Elevate Your CRA Career – Join the Ultimate 3-Day CRA Bootcamp!

Description

Elevate Your CRA Career – Join the Ultimate 3-Day CRA Bootcamp!

Why This Bootcamp is Essential
The role of a Clinical Research Associate (CRA) is evolving, requiring professionals to stay ahead in a highly regulated and competitive industry. While CRAs receive company-specific training, challenges persist in site-level implementation, data quality, career progression, and professional development.

This boot camp is the first in South Africa, offering a dynamic learning environment where CRAs can enhance their skills, exchange knowledge, and refine their expertise to become top-tier professionals in the industry.

3-Day Breakdown

Day 1: Study Set-Up

The first day focuses on the essential steps from final protocol development to regulatory and ethics committee (EC) approvals. Topics include the protocol submission process to SAHPRA and ECs, understanding National Department of Health (NDoH) requirements, including PHRCs and hospital approvals, and the legal and logistical considerations of export permits and Material Transfer Agreements (MTAs).

Day 1: Study Start-Up

Day one afternoon covers the transition from regulatory approval to site activation. Participants will engage in recruitment planning, site activation processes, and Investigator Site File (ISF) setup. This session also includes vendor management, budgeting, and contract negotiations, ensuring CRAs understand the critical elements contributing to a site’s readiness for trial implementation.

Day 2: Study Conduct

The session dives into study conduct from the first participant visit to the last. Key topics include enrolment and informed consent processes, source data review, monitoring visit report writing and review, site payments, and financial oversight. CRAs will also explore principal investigator (PI) oversight, site relationship management, investigational product (IP) accountability, safety management, and the role of centralized monitoring in maintaining compliance and efficiency.

Day 3: Study Close-Out

The final session focuses on site close-out activities, IP reconciliation, and archiving. CRAs will gain insights into the final steps of a clinical trial, ensuring proper documentation and regulatory compliance for successful study closure.

Throughout the boot camp, participants will engage with expert trainers, including Denise Witbooi (Senior CRA and Independent Consultant ), Nyeleti Bicky Mthombeni (Clinical Research Project Manager and Independent Consultant), Akhanksha Jain (Quality Specialist), and many seasoned clinical trial professionals.

Sessions will also include clinical psychologists, HR professionals, and time management experts to address common CRA challenges, such as burnout, career progression, and workload management.