Clinical Research Protocol Navigator - Rockville, United States - Axle

Axle
Axle
Verified Company
Rockville, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Axle is seeking a
_Clinical Research Protocol Navigator _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)

Overall Position Summary and Objectives 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.


Deliverables:


  • Work products and documents related to protocol writing and editing; prepare amendments and all necessary forms; develop clinical research and clinical trial protocols, informed consent documents and other regulatory or studyrelated documents with special attention to the accuracy, consistency, and completeness of documents as well as proper format, spelling, and grammar (in conjunction with the PI and other relevant experts).
  • Daily
  • Work products and documents related to developing clinical documents; review and ensure that protocols and consents meet regulatory requirements and are written in a guideline compatible format.
  • Ad-Hoc
  • Work products and documents related to collaborating with staff on safety, regulatory and monitoring entities; coordinate with staff to integrate and ensure consistency of new/revised documents.
  • Ad-Hoc
  • Work products and documents related to managing, tracking and coordinating regulatory activities for the study protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closure.
  • Ad-Hoc
  • Work products and documents related to maintaining all regulatory trial documentation including maintaining a complete and uptodate Regulatory Binder for each trial; work with staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies.
  • Ad-Hoc
  • Work products and documents related to the organization of regulatory protocol meetings and/or reports; interact closely with the clinical research team and other branch/section staff involved in protocol management; guide the protocol navigation process.
  • Daily

Work Details:


  • 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

1:


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

2:


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

3:


  • 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

4:


  • Maintain all regulatory trial documentation including maintaining a complete and uptodate Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports

5:


  • Assists researchers with protocol development, assembly and review of clinical trial documents.
  • Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
  • Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.
  • Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
  • Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
  • Assists researchers to develop initial 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.
  • Assists researchers develop and maintain trial related documents and operational procedures.
  • Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
  • Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
  • Assist researchers prepare and submit
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