Lead Regulatory and Clinical Operations Specialist

$139,395 - $181,216/Yr

National Institutes of Health

Part-time,Full-time - Senior

Onsite

Professional, Scientific, and Technical Services

About the position

The Lead Regulatory and Clinical Operations Specialist will serve in the Office of Sponsor and Regulatory Oversight at the National Cancer Institute. This role involves providing regulatory guidance, safety oversight, and operational support for clinical trials, ensuring compliance with regulations and industry best practices. The specialist will lead a team, participate in protocol development, and evaluate regulatory compliance reports, contributing to the advancement of cancer research.

Responsibilities

• Serve as a team lead for internal safety oversight staff and provide oversight for the safety oversight section of the support contract.
• Provide regulatory guidance, safety oversight, operational support, and inspections for IND and IDE products developed by the CCR.
• Participate in clinical trial protocol development and review, ensuring compliance with OSRO Policies and Procedures, NIH Policies, and ICH Good Clinical Practice guidelines.
• Evaluate essential regulatory compliance reports for validity and consistency.
• Establish standards for clinical site monitoring and implement risk-based monitoring.
• Support maintenance of safety trackers and databases.
• Collaborate with Medical Monitors in reviewing and reporting serious adverse event information.
• Provide regulatory guidance and assistance to clinical investigators and regulatory staff to ensure compliance with applicable regulations.

Requirements

• Bachelor's degree or higher in a field related to medical, health sciences, or allied sciences from an accredited institution.
• At least one year of specialized experience equivalent to the GS-13 level in the Federal Government, focusing on regulatory requirements for clinical trials, providing guidance on regulations, and preparing reports on clinical trial operations.

Benefits

• Comprehensive benefits package as a federal employee, including health insurance, retirement plans, and paid time off.