Clinical Protocol Coordinator
Bethesda · Axle Informatics LLC · USD 140,000-145,000 · Posted Oct 14, 2026
At a glance
- Location
- Bethesda · Axle Informatics LLC
- Salary
- USD 140,000-145,000 · Base salary
About the role
- The Clinical Protocol Coordinator will independently support the Division of Intramural Research, Clinical Trials Unit (CTU) at NINDS.
- The role provides regulatory and operational coordination throughout the clinical research protocol lifecycle, from development and initial submission through implementation and study closure.
Responsibilities
- Prepare regulatory documentation, maintain study records, track safety reporting and approvals, coordinate monitoring activities, and train research staff.
- Maintain complete, current, and audit-ready regulatory files for each assigned protocol, including investigator qualifications, delegation logs, safety reports, approvals, and correspondence.
- Meet with laboratory members to present updates.
- Prepare, review, and submit protocol and regulatory packages, including initial submissions, amendments, continuing reviews, informed consent documents, protocol deviations, problem reports, annual reports, and closure documentation.
- Maintain protocol trackers and status reports documenting submission dates, approval status, deadlines, monitoring activities, outstanding actions, safety reporting, and study closure.
- Review and document safety and compliance findings, promptly communicate reportable issues to the Principal Investigator (PI) and Medically Responsible Investigator, and prepare safety reports within applicable regulatory timelines.
- Coordinate monitoring visits, audits, inspections, and regulatory reviews; document findings and responses; and track corrective and preventive actions through resolution.
- Develop, assemble, review, and edit clinical research protocols, schemas, patient calendars, teaching aids, informed consent documents, and other ethics and regulatory documentation.
- Develop and review standard operating procedures (SOPs) for clinical studies.
- Prepare and review study reports, status updates, amendments, annual reports, audit documentation, and other required administrative records.
Requirements
- Master's degree in 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.
Benefits
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Employee Referral Bonus
- Healthcare Flexible Spending Account (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Skills
- Clinical Trial Management System (CTMS)
- SharePoint
- CRIS
- CiStar
- Microsoft Office
- Training Clinical Trial Site Staff
- Coordinating Project Meetings
