory experience (preferably in oncology) with a High School Diploma
• 2 years of clinical research regulatory experience (preferably in oncology) with an Associate's or Bachelor's Degree
• 1 year of clinical research regulatory experience (preferably in oncology) with a Master's Degree
• Preferred: 2 years of experience in clinical research regulatory activities, including study activation