by SOCRA | Jan 23, 2023 | Monitoring
By: Takoda Roland, CTM, CCRA, Associate Director of Clinical Operations, Sitero I have long been a proponent of the potential of eSource and its advantages in clinical trials. From my experience as a CRA (Clinical Research Associate) I first wrote about...
by SOCRA | Dec 14, 2021 | Clinical Research Associate (CRA), CRA Leadership Skills, Monitoring, Professional Development
Thomas Boothby, MS, CCRP CRA II, Boston Scientific Abstract: Research coordinators may transition to clinical research associates/monitors during their careers. This article provides an overview of how to determine whether it is the right time to make this transition,...
by SOCRA | Jul 19, 2021 | Clinical Research, Monitoring, Project Management, Protocols, quality management, Trial Management
Tracy Popp, MBAPreviously: Director, Research Financial Operations Norton Healthcare, Inc.Currently: Senior Director of Clinical Research, Tampa General Hospital Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE)...
by SOCRA | Nov 19, 2019 | Monitoring
Joanne Malia Associate Director, Clinical Documentation Management Regeneron Pharmaceuticals Abstract: Regulatory agencies are advocating for sponsors to take risk-based approaches in various clinical trial-related activities, especially in the area of...
by SOCRA | Jul 25, 2019 | Monitoring
Jane Ferguson, RN, MN, CCRP Senior CRA, Westat Abstract: Targeted monitoring is the on-site component of risk-based monitoring and focuses on the aspects of clinical research that have the most potential to impact participant safety and the credibility of the study’s...
by SOCRA | May 17, 2019 | Monitoring
By Takoda Roland, CCRA, CCRP Founder of Philadelphia Pharmaceutical Research Disclaimer: The examples noted in the following are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted...
