Regulatory Startup Project Coordinator

Job Summary

To support clinical research initiatives, the full-time remote Regulatory Startup Project Coordinator will manage the study start-up process, ensuring timely activation timelines while overseeing regulatory specialists and developing necessary study-related documents.

Key responsibilities

• Oversee progress of study projects through the activation pathway
• Develop study-related documents required for study start-up
• Coordinate with internal and external customers to ensure timely completion of regulatory tasks

Required qualifications

• Bachelor's degree required (Master's degree preferred)
• Five years' experience in clinical research, with two years in a study start-up or regulatory role
• CCRP/CCRC or equivalent certification preferred
• Working knowledge of FDA and other regulatory requirements
• Oncology experience preferred (two years)