Clinical Research

Berni Morris-Smith is a senior clinical research leader with over 30 years’ global experience in clinical trials, spanning industry, academia and government research environments. Her work has focused primarily on the Asia–Pacific region for more than two decades, where she has played a pivotal role in advancing trial delivery, access and innovation.

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With a professional background as a pharmacist and a PhD in Microbiology, Berni brings a rare combination of clinical insight, scientific rigour, and operational expertise. Her career has encompassed senior leadership roles across large pharmaceutical companies, clinical research organisations (CROs), universities, and government health departments, enabling her to work seamlessly across the full drug development lifecycle.

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Berni is widely recognised for her strategic input into drug development and clinical trial operations, particularly in solving complex logistical, regulatory and system-level challenges that often delay or prevent trials from progressing. She has a proven ability to connect the right people, expertise and processes to ensure projects move from concept to delivery.

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A key area of Berni’s expertise is the pilot development and implementation of Teletrials, including the integration of telehealth within clinical research frameworks. Most recently, her work has focused on establishing regional single points of entry for clinical trials and expanding access to novel therapies for patients in regional, rural and remote Australian communities. Her leadership in this space has contributed to new models of care and research delivery that improve equity, efficiency and trial participation.

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Alongside her operational leadership, Berni has extensive experience in governance, ethics, and research oversight. She has served for eight years on the University of the Sunshine Coast Human Research Ethics Committee, including as Deputy Chair, and has held multiple board and advisory roles within the not-for-profit and research sectors.

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Berni’s work is underpinned by a strong focus on strategy, business development and capability building. She is a trusted advisor to organisations seeking to navigate emerging technologies, develop sustainable research pathways, and build workforce capability through education, mentoring and Good Clinical Practice (GCP) training.

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Committed to improving access and culturally safe research practices, Berni holds a Graduate Certificate in Aboriginal Studies, further strengthening her work with Aboriginal and Torres Strait Islander communities and regional research partners.