Workshops are NOT included with Full Conference registration and require a separate fee.

This session provides a framework to assess the overall "health" of your clinical research program in terms of its most critical areas. By delving into key areas in compliance, business, financial, regulatory, and clinical dimensions, the session will help attendees identify gaps and inefficiencies in their programs. Participants will complete a scorecard covering essential topics, leading to an overall health score and follow-up action plans.

Objectives:

1. Explore critical, key aspects of compliance, business, financial, regulatory, and clinical dimensions that contribute to the “health” of a clinical research program

2. Identify potential gaps, inefficiencies, and areas for improvement within your clinical research program.

3. Identify best practices to improve performance, compliance and regulatory adherence.

4. Commence formulating a plan to start addressing identified gaps and inefficiencies, to enhance the overall performance and integrity of your research program.

CEU: 4.00 ACRP

Trainers:

• Cynthia Dunn, RN, BSN, MSN, CCRA, CCRP, CHRC, CPC, Clinical Research Consultant, Crescent City Research Consulting LLC

• Wendy Portier, MSN, RN, CHRC, CHC, CPC, Managing Director, Portier & Associates, LLC

• Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, CEO, Kelly Willenberg, LLC

Related Blog Content:

• Driving Improvements at Sites Through a Culture of Connectedness

Workshops are NOT included with Full Conference registration and require a separate fee.

Are you ready to thrive in your position instead of merely trying to survive while putting out fires? If so, there’s no time like the present to add or update the modern project management skills you will need in your arsenal when facing challenging projects to come.

Whether you currently manage projects, would like to in the future, or just want to be more effective in your position, there are skills you can develop and refine to boost your success. 

This workshop is for clinical research professionals who want to develop their leadership, communication, and management skills to help them successfully manage projects and lead teams.

This workshop will focus on the following topics: 

• Traits and competencies of a good Project Manager - Do you possess them? (Are you a MacGyver?) 

• Communication Skills - Speak, write, listen, understand, deliver 

• Conflict, Negotiation, and Influence - Finding common ground and being open to alternatives 

• Time Management, Planning, and Scheduling - Do you RASCI? 

• Project Budgets and Cost Management - Who needs to know the dollars and sense of the project? 

• Collaboration and team building, even with a remote or hybrid team - Building relationship within and outside the team (and over the internet) 

• Leadership and taking the lead - Do you have to be at the front of the line to be a leader? 

• Work life balance - Finding the balance in YOUR life 

Tools, assessments, and other resources will be discussed and provided so attendees can build on the information shared during the workshop and continue to develop their project management and leadership skills after the workshop. 

CEU: 8.00 ACRP

Trainers:

• Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.

• Jennifer McLeland, PhD, CCRC, ACRP-PM, RPSGT, Manager, Division of Clinical Research, Washington University School of Medicine

Related Blog Content

• Project Management Workshop Hones Skills: Core Competencies Are Useful For All Roles

Workshops are NOT included with Full Conference registration and require a separate fee.

Do you feel on top of all the sources of costs at your site, or are you surprised over and over by unexpected instances of expense? This pre-conference workshop is a great opportunity to learn the basics of clinical trial budgeting and the tips and tricks to ensure your clinical research site is accounting for the true costs to run each clinical trial you conduct. This workshop is intended for those new to budgeting and those experienced who want to ensure they are prepared for handling both the obvious and hidden wellsprings of revenue and deserts of debt throughout their studies. 

Objectives:

• Discuss the importance of the clinical trial budget for site sustainability and success.

• Identify critical costs to incorporate into your clinical trial budget.

• Review the importance for justification documents.

CEU: 4.00 ACRP

Trainer:

• Matt Lowery, ACRP-CP, CCRC, CEO / Principal Consultant, The Pathways Grp, LLC

Workshops are NOT included with Full Conference registration and require a separate fee.

In this interactive 4-hour workshop, participants will explore how an organization’s culture of quality can significantly impact the success of its risk management approaches and outcomes. You will learn how a high-performing culture of quality enhances risk management by supporting robust, proactive processes, while a lower-performing culture can hinder these efforts. Through hands-on activities, real-world case studies, and simulations, participants will gain insights into the practical effects of culture on risk management, from identifying critical risks to implementing mitigation and monitoring strategies. By the end, you’ll leave with a deep understanding of how the culture of quality shapes risk management in clinical trials.

Objectives:

• Understand how a high-performing versus lower-performing culture of quality impacts risk management processes and outcomes.

• Learn to assess Critical to Quality (CTQ) factors, critical processes, and data in clinical trials with consideration of the influence of quality culture.

• Develop skills in conducting risk assessments, including identifying and evaluating risks, and planning mitigation strategies.

• Explore continuous risk monitoring methods and how a culture of quality influences these approaches.

• Apply a maturity model to assess your organization’s current culture of quality and understand its role in shaping risk management decisions.

CEU: 4.00 ACRP

Trainer:

• Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC