Regulatory Compliance Officer - CCC | Clinical Trials Office

Why Consider this Job Opportunity

• Opportunity for career advancement and growth within the organization
• Work remotely with a flexible schedule
• Engage in meaningful work that contributes to cancer research and patient care
• Collaborative and supportive environment with a focus on compliance and regulatory standards
• Be part of a prestigious institution recognized as one of only 50 comprehensive cancer centers in the nation

• Collaborate with investigators to ensure appropriate regulatory safeguards are included in study protocols
• Conduct detailed reviews of protocols and informed consent forms prior to IRB submission
• Ensure timely submission of protocol documents and maintain communication with research project sponsors
• Develop IRB submission packets, including writing abstracts and drafting informed consent forms
• Monitor federal and sponsor regulations to provide updates and guidance to research staff

• Bachelor’s Degree in biological sciences, health sciences, social sciences, or a related medical field
• Minimum of 1 year of experience in a research or administrative role related to research projects
• Knowledge of research regulations, guidelines, and compliance issues
• Experience in developing informed consent documents and preparing regulatory documents
• Familiarity with IRB and federal or industry sponsor processes and requirements

• Experience working with regulatory agencies such as the FDA and IRBs
• Prior involvement in audits and site visits related to research compliance
• Strong organizational skills and attention to detail in managing regulatory files and documentation

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