Senior Regulatory Lead - Neurosurgery Trials (Remote)

Duke University; Durham (NC); Hybrid; USD 71,000 - 113,000; Full time

Job summary

Duke Neurosurgery seeks a Senior Regulatory Coordinator to manage high‑impact clinical trials, coordinating IND submissions and regulatory activities across multiple study teams in a fast-paced academic setting.

You will ensure compliance with FDA regulations, prepare regulatory documents, and collaborate with investigators, sponsors, and ORAQ to advance innovative brain and spine research.

Qualifications

• Associate's degree; bachelor’s degree may substitute for two years.
• Six years of research experience; a bachelor’s degree may substitute for two years.
• Completion of the DOCR North Carolina Clinical Research Apprenticeship may substitute for one year.
• Proficiency with Microsoft Office and web-based research systems.

Responsibilities

• Oversee complex neurosurgery clinical trials.
• Serve as IND submissions expert and guide FDA reviews or issues.
• Direct multiple study teams to prepare for study monitoring and audits.
• Collaborate with PIs, sponsors, and study teams to conduct clinical research.
• Maintain regulatory documentation and binders; ensure protocol compliance.

Skills

MS Office

Web-based systems

Attention to detail

Multitasking

Communication skills

Collaboration

Problem-solving

Education

Associate's degree

Bachelor's degree substitution

Tools

eReg systems

Regulatory databases

Job description

Duke Neurosurgery seeks a Senior Regulatory Coordinator to manage high‑impact clinical trials, coordinating IND submissions and regulatory activities across multiple study teams in a fast-paced academic setting.

You will ensure compliance with FDA regulations, prepare regulatory documents, and collaborate with investigators, sponsors, and ORAQ to advance innovative brain and spine research.