C02. Bridging the gap: Building Competency of the Clinical Research Workforce

Tracks
Clinical Research
Thursday, June 5, 2025
9:30 AM - 10:30 AM
Parkside 1

Chair & Speakers

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Dr Rania Salama
Senior Lecturer & Course Director
Macquarie University

Bridging the Gap: Building Competency of Clinical Research Workforce

Abstract

The MTPConnect 2021 & 2024 reports into Australia’s Clinical Trials Sector highlighted a critical shortage of skilled staff in this sector and identified that ‘in order to grow the size and capabilities of the workforce, there needs to be greater awareness of career pathways and opportunities in the clinical trials sector among graduates, and better training and workforce development programs" (MTPConnect, 2024). This is a key priority for the continued growth of trials in Australia.
There are several training options currently on offer. Most notably are the different trial sites as well as industry sponsors provide trainee programs and on-site training for new recruits. An example is the industry internship provided by the Macquarie University Clinical Trials Unit’s trainee program for clinical trial coordinators and various industry and CROs in-house training programs.
A different model is building competency, creating career pathways and professional development opportunities for the current workforce. For example, ARCS Australia provides education, competency building and professional development opportunities in the form of short courses, webinars and workshops. Short courses to build the capacity and capability of the clinical trials workforce through paid or free access to training opportunities in the form of online modules and live/recorded webinars are also available through various providers, centres and networks.
Driven by the predicted critical workforce shortage of skilled professionals, and the lack of consistency in foundational knowledge and essential skills of new graduates, the Graduate Certificate of Clinical Trials Operations at Macquarie University was developed. This innovative contemporary post-graduate formal qualification is the first of its kind, co-designed with clinical trial professionals, clinicians and industry experts to provide clinical trial operations and management recognised knowledge and skills. The new fully online course is mapped to the Joint Task Force for Clinical Trial Competency and had its first graduates in Dec 2024.
The expert panel members in this forum will bring different perspectives to highlight distinct features, target audience and gaps filled as well as explore synergies and future collaborations between the different models through an engaging discussion with the audience.

Biography

Dr. Rania Salama is a Senior Lecturer, Course Director of the Graduate Certificate of Clinical Trial Operations, and the Director of Education in the Department of Health Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University. A pharmacist by training, she holds a Master of Science (MSc) and a PhD in pharmaceutical sciences from the University of Sydney. She leads research projects in collaboration with industry, focusing on respiratory drug development from basic formulation science to clinical trials at the Woolcock Institute of Medical Research.  She is an internationally renowned higher education leader with extensive experience in both the Australian public and private higher education sectors. As a passionate educator and Senior Fellow of the Higher Education Academy, Dr. Salama also holds a Master of Education in Higher Education Leadership. Her educational research focuses on innovative practices for enhancing student engagement and motivation through online and hybrid learning modes, emphasising employability and lifelong learning skills.
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Lisa Riedl
Senior Director, Country Head Site Management & Monitoring ANZ (Biopharmaceuticals)
AstraZeneca Pty Ltd

Bridging the gap: Building Competency of the Clinical Research Workforce

Abstract

The MTPConnect 2021 & 2024 reports into Australia’s Clinical Trials Sector highlighted a critical shortage of skilled staff in this sector and identified that ‘in order to grow the size and capabilities of the workforce, there needs to be greater awareness of career pathways and opportunities in the clinical trials sector among graduates, and better training and workforce development programs" (MTPConnect, 2024). This is a key priority for the continued growth of trials in Australia.
There are several training options currently on offer. Most notably are the different trial sites as well as industry sponsors provide trainee programs and on-site training for new recruits. An example is the industry internship provided by the Macquarie University Clinical Trials Unit’s trainee program for clinical trial coordinators and various industry and CROs in-house training programs.
A different model is building competency, creating career pathways and professional development opportunities for the current workforce. For example, ARCS Australia provides education, competency building and professional development opportunities in the form of short courses, webinars and workshops. Short courses to build the capacity and capability of the clinical trials workforce through paid or free access to training opportunities in the form of online modules and live/recorded webinars are also available through various providers, centres and networks.
Driven by the predicted critical workforce shortage of skilled professionals, and the lack of consistency in foundational knowledge and essential skills of new graduates, the Graduate Certificate of Clinical Trials Operations at Macquarie University was developed. This innovative contemporary post-graduate formal qualification is the first of its kind, co-designed with clinical trial professionals, clinicians and industry experts to provide clinical trial operations and management recognised knowledge and skills. The new fully online course is mapped to the Joint Task Force for Clinical Trial Competency and had its first graduates in Dec 2024.
The expert panel members in this forum will bring different perspectives to highlight distinct features, target audience and gaps filled as well as explore synergies and future collaborations between the different models through an engaging discussion with the audience.

