Who should attend

This course is targeted at those wishing to enter the management side of clinical trial research, and is suitable for clinicians, nurses, physiotherapists, psychologists, pharmacists, and other allied health professionals; biomedical and public health researchers; clinical trial coordinators; and those working in the health industry who are interested in developing their skills and knowledge of managing clinical trials.

What will you learn

On completion of this course participants will be able to:

• Recognise and evaluate different management and communication styles.
• Describe the roles and responsibilities of a manager in overseeing clinical trial coordination processes from start up to close out.
• Identify and implement tools and systems to aid quality trial and staff management.
• Formulate appropriate training and monitoring program(s) to induct, upskill and oversee staff.
• Develop strategies for engagement and relationships with clinical trial sponsors, CROS and other key stakeholders.
• Apply regulatory and legal requirements with respect to management of clinical trials.

Program structure

• Day 1 will focus on you and your own management and leadership styles.
• Day 2 will focus on your team and how to get the best out of them by applying the unique styles you learnt about in Day 1.
• Day 3 will focus on the trial and the special demands a clinical trial manager may have that differ from other job spaces.

Accelerate your qualification

Eligible participants who complete the micro-credential can receive 6 credit points of unspecified credit towards Masters degrees in Public Health, Clinical Research, Health Management, Biostatistics or Occupational and Environmental Health.

Note: Successful completion of a micro-credential does not guarantee admission into an award course. Prospective students must meet the eligibility and admission requirements for the award course. A micro-credential can only be used as credit towards a single degree on one occasion, and is valid for 7 years.

For more details please email pgradenq@monash.edu or shortcourses.depm@monash.edu.

Dr Marina Skiba

Marina has 30 years experience in clinical research with expertise in protocol development, ethics applications, data management and project co-ordination. She has been involved in a variety of research from early and late phase interventional studies and mechanistic trials to community based, observational research. She has worked for SPHPM for 25 years and was the Regulatory Affairs Manager for Clinical Pharmacology Alfred Hospital/Monash University 1996 to 2016. During that time she provided support to Clinical Pharmacology researchers, honours students, PhD students, visiting academics and registrars.

She is a founding member of the SPHPM Research Governance Committee (formed in 2001) and chaired the committee from 2010 to 2014. She has been the Research Governance Officer for the school since 2010 where she co-ordinates the running of the annual self-audits, contributes to Research Governance, Ethics and Clinical Trial education and training within SPHPM and provides support to staff and students in matters of research governance.

Marina also provides support for external organisations in setting up their own Research Governance Strategy. An example of this was her contribution to the SPHPM collaboration with senior members of the Sri Lankan medical research community in establishing the 2018 Code of Conduct for Health Research in Sri Lanka and the 2019 Research Governance Strategy in Sri Lanka.

Dr Simone Sparks

BSc (Hons), MPH, PhD
Senior Clinical Trials Manager, Monash University

Simone has been managing clinical trials for over ten years. Before that she has worked in the public health space as a molecular biologist specialising in outbreak investigations of food borne and hospital pathogens. Simone completed her MPH and PhD from Melbourne University and has a passion for disease prevention (both communicable and non-communicable). Her PhD involved the design of a plant based vaccine for a vaccine preventable disease in humans and animals. Her MPH specialised in epidemiology and statistical analysis.

Simone has worked in all aspects of clinical trials including design, initial trial set-up (document preparation, ethics, database development), recruitment and close-out. The trials have been large multi-centre trials across Australia and within General Practices.

For a full list of terms and conditions, visit our webpage.