Background
Throughout the YCC Clinical Trials Operational Planning project, We will use the following guiding principles to steer our work:
- Efficiency – clinical trials operations will be streamline to enable more efficient workflows and processes
- Flexibility – clinical trials operations should be flexible with the tools and structures in place to adapt to evolving needs of the workforce, our patients, and our business
- Long-Term Stability – clinical trials operations will be engineered for sustainable transformation, providing YCC a scalable model for future growth
- Risk Mitigation – clinical trials operations will promote compliance, mitigating risk wherever possible.
The project is now in the Design Phase, where any accepted Assessment Phase recommendations are fleshed out with details for implementation. There are four teams involved in the Design Phase:
- Transformation Team – Responsible for crafting the new model, including job descriptions, competency models and implementation plan management. This process works in parallel with the Workflow Team.
- Workflow Team – Responsible for creating and updating materials to align to the change (e.g. SOPs, roles and responsibilities, technology impact analysis, and training plan. Will review and update associated workflows to reflect recommendation changes.
- Advisory Team - a select group of faculty and staff members identified by Transformation Team will review and provide feedback on the completed materials and workflows. This team will be asked to react to and identify issues prior to rollout. Membership for the Advisory Team will update for each Design Phase Step.
- Communications Team – Responsible for overseeing the communications plan, developing and reviewing targeted communications, escalating risks to the planning team, and acting as an intermediary between the YCC Staff and the Transformation Team.
Each Step will follow a 5-part process with input from the Teams above varying for each part:
Scope < Design < Develop < Review < Implement
We anticipate this work will be completed in Q4 of 2022 following the high-level timeline below.
Our Team
Core Team
- Alyssa Gatemen, YCC
- Margaret Gilshannon, YCC
- Leah Guidry, Huron
- Erin Pennington, Huron
- Adam Roshka, YCC
- Ian Krop, YCC
- Nirmala Thevathasan, YCC, Interim
- Cheryl Majeske, Huron
Project Management Office
- Erin Pennington, Huron, PMO Director
- Shannon Chism, Huron, Technology Lead
- Cheryl Majeske, Huron, Administrative Support/Communications Support
- Pamela Gonzalez, Huron Change Management/Communication Co-Lead
- Catrina VanAllen, Huron Change Management/Communication Co-Lead
Timeline
Design Team Members
Transformation Team
- Dr. Stephanie Halene
- Alyssa Gateman
- Margaret Gilshannon
- Leah Guidry, Huron
- Dr. Ian Krop
- Erin Pennington, Huron
- Sara Raboin
- Adam Roshka
- Talia Mitchell
- Nirmala Thevathasan
Workflow Team
- Shannon Chism, Huron
- Charmi Doshi, Huron
- Pamela Gonzalez, Huron
- Catrina VanAllen, Huron
- Erin Van Hoy, Huron
Step 1 Advisory Team
- Jazmin Figueroa-Bodine
- Patti Brand
- Anne Caldwell
- Diane Eannotti
- Rachel Hurtado
- Barb Johnson
- Katie Kelley
- Julie Lecco
- Rebecca Lilian
- Maureen Major Campos
- Talia Mitchell
- Kira Pavlik
- Jen Pope
- Zia Rahman
- Jaime Rotatori
- Kert Sabbarth
- Lauren Slater
- Roberta Sterling
- Diane Wall
- Christina Wiess
- Katie Wildman
- Danyell Williams
Step 2 Advisory Team
- Tamara Ballintyn
- Dina Boncek
- Dr. Sabrina Browning
- Dr. Emily Collier
- Carol Deminie
- Dr. Hari Deshpande
- Roxana Galvan
- Heather Gerrish
- Jessica Goepfert
- Dr. Sarah Goldberg
- Rachel Hurtado
- Kelly Jose
- Alison Kannon
- Mary Kate Kelly
- Dr. Pam Kunz
- Monika Lau
- Christine Ly
- Dr. Zia Rahman
- Amy Rodrigues
- Jessica Rowe
- Lauren Slater
- Ria Syam
- Diane Wall
- Donna Wesolowski
- Christina Wiess
- Katie Wildman
Communication Team
- Sarah Andrychowski
- Patti Brand
- Rosy Cruz
- Carol Deminie
- Gabbi Douglas
- Rachel Hurtado
- Alison Kannon
- Kira Pavlik
- Lauren Slater
- Dr. Stacey Stein
- Katie Wildman
- Dr. Farzana Pashankar