Experienced Clinical Research Coordinator
This program targets the experienced Clinical Research Coordinator (CRC) with more than 2 years of experience, Senior Clinical Research Coordinators and Project Managers.
Individuals in this program have a fair understanding of MGH policies and procedures, are very familiar with the conduct of clinical trials, possess adequate understanding of GCP’s and are able to apply to current practice.
This program focuses on the administrative processes behind the implementation and conduct of clinical trials.
No Current Offerings
A Primer on Complex Trait Genetics
A Primer on Complex Trait Genetics: Principles for the Beginning Investigator Monday, September 23, 2019, 8:00am – 3:00pm, Simches Room 3.110 This event is sponsored by the MGH Division of Clinical Research. Are you able to keep up with the …
Advanced FAQ on ClinicalTrials.Gov
Sponsored by the Division of Clinical Research Speaker: Isabel Chico Calero, QI Program Regulatory Specialist The course will cover the most common challenges with results reporting and study cases, as well as a live walk-through demo and the opportunity to …
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 …
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 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: 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 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 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 …
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 …
Community Access, Recruitment, and Engagement (CARE) Seminar and Workshop
Sponsored by the MGH Division of Clinical Research Jonathan Jackson, PhD This seminar will cover an introduction to engagement, recruitment, and retention for inpatient and outpatient populations, including a focus on best practices and common mistakes. The seminar will demonstrate …
Community Access, Recruitment, and Engagement (CARE) Study Staff Session
Jonathan Jackson, PhD The CARE lunchtime series for study staff provides an opportunity to engage in discussion of community engagement in research and the crucial role of study staff in recruitment. The presentation will include coverage of best practices for …
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 …
Epic Research Charge Review and Insight Patient Care Corrections Workshop
• Do you have questions about the Epic charge review process? • Are you new to MGH research billing and responsible for reviewing charges in Epic? • Has it been a while since you last reviewed charges in Epic and …
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 …
HOW TO: Make the Transition to an Electronic Lab Notebook
Want your lab to go electronic but are struggling on how to make the change? Come to this session to learn how to transition to LabArchives, the Partners supported electronic lab notebook. Topics include: • How to access and navigate …
IRB Issues for the Bench and Desk Scientist
Sponsored by the MGH Division of Clinical Research and the Human Research Committee Elizabeth Hohmann, MD, Chair and Physician Director, Partners Human Research Committee The purpose of this seminar is to discuss ethical, regulatory, and institutional issues relevant to analysis …
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 …
Introduction to Bioinformatics of Next Generation Sequencing
Introduction to Bioinformatics of Next-Generation Sequencing Speaker: Ruslan Sadreyev, Director of Bioinformatics This introductory mini-course is intended for experimental and clinical researchers who would like to get oriented in basic Bioinformatics concepts and tools. It is intended as a primer …
LabArchives Training and Researcher Panel
LabArchives Training and Researcher Panel As of October 1, 2016: Enterprise Research Infrastructure & Services, ERIS, has an enterprise license for LabArchives (http://www.labarchives.com/) for all researchers to use at no cost. LabArchives is a web-based application designed for scientists to …
LabArchives User Group Session
Session Facilitators: • Lynn Simpson, Research Data & Analytics Services Manager • Jeremy Alphonse, EDC Project Analyst Enterprise Research Infrastructure & Services (ERIS) As of October 1, 2016: Enterprise Research Infrastructure & Services, ERIS, has an enterprise license for LabArchives …
LabArchives User Group Session
LabArchives User Group Session Session Facilitators: • Lynn Simpson, Service Manager • Ashley Procter, Application Analyst Enterprise Research Infrastructure & Services (ERIS) Enterprise Research Infrastructure & Services, ERIS, has an enterprise license for LabArchives for all researchers to use at …
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! 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! 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! 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! 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! 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: …
Next Generation Sequencing: An Introduction and Clinical Applications
This course is intended for investigators and research staff at all levels interested in next-generation sequencing resources and applications. It will include an introductory lecture on next-generation sequencing technology and sample preparation, lectures on how to interpret the data and …
Qualitative and Mixed Methods Overview- Investigator Section
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 This four-session course provides a practical introduction for clinical …
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 …
R User Group Meeting
R is a free and open programming language for statistical computing, data analysis, and graphical visualization. Along with this powerful software, comes a dynamic and vast community. The Partners R User Group seeks to bring this community together to share …
REDCap Training Courses--delete/combine with redcap course
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REDCap, RPDR and Epic Integration – What’s the future?
REDCap, RPDR and Epic Integration – What’s the future? Speaker: Lynn Simpson, MPH, Research Data & Analytics Services Manager Enterprise Research Infrastructure & Services (ERIS) Last year, Partners Research Computing developed a tool to allow users who have access to …
REDCap: API and DET User Group Meeting
REDCap: API and DET User Group Meeting Speakers: • Dimitar Dimitrov, Systems Designer • Jeremy Alphonse, Project Analyst Enterprise Research Infrastructure & Services (ERIS) The REDCap Application Programming Interface, API, allows external applications to connect to REDCap remotely, and is …
REDCap: Getting Started
Instructors: Lynn Simpson, Research Data Collection Services Manager, Jeremy Alphonse, Research Data Collection Services Project Analyst Research Information Science and Computing (RISC) Applications and Services In collaboration with the Harvard Catalyst, REDCap is a free, secure, web-based application hosted by …
REDCap: New Feature Release and User Group Meeting
REDCap v7.4: New Feature Release and User Group Meeting Session facilitators: • Lynn Simpson, Service Manager • Jeremy Alphonse, Project Analyst Enterprise Research Infrastructure & Services (ERIS) Partners HealthCare recently upgraded REDCap from v7.0 to v7.4. This user group session …
REDCap: eConsent
Speakers: • Evan Dechambeau Enterprise Research Infrastructure & Services (ERIS) The REDCap eConsent project is a template that can be used by those who have approval from the IRB to collect the consent document requiring handwritten signatures for their study …
RPDR
The Research Patient Data Registry (RPDR) brings clinical information to the researcher's fingertips and ensures the security of patient information by controlling and auditing the distribution of patient data within the guidelines of the IRB. This course will provide an …
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 …
Responsible Conduct of ‘Omics’ Research
Responsible Conduct of ‘Omics’ Research Sponsored by the Division of Clinical Research at MGH Join us for this exciting course looking at complex challenges that have become widespread due to rapid advances in genomic technologies, large scale data sharing, and …
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 …
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 …
Study Electronic Data Capture: REDCap and StudyTRAX
Objectives: Upon conclusion of this program, participants should be able to: • Compare and distinguish functionality between REDCap and StudyTRAX • Describe the key factors, reasons and issues related to choosing between REDCap and StudyTRAX • Analyze which application best …
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 …
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 …