Clinical Research Specialists (CRS) on the JAX Clinical & Translational Research Support (CTRS) team provide support to JAX investigators for development of human research content for grant applications per regulations and policies of the funding entity.
Services include:
- Study design, sampling strategies, selection of appropriate outcome measures, and guidance regarding implementation and data safety monitoring plans
- Development of human subjects sections for NIH grants in compliance with federal, state, and institutional regulations and policies
- Development of justifications for use of human materials (specimens and/or data) that is not human subjects research per NIH requirements
- Navigation of the IRB review process including Single IRB and regulatory support
- Registration of clinical trials on clinicaltrials.gov (if required)
