Clinical Protocol Coordinator

The role, as AXLE INFORMATICS describes it

(ID: 2026-3801)

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees

• Paid Time Off and Paid Holidays

• 401K 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)

• Transportation Reimbursement Account (TRN)

Position Overview

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 include preparing regulatory documentation, maintaining study records, tracking safety reporting and approvals, coordinating monitoring activities, and training research staff.

Additional Qualifications

Education

• Master's degree.

• Field of study: General Medical and Health Services.

Experience and Qualifications

• 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.

Software

• Clinical Trial Management System (CTMS)

• SharePoint

• CRIS

• CiStar

• Microsoft Office

Skills

• Training clinical trial site staff

• Coordinating project meetings

Deliverables

• 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

Statement of Work Details

• 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.

• Prepare, review, and submit Investigational New Drug (IND) and Investigational Device Exemption (IDE)

Read the full advert and apply on AXLE INFORMATICS’s site →