Agenda

Clinical Research Nursing Conference

2024 Conference Agenda

Day 1

08:00 - 08:30 Welcome and Course Overview

Jennifer Goldfarb, MSN, RN, CCRP, Executive Director, Clinical Research, Department of Pediatrics, University of Minnesota

8:30 - 9:15 Introduction to Clinical Research Nursing: Scope and Standards of Practice

Jennifer Goldfarb, MSN, RN, CCRP, Executive Director, Clinical Research, Department of Pediatrics, University of Minnesota

This session will provide an overview of key concepts of the clinical trial process, along with an introduction to the Clinical Research Nursing Scope and Standards of Practice Guidelines, with associated competencies. The conceptual framework describing the who, what, when, where, and why of Clinical Research Nursing practice will be explored. The five tenets of clinical research nursing will also be discussed, along with the guiding principles that give direction to nurses practicing in this clinical research specialty.

9:15 - 10:00 Roles and Practice Dimensions of the Clinical Research Nurse

Michele Toms, BSN, RN, CCRC, Clinical Research Support Office Staffing Core, Children’s Hospital of Philadelphia

Loana Ward, RN, Nurse Manager, Clinical Trials Office, University of Minnesota

This session will further explore the various roles and responsibilities of the clinical research nurse. Interactive exercises are designed to increase attendees’ ability to delineate these practice roles and the activities they encompass, as well as lead to a better understanding of the application of theory to the conduct of research. Position descriptions will be discussed and compared.

10:00 - 10:15 Break

10:15 - 11:30 Informed Consent Process (eConsent)

Michele Toms, BSN, RN, CCRC, Clinical Research Support Office Staffing Core, Children’s Hospital of Philadelphia

Alisha Olson, BSN, RN, CCRP, Research Nurse Supervisor, Department of Pediatrics, University of Minnesota

This session will provide an overview of the informed consent process with a small group practice session using case studies. Barriers to understanding and the critical role of the Clinical Research Nurse in the informed consent process will be emphasized, along with strategies to improve the process and ensure consent is truly both voluntary and informed. Electronic consenting challenges and best practices will be discussed.

11:30 - 12:30 Lunch

12:30 - 1:30 Concepts in Project Management

Jennifer Goldfarb, MSN, RN, CCRP, Executive Director, Clinical Research, Department of Pediatrics, University of Minnesota

The Clinical Research Nurse fulfills multiple roles within any given project - Educator, Coordinator, Facilitator, Patient Advocate, Manager. This session will share best practices in the start-up and ongoing management of clinical research projects. Budgeting and financial management will be discussed in detail.

1:30 - 2:15 Operationalizing a Protocol - Evaluating Study Protocol Needs and Operational Considerations

Loana Ward, RN, Nurse Manager, Clinical Trials Office, University of Minnesota

Use of facility capabilities listings to guide operational feasibility will be discussed. Consideration for billing designations related to space use for clinical research. Ancillary department collaborations and expertise availability for complex protocols. Implementing clinical research protocols with consideration of standard of care protocols from a feasibility perspective.

2:15 - 2:30 Break

2:30 – 3:45 Team Management

Jennifer Goldfarb, MSN, RN, CCRP, Executive Director, Clinical Research, Department of Pediatrics, University of Minnesota

Alisha Olson, BSN, RN, CCRP, Clinical Research Nursing Supervisor, Department of Pediatrics, University of Minnesota

Clinical research nurses require effective leadership and management skills regardless of job setting or title. In this interactive session, we will discuss considerations for leadership and management of the multidisciplinary clinical research team. Communication strategies, team dynamics, and conflict management will be discussed. Practical tools and techniques will be shared.

3:45 - 4:15 Wrap up

Day 2

8:00 - 8:45 Documentation Best Practices

Michele Toms, BSN, RN, CCRC, Clinical Research Support Office Staffing Core, Children’s Hospital of Philadelphia

Detailed discussion of best practices related to study documentation. Optimizing documentation in the electronic health record and use of electronic CRFs. Source document creation and quality assurance considerations will be explored.

8:45 - 10:45 Program Management

Jennifer Goldfarb, MSN, RN, CCRP, Executive Director, Clinical Research, Department of Pediatrics, University of Minnesota

Maria Hendricks, MSN, RN, Director, Clinical Research Operations, Abramson Cancer Center, University of Pennsylvania

In this interactive session, we will discuss considerations for clinical research program management. We will examine ways to build financial infrastructure and develop operational dashboards for clinical research units and/or programs. Financial and operational management best practices, along with effectively determining how to budget for and track staffing costs, and how to establish key performance indicators (KPIs) will be discussed. Practical tools and templates will be shared.

10:45 - 11:00 Break

11:00 - 12:00 Sharing Best Practices (Part 1)

Conference Faculty

Attendees are invited to share their best practices (templates, tools, workflow). Guided conversation and group activity regarding the following topics:

Project & Program Management
- Study Start-Up, Budget & Finance
- Facility capability listing
- Staffing Models
- Performance Management/ Dashboards
DEI/Decentralized Clinical Trials
- Innovative Technology, Community Partnerships
- Models of Care, Trial Availability/ Feasibility Review
- Research Payments/Incentives; Language Interpretation/Translation; Participant Partner models
Professional Development
- Promoting abstract/poster publications/ sharing best practices
- Orientation/training and mentorship/ CRN career ladder
- CRN and SOCRA certification

12:00 - 1:00 Lunch

1:00 - 1:45 Sharing Best Practices (Part 2)

Conference Faculty

Guided conversation and group activity regarding the following topics:

Project & Program Management
- Study Start-Up, Budget & Finance
- Facility capability listing
- Staffing Models
- Performance Management/ Dashboards
DEI/Decentralized Clinical Trials
- Innovative Technology, Community Partnerships
- Models of Care, Trial Availability/ Feasibility Review
- Research Payments/Incentives; Language Interpretation/Translation; Participant Partner models
Professional Development
- Promoting abstract/poster publications/ sharing best practices
- Orientation/training and mentorship/ CRN career ladder
- CRN and SOCRA certification

1:45 - 2:30 Competencies, Education and Professional Development

Maria Hendricks MSN, RN, Director, Clinical Research Operations, Abramson Cancer Center, University of Pennsylvania

We will explore clinical research nursing competencies from the professional practice standards and identify real-world application in various roles and associated responsibilities. Current trends in education and professional development opportunities for CRNs will be presented. This session will be interactive, and we will welcome conference participants to share their insights and experience.

2:30 - 2:45 Break

2:45 - 4:00 Trends and Future Directions – IDE, Decentralized Clinical Trials, & Participant Partners

Maria Hendricks MSN, RN, Director, Clinical Research Operations, Abramson Cancer Center, University of Pennsylvania

This session will discuss current industry trends, issues, and future directions with a focus on inclusion, diversity, & equity (IDE), considerations for decentralized clinical trials and participant partners that Clinical Research Nurses encounter in their practice. We will use a panel format to discuss and explore important contributions the CRN is poised to make in identifying and meeting these challenges and opportunities.

4:00 - 4:15 Post conference Q&A / reflection