The expansion of YCCI’s Office of Quality Assurance and Training includes changes in leadership roles that will expand the program’s capability to provide support for the research community.
Alyssa Gateman, MPH, CCRP, has assumed the position of director of the Office of Quality Assurance (QA), overseeing QA activities, study monitoring, and administrative support for review committees. Gateman is a respected QA expert who arrived at Yale in July from Dana-Farber/Harvard Cancer Center, where she was director of the Quality Assurance Office for Clinical Trials. Her experience includes managing an internal auditing program, data collection design of investigator-initiated clinical trials, data and safety monitoring, and multicenter study review. She is leading Yale’s current quality initiatives, including departmental reviews to assess resources and implementing a risk-based stratification system for auditing studies.
“The QA office is a valuable resource for investigators that we encourage them to use,” said Gateman. “We are happy to help with any clinical research quality-related issues.” QA activities include conducting internal audits, identifying areas for system improvements, working with investigators who are undergoing an external audit, reviewing external audit and monitoring reports, and providing centralized monitoring of investigator-initiated multicenter studies, including activities related to Data and Safety Monitoring Boards.
Susan Anderson, RN, BSN, MFA has assumed the role of director of training, overseeing clinical research training activities for faculty and research staff. She brings almost 30 years of experience in clinical research to this position. She will continue to oversee face-to-face and online Good Clinical Practice training; the monthly series Coffee and Conversation and Lunch and Learn; a three-part introduction to clinical research course; and the Quarterly Faculty Dinner series. She will also be involved in several new initiatives, including:
- Collaborating with the Smilow Cancer Hospital’s Oncology and Nursing Education program to develop and implement required training for all nursing and support staff involved with clinical research.
- Implementing a new training program for Yale affiliates in Greenwich and Bridgeport
- Working with Clinical and Translational Science Award (CTSA) sites around the country to define and standardize training for researchers and staff that is specific to their clinical research-related roles and responsibilities.
Anderson is also available to develop ad hoc training activities for individual investigators and departments. “As clinical research continues to grow, it’s increasingly important to provide training opportunities for the research community,” she said. “I’m happy to be able to use my experience to develop these activities.”
For QA assistance, contact Alyssa Gateman at 203-785-3661 or alyssa.gateman@yale.edu.
For questions about training, contact Susan Anderson at 203-785-2902 or susan.anderson@yale.edu.