Please join us in an empowering session with Sue Friedman, DVM on her story and how she decided to empower others. Sue will provide her story and where it has taken her to be a FORCE in the awareness and promotion of clinical research.

General interest or hot topic: Due to COVID-19, healthcare providers and researchers both entered a new paradigm in which the need arose to adjust the mechanisms of how we connect with our patients and study participants alike. With the availability of the focused study (discussed herein) completely virtual and the potential of a nationwide participant population, this protocol is being used as a potential reference of recruitment methods utilizing new technologies available outside of the clinical setting from outreach to enrollment.

Leadership and professionalism avenues can be difficult for coordinators to navigate. There are many different challenges in finding pathways to advance your career as a clinical research professional. This session will provide an overview of educational opportunities as well networking and development strategies. The speakers offer a wide variety of degrees among themselves as well as different clinical, research and professional experiences. Each of the speakers is from a different site and with diverse work backgrounds, offering the audience a wide variety of information. They will show evidence of their collaborative work to advance the profession and how training and networking has been effective within their research roles. This session will include a panel discussion where audience members can become active participants in asking questions and dialoguing with each other.

In this session, two key opinion and thought leaders from the clinical research industry will discuss their very distinctive, yet successful career pathways. Careers in clinical research do not sit solely into two baskets, the Clinical Research Coordinator (CRC) or the Clinical Research Associate (CRA). As the clinical research industry continues to evolve, so does the work needed to support these new methods. The skills gained in and throughout varied positions, help pave one’s career pathway. The ability to leverage those experiences and parlay them into the next opportunity is key. Multiple business functions provide exposure to processes throughout the clinical research enterprise and enable a diversified set of skills. Each steppingstone, though it may not seem like a direct route, provides the building blocks for success. Clinical research professionals by design, pay attention to details, follow the rules, and have a common goal to improve health. Identifying steps for navigating career silos and assessing opportunities are proven tools for career growth. Presenters will provide insights on how clinical research professionals can leverage their experience and expertise to impact their careers. Analyzing lessons learned, tips for career development and case studies will be addressed in this session.

Clinical trial monitoring procedures has evolved significantly over the last twenty five years and each year processes and procedures change, tools to increase efficiency and reliability are put into practice. What does the future look like for the site monitor, what skills will be needed? How will we attract, retain and develop the clinical monitor of the future now?

Despite decades of experience, regulatory supervision, and ethical analysis, the informed consent process for research is still not highly effective for ensuring informed decision-making. Consent forms are typically long, dense, and complex. Multi-center trials can collectively require hundreds of consent documents, each with site-specific language. The degree to which investigators spend time explaining and discussing the protocol with potential participants is variable and poorly documented. Whether individuals are actually making an informed decision about participation is rarely assessed. To advance translational science and maintain public trust, the ethical pillars of consent must be strengthened by investing in innovative approaches for informed decision-making about research participation, and for documentation of informed consent. This panel will discuss innovative eSolutions for research consent. Consent Builder (CB) is a consent document building tool that can benefit IRBs and study teams dealing with preparation and review of consent documents. An innovative two-part template provides consistent description of the study while accommodating site-specific local verbiage. Interactive Consent (iConsent) is a web-based platform to improve informed decision-making leveraging multimedia and adult learning principles to communicate the concise consent summary. A clinical trial of iConsent demonstrated significant improvements in knowledge, satisfaction and clarity of information. Electronic consent (eConsent) platforms allow participants to digitally sign consent documents on-site or remotely using a computer or tablet; while maintaining compliance with FDA, HHS, and related regulations. These eSolutions can be used together or individually to improve informed decision-making and support a high-quality consent process.