The objective of this Administrative Supplement for a Quality Assurance/Quality Control position is to ensure high quality submissions to the NCATS prior approval process.
The specific aims are as follows: 1) Ensure adherence to NIH and NCATS policies regarding CTSA-related submissions to NCATS and submissions to the eRA Human Subjects System, and participate in process improvement across the CTSA consortium. 2) Improve the quality of the prior approval submissions across all partner institutions for Pilot awards and KL2 projects by reducing inaccurate information and incomplete submissions 3) Implement a formal quality review process prior to submission to NCATS. 4) Develop a centralized management process for submissions to the eRA Human Subjects System to ensure consistency, accuracy, and efficiency. 5) Review and compile data on any problem submission areas and develop corrective action plans. This will be accomplished by having a dedicated Research Navigator who will ensure these specific aims are implemented and followed not only at Johns Hopkins (JH) but at partner institutions also. To ensure consistency across JH and University of Maryland, the Research Navigator position will be split between the two institutions 75% and 25%, respectively, to allow for a well-coordinated, cohesive, high-quality process.
As an active NCATS CTSA program involved in translational research, the Johns Hopkins ICTR and its partner institutions are committed to providing high-quality review of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall prior approval process. Having dedicated personnel to do this important work will make the translational research review process more efficient and effective allowing for studies to open more quickly.