Remote Protocol Navigator – Clinical Research & Policy

Frederick National Laboratory for Cancer Research; United States; Remote; USD 93,000 - 133,000; Full time

Job summary

Frederick National Laboratory for Cancer Research seeks a Protocol Navigator to provide protocol development and navigation support within the CMRPD. The role collaborates with allergy, immunology, and infectious disease investigators to ensure accurate, compliant study documents and timely approvals.

The PN/PDP team manages timelines, coordinates with PIs and medical writers, and interfaces with IRB and regulatory offices. Remote work is possible with NIH coordination.

Qualifications

• Bachelor’s degree or four years related biomedical research experience.
• Experience coordinating multiple protocols with deadlines and regulatory approvals.
• Knowledge of regulatory requirements for human subjects research.

Responsibilities

• Provides protocol development and implementation support for NIAID intramural research protocols.
• Serves as the point of contact and project manager for an assigned portfolio of protocols.
• Orchestrates meetings with PIs and staff to set timelines and start-up logistics.
• Reviews study documents for accuracy and alignment with policies and guidelines.
• Coordinates with IRB, FDA-related offices, and other bodies to obtain required approvals.
• Attends NIH meetings and supports timely submissions and amendments.

Skills

Regulatory knowledge

Project management

Communication

Attention to detail

Team collaboration

Security clearance readiness

Medical writing

Education

Bachelor’s degree or 4 years related experience

Tools

MS Word

MS Office

Job description

Frederick National Laboratory for Cancer Research seeks a Protocol Navigator to provide protocol development and navigation support within the CMRPD. The role collaborates with allergy, immunology, and infectious disease investigators to ensure accurate, compliant study documents and timely approvals.

The PN/PDP team manages timelines, coordinates with PIs and medical writers, and interfaces with IRB and regulatory offices. Remote work is possible with NIH coordination.