About Us
The Clinical Trials Audit and Compliance (CTAC) team has experience in the roles of investigators, bench scientists, clinical research coordinators and nurses, clinical trial monitors, regulatory, research and development, and quality assurance for over 100 years. Our mission is simple: to help Emory researchers implement studies with compliance and efficiency which will lead to reliable and accurate data to contribute to science. Our efforts to support researchers are flexible and dynamic in order to provide unique one-on-one service to every researcher and every protocol.
Meet Our Team
Stephanie deRijke, RN, MSN, CIP
CTAC Senior Director
Stephanie deRijke's clinical research experience includes serving as an investigator of gastroenterology trials at the NIH Clinical Center in Betheda, MD and a coordinator for hypertension and diabetes trials in private practice in Decatur, GA. She obtained both a BSN and MSN from the Nell Hodgson Woodruff School of Nursing at Emory University and began her nursing career in Labor and Delivery at Emory University Hospital Midtown.
Kirsten Gerner-Smidt, BS
CTAC Senior Auditor
Kirsten Gerner-Smidt joined CTAC in September 2010, just after the establishment of the department. Prior to joining CTAC, Gerner-Smidt worked as a Clinical Trial Coordinator III at Winship Cancer Institute in the field of Neuro-oncology.
Gerner-Smidt has 30 years of clinical research experience, mainly in the field of oncology, gastroenterology and medical devices. She has worked in various pharmaceutical and bio tech companies; the most notable roles being Roche Diagnostics in Denmark's implementation of Research Quality System and QA program and Contura International overseeing the medical device vigilance/adverse event surveillance and implementation of the ISO certification. Gerner-Smidt obtained her certification as lead auditor in 1991, before moving to the USA in 2005. Gerner-Smidt joined the Emory Community in 2005 in Research Pathology.
Joanna Duncan, RN, BSN
CTAC Senior Auditor
Joanna Duncan joined CTAC September 2014. Prior to joining CTAC, she worked as a research nurse for the Interventional Cardiology research team at Emory University Hospital Midtown. Duncan's nursing experience includes cardiac catheterization, critical care, and emergency medicine. She obtained her nurse training and began her nursing career in the United Kingdom. Duncan came to the US in 1993 and worked in the Grady Emergency Department. Later, she obtained a BS degree from the University of St. Francis in Joliet, IL.
Toni Marie Webb, BA
CTAC Auditor
Toni Marie Webb joined CTAC as a Clinical Trial Auditor January 2011. Prior to joining CTAC, she worked as a Senior Clinical Research Associate with Pharmaceutical Product Development monitoring clinical trials. She has worked as a clinical trials monitor or auditor within various therapeutic areas for over 10 years. Webb is a graduate of the University of New Orleans with a Bachelor of Arts degree.
Mission
Clinical Trials Audit and Compliance works to ensure compliance in clinical trials at Emory by:
Reviewing the conduct of clinical trials for compliance with federal regulations, Good Clinical Practice (GCP), sponsor requirements, and Institutional policies.
Educating study teams on best practices as part of GCP to meet federal regulatory requirements. Providing tools to study teams to enhance documentation of compliance.
CTAC reviews monitoring reports to identify patterns of errors or single instances that require resolution and/or reporting to IRBs. We help with root cause analysis and corrective and preventive action plans to respond to monitors.
Advising and consulting study teams based on specific needs of a clinical trial or clinical department at Emory.
Contact Us
Where to Find Us
We are located on the Emory campus in the 1599 building, across from the CDC and next to the Emory Conference Center at 1599 Clifton Rd. Suites 5.104 and 5.105, Atlanta, GA 30322