Clinical Research Level 2 Programme (July 2023 intake)

Programme Duration: 06 July 2023 to 21 July 2023

Venue: NTU@one-north

Organiser: SCRI Academy

The CRC Level 2 Programme is run once a year every July. This year, SCRI was thrilled to welcome 36 participants for the third run of the programme since it was launched in 2021. The class size for this run saw a whopping increase from the usual 20 participants thanks to overwhelming response in registrations and positive reviews from past participants from both hospitals and polyclinics at the public healthcare clusters.

This programme is designed to equip CRCs with at least two years of experience in coordinating clinical research studies. The course curriculum is designed to equip them with essential project management concepts and tools commonly employed in clinical research studies. Through the six-day programme held over three weeks, the CRCs acquired the necessary skills to effectively coordinate investigator-initiated clinical research studies across a wide range of study designs. To make lessons more engaging, the CRCs honed their skills through case-studies, group discussions and practice-based activities. Investigator-initiated trials are led by research clinicians in the public healthcare setting according to their research interests to provide better care for their patients. Hence, these researchers, also known as Principal Investigators (PI) would require the steady support from CRCs in areas such as drafting the study design and research protocol, preparing the research site, gaining regulatory approvals, patient recruitment, as well as monitoring the progress of the research study.

Participants actively participating in various group discussing and presenting to the class.

SCRI is thankful for the strong support from clinical research professionals who helm from both the public and private sectors who came onboard as guest speakers and trainers to make this a fulfilling course for the CRCs serving the nation’s public healthcare needs.

Guest speakers included Dr Yeo Jing Ping, Vice President, Asia Pacific Head from Cytel (Singapore) Pte Ltd, Ms Michelle Ho, Executive Director, Quality Management from Syneos Health, Ms Stacey Low, Associate Director, Quality Management from Syneos Health and Ivy Cruz Dimarucut, Senior Legal Counsel from MOH Holdings.

Dr Yeo Jing Ping shared on the overview of regulatory framework in Singapore. She also emphasised on IRB submission requirement and the types of research that require IRB review.

Ms Michelle Ho offered valuable perspectives on establishing a Quality Management System (QMS) within the context of clinical research. In addition, she highlighted the importance of detecting root causes of deviations / non-compliance and rectifying them with appropriate corrective and preventive actions.

Ms Stacey Low provided the participants with guidance on how to be inspection-ready and covered what they should anticipate before, during and after the inspection by auditors.

Ms Ivy Cruz Dimarucut discussed the different types of legal agreements employed in clinical trial protocols to protect both clinical trial participants and researchers. She explained the process of conducting an agreement review and also highlighted the significance of insurance in clinical trials.

Guest Speakers and SCRI Trainers: Top from left: Ms Michelle Low, Ms Stacey Tan, Dr Yeo Jing Ping, Mr Lin Yuchen, Ms Wendy Zhao. Bottom from left: Ms Ng Xuanhui, Ms Tan Siew Hoon, Ms Ivy Cruz Dimarucut, Mr Eric Seow, Mr Ivanus Manopo.

When asked what was their personal takeaway from the course, one attendee said: “The programme benefited me a lot. It refreshed my memory on important good practices to apply in my daily work and deepened my knowledge on the various aspects of coordinating clinical trials,”

“I have gained more knowledge on juggling various aspects of a clinical study and keeping everything in order,” another attendee added.

“I learned a lot about the different aspects of managing a clinical trial, especially from a non-CRC perspective, such as from a Project Manager point of view,” shared another attendee. 

Congratulations to all CRCs who completed the programme and we wish you all the best in your career ahead!

Click here to find out more about the CRC Level 2 Programme and stay tuned for updates on the next intake.

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