Conducting Close-Out Monitoring Visits as a CRA

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Description

Are you an aspiring or early-career clinical research professional wanting to enhance your industry skills to enhance your CV and job-readiness? In clinical research, a Clinical Research Associate (CRA) is required to master the execution of Close-Out Monitoring Visits (COV) to ensure the successful conclusion of clinical trials.

Our 2-hour interactive masterclass is designed to provide you with comprehensive knowledge and practical skills to effectively conduct close-out visits, ensuring compliance with regulatory standards and the integrity of study data.

🎯 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.

Key Benefits

• Enhanced Competence: Develop the skills necessary to perform thorough and compliant close-out visits, ensuring high-quality clinical trial closure.
• Regulatory Adherence: Learn to navigate complex regulatory requirements, reducing the risk of non-compliance during trial closure.
• Career Advancement: Strengthen your CV with specialised training, increasing your competitiveness in the clinical research field.
• Practical Application: Engage in interactive sessions that provide hands-on experience with real-world scenarios, preparing you for challenges encountered during close-out visits.

By participating in this masterclass, you’ll gain practical insights and tools to excel in conducting Close-Out Monitoring Visits as a Clinical Research Associate (CRA), ensuring the highest standards of data integrity and regulatory compliance in your clinical trials.

What You’ll Learn:

• Purpose and Importance of Close-Out Visits: Understand the critical role close-out visits play in finalising clinical trials, including administrative, regulatory, and participant-related procedures.
• Preparation Strategies: Learn how to prepare thoroughly for close-out visits from various perspectives, including data management, project management, clinical research coordination, and monitoring.
• Conducting the Visit: Gain insights into managing the close-out visit effectively, including final reconciliation of study documents, investigational product accountability, and ensuring all regulatory obligations are met.
• Post-Visit Responsibilities: Explore sponsor responsibilities, investigator recordkeeping, archiving, and quality assurance tasks following the close-out visit.
• Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements during the study close-out phase.

Who Should Attend?

• Aspiring or early-career Clinical Research Associates (CRAs): Professionals seeking to enhance their expertise in conducting close-out visits.
• Clinical Trial Managers and Coordinators: Individuals responsible for overseeing trial operations and site management.
• Quality Assurance Specialists: Personnel involved in ensuring compliance and data integrity in clinical research.
• Regulatory Affairs Professionals: Those focusing on adherence to regulatory standards in clinical trials.

Format, Date and Time

This is a paid online event. Current Clueo Clinical IBP^TM trainees: please follow the instructions provided during your onboarding.

Attendees will receive access link and password before the event.