Senior Regulatory Lead - Neurosurgery Trials (Hybrid)

Duke Clinical Research Institute; Durham (NC); Híbrido; USD 71 000 - 113 000; Tempo integral

Resumo da oferta

Duke Neurosurgery is seeking a Senior Regulatory Coordinator to support complex neurosurgery clinical trials, from IND submissions through study closeout, in a fast-paced academic research setting.

Hybrid work arrangement with on-site and remote days; contributor will coordinate with investigators, sponsors, and regulatory staff to ensure compliance with federal regulations and Duke policies. This role emphasizes leadership in regulatory processes and study integrity.

Qualificações

• Associate's degree; six years of research experience; a bachelor’s degree may substitute for 2 years of required experience.
• Proficiency with Microsoft Office applications and research-related software.
• Ability to manage multiple studies and priorities with attention to detail.

Responsabilidades

• Oversee Complex Neurosurgery Clinical Trials and provide guidance for IND submissions and FDA correspondence.
• Coordinate study monitoring, audits, and communications across investigators, sponsors, and teams.
• Ensure regulatory compliance and study quality through documentation, SOPs, and regulatory reporting.

Conhecimentos

Microsoft Office

Attention to detail

Communication skills

Collaboration

Problem-solving

Formação académica

Associate's degree

Clinical Research Apprenticeship

Bachelor's degree substitution

Descrição da oferta de emprego

Duke Neurosurgery is seeking a Senior Regulatory Coordinator to support complex neurosurgery clinical trials, from IND submissions through study closeout, in a fast-paced academic research setting.

Hybrid work arrangement with on-site and remote days; contributor will coordinate with investigators, sponsors, and regulatory staff to ensure compliance with federal regulations and Duke policies. This role emphasizes leadership in regulatory processes and study integrity.