Clinical Research Protocol Navigator

3 weeks ago


Bethesda, United States VeeAR Projects Inc. Full time

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.
  • 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.
  • Assists researchers with protocol development, assembly and review of clinical trial documents.


Specific Qualifications:

  • Master’s in nursing or related field


Any of the following certifications will work:

Certifications & Licenses:

  • Association of Clinical Research Professionals Certified Professional (ACRP-CP)
  • Association of Clinical Research Professionals (ACRP)
  • Certified Clinical Research Professional (CCRP)
  • Certified Clinical Research Coordinator (CCRC)
  • Certified Clinical Research Associate (CCRA)


Skills:

  • Liaising with regulatory authorities
  • Training clinical trial site staff
  • Previous clinical trial work
  • Phase I or II experience
  • Regulatory compliance
  • Protocol development
  • Protocol navigation
  • Regulatory affairs
  • Clinical Research
  • IRB submissions
  • Clinical Trials
  • Data Integrity
  • Research
  • ICH/GCP
  • Strong writing skills with experience writing clinical research protocols.



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