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Clinical - Clinical Trial

2 months ago

BETHESDA, United States Guidehouse Full time
p style="text-align:left">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.

  • 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.