Regulatory Compliance Specialist

7 days ago


Durham, North Carolina, United States Duke University Full time

Duke University, a world-class academic medical center, is seeking an experienced Regulatory Coordinator to join its team. This exciting opportunity offers a competitive salary and benefits package.

About the Role

This Clinical Research Coordinator position plays a vital role in ensuring compliance with regulatory requirements for multiple complex oncology clinical trials and research studies. The successful candidate will work closely with study sponsors, researchers, and other stakeholders to ensure seamless execution of these studies.

Key Responsibilities:
  • Maintain study level documentation, including regulatory binders, enrollment logs, and patient registration in the system of record;
  • Develop and submit Institutional Review Board (IRB) documents, such as consent forms, protocols, and continuing reviews;
  • Provide regulatory and safety reports and maintain study compliance according to institutional requirements, protocols, and other applicable policies;
  • Oversee maintenance of Delegation of Authority Logs and training of key personnel on study-specific duties;
  • Collaborate with study teams to summarize and clarify professional guidelines and code of ethics related to regulatory and safety issues in the conduct of clinical research;
Requirements:
  • A minimum of two years of research and/or regulatory experience; A Bachelor's degree may substitute for 2 years of required experience;
  • Oncology or research experience, training, education preferred;
  • Excellent communication, organizational, and problem-solving skills;
Benefits:

Duke University offers a comprehensive benefits package, including a competitive salary, health insurance, retirement savings plan, paid time off, and access to professional development opportunities. As an equal opportunity employer, Duke University is committed to creating a diverse and inclusive environment that values all individuals' unique perspectives and contributions.

The estimated salary range for this position is $55,000-$65,000 per year, depending on qualifications and experience.



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