Regulatory Specialist II

Job Summary

To support the Office of Clinical Trials, the full-time Regulatory Specialist II will manage a dedicated portfolio of clinical divisions, facilitating study startup and maintenance of commercially sponsored clinical trials through coordination with internal and external partners, IRB submissions, and document management.

Key responsibilities

• Facilitate accelerated study startup activities, including feasibility surveys and initial applications to the IRB
• Monitor and report critical study start-up milestones, ensuring smooth implementation from conception to activation
• Create and maintain an electronic regulatory binder, ensuring all required documents are accurate and up to date throughout the study

Required qualifications

• Bachelor's Degree
• Two years of experience in academic, government, or industry-based clinical research
• Familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research
• Experience with study startup activities in interventional clinical trials is preferred