Clinical Research Discussion Group: Learn Something New!
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 discussion group is to help study staff learn about different aspects of clinical research from peers.
Audience: Study staff new to clinical research with less than 1 year of research-related experience or experienced study staff looking to learn the basics of a new skill.
Prerequisites: To get the most from this program participants should complete CITI Training in Human Subjects Research and Clinical Research Conduct: Research Staff Training 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.
Sessions will be limited to 25 participants. Participants must register for each session individually. Please feel free to bring lunch to each session.
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Learn Something New! Agreements, DUAs and MTAs
Speaker: Jason Ng, Agreements Associate, Research Management Stephanie Stone, Director of Contracting, Research Management Like most researchers, you’ve heard the acronyms, have some idea of what they are but no idea which one applies to your research and where to …
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! Effectively Communicating with the Study Team
Tara Bresnahan, Clinical Research Nurse Manager, Division of Vascular & Endovascular Surgery Communication is instrumental in the implementation of clinical trials. Effective team communication can save time and help ensure compliance with GCP Guidelines, protocol adherence, and patient safety. This …
Learn Something New! How to write study-related standard operating procedures (SOPs)
Speaker: Mallory Hillard, MSN, RN , Diabetes Research Center Standard operating procedures (SOPs) are a set of step-by-step instructions created to help study teams perform study-related tasks accurately and uniformly. In this session, we will discuss common SOPs for research …
Learn Something New! Implementing a Peer Review Program
Speaker: Barbara Steiner, Ed.M. Senior Clinical Research Coordinator, Diabetes Research Center In this session, we will discuss the peer review program developed by the MGH Diabetes Research Center and how the self-assessment checklist is a vital part of that program. …
Learn Something New! Informed Consent: The speed dating of clinical research
Speaker: Caitlin Stafford, Clinical Studies Specialist, General Surgery/Section Colon and Rectal Surgery In this session, we will briefly review regulations and polices involved in the informed consent process. The goal of this session is to teach new study coordinators how …
Learn Something New! Managing Multiple Studies: What's the Plan?
Ashley Seiger, Program Manager, Center for Genomic Medicine In this session we will review the challenges of managing multiple studies at once and provide tools for being successful and compliant. This session will go over some strategies for prioritizing, delegating, …
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! Personalizing recruitment programs: Enhancing the patient-researcher experience
Nicole DiOrio, Clinical Research Coordinator, Reproductive Endocrine Unit This session is designed for clinical research teams interested in rebuilding or revising their recruitment initiatives. This course emphasizes the “back to the bedside” philosophy and how it can be leveraged to …
Learn Something New! Planning for IRB Submission of a New Protocol and Using Insight
Speaker: Grace Ha, Project Manager Cardiovascular Research Center 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! Reading a Clinical Research Protocol: Where to Begin?
Speaker: Caitlin Stafford, Clinical Studies Specialist, General Surgery/Section Colon and Rectal Surgery One of the very first things a new clinical research coordinator is asked to do is read a study protocol. Depending on the complexity and number of protocols …
Learn Something New! Recruitment Resources @ Partners (RALLY, RODY, RSVP, ResearchMatch)
Speaker: Francine Molay, Senior Project Manager, Division of Clinical Research In this session, we will discuss recruitment methods supported by MGH and Partners – RALLY, RODY, RSVP and ResearchMatch. We will describe each method, how to get access, how to …
Learn Something New! Strategies for Managing Investigator Initiated Studies
Speaker: Katherine Brock, Administrative Manager, Division of Nephrology Principal Investigator (PI) initiated studies offer scientists the freedom to perform the research that they are most passionate about however that investigative freedom also increases the responsibilities of the study team. Unlike …
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! Study Team Roles and Responsibilities: What you can and cannot do!
Speaker: Holly Duddy RN, BSN, Interdisciplinary Brain Center, Department of Neurology As part of a research study an investigator may decide to delegate certain tasks to members of the study team, who are trained to perform such tasks. In this …
Learn Something New! Training A New Hire: What should happen during the first two weeks of employment
Camille Staco-Targete, Operations Manager, Diabetes Research Center Participants will be provided resources and materials to help them create a 2 week training schedule for new hires and implement the employee’s training. They will have the opportunity to practice creating a …
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, …
Learn Something New! Welcome, Introductions, Program Overview, Resources
Speaker: Stacey Grabert, DCR Clinical Research Education In this session, the DCR will welcome new study staff to MGH, introduce the DCR and other resources, review the “Learn Something New!” Program and provide an opportunity for new clinical research staff …
Learn Something New! What are the Different Types of Study Designs?
Speaker: Judy Hung, MD, Associate Director, Echocardiography, Division of Cardiology New to research? Confused about the different study designs? Join us for an introductory session describing the types of clinical trial designs and how to develop and outline of a …
Learn Something New! Where to Start During Study Start-up?
Grace Ha, Project Manager, Cardiovascular Research Center This session will provide an overview of what is required to start up a study, when it should be done, issues you may encounter during implementation and how those should be overcome. Audience: …