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Today, we dive into the nitty-gritty world of clinical trial compliance with our fabulous guest, Teresa Davis, who brings over 15 years of experience to the table. If you’ve ever wondered about the behind-the-scenes magic that keeps clinical trials running smoothly, this episode is for you!

In this episode, Teresa shares her journey from an English and art background to becoming an Associate Director of Clinical Operations, specializing in clinical compliance. Inspired by her sister and motivated by her niece’s life-saving clinical trial, Teresa's path into the industry is both heartwarming and inspiring.

Teresa’s passions within the industry are Site Monitoring, Risk-based Quality Management (RBQM), Clinical Compliance, and Vendor Governance. She is currently an Associate Director (contractor) of Clinical Operations within a ClinOps Compliance Team.

She is a wife and mother to two children: a son, and a daughter. She spends her time outside of work shuttling kiddos to taekwondo, t-ball, and gymnastics events. Her husband is a full-time football coach.

Highlights of the Episode:

• Teresa’s introduction to clinical research through her sister and the Healthcare Business Women's Association.
• The life-changing impact of her niece’s participation in a clinical trial for pulmonary arterial hypertension.
• Teresa’s deep dive into risk-based monitoring (RBM) and risk-based quality management (RBQM).
• The role of a Clinical Research Associate (CRA) and the transition from paper to electronic medical records.
• Insights into the importance of compliance, quality processes, and regulatory adherence in clinical trials.
• Fun and informative stories about working with cutting-edge technologies like oncolytic viruses and genetically modified organisms.

Key Takeaways:

• Understanding Compliance: Learn about the compliance funnel that blends regulations, company SOPs, and protocols to ensure patient safety and data integrity.
• The Power of Data: Discover how risk-based monitoring and quality management improve clinical trial efficiency and safety.
• Career Pathways: Teresa’s advice for aspiring professionals includes certifications, joining CRA programs, and building a robust LinkedIn profile.
• Networking and Growth: The importance of networking, volunteering, and staying updated with industry changes to advance your career in clinical research.

Episode Highlights:

• [0:01] Suzanne’s enthusiastic welcome and introduction of Teresa Davis.
• [0:30] Teresa’s career journey and the pivotal moments that shaped her path.
• [2:00] A deep dive into risk-based monitoring and quality management.
• [10:00] The transition from paper to electronic systems in clinical trials.
• [18:00] The importance of compliance, training, and documentation.
• [30:00] Teresa’s advice for breaking into the industry and growing your career.
• [40:00] Exciting advancements in personalized medicine and clinical research.

📞 Connect with Teresa:

• LinkedIn: www.linkedin.com/in/teresasuedavis
• Email: TeresaSueDavis08@Gmail.com

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!