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State and Site Coordinator Responsibilities in Regulatory Study Oversight

Learn about the oversight roles of coordinators in ensuring the integrity of a regulatory study and the crucial tasks they handle in collaboration with the NCSBN, including compliance monitoring, training, and data tracking.

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State and Site Coordinator Responsibilities in Regulatory Study Oversight

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  1. State and Site Coordinator Responsibilities Nancy Spector, PhD, RN Director of Regulatory Innovations Renee Nicholas, Coordinator, Regulatory Innovations

  2. Oversight of study • NCSBN four dedicated staff members • Research advisory panel • Three state coordinators

  3. Oversight of Study • Each site has a site coordinator • Site coordinator kick-off meeting • Control and intervention calls monthly

  4. State Coordinator • Deb Bacharz, Illinois • Ashley Trantham, North Carolina • Joyce Zurmehly, Ohio • Lea Yoakem, Research Assistant

  5. State Coordinator • Major Goal: Ensure integrity of the study

  6. State Coordinator • Assist with compliance of the study protocol • Intermediary between NCSBN and sites

  7. State Coordinator • Develop rapport with the site coordinators • If needed, step in as a site coordinator

  8. State Coordinator • Assist with IRB process: Initial and ongoing • Provide training for sites, as needed

  9. State Coordinator • Monitor new nurse/preceptor/manager enrollment • Tracking of progress of site coordinator data submission

  10. State Coordinator • Tracking of progress of new nurse, preceptor, and manager surveys • Tracking of preceptor and new nurse training

  11. State Coordinator • Will connect regularly with NCSBN staff • Will connect regularly with site coordinators

  12. State Coordinator • Always available for questions • NCSBN is a resource too: ttp-help@ncsbn.org Or nspector@ncsbn.org

  13. Site Coordinator • Goal also to ensure integrity of the study • That important site contact

  14. Site Coordinator • Maintain compliance with study protocol • IRB submission • Timing is key – Start early! • Central IRB Forms • CITI training • Consent forms – amendments • State Coordinator is here to help

  15. Site Coordinator • Nurses in both the intervention and control groups will need to review, understand and sign an informed consent form in order to become a study participant • Once the consent form is signed, the new nurse, preceptor and nurse manager (intervention group) may be enrolled

  16. Site Coordinator • Enroll new nurses, preceptors and nurse managers (intervention group) • New nurse enrollment based on inclusion/exclusion criteria • Facilitate preceptor training module in intervention group – Begin March 1st • Develop rapport with new nurses and preceptors

  17. Site Coordinator • Survey submission and timelines • Module completion during the first 3 months • Assist with collecting time spent on modules • Reminders when surveys are overdue

  18. Site Coordinator Ensuring institutional support • Allotted time during the work day to complete surveys and modules (intervention group) • Opportunities for participation in committees, etc.

  19. Site Coordinator • Complete an institutional demographics and outcomes survey at the beginning of the study, at 12 months, and at the end of the study • Survey will be available online with your site coordinator user ID and password www.transitiontopractice.org • Start early and ask questions!

  20. Site Coordinator Focus groups: • Challenges/solutions • Cost/benefit

  21. Site Coordinator Monthly Conference Calls Dial-in number: 1-866-396-9373 Conference code:1617241

  22. Site Coordinator Many resources: • Laminated Cards • Posters • Brochures • Newsletters • Site Coordinator Manual • State Coordinator • ttp-help@ncsbn.org • Each other! • Conference calls • Discussion forum

  23. Site Coordinator • You are pivotal to the success of the study!

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