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 …
Basic Introduction to ClinicalTrials.Gov
Sponsored by the Division of Clinical Research Speaker: Isabel Chico Calero, QI Program Regulatory Specialist This course will cover an introduction to requirements, reasons to be compliant, study classification and basic registration/results. This course is intended for individuals who are …
CITI-Animal Care and Use Series
The ACU series covers general principles of the ethical care and use of animals in research, training, and testing. It is designed to meet U.S. Department of Agriculture (USDA) and Office of Laboratory Animal Welfare (OLAW) requirements for basic training …
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 Conduct: Training for Research Staff at MGH
This online training program is designed to provide basic training in clinical research, and supply a list of resources for the research community at Massachusetts General Hospital (MGH), while reviewing Good Clinical Practice, Essential Regulatory Documents, and Research Record Keeping, …
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 Research Spotlight Series: Welcome Lunch for New Clinical Research Study Staff
The Division of Clinical Research would like to welcome new clinical research study staff to MGH! Please join us for lunch and the opportunity to network, get advice and ask questions. Registration is required. Contact dcredu@partners.org with questions.
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 …
ECG (12 Lead Placement) Training- NOW ONLINE
Clinical Research Skills Trainings Due to continuing COVID-19 restrictions, we will not be able to host live Clinical Research Skills trainings. If you or a new hire needs a Clinical Research Skills training, please complete the online training using the …
Ethics in Clinical Research
Ethics and Clinical Research Protocols Sponsored by the MGH Division of Clinical Research Melissa Frumin, M.D., M.S., Chair, Partners IRB In this course, participants will receive an overview of the ethical foundation of Human Subject Protection in clinical research. This …
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 …
Human Subjects Research (CITI Training)
The HSR series covers the historical development of human subjects protections, as well as current information on regulatory and ethical issues. It includes Biomedical and Social-Behavioral-Educational tracks, as well as courses specific to institutional/signatory officials and IRB chairs.
IATA Shipping Training of Biologicals and Dry Ice
The online training program will cover the necessary requirements for certification to ship biological materials and dry ice. A test will be given at the end of the presentation in order for your shipping certificate to be achieved. This training …
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 …
IRB: New Submission
IRB Roundtable: New Submissions Speakers: Sheldon Ratnofsky, Human Research Specialist Learn how the Administrative Chairs (voting members of the IRB) review and consider ethical, scientific and regulatory aspects of human subjects research during full board review of new protocols. The …
Insight eIRB Training
This training has been constructed to assist in understanding the eIRB submission process.
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, …
Maintaining a Regulatory Binder is not as Easy as it Seems!
Every study should have a regulatory binder or file whether survey research or drug/device clinical trials. There is a standard set of documents referred to as “essential documents” that should be filed and maintained in the regulatory binder. In this …
Out of Hospital Research Vistis
MGH has seen an increase in the number of studies conducting follow-up visits at locations not on main campus or satellite sites. There are many reasons for out of hospital research visits – research subjects do not have transportation, coming …
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 …
Peer to Peer Review
Course Description: This course will orient the research coordinators on the concept of a peer to peer review, its importance at their workplace, and also guide the step by step process of conducting peer review in their respective departments. Learning …
Phlebotomy Training for Clinical Research Coordinators- NOW ONLINE
Clinical Research Skills Trainings Due to continuing COVID-19 restrictions, we will not be able to host live Clinical Research Skills trainings. If you or a new hire needs a Clinical Research Skills training, please complete the online training using the …
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 Bootcamp: 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 special protections afforded to them? Are you aware of federal regulations and IRB …
QI Bootcamp: Investigational Product Accountability: What is this and How do I do it?
Many drug and device clinical trials are conducted at Partners Institutions. Study teams have the option of using the investigational drug service to manage study drug accountably or storing and managing accountably onsite. For device trials often the only option …
QI Bootcamp: Navigating the Vast Realm of Unanticipated Problems, Deviations and Violations!
What is an unanticipated problem? Is it more than just an adverse event? When is it a deviation? When is it a violation? In this session, we will discuss events that constitute an “unanticipated problem,” regulations governing unanticipated problems and …
QI Bootcamp: Session of the Unknown!
As part of the registration process participants will be asked to list a topic or two related to the regulations, study implementation, audits etc. that they have struggled with or would like to learn more about. Participants are welcome to …
QI Bootcamp: Study Documentation: If it isn’t Documented it Didn’t Happen!
Per Federal Regulations, Good Clinical Practice, and IRB policies, investigators and research staff are required to keep case histories on enrolled subjects. In this session, we will review requirements for source documentation and record keeping of subject files. The presentation …
QI Bootcamp: What is the Quality Improvement (QI) Program?
The Partners Human Research Quality Improvement (QI) Program provides education and support to the Partners research community to ensure the optimal conduct of human research within the framework of federal regulations, institutional policies, and good clinical practice. In this session, …
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 …
R Intro Training
**IMPORTANT: Please register for the course using the following link: https://rc.partners.org/r-intro-training-registration-site-mgh ***You will not enroll on LEARN for this course. This training course targets research scientists who have no or little knowledge of R. This hands-on training will provide many …
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 …
Research Administrator Discussion Group (RADG)
Monthly meeting for research administrators
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: ICH E6 Guideline Revisions
Sponsored by the MGH Division of Clinical Research Daniel Jones, MSN RN Senior QA/QI Specialist of the Partners Quality Improvement Program Did you know that the E6 Guidelines were revised and adopted by ICH on 12/15/2016? Who do these revisions …
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 …
Spotlight Series: RedCap Regulatory Binder Version 2.0
Speaker: Oluwanisola Odesina, Quality Improvement Specialist, Partners Quality Improvement Program The Partners Quality Improvement Program (QI) and Enterprise Research Infrastructure and Service (ERIS) have updated the Electronic Regulatory Binder (eReg Binder) project in Redcap. The eReg Binder assists sites with …
Strategies for Recruiting and Retaining Study Subjects
Strategies for Recruiting and Retaining Study Subjects Speaker: Barbara Steiner, EdM, Senior Clinical Research Coordinator, Diabetes Research Center, MGH In this session, we will identify strategies to recruit and retain subjects from the practical standpoint of a study coordinator working …
Vital Signs Training- NOW ONLINE
Clinical Research Skills Trainings Due to continuing COVID-19 restrictions, we will not be able to host live Clinical Research Skills trainings. If you or a new hire needs a Clinical Research Skills training, please complete the online training using the …
Welcome to the Genetic Code: An Overview of Basic Genetics
This introductory course will review fundamental language and concepts including DNA anatomy and genome organization; genotype-phenotype correlations; basic population genetics; and genotyping. Participants will have the opportunity to submit questions to the faculty prior to the lectures. This course is …
What Does the IRB Really Want? How to Write a Human Studies Protocol
Sponsored by the MGH Division of Clinical Research and the Human Research Committee Elizabeth Hohmann, M.D., Chair and Physician Director, Partners Human Research Committee This practical lecture addresses "Full Review Protocols" - those of more than minimal risk which must …
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 …