Clinical Research Protocol Navigator

Job Family:

Clinical Trial Operations (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:

We are currently searching for a Clinical Research Protocol Navigator. The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. This role is centered around clinical research protocol and informed consent document development and requires expert writing skills. This role also includes IRB submissions, regulatory document management, amongst other regulatory study tasks. This is a full-time opportunity located in Bethesda, MD.

• Develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.

• Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation.

• Prepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation.

• Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.

• Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports.

• Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.

• Work with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures SOPs pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.

• Coordinate with other offices e.g., Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication to integrate and ensure consistency of new revised documents with policies.

• Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities.

• Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.

• Develop clinical research informed consent and other ethics and regulatory related documentation description.

• Collect, organize, and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.

• Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.

• Write and edit study protocols, and amendments, reviews, reports, and other necessary forms.

• Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.

• Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.

#SOAR

What You Will Need:

• Master’s Degree in any of the following: Miscellaneous Health Medical Professions, Nursing, Biology Multi-Disciplinary or General Science, Health, and Medical Preparatory Programs, General Medical and Health Services, Neuroscience, Health and Medical Administrative Services, Cognitive Science and Biopsychology, or Miscellaneous Biology.

• A minimum of TWO (2) year of experience in a clinical trial or clinical research setting.

• Liaising with regulatory authorities

• Training clinical trial site staff

• Experience with Phases I or II experience, Regulatory compliance, Protocol development, and/or Protocol navigation.

• Previous experience with Regulatory affairs, IRB submissions, On-site visits, and/or Data Integrity

• Strong writing skills with experience writing clinical research protocols.

• Proficient with Clinical Trial Management System (CTMS), Electronic Medical Records System, and/or Electronic Data Capture System

What Would Be Nice To Have:

• PhD Degree Preferred

• A certification in any of