Workshop:

So You Want to Do Clinical Trials Research!

Scott Corley, Sharleen Maley, Supriya Arora, Dr. Alan Rosenberg

Wednesday, November 18 11:00 - 12:00

Moderator: Chris Plishka

Workshop Description:  Have you had an interest in doing research but didn’t know where to start? Perhaps you have had questions about what your responsibilities would be as a Principal Investigator or a Clinical Research Coordinator. What training do you need? What do you need to know about working with the research ethics board, the research sponsor and Health Canada? How do you recruit patients into your trial? Saskatchewan’s Clinical Trial Support Unit will address these questions and more as they present an overview of how to initiate and carry out clinical research.

Learning Objectives: 

  • Understand the responsibilities of a Principle Investigator or Clinical  Research Coordinator

  • Understand the training required to manage or coordinate a clinical trial

  • Understand the process of working with research ethics boards, research sponsors and Health Canada

  • Learn tips and tricks for recruiting patients to clinical trials

  • Identify pitfalls to watch out for

Scott Corley is the Director of the Clinical Trial Support Unit (CTSU), which provides clinical trial support to the University of Saskatchewan, Saskatchewan Health Authority and Saskatchewan Cancer Agency. Scott has worked in various roles in clinical research since 1989, including programmer, database administrator, statistical analyst, project manager and program manager. Until moving to Canada in 2009, he worked at clinical trial organizations in Seattle, Washington, including the Biostatistics Cardiovascular Research Unit at the University of Washington, Axio Research Corporation and Cancer Research And Biostatistics. He has been CTSU Director since 2012.

Sharleen Maley  graduated from the University of Saskatchewan with a BSC in Physiology, and then moved on to graduate studies, completing a Post-Graduate Diploma in Toxicology. She started her career working with patients as an Addictions Counsellor at an in-patient treatment facility in 1998, before leaving that position and starting work at the Saskatchewan Drug Research Institute (SDRI) as a Clinical Research Professional in 2003. SDRI had numerous name changes, however Sharleen continued working with the same unit, which was eventually renamed the Clinical Trial Support Unit. In 2013, she became dedicated to the Saskatchewan Clinical Stroke Research Chair, Dr. Michael Kelly, as his Research Program Manager. There she is involved in both laboratory and clinical research. She has been working with the stroke team since then, and brings over 17 years of clinical research experience to our discussion today.

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Supriya Arora is a highly skilled and dynamic Clinical Research Professional having more than 10 years of experience working both in corporate and institutional sectors. She completed her master’s degree in bioinformatics in India. Her desire to contribute to health care led her to move to the field of clinical research. While working as a Clinical Research Associate with various contract research organizations in India, she acquired comprehensive clinical research experience in a variety of therapeutic areas.

 

Supriya moved to Canada in 2011 and has been associated with the Clinical Trial Support Unit (CTSU) since 2013. She has served the CTSU in various roles, including Clinical Research Coordinator, Clinical Study Monitor and her current role of Clinical Research Professional. She has extensive knowledge of regulatory guidelines and her experience in a variety of research-related roles has given her a broad understanding of clinical research, including study coordination, study monitoring, project management, quality management, regulatory affairs, regulatory submissions to Health Canada and study budget negotiation.

Dr. Alan Rosenberg graduated from the University of Saskatchewan’s College of Medicine. Following specialty training in pediatrics at the Universities of Toronto and Manitoba he did subspecialty training in pediatric rheumatology at the University of British Columbia. He returned to Saskatchewan in 1981 to establish the province’s first program in pediatric rheumatology to serve Saskatchewan children with arthritis and related rheumatic diseases.  Since 1981 Dr. Rosenberg has directed the Pediatric Rheumatic Disease Research and Innovation Laboratory, University of Saskatchewan, among the world’s oldest, continuously maintained pediatric rheumatology research programs.

 

Dr. Rosenberg has held headships of the Department of Pediatrics, the Division of Rheumatology, and the Division of Pediatric Research from 2009 to 2018.             

 

Dr. Rosenberg’s research has included studies of childhood rheumatic diseases exploring how genetic, lifestyle and environment interact to influence the occurrence and outcomes of disease and investigating the earliest origins of inflammatory-mediated chronic diseases.

 

Dr. Rosenberg promotes and facilitates transdisciplinary collaborations in child health research and leads and participates in national and international research consortia. His research exemplifies how research agendas can be propelled by collaboration with a wide array of biomedical and non-biomedical disciplines and, by engaging trainees, can inspire and guide the next generations of biomedical researchers.

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Simona Meier has over 10 years’ experience in clinical research in the academic setting. She has worked as a Clinical Research Professional at the University of Saskatchewan since 2007. Her position involves helping investigators to set up, maintain and complete clinical research studies (both contracted and investigator-initiated), providing clinical research expertise to research sites, research ethics boards and policy-makers, and acting as a liaison among investigators, study staff, sponsors and other research, regulatory, and health agencies in all administrative aspects of study management. She has recently been working on a project in which she has taken on the study monitor role (CRA).

 

Simona has been ACRP certified since 2017 and SoCRA certified since 2009. Simona received her B.Sc. in Biology from the University of Regina in 2005 and her B.A. (Hon) in Psychology from the University of Regina in 2006.

 

Simona has volunteered with ACRP since 2017, when she participated as a Subject Matter Expert (SME) in the development of the ACRP Certified Professional (ACRP-CP) exam. She has participated as an Item Writer for ACRP since 2018 and has been a member of the ACRP Canada Chapter Executive since 2018.

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