Clinical Protocol Coordinator

Axle • Bethesda, MD

4d • Onsite

About The Position

Axle is seeking a Clinical Protocol Coordinator to support the Division of Intramural Research, Clinical Trials Unit (CTU), at the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), in Bethesda, Maryland. The position independently provides regulatory and operational coordination throughout the clinical research protocol lifecycle, from development and initial submission through implementation and study closure. The coordinator prepares regulatory documentation, maintains study records, tracks safety reporting and approvals, coordinates monitoring activities, and trains research staff.

The role supports NINDS’s Intramural Research Program, including the Stroke Movement Disorders Program, Parkinson’s Disease Clinic, Behavioral Neurology Unit, and other assigned research programs. The coordinator works with investigators, research coordinators, protocol navigators, CTU staff, safety personnel, monitoring entities, IRB administrators, and NIH offices to support compliant clinical research. This includes advising investigators on documentation and approvals, maintaining knowledge of applicable requirements, and helping ensure research complies with Good Clinical Practice (GCP), NIH policies, FDA regulations, and federal human-subject research requirements.

Axle describes itself as a bioscience and information technology company focused on translational research, biomedical informatics, and data science. The position offers a market-competitive base salary of $140,000–$145,000, with actual compensation varying by experience, qualifications, skills, and location.

Requirements

• Master’s degree; field of study: General Medical and Health Services.
• Minimum of nine years of experience in clinical protocol coordination or a related field.
• Familiarity with Institutional Review Board (IRB) requirements.
• Previous clinical trial work.
• Experience training clinical trial site staff.
• Ability to coordinate project meetings.
• Knowledge of or experience with Clinical Trial Management Systems (CTMS), SharePoint, CRIS, CiStar, and Microsoft Office.
• Ability to support compliance with Good Clinical Practice, NIH policies, FDA regulations, and applicable federal requirements governing human-subject research.

Responsibilities

• Develop, assemble, review, edit, and submit clinical research protocols and related documents, including schemas, patient calendars, teaching aids, informed consent documents, and ethics and regulatory materials.
• Develop and review standard operating procedures for clinical studies.
• Prepare, review, and submit initial regulatory packages, amendments, continuing reviews, protocol deviations, problem reports, annual reports, closure documentation, study reports, and regulatory correspondence.
• Prepare and submit Investigational New Drug and Investigational Device Exemption safety reports, clinical study reports, and clinical data to monitoring agencies.
• Maintain complete, current, accurate, and audit-ready regulatory files, binders, investigator qualifications, delegation and trial logs, safety reports, approvals, study applications, and correspondence.
• Serve as a Protocol Navigator, providing day-to-day regulatory and operational support for assigned studies and managing regulatory activities from protocol conception through closure.
• Maintain study databases, protocol trackers, and status reports; conduct basic analyses; and track submissions, approvals, deadlines, monitoring activities, requests, outstanding actions, safety reporting, and study closure.
• Coordinate with IRB administrators to collect, review, and maintain IRB records and stay current on guidance for protocol and informed consent submissions and amendments.
• Develop and submit protocol actions through the NIH Protocol Tracking and Management System and submit regulatory packages to the IRB, Radiation Safety Committee, and other applicable oversight bodies.
• Coordinate communications with the IRB, NIH Clinical Center, and other NIH offices regarding approvals, institutional policies, and regulatory requirements.
• Track and review adverse events, toxicities, protocol deviations, participant safety concerns, and emerging trends; prepare required reports within applicable timelines and promptly communicate reportable issues to the Principal Investigator and Medically Responsible Investigator.
• Coordinate monitoring visits, audits, inspections, regulatory reviews, and quality assurance activities involving the FDA, NIH, pharmaceutical organizations, and other oversight entities; document findings and responses and track corrective and preventive actions through resolution.
• Implement and document revisions resulting from corrective and preventive action plans to support regulatory compliance and process improvement.
• Support protocol coordination by matching and locating control subjects, completing registration phone calls, reviewing study questionnaires, and resolving patient queries.
• Maintain master subject lists, update enrollment status, assign study identification numbers, and obtain patient demographic information.
• Coordinate protocol activities with investigators, research coordinators, protocol navigators, CTU staff, safety personnel, monitoring entities, and collaborating NIH offices.
• Participate in staff meetings, protocol development meetings, research coordinator forums, and multidisciplinary research meetings; meet with laboratory members to present updates.
• Develop training plans and train research staff on protocol development and conduct, regulatory changes, IRB and FDA submissions, radiation safety, ethics clearances, technology transfer, and protocol submission procedures.
• Advise investigators on documentation and approvals needed to initiate clinical studies based on research type, location, and complexity.
• Maintain current knowledge of clinical research regulations, guidance, and best practices through continuing education and required training.

Benefits

• 100% medical, dental, and vision coverage for employees
• Paid time off and paid holidays
• 401(k) match up to 5%
• Educational benefits for career growth
• Employee referral bonus
• Flexible Spending Accounts: Healthcare (FSA), Parking Reimbursement Account (PRK), Dependent Care Assistant Program (DCAP), and Transportation Reimbursement Account (TRN)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior