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) safety reports, clinical study reports, and regulatory correspondence, including initial submissions, information requests, amendments, and annual reports.

• Maintain complete and accurate regulatory binders, investigator qualifications, trial logs, safety reports, approvals, study applications, and correspondence.

• Serve as a Protocol Navigator, providing day-to-day regulatory and operational support for assigned clinical research studies.

• Manage, track, and report regulatory activities throughout the protocol lifecycle, from conception and development through study closure.

• Maintain study databases, conduct basic analyses, and track study requests, protocol submissions, approvals, deadlines, and outstanding actions.

• 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 initial protocol and informed consent submissions and amendments.

• Develop and submit protocol actions through the NIH Protocol Tracking and Management System.

• Prepare and submit regulatory packages to the IRB, Radiation Safety Committee, and other applicable oversight bodies.

• Coordinate communication with the IRB, NIH Clinical Center, and other NIH offices regarding protocol approvals, institutional policies, and regulatory requirements.

• Track and review adverse events, toxicities, protocol deviations, participant safety concerns, and emerging trends; prepare required reports in accordance with IRB processes and policies.

• Communicate safety concerns and significant protocol findings promptly to the PI and Medically Responsible Investigator.

• Coordinate monitoring visits, audits, inspections, and regulatory reviews, including quality assurance activities involving the Food and Drug Administration (FDA), NIH, pharmaceutical organizations, and other oversight entities.

• Implement and document revisions resulting from corrective and preventive action plans to support regulatory compliance and process improvement.

• Ensure research activities comply with Good Clinical Practice (GCP), NIH policies, FDA regulations, and applicable federal requirements governing human-subject research.

• 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.

• Provide regulatory and clinical research support for the NINDS Intramural Research Program, including the Stroke Movement Disorders Program, Parkinson’s Disease Clinic, Behavioral Neurology Unit, and other assigned research programs.

• Develop training plans and educate research staff on protocol development, trial conduct, regulatory changes, IRB and FDA submissions, radiation safety, ethics clearances, technology transfer, and protocol submission procedures.

• Advise investigators on the documentation and approvals needed to initiate clinical studies based on the type, location, and complexity of the proposed research.

• Maintain current knowledge of clinical research regulations, guidance, and best practices through continuing education and required training.