Part Time CTO Protocol Writer

Part-time Scientific Writers assist faculty and research staff in the development of scientific documents including clinical research documents (e.g., clinical protocols, informed consent forms, IND/IDE applications), grant applications (e.g., new and competing applications, annual reports), study reports (e.g., scientific manuscripts, meeting abstracts, posters, slide sets), and related documents (e.g., internal reports, standard operating procedures, working guidelines). They ensure that the documents are readable, clear, and consistent and that they conform to any applicable style and regulatory requirements as specified by the applicable agency, journal, scientific society, or meeting sponsor. Scientific Writers also manage document control and versioning among one or more authors. They work under general supervision, resolving most standard issues independently and referring complex issues to an upper-level manager. Scientific Writers typically report to a manager or director.

In partnership with the Assistant Director of Investigator Initiated Trials Research Operations (IITRO), the hourly protocol writer supports Massey investigators in developing documents associated with IITs:

• Create clinical research documents including but not limited to clinical protocols, informed consent form(s), FDA Investigational New Drug applications, Investigational Device Exemption applications
  
• Assist with submitting applications for funding opportunities including but not limited to non-profit foundation requests for proposals, VCU/Massey, and where appropriate NIH grants specific to support of clinical research activities
  
• Compile study reports including but not limited to scientific manuscript, meeting abstracts, final study summaries, posters, slide sets