Upcoming
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! 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! 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! 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! 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! 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! 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. …
MGH Clinical Research Council
The Massachusetts General Hospital Clinical Research Council Meetings are held once a month on Tuesdays in the O'Keeffe Auditorium from 12:00pm to 1:00pm. This monthly meeting is a forum open to all members of the clinical research community, in particular …
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! 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! 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! Creating Case Report Forms to Help Study Visits Run Smoothly and per Protocol
Meghan Feldpausch, NP, Neuroendocrine and Pituitary Tumor Clinical Center 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 …
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! 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! 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! 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! 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: …
Coming Soon
A Clinical Research Fellow’s Guide to Mentoring and Resources
This orientation program will provide a networking opportunity for new clinical research fellows. Dr. Karen Miller will discuss strategies and resources for a successful research fellowship and career at MGH. Dr. Andrew Nierenberg will introduce the Division of Clinical Research …
QI Roundtable - Study Start-Up
Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker: Daniel Jones, QA/QI Speacialist Isabel Chico-Calero, QI Program Regulatory Specialist This series is designed for all …
Clinical Research Billing From Study Start to Completion
Sponsored by MGH Division of Clinical Research and the MGH Office of Research Compliance Speaker: Pamela Richtmyer, Director, Partners Human Research Quality Improvement Program This presentation will provide a basic overview of clinical research billing. Attendees will gain a general …
Clinical Research Day Panel Discussion
Panel Discussion: Can Genetic Studies Lead to New Treatment? Thursday, October 3, 2019 |11:00am-12:00pm | O’Keefe Moderator Maurizio Fava, MD, Director, Division of Clinical Research, MGH Research Institute Panelists Hal Dietz, MD, Victor A. McKusick Professor of Medicine and Genetics, …
Clinical Skills Training Discussion Group
The MGH Division of Clinical Research is looking to expand its clinical research skills training program by including quarterly sessions on study-related activities such as consenting subjects, obtaining an accurate medical history, assessing eligibility criteria etc. We would like input …
ClinicalTrials.gov
Join us for this exciting technical training offered to investigators and study staff to provide the tools to navigate the ClinicalTrials.gov database proficiently and ensure compliance with current regulatory requirements. The workshop will include a practical summary of current regulatory …
CQH-Mart
Speakers: Roy Perlis, MD Center for Quantitative Health, Victor Castro, Research Information Science and Computing (RISC) Course Description Electronic health records are an emerging tool for the study of clinical outcomes, risk stratification, and pharmacovigilance, among many other topics relevant …
IRB Roundtable: Continuing Review and Amendments
Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speakers: Jo O'Driscoll-Davis, Assistant Director for Continuing Review and Administrative Chair Michael Ducey, Senior Human Resource Specialist …
QI Roundtable: Source Documentation
Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker: Stephen Hayes, Partners Human Research, Senior QA/QI Specialist Per Federal Regulations, Good Clinical Practice, and Partners …
Spotlight Series - Clinical Research Coordinator Discussion Group
Sponsored by the Division of Clinical Research Please join us for our quarterly clinical research coordinator discussion group. Network with other research coordinators. Bring your study-related questions or issues. You can also submit them ahead of time when you register. …
Developing a Peer to Peer Auditing Program
Sponsored by the Division of Clinical Research and MGH Diabetes Research Center Marielle Mugford, Senior Clinical Research Coordinator, Diabetes Research Center The Diabetes Research Center at MGH has a unique internal auditing program to ensure compliance with Federal Regulations, GCP …
Good Clinical Practice in Research at an Academic Research Institution
