Page 372 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: E001
SOP Title: Clinical Research Educator’s Office Hours
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to describe the procedures to be followed for planning and holding dedicated time slots (“office hours”), interim research education and training support, and credentialing.
2. INTRODUCTION
Children’s Health is responsible for ensuring that all staff who are engaged in human subjects research at the institution have the appropriate education, training, and expertise to comply with federal, state, and institution requirements for conducting human subjects research. The Research Educator designated for the Research Administration (RA) department is an integral part of this strategic priority. In the current state of Pandemic, the current SOP outlines the provision of opportunities for education, training, and resources, including office hours where the educator has dedicated time to being available for questions or scheduled meetings.
3. SCOPE
This SOP applies to all activities to plan and fulfill research education support.
4. RESPONSIBILITIES
4.1 Interim Research Education Resources
• Coordinate with the direct supervisor to establish the onboarding plan for new team members, or team members assuming a new role within Research Administration.
• Schedule and assign computer-based training (CBT), non-clinical research modules, and competencies via the Learning Institute.
• Schedule and assign didactic, non-clinical research modules, and clinical and non-clinical competencies as applicable.
• Document all training and documentation for RA research personnel; and initiate and bridge communication for onboarding and competency check-off for clinical staff with a clinic preceptor and Medical Staff Services.
• Assess need and execute Just in Time and Refresher Training for RA research personnel.
• Identify and onboard preceptors; pair research personnel with a preceptor appropriate to their research and clinical needs.
• Developing training plans for new or transitioning studies or research portfolios; holding PACT meetings and PI introductory meetings
• The research educator will reserve 6-8 hours each week for covering the above research education support
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