Our industry struggles with inefficiencies in conducting clinical trials effectively and on time. While issues like poor communication between sponsors, contract research organizations, and sites, and even excessive reliance on technology, are often highlighted, the core issue lies in human behavior. The natural reluctance of individuals to embrace change (whether driven by fear or disinterest), coupled with leaders' inability to communicate and sustain changes effectively, hampers progress. This session will delve into how clinical research professionals across all roles can enhance their careers and drive industry-wide improvements by mastering change management and fostering acceptance. By learning to navigate and implement change effectively, professionals can significantly contribute to their organizations and the broader clinical research field.

CEU: 1.00 ACRP

Speaker:

• Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra

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Leadership & Professionalism Journey Sponsor

Connect with your colleagues and 100+ leading-edge organizations and suppliers helping you get better results in clinical research.

Relax and unwind with a beverage and light hors d'oeuvres in the Expo Hall.

This session will help attendees learn how project management techniques can streamline the clinical study start-up process. Discover essential skills like time management, risk assessment, and effective communication, and explore practical tools for strengthening them. Through interactive activities, attendees will be able to develop a robust project plan, manage resources efficiently, and mitigate risks. Attendees will also be able to enhance their ability to handle complexities and minimize delays, ensuring timely study initiation. This session is ideal for clinical research professionals aiming to improve start-up efficiency, as it will offer practical takeaways, including templates and checklists, to apply immediately to their work.

CEU: 1.00 ACRP

Speakers:

• Tamika Harris, Clinical Operations Manager - Regulatory, Merck

• Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck

Related Blog Content

• Applying Project Management Best Practices to Accelerate Study Start-Up Timelines

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Study & Site Management Journey Sponsor

Numerous clinical trial failures are traced by the U.S. Food and Drug Administration back to inadequate oversight by principal investigators (PIs). This session delves into real-world examples of such failures, highlighting  the threats posed to participant safety and trial integrity. We will explore key focus areas, including the qualifications of delegated individuals, adequacy of training, requirements for continuous supervision, and provisions for third-party oversight. Attendees will learn how to avoid common pitfalls and enhance PIs' knowledge to ensure trial success. Additionally, we will discuss the practical application of risk-based quality management, the ongoing debate on the necessity of monitoring, and the impact of training deficits. This session is essential for clinical research professionals aiming to support PIs and uphold the integrity of clinical trials.

CEU: 1.00 ACRP

Speakers:

• Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah

• Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Owner, Independent Consultant, Responsibility Research

• Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC , Independent Clinical Research Professional, Medical Writer, Consultant

Study & Site Management Journey Sponsor