Good Clinical Practice in Research at an Academic Research Institution May 28 | June 04 | June 11 | June 18 | June 25 185 Cambridge Street | Simches 3rd Floor, Room 3.110 Sponsored by the MGH Division of Clinical …
IRB Roundtable: Amendments and Reporting to the IRB
Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker:Jo O'Driscoll-Davis, Assistant Director for Continuing Review and Administrative Chair Per Federal Regulations, and Partners HRC policies, …
QI Roundtable: Protocol Adherence and Reporting Requirements
Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI). Speaker: Isabel Chico Calero, QI Program Regulatory Specialist You are working on an exciting new study. Are …
SOCRA Certification Exam
Want to Become a Certified Clinical Research Professional? The MGH Division of Clinical Research and the Society of Clinical Research Associates (SOCRA) are hosting a certification exam at MGH. Participants who successfully complete the exam will become a Certified Clinical …
IRB Roundtable: Consent Form Writing
Did you know that most of your research subjects are reading at the 8th-grade level or lower? Learn how to write the simplest, clearest consent forms, so that every one of your subjects can be fully informed. This workshop will …
Pitching/Consenting Research Opportunities in Acutely Ill Subject
Speaker: Brittany Mills, Assistant Project Manager This course focuses on the “soft skills” needed when approaching potential research subjects, who are inpatients. Ms. Mills will discuss the best practices for involving inpatients in research including how to approach the family …
QI Roundtable: Consent Process
Speaker: Daniel Jones, QI Specialist Informed consent: it’s more than just a document. Do you know the ethical considerations that factor into obtaining truly informed consent? If your study involves vulnerable populations, such as children, are you knowledgeable of the …
Basic Biostatistics for Clinical Research
Sponsored by the MGH Division of Clinical Research and the MGH Biostatistics Center Brian Healy, PhD, MGH Biostatistics Center This course will provide clinical researchers with a solid foundation in biostatistical concepts. Intended for those with minimal statistical experience, these …
No Current Offerings
Applied Biostatistics for Clinical Trials
This four-session seminar series will be offered on Thursdays in February and March. In this series, participants will review statistical approaches commonly used in research. Each of the four sessions will focus on a different theme using concrete and realistic …
Budgeting for Industry Sponsored Clinical Trials
Budgeting for Industry Sponsored Clinical Trials This program is sponsored by the MGH Division of Clinical Research and the Partners Clinical Trials Office Francine Molay, Project Manager, MGH Division of Clinical Research Sarah Bernardo, Senior Financial Analyst & MCA Specialist, …
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 …
Clinical Research Skills: Essential Documents: What are they? What do they mean? How should they be filed?
Daniel Jones, Senior QA/QI Specialist, Human Research Quality Improvement Program “If it wasn’t documented it didn’t happen!” In this session, we will review the list of essential documents and GCP requirements for documentation. For each document, we will describe the …
Clinical Research Skills: I'm New - What Should I Know?
Stacey Grabert, Assistant Director DCR Center for Clinical Research Education In this session, the DCR will welcome new study staff to MGH and introduce the clinical research skills program. We will review the new hire manual, mandatory training, relevant websites, …
Clinical Research Skills: Making Connections: Essential patient outreach skills
Nicole DiOrio, Clinical Research Coordinator, Reproductive Endocrine Unit This is a crash course on building patient outreach skills. Topics will include outreach initiatives, managing follow-up communications, and diffusing challenging patient interactions. Participants will learn strategies to initiate contact with potential …
Clinical Research Skills: Managing PI Initiated Studies
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 industry …
Clinical Research Skills: Reading a Clinical Research Protocol: Where to begin
Allie Sosinsky, Program Coordinator, Psychiatry 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 along with a limited amount of time …
Clinical Research and StudyTrax: Strategies to retain subjects and publish faster
Course Director: John Putzke, ScienceTrax Upon conclusion of this program, participants should be able to: • Identify common factors associated with subject dropout and missing data • Recognize the challenges that delay data analysis and publication of results • Appraise …
IACRN Informational Session
International Association of Clinical Research Nurses (IACRN) is the first professional research association dedicated to nurses. Come learn about the Boston chapter and international membership opportunities, resources and programs. Recently released ANA approved scope and standards of practice for research …
