The Pathology Clinical Research Unit
The Pathology CRU will partner with you from the very start of any project. There are many steps in this process, so please contact the Pathology Regulatory Coordinator who will help you navigate next steps. myRESEARCHpath is also a valuable resource.
The Pathology CRU supports both PI-initiated research and sponsored research. Our staff provide a wide range of services that include but are not limited to:
- Study start-up and feasibility
- Sponsor communication
- Initial study preparation including consent writing and iRIS submission creation
- Regulatory documentation and compliance
- Collaboration with finance for budget preparation and study invoicing
- Participation in study setup in OnCore
- Study staff training, organization, and support
- Study monitoring visit coordination
- Clinical Quality Management Plan (CQMP) implementation
- Study data collection
- Study closeout
The CRU is actively growing and expanding resources to further address the needs of the department. The goal of the CRU is to be able to support all users in every aspect of their clinical research goals. Your first point of contact is the CRU regulatory coordinator and depending on your specific needs, you will be connected to the appropriate person to assist you!
Meet Our Team
Chanjuan Shi, MD, PhD, is the research chair for the Pathology Department. She is a highly accomplished gastrointestinal (GI)/liver pathologist. She joined Duke Pathology in February 2020 as a full professor, and currently she is the chief of Gastrointestinal Pathology and Liver Pathology.
In addition, she has extensive experience in independent and collaborative research with focus on digestive system cancers. She has published more than 170 peer reviewed articles and many book chapters.
She has also been active in national and international professional organizations including holding important leadership positions. Currently she is a co-vice chair of the American Joint Committee on Cancer (AJCC) editorial committee, and she serves as a standing member for the WHO Classification of Tumour Editorial Committee.
Contact Dr. Shi at: chanjuan.shi@duke.edu
Kristy Averette, MSN, RN, CCRP, is the research practice manager (RPM) for the Dermatology and Pathology CRU. Kristy has worked at Duke since 2007. While initially working in a translational research lab on campus, she has held several progressive positions within Duke Health over the years. Ten years of her research career was spent in the Department of Neurosurgery before transferring to the Department of Medicine CRU leadership team. She also spent five years as a bedside nurse in Duke University Hospital on unit 7800, a pulmonary transplant step-down unit. She joined the Dermatology and Pathology CRU as RPM in March of 2020 and has served as a member of the Duke University Health System Institutional Review Board.
Contact Kristy at: kristy.averette@duke.edu
Beth Handel, BS, MLS (ASCP), is the senior regulatory coordinator for the Duke Pathology CRU. She came to Duke Pathology in 1987 and initially worked in various DUHS Clinical Laboratories such as Clinical Pediatrics Lab and Point-of-Care Testing as a medical laboratory scientist on the bench and in supervisory roles. In 2000, she transitioned into research as a research analyst and then clinical research coordinator and spent the next 23 years in the laboratory performing principal investigator-initiated research, as well as clinical laboratory instrumentation and medical device studies for private industry under DUHS laboratory directors. Beth began her duties as Pathology regulatory coordinator in 2018.
Contact Beth at: elizabeth.handel@duke.edu