Clinical Research Skills: Intermediate
Clinical research is complicated. It is governed by regulations, guidelines and institutional polices. Study start-up, conduct and close-out involve so many different tasks – IRB submissions, recruiting, enrolling, financial management, data collection, analysis – just to name a few. Clinical research can be overwhelming even for experienced study staff.
The goal of the clinical research skills program is to help study staff learn about different aspects of clinical research from peers through practical application of a skill while maintaining compliance with Good Clinical Practice and institutional policies.
All clinical research study staff can attend. Participants must have completed CITI Training in Human Subjects Research and Clinical Research Conduct: Research Staff Training at MGH prior to enrolling in the skills program. It is preferred but not mandatory to have completed Good Clinical Practice in an Academic Research Institution prior to enrolling in the skills program.
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Clinical Research Skills: Developing a Strategy for IRB Submissions
Francine Molay, Project Manager, Division of Clinical Research While the IRB provides courses on using the IRB module in Insight, this session presents a nuts and bolts approach to completing an IRB application and uploading required documents. The goal of …
Learn Something New! Budgeting, Tracking, Invoicing and Working with the Clinical Trials Office
Speaker: Francine Molay, Senior Project Manager, Division of Clinical Research Financial management of a study is often low on the priority list of a coordinator’s responsibilities. The objective of this session is to instill the importance of monitoring the budget …
Learn Something New! Creating Case Report Forms to Help Study Visits Run Smoothly and per Protocol
Meghan Feldpausch, NP, Metabolism Unit Study coordinators are responsible for collecting data at each study visit. This session offers helpful hints for creating case report forms that are clear, concise and ensure that everything is being done as it should …
Learn Something New! Managing Up! How to Work Effectively with your PI
Nicholas Giordano, Clinical Research Program Manager, Emergency Medicine The relationship between a PI and researcher is one of mutual dependence. This course is designed to guide clinical researchers into an efficient, productive, and healthy relationship with their PI. We will …
Learn Something New! Study Monitoring: Preparing for a Visit and Working with Monitors
Speaker: Erin Elias, Clinical Trial Monitor, Medical Oncology, Dana Farber Cancer Institute This session will provide an overview of monitoring including different types of monitors, how to prepare for a monitoring visit and how to effectively work with a monitor. …
Learn Something New! Transitioning a Study: What to Do When You Inherit a Study?
Devin Qualls, Clinical Trials Project Manager, Neurology When new clinical research coordinators inherit a study, it can be challenging to know where to begin. This session will go over different strategies and resources you can utilize after inheriting a study, …