Biography

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Nicola Chapman
Head of Clinical Operations, Clinical Trials Unit
Macquarie University

Bridging the gap: Building Competency of the Clinical Research Workforce

Abstract

The MTPConnect 2021 & 2024 reports into Australia’s Clinical Trials Sector highlighted a critical shortage of skilled staff in this sector and identified that ‘in order to grow the size and capabilities of the workforce, there needs to be greater awareness of career pathways and opportunities in the clinical trials sector among graduates, and better training and workforce development programs" (MTPConnect, 2024). This is a key priority for the continued growth of trials in Australia. There is a number of training options currently on offer. Most notably are the different trial sites as well as industry sponsors provide on-site training for new recruits. An example is the industry internship provided by the Macquarie University Clinical Trials Unit’s trainee program for clinical trial coordinators and various industry and CROs in-house training programs for clinical research associates. A different model is building competency, creating career pathways and professional development opportunities for the current workforce. For example, ARCS Australia provides education, competency building and professional development opportunities in the form of short courses, webinars and workshops. Short courses to build the capacity and capability of the clinical trials workforce through paid or free access to training opportunities in the form of online modules and live/recorded webinars are also available through various providers, centres and networks. Driven by the predicted critical workforce shortage of skilled professionals, and the lack of consistency in foundational knowledge and essential skills of new graduates, the Graduate Certificate of Clinical Trials Operations at Macquarie University was developed. This innovative contemporary post-graduate formal qualification is the first of its kind, co-designed with clinical trial professionals, clinicians and industry experts to provide clinical trial operations and management recognised knowledge and skills. The new fully online course is mapped to the Joint Task Force for Clinical Trial Competency and had its first graduates in Dec 2024. The expert panel members in this forum will bring different perspectives to highlight distinct features, target audience and gaps filled as well as explore synergies and future collaborations between the different models through an engaging discussion with the audience.

Biography

Nicola Chapman heads up the thriving Macquarie University Clinical Trial Unit. She has helped grow the unit from a team of 19 staff just 6 years ago to more than 100 staff now. The CTU manage more than 600 active patients across more than 200 trials at any one time. The centralised CTU supports any clinician across the Macquarie University Hospital and clinics who wants to provide clinical trial options for their patients. Nicola has built a culture that unifies the team by prioritising patients and patient experience on clinical trials. She has driven programs to attract, train and retain staff. The CTU has visible career development and multiple clinical trial career streams. Nicola has more than 30 years of clinical trial experience in Australia and New Zealand with sponsors and sites. She has worked as a trial coordinator and a CRA as well as roles in quality, training and management. She is passionate about the difference that clinical trials makes for patients, for doctors, for hospitals and more broadly for health care and the economy.
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Maryam Rabiei
Senior CRA Manager
Medpace

C02. Bridging the gap: Building Competency of the Clinical Research Workforce

Abstract

The MTPConnect 2021 & 2024 reports into Australia’s Clinical Trials Sector highlighted a critical shortage of skilled staff in this sector and identified that ‘in order to grow the size and capabilities of the workforce, there needs to be greater awareness of career pathways and opportunities in the clinical trials sector among graduates, and better training and workforce development programs" (MTPConnect, 2024). This is a key priority for the continued growth of trials in Australia. There is a number of training options currently on offer. Most notably are the different trial sites as well as industry sponsors provide on-site training for new recruits. An example is the industry internship provided by the Macquarie University Clinical Trials Unit’s trainee program for clinical trial coordinators and various industry and CROs in-house training programs for clinical research associates. A different model is building competency, creating career pathways and professional development opportunities for the current workforce. For example, ARCS Australia provides education, competency building and professional development opportunities in the form of short courses, webinars and workshops. Short courses to build the capacity and capability of the clinical trials workforce through paid or free access to training opportunities in the form of online modules and live/recorded webinars are also available through various providers, centres and networks. Driven by the predicted critical workforce shortage of skilled professionals, and the lack of consistency in foundational knowledge and essential skills of new graduates, the Graduate Certificate of Clinical Trials Operations at Macquarie University was developed. This innovative contemporary post-graduate formal qualification is the first of its kind, co-designed with clinical trial professionals, clinicians and industry experts to provide clinical trial operations and management recognised knowledge and skills. The new fully online course is mapped to the Joint Task Force for Clinical Trial Competency and had its first graduates in Dec 2024. The expert panel members in this forum will bring different perspectives to highlight distinct features, target audience and gaps filled as well as explore synergies and future collaborations between the different models through an engaging discussion with the audience.

Biography

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