Clueo Clinical

Masterclass: Effective Communication Strategies for Stakeholder Management in Clinical Research
2026-02-14 15:00 - 17:00 (Australia/Melbourne)
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Are you an aspiring or early-career clinical research professional looking to improve your communication skills with stakeholders to achieve better compliance? Effective communication is a game-changer for achieving better compliance and success in clinical trials. This interactive 2-hour masterclass will equip you with practical strategies to improve collaboration, build trust, and manage complex conversations with sponsors, ethics committees, investigators, and site teams.

Key Benefits:

🔹 Boost Confidence: Master essential communication techniques to enhance your ability to engage with key stakeholders.🔹 Foster Collaboration: Learn how to create stronger connections and improve teamwork across all levels of the clinical trial process.🔹 Navigate Challenges: Gain strategies to handle difficult conversations and resolve conflicts with sponsors, CROs, and site staff.🔹 Achieve Better Compliance: Sharpen your communication skills to ensure clearer documentation, reporting, and decision-making, driving compliance and successful trial outcomes.🔹 Learn from Experts: Benefit from real-world case studies and actionable insights shared by clinical research professionals

What You’ll Learn:

✅ How to communicate effectively with sponsors, CROs, and site staff✅ How to navigate complex conversations with sponsors, ethics committees, and investigators✅ Best practices for conflict resolution and handling difficult conversations✅ Strategies to improve team collaboration and cross-functional communication✅ Real-world case studies and actionable insights from clinical research experts

Who Should Attend?

🔹 Aspiring Clinical Research Associates (CRAs)🔹 Clinical Trial Assistants (CTAs)🔹 Research Nurses & Study Coordinators🔹 University Graduates & Career Changers in Clinical Research🔹 Anyone looking to strengthen their industry communication skills

📍 Format: Live Virtual Masterclass. This online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee will receive a certificate of completion to boost your CV and enhance your employability.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided during registering.

✨ Early Bird Discount: Save 20%✨ Group Discount: Enrol with 2 or more colleagues and save 30%!

Masterclass: Preparing for Audits and Regulatory Inspections in Clinical Trials
2026-02-24 15:00 - 17:00
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In the highly regulated clinical research industry, compliance with Good Clinical Practice (GCP) and regulatory requirements is non-negotiable. Regulatory agencies such as the FDA (United States), and TGA (Australia) conduct inspections to ensure that clinical trials meet the highest standards of data integrity, patient safety, and ethical conduct. In addition, sponsors and Contract Research Organisations (CROs) frequently audit trial sites to assess compliance with protocol requirements, GCP guidelines, and applicable regulations.

Failing an audit or inspection can result in serious consequences, including trial delays, regulatory sanctions, financial penalties, and reputational damage. Therefore, being inspection-ready at all times is essential for clinical research professionals involved in trial management, monitoring, and site operations.

This 2-hour interactive masterclass provides a structured, step-by-step approach to preparing for regulatory inspections and audits. Attendees will gain insider knowledge, proven strategies, and real-world case studies to navigate inspections confidently, minimise compliance risks, and implement proactive quality assurance practices.

Key Benefits:

🔹 Understand Global Regulatory Expectations – Learn TGA, FDA and inspection requirements and common audit findings.

🔹 Achieve Audit Readiness – Develop proactive strategies to ensure continuous compliance and prepare teams effectively.

🔹 Minimize Compliance Risks – Identify gaps early, implement CAPA strategies, and avoid critical findings.

🔹 Confidently Handle Inspections – Master best practices for interviews, document requests, and regulatory responses.

🔹 Learn from Real-World Cases – Gain insights from actual audit scenarios and interactive expert discussions.

🔹 Strengthen Collaboration – Improve compliance alignment across sites, sponsors, and CROs.

What You’ll Learn:

✅ Understanding ICH-GCP, FDA, EMA, and TGA inspection requirements

✅Common audit findings and how to prevent them

✅Best practices for site, sponsor, and CRO audit readiness

✅ Effective CAPA (Corrective and Preventive Actions) planning

✅How to handle inspection interviews and document requests

✅Real-world case studies of regulatory compliance challenges

Who Should Attend?

🔹 All Aspiring Clinical Researchers

🔹 Clinical Research Associates (CRAs)

🔹 Clinical Trial Assistants (CTAs)

🔹 Regulatory Affairs & Quality Assurance Professionals

🔹 Sponsors & CRO Teams

🔹 Anyone involved in clinical trial compliance & oversight

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!

Masterclass: Best Practices for TMF Filing and Maintenance Throughout Clinical Trials
2026-02-27 15:00 - 17:00
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Proper management of the Trial Master File (TMF) is essential for ensuring regulatory compliance, maintaining data integrity, and supporting the success of clinical trials. A well-maintained TMF not only facilitates smoother audits and inspections but also demonstrates the trial’s adherence to Good Clinical Practice (GCP) and regulatory requirements.

Are you an aspiring or early-career clinical research professional looking to strengthen your TMF filing and maintenance skills? Managing essential trial documentation effectively is a critical skill for Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), Study Coordinators, and other research professionals.

This interactive 2-hour masterclass will provide you with practical strategies to improve your TMF documentation processes and ensure your files are always audit- and inspection-ready. Learn how to maintain document integrity, apply best practices for version control, conduct quality control (QC) checks, and meet regulatory expectations to prevent findings during audits.

Key Benefits:

🔹 Ensure Compliance & Inspection Readiness – Learn how to maintain a complete and accurate TMF to meet regulatory and sponsor requirements.🔹 Reduce Audit Risks – Identify common TMF deficiencies and implement corrective actions to improve documentation quality.🔹 Enhance Your Career Prospects – Gain expertise in TMF management, a crucial skill valued by sponsors, CROs, and regulatory agencies.🔹 Hands-on Learning with Industry Experts – Access real-world case studies and actionable insights from experienced professionals.

What You’ll Learn:

✅ Understanding TMF Structure & Regulatory Expectations – Learn about essential documents and global regulatory requirements (ICH-GCP, EMA, FDA).✅ Best Practices for TMF Filing & Maintenance – Organise, categorise, and maintain TMF documentation efficiently.✅ Document Version Control & QC Checks – Implement processes to track changes, prevent errors, and maintain data integrity.✅ Strategies for Ensuring Inspection Readiness – Proactively identify and resolve TMF gaps before audits and inspections.

Who Should Attend?

🔹 Aspiring Clinical Research Associates (CRAs)🔹 Clinical Trial Assistants (CTAs)🔹 Research Nurses & Study Coordinators🔹 University Graduates & Career Changers in Clinical Research🔹 Anyone looking to strengthen their industry communication skills

📍 Format: Live Virtual Masterclass. This online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee will receive a certificate of completion to boost your CV and enhance your employability.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBPTM), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided during registering.

✨ Early Bird Discount: Save 20%✨ Group Discount: Enrol with 2 or more colleagues and save 30%!

📢 Referral Bonus!

Share this event with your network! For every friend or colleague you refer who registers, you’ll receive an addition 10% discount on your own ticket! Plus, the person you refer will get a 10% special discount too!
