1. Clinical Research Coordinator Training Initiative
Lydia Klinger, CRA
Wright Center for Clinical & Translational Research
Meghan Wright, MEd
Office of Research Subjects Protections

2. How did this thing get started?
Lydia

3. Background
Multiple groups identified a need to have standardized, comprehensive training for CRCs across the institution.
Coordinators were trained differently in different areas.
Knowledge gaps slowed the progress of research.
High turnover in some areas was attributed to lack of training and support.
Wright CCTR and Office of Research & Innovation collaborated to form a Clinical Research Coordinator Education Task Force to address the problem.
Lydia

4. Clinical Research Coordinator Task Force Membership
Wright Center for Clinical and Translational Research
Office of Research
School of Medicine
Department of Internal Medicine
Department of Pediatrics
Massey Cancer Center
School of Nursing
Lydia

5. Lydia

6. Workforce Development A Priority for the Wright CCTR
The translational science workforce has the skills and knowledge necessary to advance translation of discoveries.
The Domain Task Force focuses on: Building an environment that supports and values translational science as “the place to go” for those who want to pursue high-impact careers in health sciences.
Training and educating a world-leading, continuously learning workforce
Developing a translational science workforce that can meet the needs of today and tomorrow
Lydia

7. Overall Goals & Purpose
Improve clinical research operations compliance by providing ease of access to training and resources
Standardize training and education processes for clinical research professionals
Provide clear documentation and structure of training and education for supervisors and employees
Meghan

8. Besides VCU, who will benefit?
Meghan

9. Managers Easy-to-provide training materials Easy-to-access resources
Assurance that each employee will have all applicable knowledge and skills at the end of their onboarding and orientation.
Increases communication between managers and employees.
Meghan

10. Clinical Research Coordinator
Resources and training are available in one easy-to-access place.
Standardized training means easily transferrable skills and education.
Clear guidance and expectations for job requirements.
Consistently trained and organized workforce can better advocate for promotions and professional development.
Meghan

11. And most importantly…
Improving the understanding and appreciation of the role of a Clinical Research Coordinator across the clinical research workforce.
Meghan

12. Meghan
Across the world, the importance of the CRC is being recognized. While we aren’t getting $35M to fund this program, the OVPRI and Wright Center are committed to establishing a full educational program.

13. Comprehensive Onboarding Checklist Pilot & Launch
Phase 1
Development
Phase 2
Comprehensive Onboarding Checklist Pilot & Launch
Phase 3
Bootcamp, SOPs, Mentor Program
Phase 4
Toolkit website, online training content, expansion to existing CRCs and all research coordinators
Lydia

14. Phase 1: Development
Gathered all existing documents used to onboard and orient new CRCs.
Reviewed, compared, and combined existing documents with a focus on creating one universal, comprehensive onboarding checklist/training.
Determined the goals of the Task Force and began establishing timelines.
Brainstormed formats for onboarding, training, and resource storage.
Lydia

15. Phase 1: Development (cont.)
Based planning and resource gathering around Joint Task Force for Clinical Trial Competency “Competency Domains for the Clinical Research Professional.”
Lydia

16. Phase 2: Onboarding Checklist & Orientation Module
Comprehensive list of information, resources, job requirements, and competencies of a CRC
Determined approximate time frame & order
Links to resources/more information
Learn or refer back to later
Clinical permissions & VCUHS Orientation
Discussed audience, drafted & discussed Compliance policy
Meghan
Nurse manager, new VCU employees in HS space

17. Phase 2: Onboarding Checklist & Orientation Module (cont.)
Organized and input onboarding checklist in REDCap
Tried and tested functional logistics of REDCap (both manager & employee)
Piloted Checklist – new CRCs
Received Feedback  Changes to Checklist & Delivery System
Meghan

18. Initial REDCap Checklist
Meghan

19. Phase 2: Onboarding Checklist & Orientation Module (cont.)
Put checklist in new learning management system
Separate checklists for employees and managers based on task
Central system for training and evaluation, including VCU employee requirements
Creating a more user-friendly interface
Meghan

20. Phase 3: Bootcamp, SOPs, Mentoring Program
Institutional SOPs –
Based on purchased SOPs & Massey
Open to public comment
Committee review from SOM, Wright Center, Massey
Will be linked to corresponding checklist topic
Standardized job descriptions and job families
Communicate to research community & provide education sessions
Lydia

21. Phase 3: Bootcamp, SOPs, Mentoring Program (cont.)
Consulted existing CRC in-person training curriculum topics
Logistics (3x per year, or as needed)
In-person hands-on training in certain topic areas
Consent, regulatory binders, case studies
Lydia

22. Phase 3: Bootcamp, SOPs, Mentoring Program (cont.)
Lydia

23. Phase 4 and Beyond: Toolkit Website & Expansion
Website to house all resources a CRC may need, organized by domain and task
Expand to all (including current) CRCs
Expand to other clinical research professionals & customize checklist
Create and include online training content & assessment
Meghan

24. Phase 4 and Beyond: Toolkit Website & Expansion (cont.)
Establish comprehensive and dynamic calendar of training & PD opportunities for all CRCs
Other Professional Development
Annual Coordinator Council schedule
Information sharing platform
Annual CRC Workshop
Meghan

25. Future Planning
Establish clear stepping stones for CRCs for promotion and professional development
Improve CRC representation across clinical research planning and administration
VCU can be a model for maximizing the knowledge and experience of CRCs.
Lydia

26. Questions?

27. Contact us!
Lydia Klinger, Wright CCTR Meghan Wright, VCU IRB