Senior Regulatory Compliance Officer

Job Summary

Providing regulatory expertise for investigator-initiated oncology clinical trials, the full-time Senior Regulatory Compliance Officer will ensure compliance with university, state, and federal regulations while managing submissions and supporting junior team members in a remote setting.

Key responsibilities

• Oversee regulatory research compliance across disease teams and assist in managing complex submissions
• Serve as a subject matter expert, reviewing regulatory documents and providing guidance to the research team
• Participate in the development of standard operating procedures and training programs for compliance staff

Required qualifications

• Bachelor's degree in a relevant field or equivalent combination of education and experience; Master's degree preferred
• Clinical research certification from SoCRA or ACRP is required
• 3-5 years of experience in a clinical research or administrative capacity
• Considerable knowledge of clinical research regulations and compliance issues
• Experience in a regulatory affairs capacity in a medical research setting is desired