Regulatory Project Manager

Job Summary

Managing clinical trial submissions, the full-time salaried Regulatory Project Manager will coordinate new study activations, maintain regulatory compliance, and mentor research coordinators while working remotely.

Key responsibilities

• Coordinate new clinical trial submissions, including obtaining necessary approvals and informed consent documents
• Maintain regulatory documentation to ensure compliance with institutional, state, federal, and sponsor requirements
• Collaborate with investigators and internal stakeholders to facilitate timely approvals and study activations

Required qualifications

• Bachelor's degree
• Minimum of 2 years of experience in regulatory management and conduct of oncology clinical trials
• Working knowledge of clinical trials, federal, state, and local regulations, and IRB requirements
• Experience with consent form and protocol development