Senior Regulatory Compliance Coordinator

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