Cancer Clinical Trials Regulatory Specialist 2 (Remote)

Responsibilities

• Prepare and submit regulatory applications and documentation for clinical research studies, including IRB submissions, amendments, IND/IDE applications, IND/IDE annual reports, and IND/IDE withdrawals.
• Maintain regulatory compliance across the study lifecycle and serve as a liaison with internal and external regulatory agencies, including IRBs, FDA, sponsors, and institutional stakeholders.
• Provide regulatory guidance and support to principal investigators, study teams, and research staff to ensure adherence to federal, state, local, and institutional requirements.
• Support regulatory applications for industry-sponsored, investigator-initiated, and collaborative clinical research studies.
• Oversee and maintain regulatory documentation and safety reporting processes; ensure timely and compliant submission.
• Monitor changes in applicable regulations and assess operational impact; implement updates to maintain compliance and improve regulatory processes.
• Develop and deliver regulatory training and educational materials for research personnel, including onboarding, presentations, and one-on-one support.
• Manage regulatory projects and initiatives to improve operational efficiency, quality, and study start-up processes.
• Contribute to the development, implementation, and continuous improvement of Standard Operating Procedures (SOPs) and regulatory guidance documents.
• Mentor and provide subject matter expertise to regulatory staff and research teams on IRB processes, FDA requirements, and clinical research regulations.
• Collaborate across multidisciplinary teams to support high-quality clinical research operations and ensure timely study activation and maintenance.

Qualifications

• Bachelor’s degree and five years of related experience or a combination of relevant education and experience.
• Excellent communication and organizational skills and superb attention to detail.
• Experience with MS Office products and database applications required.
• Excellent inter-personal skills and customer service focus is required.
• Experience in clinical research management and oversight, including project management in a dynamic research setting.
• Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
• Experience in developing and implementing training/education.
• Demonstrated ability to manage multiple projects and staff under varying time constraints.
• Strong writing skills.