Senior Regulatory Compliance Coordinator

Job Summary

To support the management of cancer clinical trials, the full-time Senior Regulatory Compliance Coordinator will oversee the regulatory submission process, ensure compliance from trial approval to closure, and mentor junior staff while working remotely.

Key responsibilities

• Assist in the development of investigator-initiated clinical trial protocols and informed consent forms, ensuring compliance with regulatory requirements
• Submit protocol applications for IRB review and track new protocols through the approval process, addressing committee inquiries as needed
• Collaborate with investigators and research teams to maintain regulatory compliance and facilitate communication throughout the clinical trial lifecycle

Required qualifications

• Bachelor's Degree (Master's preferred) in science or healthcare policy
• 5+ years of experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance within the Medical Device Industry
• Knowledge of Good Clinical Practice guidelines and federal regulations
• Oncology experience and some medical knowledge preferred
• Certification in SoCRA, ACRP, or RAPS is preferred