Senior Clinical Protocol Navigator for Trials & Regulatory

PriceSenz LLC; Bethesda (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

PriceSenz LLC in Bethesda, MD is seeking an experienced Clinical Protocol Coordinator to provide regulatory, operational, and administrative support to a Clinical Trials Unit within a neurological research program.

The role will support researchers across the full clinical study lifecycle, including protocol development, IRB and regulatory submissions, study documentation, adverse event tracking, and day-to-day coordination of assigned clinical trials.

Qualifications

• Master’s degree in General Medical and Health Services or a related field.
• Minimum of 9 years of experience in clinical protocol coordination or a related field.
• Familiar with IRB requirements and regulatory documentation.
• Experience training clinical trial site staff and coordinating project meetings.
• Experience with CTMS, SharePoint, CRIS, and CiStar is preferred.

Responsibilities

• Assist researchers with protocol development, documentation, and SOPs.
• Prepare IND/IDE safety reports, regulatory correspondence, and submissions.
• Maintain regulatory binders and study documentation for assigned trials.
• Track adverse events, protocol actions, and IRB/NIH submissions.
• Coordinate protocol activities among investigators, coordinators, and regulatory teams.

Skills

IRB familiarity

Regulatory coordination

Documentation skills

Communication skills

Project coordination

Education

Master’s degree in General Medical and Health Services or a related field

Tools

CTMS

SharePoint

CRIS

CiStar

Microsoft Office

Job description

PriceSenz LLC in Bethesda, MD is seeking an experienced Clinical Protocol Coordinator to provide regulatory, operational, and administrative support to a Clinical Trials Unit within a neurological research program.

The role will support researchers across the full clinical study lifecycle, including protocol development, IRB and regulatory submissions, study documentation, adverse event tracking, and day-to-day coordination of assigned clinical trials.