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! 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! 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 …
MGH Research Compliance Quarterly Discussion Group
MGH Research Compliance Quarterly Discussion Group Wednesday, July 8 | 1:00-2:00 | Virtually via Zoom Speaker: Kele Piper, Director of MGH Research Compliance It is finally here! Join us to get an opportunity to review the new Controlled Substances Database …
Payments to Research Subjects: Remuneration and Reimbursement
We will review the do's and don’ts of research subject remuneration and the policies on payments to human subjects and cash control accountability. This course is geared towards investigators, research nurses, study coordinators and other study staff. Please contact dcredu@partners.org …
Qualitative and Mixed Methods Overview- Clinical Research Coordinator Section
Location: Garrod/Mendel Conference Room, Simches Research Building, 2nd floor Speaker: Jordan Neil, PhD,MGH DCR Qualitative & Mixed Methods Research Unit Sponsored by the MGH Division of Clinical Research and the Mongan Institute of Health Policy This four-session course provides a …
Qualitative and Mixed Methods Overview- Investigator Section
Location: Garrod/Mendel Conference Room, Simches Research Building, 2nd floor Speaker: Lara Traeger, PhD, Associate Director of the MGH DCR Qualitative & Mixed Methods Research Unit Sponsored by the MGH Division of Clinical Research and the Mongan Institute of Health Policy …
Recent FDA Inspections at MGH: Observations, Citations, and Lessons Learned
Speaker: Pamela Richtmyer, Senior Research Compliance Associate, MGH Research Compliance Please join us as Pamela Richtmyer discusses recent FDA inspections at MGH, lesson learned from those inspections and how we can prevent citations moving forward. This course is geared towards …
Series on Global Health Research: Developing Meaningful and Productive Global Health Research Partnerships
Jessica Haberer, MD, MS Global Health Research Unit Director of Research, MGH Center for Global Health Associate Professor, Harvard Medical School Developing productive and meaningful global health research partnerships In this session, Dr. Haberer will discuss methods for identifying and …
Series on Global Health Research: Essentials of Global Health Research Administration
Jessica Haberer, MD, MS Global Health Research Unit Director of Research, MGH Center for Global Health Associate Professor, Harvard Medical School Essentials of global health research administration This session will discuss some of the particular issues related to managing and …
Series on Global Health Research: Successful Career Paths in Global Health Research
Jessica Haberer, MD, MS Global Health Research Unit Director of Research, MGH Center for Global Health Associate Professor, Harvard Medical School The following speakers will discuss their careers in global health research: • Jessica Haberer, MD, MS (General Medicine) • …
Spotlight Series: Delegation of Responsibilities in a Clinical Research Study
Sponsored by the MGH Division of Clinical Research and the MGH Clinical Research Center Speaker: Kathy Hall, MS, APC-BC, NE-BC, Nursing Director, MGH Clinical Research Center As part of a research study an investigator may decide to delegate certain tasks …
Spotlight Series: Recruitment Options: Research Match, RSVP for Health and the Research Portal
Speaker: Francine Molay, Senior Project Manager, Division of Clinical Research Please join us for an informal discussion on Research Match, RSVP for Health and the Research Portal and how they can be used to recruit potential study subjects. Francine will …
The Nuts and Bolts of Behavioral Health Intervention Development; Basic Information for Novice or Non-Psychologists
Sponsored by the Division of Clinical Research Ana-Maria Vranceanu, PhD This course will provide basic, introductory information for individuals interested in developing and testing behavioral health interventions. We will first define and provide guidance on how to choose a theoretical …
Trial Innovation Unit Workshop: Resources for translating a great idea into the clinic
Sponsored by the Division of Clinical Research Speaker: Dr. Judy Hung Do you have a great idea but don’t know how to get it translated into clinical space? Join us for this workshop with Dr. Judy Hung, Director of Trial …
eIRB Training: A Hands-On Introduction to eIRB
This training is a hands-on workshop for users that need to submit to the Partners IRB. The workshop will focus on the basics of how to navigate, track, and submit common submission types using eIRB. The eIRB/Humans module within the …