Seminars & Workshops
Clinical Research Staff Quarterly Training: Best Practices for Completing Regulatory Documents

Are you utilizing best practices when completing regulatory documents?

Tufts Medical Center and Tufts CTSI Professional Education invite you to join us on September 15 for the next Clinical Research Staff Quarterly Training session. This interactive, live session will highlight best practices for completing and managing regulatory documents for industry-funded clinical trials. We will focus on the regulatory documents that are required before study initiation. You will also learn strategies for keeping a well-organized digital regulatory binder. Plus – participate in a team-based scavenger hunt activity for a chance to win a $5 Dunkin gift card for all team members.

Who Should Attend?

All clinical research staff involved in study start-up for industry-funded trials at Tufts MC are invited.

Featured Speaker

Vidya Iyer, MBBS, CPI, Director of Clinical Research at Tufts Medical Center

Learning Objectives

By the end of this workshop, participants will be able to:

  • Identify the required documents for study start up
  • Distinguish between FDA-required and sponsor-specific forms
  • Discuss tips and tricks for completing regulatory documents
  • Utilize best practices for organizing regulatory forms in digital format (“Regulatory Binder”)

Details

Thursday, September 15, 2022
1:00-2:00PM
Live online (a link will be sent to those who register).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by noon on September 15, 2022.

For questions and further information, please email Shane Cox.

 

Seminars & Workshops
Clinical Research Staff Quarterly Training: Career Paths in Research

Where can you go from here?

Tufts Medical Center and Tufts CTSI Professional Education invite you to join us on May 19 for the next Clinical Research Staff Quarterly Training session.

In this session we feature a panel discussion focused on the variety of traditional and non-traditional careers in clinical and translational research. Hear success stories of Tufts Medical Center research staff. Learn how you can leverage the skills you are developing now into avenues you might not have considered. This will be an interactive session, and we encourage you to send us your questions in advance – we can’t wait to see you there!

Research coordinators and anyone else interested in learning about research career paths are invited to attend.

Learning Objectives

After attending this event, participants should be able to:

  • Identify at least three possible career paths for research coordinators.
  • Describe the transferable skills developed by working as research staff.
  • Identify certifications and other educational options for career advancement.

Details

Thursday, May 19, 2022
1:00-2:00PM
Live online (a link will be sent to those who register).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by noon on May 19, 2022.

For further information, please email Shane Cox.

 

Seminars & Workshops
Clinical Research Staff Quarterly Training: Clinical Research from a Research Administration Perspective

What is the role of the research coordinator in the clinical trials agreement and budget process? What can hold up study approval?

Tufts Medical Center (Tufts MC) and Tufts CTSI Professional Education invite you to join us on Thursday, January 27, 1:00-2:00PM for the next Clinical Research Staff Quarterly Training session. We will kick off our 2022 series with an interactive session focusing on the clinical research process from the Research Administration perspective.

You will learn how to help Research Administration develop clinical research budgets and complete the Medicare Coverage Analysis. We will walk through an overview of the Medicare Coverage Analysis process and give insight to the process of negotiating Clinical Research agreements. You will also learn how to help your Research Administrator develop budgets, track expenses, and closeout the study from a financial perspective. We will also cover how to utilize the CTMS to improve communication with Research Administration and will preview how upcoming changes in EPIC will affect the pre-registration process for clinical research studies.

Research coordinators, research managers, and anyone involved in study start-up & close-out at Tufts MC are invited to attend. This training will give you the knowledge to confidently navigate the approval process.

Featured Speakers

Olivia Lovegreen, Manager, Clinical Trials and Compliance, Research Administration

Carly Tucker, MPH, Clinical Research Compliance Specialist, Compliance Department

Swetha Chinta, MS, Research Analyst, Tufts CTSI

Learning Objectives

After attending this event, participants should be able to:

  • Identify barriers in the startup process.
  • Identify methods for improving the startup process.
  • Identify what your research administrator needs from you and/or your PI, and when.
  • Describe techniques for improving communication with the Research Administration department.

Details

Thursday, January 27, 2022
1;00-2:00PM
Online via Zoom (a link will be sent to those who register).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by noon on January 27, 2022.

For further information, please email Shane Cox.

 

 

 

Seminars & Workshops
Clinical Research Staff Quarterly Training: Integrating the Clinical Trials Management System into Your Research Workflow

Tufts Medical Center and Tufts CTSI Professional Education invite you to join them on Zoom on Thursday, December 15 at 1:00PM for the next Clinical Research Staff Quarterly Training session: “Integrating the “Clinical Trials Management System into Your Research Workflow.”

This quarter’s session is all about how research staff can use the Clinical Trials Management System (CTMS) to its full potential. Using the system is a requirement at Tufts MC and it’s designed to address the needs of research staff for activating new clinical studies, tracking clinical progress, and managing financials.

You’ll get a brief overview of the CTMS, then take a deeper look from four different perspectives: clinical research billing review, Research Administration, Research IT, and clinical research coordinator workflow. Learn from your peers in breakout rooms to see live demonstrations of the CTMS in action for different study activities. This is a great opportunity for advanced CTMS users to share their own tips and tricks with their peers, and for newer users to learn how other departments are using the CTMS. Come prepared to discuss your experience with the CTMS in breakout rooms.

Who Should Attend?

All clinical research staff involved in entering clinical trial data through the CTMS at Tufts MC are invited to attend. Both experienced and new users of the CTMS should attend.

Featured Speakers

Swetha Chinta, Research Analyst II, Tufts CTSI

Christian Lawlor, Clinical Research Coordinator III, Neely Cancer Center, Tufts Medical Center

Olivia Lovegreen, Director of Clinical Trials Office & Regulatory Operations, Tufts Medical Center

Danielle Riggs, Executive Director of Research Administration, Tufts Medical Center

Ajay Tupil, Clinical Research Coordinator I, Neely Cancer Center, Tufts Medical Center

Learning Objectives

By the end of this workshop, participants will be able to:

  • Describe the benefits of using the CTMS
  • Identify points in the research process when data should be entered into the CTMS
  • Describe the process for entering patient and study data into the CTMS
  • Describe how study data entered into the CTMS are used by Research Administration and clinical research billing review

Details

Thursday, December 15, 2022
1:00-2:00PM
Live online (a link will be sent to those who register).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by noon on December 15, 2022.

For questions and further information, please email training@tuftsctsi.org.

Seminars & Workshops
Clinical Research Staff Quarterly Training: July 2021

The July 2021 Clinical Research Staff Quarterly Training will focus on hot topics in IRB and research compliance.

Big changes are coming to IRB forms and submission processes. Join us on July 15 for the next session of the Tufts Medical Center (Tufts MC) and Tufts CTSI Professional Education Clinical Research Staff Quarterly Training series. You’ll get the inside scoop on what is new, what you will be required to do, and best practices for working with the Tufts IRB. If you are involved in study start-up activities or interact with research participants or IRB submissions, these sessions are for you! These quarterly trainings are also a great way to get connected to the community of clinical research professionals at Tufts MC.

The July session continues our focus on topics in research compliance specific to Tufts MC. Whether you are an experienced coordinator, or new to Tufts MC, there will be something here that is relevant to your work.

Featured Speakers

Christine Choy, IRB Supervisor and Database Administrator

Caitlin Farley, IRB Administrator II

Carly Tucker, Clinical Research Compliance Manager

Featured Topics

Diversity Enrollment, Biospecimen Banking, and More

The IRB office recently updated their forms and templates to reflect new processes to highlight and improve enrollment of diverse populations, their updated Biospecimen banking (formerly tissue banking) policy, and much more. You will learn about all of these changes; which forms, templates, and policies were revised, created, and eliminated; and how these changes will affect current and new studies.

