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

How did this thing get started? Lydia

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

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

Lydia

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

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

Besides VCU, who will benefit? Meghan

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

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

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

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. http://www.channelnewsasia.com/news/singapore/clinical-research-coordinators-in-singapore-to-get-salary-9167228

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

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

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

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

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

Initial REDCap Checklist Meghan

Phase 2: Onboarding Checklist & Orientation Module (cont.) Put checklist in new learning management system (Talent@VCU) 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

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

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

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

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

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

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

Questions?

Contact us! Lydia Klinger, Wright CCTR lydia.klinger@vcuhealth.org Meghan Wright, VCU IRB wrightmk2@vcu.edu