Clinical Protocol Coordinator

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

Clinical Protocol Coordinator / Protocol Navigator

Location: Bethesda, MD — Onsite

Employment Type: Contract, Full-Time (40 hours/week)

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

Experience: 9+ years in clinical protocol coordination or a related field

Position Overview

We are seeking an experienced Clinical Protocol Coordinator to provide independent 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.

This position also serves as a Protocol Navigator, providing hands‑on support for assigned studies and collaborating closely with investigators, physicians, research coordinators, regulatory specialists, safety personnel, and monitoring entities.

Key Responsibilities

Protocol Development & Documentation

• Assist researchers with the development, assembly, review, and editing of clinical trial documents.
• Develop protocol documentation, including study schemas, patient calendars, and teaching aids.
• Develop informed consent forms and other ethics and regulatory‑related documentation.
• Develop and maintain standard operating procedures (SOPs) for clinical studies.
• Write and edit study protocols, amendments, reviews, reports, and other required forms.
• Prepare study reports, status updates, audit documentation, and other administrative materials.

Regulatory & IRB Support

• Prepare IND and IDE safety reports, clinical study reports, and regulatory correspondence, including initial submissions, information requests, amendments, and annual reports.
• Collect, organize, and maintain study documentation, including investigator qualifications, trial logs, and safety reports.
• Maintain complete and up-to-date Regulatory Binders for each assigned trial.
• Maintain accurate records of protocols, study applications, safety reports, annual reports, and correspondence.
• Track and review adverse event files and prepare reports in accordance with IRB processes and policies.
• Support the IRB administrator in collecting, reviewing, and maintaining IRB records.
• Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Communicate with the IRB and NIH Clinical Center to support protocol approval and regulatory submissions.
• Organize quality assurance activities with regulatory bodies, including the FDA, NIH, pharmaceutical sponsors, and other relevant entities.
• Initiate, implement, and document revisions resulting from corrective and preventive action plans to support continuous compliance and process improvement.

Study Coordination & Operations

• Maintain study databases, conduct basic analysis, and prepare and submit clinical data to monitoring agencies.
• Track study requests, protocol approvals, submissions, and approval status.
• Support protocol coordination, including matching and locating control subjects, completing registration calls, reviewing study questionnaires, and resolving patient queries.
• Coordinate protocol activities among investigators, research coordinators, protocol navigators, Clinical Trials Unit staff, and collaborating NIH offices.
• Participate in Clinical Trials Unit staff meetings, Protocol Navigator meetings, protocol development meetings, research coordinator forums, multidisciplinary research meetings, and other required meetings.
• Collaborate with clinical research scientists, physicians, research coordinators, regulatory specialists, safety personnel, and monitoring entities to support study implementation and execution.
• Provide regulatory and clinical research support for neurological research programs, including Stroke and Movement Disorders, Parkinson’s Disease, and Behavioral Neurology.

Required 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.
• Previous clinical trial experience.
• Familiarity with IRB requirements and regulatory documentation.
• Experience training clinical trial site staff.
• Experience coordinating project meetings.
• Experience with a Clinical Trial Management System (CTMS), SharePoint, CRIS, and CiStar.
• Proficiency with Microsoft Office.
• Strong written and verbal communication, organizational, and documentation skills.

Preferred Qualifications

• Experience with IND and IDE regulatory submissions.
• Experience with the NIH Protocol Tracking and Management System.
• Experience supporting neurology research programs.
• Familiarity with FDA, NIH, and pharmaceutical sponsor quality assurance processes.
• Full‑time, 40 hours per week.
• Onsite at the assigned research facility in Bethesda, MD.

PriceSenz is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or disability.