Best Practices for IRB Submissions and Responding to IRB Comments

The IRB office will provide tips and guidance for a smooth and efficient IRB review of your projects. You will learn best practices for submitting studies to the Tufts IRB, responding to comments and requested revisions, and getting your study approved as quickly as possible.

Third Party Vendor Risk Assessment Update

This short update will cover the EVA page for approved research vendors including: where to find the list, how to best understand and use the approved vendors list, and other tips and tricks for this new vendor review.

Who should attend

Clinical research staff are encouraged to attend.

Details

Thursday, July 15
1:00-2:00PM
Online via Zoom (a link will be sent to those who register).

Registration

To attend, please register here.

 

 

Seminars & Workshops
Clinical Research Staff Quarterly Training: May 2021

The May Clinical Research Staff Quarterly Training will focus on hot topics in research compliance.

Tufts Medical Center and Tufts CTSI Professional Education are excited to announce the re-launch of the Clinical Research Staff Quarterly Training series. The first training in the new series will focus on topics in research compliance specific to Tufts Medical Center.

Featured Topics

Clinical Research Pre-Registration

The Clinical Research Pre-Registration (Pre-Reg) form is used for patients coming into the hospital for inpatient or outpatient study visits that are scheduled for ancillary care. You will learn how to complete a Clinical Research Pre-Registration form and the importance of this information as it relates to research billing compliance.

Greenphire Clincard

Greenphire Clincard system is the preferred method for providing compensation or reimbursement to subjects in clinical research studies. We will discuss how to get studies added to Clincard, why the system is the most compliant way to pay research subjects, FAQs around using the system and important things to consider when requesting an alternative method.

Research Third Party Vendor Onboarding and Risk Assessment

Wellforce has recently rolled out a new Third Party Risk Management (TPRM) process including a new TPRM Vendor Onboarding Form. We will discuss when this form should be completed as part of study start-up and how to best complete it as it relates to research.

Who should attend

Clinical research staff are encouraged to attend.

Details

Friday, May 7
1:00-2:00PM
Online via Zoom (a link will be sent to those who register).

Registration

To attend, please register here.

 

 

Seminars & Workshops
Clinical Research Staff Quarterly Training: October 2021

The October 2021 Clinical Research Staff Quarterly Training will focus on sponsor-initiated studies.

Join us on October 21 for the next session of the Tufts Medical Center (Tufts MC) and Tufts CTSI Professional Education Clinical Research Staff Quarterly Training series.

This quarter will be all about sponsor-initiated studies: from study start-up to audits, we will cover tools, resources, tips, and best practices to help you run a successful study. These quarterly trainings are also a great way to get connected to the community of clinical research professionals at Tufts MC.

Featured Speakers

Alyssa Cabrera, MPH, Senior Project Manager, Tufts CTSI

Carly Tucker, MPH, Clinical Research Compliance Manager, Tufts Medical Center

Kimberly Garabedian, IRB Analyst, Tufts Medical Center

Vidya Iyer, MBBS, CPI, Manager, Tufts CTSI Clinical and Translational Research Center (CTRC)

Featured Topics

The Study Start-up Toolkit

This section will cover how the Study Start-up Toolkit can be used as a resource for getting clinical trials up and running. We will walk you through key sections of the toolkit and how it can support overall trial efficiency. You will walk away with a clear understanding of study start-up and your role in supporting sponsor-initiated studies during this phase.

Being Audit-Ready

Did you know there are a number of resources available to help you maintain audit readiness? The Tufts Health Sciences IRB will discuss best practices for conducting routine self-audits to keep your regulatory files in order and introduce self-auditing tools to ensure your study is always in an audit-ready state! In addition, the Tufts MC Compliance Department will also discuss their audit preparation resources.

Surviving the Sponsor Audit

In this section, we will cover a broad overview of the regulatory bodies that can audit an investigator/site. You will learn some of the major reasons for being audited and the difference between sponsor audit versus a monitoring visit. You get an in-depth review of best practices and tips that will prepare you for sponsor audits.

 

Who should attend

Clinical research staff are encouraged to attend.

