Beginner Clinical Research Coordinator
This program is designed for the Clinical Research Assistant (CRA) and Clinical Research Coordinators (CRC I) with less than 2 years of clinical research experience.
Individuals may be new to clinical research or to MGH with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.
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 …
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 …
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 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: 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 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 Registration and Results Reporting
This course will provide participants with information on the requirements for clinical trials registration on ClinicalTrials.gov, results reporting, record maintenance, and consequences for noncompliance. The course is recommended for investigators and study staff involved in the conduct of clinical trials …
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 27 | June 3 | June 10 | June 17 | June 24 Zoom Sponsored by the MGH Division of Clinical Research, Partners Human Research Committee and Partners Human …
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, …
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 …
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 …
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! 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 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, …
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 …
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 - 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 …
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 …
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 …
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 …
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 …
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. …
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 …
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 …