Meet Jean Smart, Clinical Trials BC
7 May 2021
We are honoured to have an accomplished and internationally-recognized leader in clinical research as part of our team.
Jean Smart, Clinical Trials BC’s regulatory affairs and quality officer since September 2018, has diverse experience in international policy and governance projects, in industry compliance, and with academic networks, the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and in the public sector.
“We should focus on quality in everything we do, and through quality, we can achieve excellence. We need to avoid complacency – my least favorite and my most feared word.”
Jean got involved with BC AHSN due to the potential that the network held within the province, coupled with her international background in regulatory affairs that was relevant to the BC research landscape. She began her involvement with the Network through a predecessor, called the British Columbia Clinical Research Infrastructure Network (BCCRIN), and acted as the regulatory lead during BCCRIN’s transition to Clinical Trials BC within BC AHSN.
“British Columbia has a lot of potential for development, and I was impressed with and felt aligned with BC AHSN’s objectives,” Jean noted in an interview. “I was delighted when a new position evolved within Clinical Trials BC, which was a perfect fit for me.”
Jean’s background is in regulatory affairs with a major interest in research policy and governance development, with an emphasis on implementation.
“My passion is in quality education and helpful resources as a means to implement policy and achieve compliance,” she said. “I believe in a ground-up approach with top support.”
As Regulatory Affairs and Quality Officer, Jean builds on this passion. She leads the Clinical Trials BC team in numerous strategic projects, including developing and implementing a Quality Management System Program and Investigators Only Program for the province, regulatory and compliance consulting and assessment, leadership training and mentoring burgeoning clinical researchers, compliance education (research education and resource bank) and more.
“I see BC in a compliant, sharing, collaborative and resource-rich state.”
Jean is always modest about her accomplishments, but others in the BC AHSN network are quick to recognize her longstanding efforts in the province.
“Jean is a real enabler and champion of building a strong infrastructure for clinical research in BC. She’s a rare, valuable and much-appreciated asset to the clinical research community in BC, Canada and internationally,” said Cindy Trytten, Director, Research & Capacity Building at Island Health in a recent email. “In BC, the vast majority of individual clinical research sites and organizations have benefited tremendously, not only from her vast knowledge and expertise around the continually-changing and complex regulatory landscape for clinical trials, but from her always-positive approach to helping us meet the vast array of quality and compliance standards.”
Jean’s passion for attracting more clinical research to the province is visionary, and she sees great potential as the Clinical Trials BC unit of BC AHSN grows.
“On the regulatory and quality side, I see BC in a compliant, sharing, collaborative and resource-rich state,” she noted. “There’s no question that quality management requires a commitment on the part of organizations and agencies. It also requires expertise, resource and leadership. Collective guidance and leadership for the quality strategy and initiatives is essential to effecting change within the province and individual institutions.”
“Quality is one of the means to achieve everything we want to do in the BC AHSN organization through Clinical Trials BC,” she continued. “We are the liaison active with industry, researchers and teams, institutions, agencies, interprovincial, national, international on initiatives for the promotion and enhancement of clinical trial research in BC. “
“I believe in a ground-up approach with top support.”
From her regulatory perspective, Jean feels that there are certain areas of focus that BC AHSN should follow to develop a united presence across the province.
She emphasized that BC AHSN needs talent development and mentoring to build up quality leadership and resources that are available, accessible and for sharing with everyone in BC.
Another focus is strong policies and governance. “We need to keep involved in contributing to the development and review of new and modernized guidelines at all levels,” Jean said. “If we have a reasonable, flexible approach to increase efficiency and focus on relevant activities, we can implement policy, promote innovative and adaptive approaches. At the same time, we can continue to ensure participant protection and reliability of trial results…We have great ideas in BC and we can be the lead in this.”
Most importantly, a focus on quality is paramount. “We should focus on quality in everything we do, and through quality, we can achieve excellence. We need to avoid complacency – my least favorite and my most feared word,” she continued.
To Jean, British Columbia is a unique place to develop an academic health science network. “BC is a big place – it’s a challenge due its geographic immensity,” she observed. “In other situations, you can open a door, walk around and visit everyone and check on things easily. In BC, we open lines, meet out of the office, participate in electronic communities of practice (eCoPs), telechat and come up with creative means to connect and stay connected. I hope that we, as the Clinical Trials BC team, are viewed as approachable and reachable despite these distances.”