Children’s Healthcare of Atlanta employs a full time Research Educator who works specifically with the clinical research staff. The educator collaborates with our institutional partners at Emory University and others to plan, develop, train, and implement research priorities across the enterprise.
All research staff working on Emory IRB approved projects are required to complete a live course- “Introduction to Clinical Research at Emory for Coordinators and Nurses”. This course is designed to provide a basic framework of the roles and responsibilities for clinical research staff to highlight the tools to needed to successfully perform their job. The course introduces the new and existing clinical research staff to the federal regulations governing the conduct of clinical research including relevant institutional policies and procedures. The course also provides an integrated and practical overview of the operational procedures to facilitate compliance in clinical research.
Employees are also required to complete the online training titled “Children’s Research Process Training” at hire and annually. This course is divided into three segments; Study Start-up, Study Conduct, and Study Closeout, and is designed to educate the research coordinator or nurse about the entire life cycle of a research project at Children’s.
In addition, Children’s hosts quarterly staff meetings. These meetings cover a wide array of topics and are frequently used to introduce significant changes to policies/procedures, roll out new system initiatives, introduce changes to processes or federal and regulatory rules.
New Children’s employees are required to attend an in-person Research Administration Orientation (RAO) within the first month of employment. During the RAO, representatives from the IRB, Research Compliance, and Research Finance discuss their specific areas and how they will interface with the coordinator or nurse. Research specific SOP’s are also reviewed during the RAO. Children’s policies, SOP’s and guidelines are housed on our internal website, Careforce Connection, and can be accessed by all Children’s staff or those with sponsored accounts from other institutions.
Individualized coordinator/nurse training with the Research Educator is available as well. Mock consent training is the most commonly used service provided by the educator; however, other ad hoc training is also available. The educator partners with the research compliance team to address items identified by their audit program and ensure proper adherence to federal regulations, institutional policies and procedures, and ICH/GCP guidelines. Children’s research managers also complete an orientation checklist with each employee to verify mastery of key concepts related to their role as a research coordinator or nurse.
We believe that continuing education beyond what is offered here at Children’s is important and provide funds for four staff members per year to attend national conferences via a scholarship program. Our primary focus is on the conferences hosted by the two main research professional associations (Association of Clinical Research Professionals and The Society of Clinical Research Associates), but other conference attendance is supported as well.
Children’s and Emory partner to host a monthly meeting that covers a variety of research topics from federal regulations to specific operational issues. The sessions are teleconferenced to reach a broader audience.
Lastly, Children’s requires human subjects’ protection training every three years via the CITI program. The CITI GCP module is required every three years for federally funded studies but is recommended as best practice regardless of the funding source.