Clinical Protocol Coordinator

Axle • Bethesda, MD

1d • $140,000 - $145,000

About The Position

Axle is seeking a Clinical Protocol Coordinator to support the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) in Bethesda, Maryland. The coordinator independently supports the Division of Intramural Research, Clinical Trials Unit (CTU), providing regulatory and operational coordination throughout the clinical research protocol lifecycle, from development and initial submission through implementation and study closure.

The role includes preparing and submitting regulatory documentation; maintaining complete, current, audit-ready study records; tracking approvals, safety reporting, deadlines, and outstanding actions; coordinating monitoring visits and other oversight activities; and training research staff. The coordinator also supports subject-related protocol activities, maintains study databases and enrollment information, and advises investigators on requirements for initiating clinical studies.

The position supports the NINDS Intramural Research Program, including the Stroke Movement Disorders Program, Parkinson’s Disease Clinic, Behavioral Neurology Unit, and other assigned research programs. Research activities must comply with Good Clinical Practice (GCP), NIH policies, FDA regulations, and applicable federal requirements for human-subject research.

Requirements

• Master’s degree in General Medical and Health Services.
• At least nine years of experience in clinical protocol coordination or a related field.
• Familiarity with Institutional Review Board (IRB) requirements.
• Previous clinical trial work.
• Experience or skill in training clinical trial site staff.
• Experience or skill in coordinating project meetings.
• Knowledge of or ability to work with Clinical Trial Management Systems (CTMS), SharePoint, CRIS, CiStar, and Microsoft Office.

Responsibilities

• Develop, assemble, review, edit, and submit clinical research protocols, schemas, patient calendars, teaching aids, informed consent documents, and other ethics and regulatory documentation.
• Prepare, review, and submit initial regulatory packages, amendments, continuing reviews, protocol deviations, problem reports, annual reports, closure documentation, and other required study records.
• Prepare and review standard operating procedures (SOPs) for clinical studies.
• Prepare and review study reports, status updates, audit documentation, and regulatory correspondence, including IND and IDE safety reports and clinical study reports.
• Maintain complete, accurate, current, 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 development through study closure.
• Maintain protocol trackers, study databases, and status reports; conduct basic analyses; and track submissions, approvals, deadlines, monitoring activities, safety reporting, requests, outstanding actions, and study closure.
• Prepare, review, and submit clinical data to monitoring agencies.
• 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 prepare regulatory packages for the IRB, Radiation Safety Committee, and other oversight bodies.
• Coordinate 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 regulatory timelines and communicate significant issues promptly to the PI and Medically Responsible Investigator.
• Coordinate monitoring visits, audits, inspections, regulatory reviews, and quality assurance activities involving 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 compliance and process improvement.
• Ensure research activities comply with GCP, NIH policies, FDA regulations, and applicable federal human-subject research requirements.
• Support protocol coordination by locating and matching 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.
• Develop training plans and educate 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 the proposed research type, location, and complexity.
• Maintain current knowledge of clinical research regulations, guidance, and best practices through continuing education and required training.
• Meet with laboratory members to present updates.

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, including healthcare FSA, parking reimbursement account (PRK), dependent care assistance program (DCAP), and transportation reimbursement account (TRN).

What This Job Offers

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