Details

Thursday, October 21, 2021
1:00-2:00PM
Online via Zoom (a link will be sent to those who register).

Registration

To attend, please register here.

 

 

Seminars & Workshops
Obtaining Informed Consent with Special Populations

Are you a clinical research team member obtaining informed consent from human research volunteers?

Could you or your team use information on best practices and strategies for obtaining informed consent from special populations?

Join Tufts CTSI for a blended synchronous/asynchronous workshop focused on providing hands-on practice consenting research participants from special populations. This training has two parts: a required, self-paced pre-work tutorial on Tufts CTSI I LEARN, and a live Zoom practice session.

In the live portion of the workshop, all participants will practice obtaining informed consent with members of Tufts CTSI’s Stakeholder Expert Panel and student actors from the Boston Arts Academy in two role-play scenarios: an adolescent research participant and an adult with temporary diminished capacity. Panel members are former research participants and individuals with experience as simulated patients. This is a learning and skill building opportunity for you, and you will not be evaluated in any way.

Participants must complete all of the pre-work on Tufts CTSI I LEARN in order to receive the Zoom link for the live training. While in the live session your active participation in the role-play activity is required. You will also learn through providing feedback to others and engaging in group discussion. This will ensure that you get the most out of what this training has to offer.

Clinical research coordinators, investigators, research fellows, research nurses, and anyone involved in obtaining informed consent are encouraged to attend.

Learning Objectives

After attending this event, participants should be able to:

  • Demonstrate professional judgement on whether a potential participant has the capacity to provide willing and uncoerced consent.
  • Distinguish between competency and capacity with respect to informed consent conversations.
  • Distinguish between assent and consent to participate in research.
  • Demonstrate (using plain language) explaining the informed consent process, in a virtual setting, to participants from special populations.

Details

Live Session: Thursday, February 3, 2022
3;00-5:00PM
Online via Zoom (a link will be sent to those who register and complete the I LEARN pre-work).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by noon on February 2, 2022.

NOTE: Registration will open on Monday, January 10.

Prerequisite: CITI basic human subjects protection training. Participants will be required to upload proof of CITI completion to the Tufts CTSI I LEARN course site before the live session.

For further information, please contact Noelle Weicker, MHS.

 

 

 

Seminars & Workshops
Obtaining Informed Consent: A Practical Approach

Are you a clinical research team member who obtains informed consent from human research volunteers?

Could you or your team use information on best practices and strategies for obtaining informed consent?

Join Tufts CTSI for a blended synchronous/asynchronous workshop focused on providing hands-on practice consenting research participants. This training will take place in two parts: Part 1 of this workshop will be offered online, self-paced through Tufts CTSI I LEARN; Part 2 will take place in a live Zoom meeting and provide an opportunity to practice obtaining informed consent with members of Tufts CTSI’s Stakeholder Expert Panel. Panel members are former research participants and individuals with experience as simulated patients. This is a learning and skill building opportunity for you and will not be evaluated in any way.

Participants must complete all of the pre-work on Tufts CTSI I LEARN in order to receive the Zoom link for the live training. While in the live workshop, your active participation in the live role-play activity is required. You will also learn through providing feedback to others and engaging in group discussion. This will ensure that you get the most out of what this training has to offer.

Clinical research coordinators, investigators, research fellows, research nurses, and anyone involved in obtaining informed consent are encouraged to attend.

By the end of this workshop, participants of Parts 1 & 2 should be able to:

  • List the essential elements of informed consent.
  • Demonstrate (using plain language) explaining the informed consent process, in a virtual setting.
  • Demonstrate multiple techniques to verify participants’ comprehension.
  • Identify 2-3 key considerations for obtaining informed consent in a remote or virtual setting.

Details

Live session via Zoom: Thursday June 23, 2022, 10:00AM-noon ET 

Registration

To attend, please register here via Tufts CTSI I LEARN.

Prerequisite

CITI basic human subjects protection training. Participants will be required to upload proof of CITI completion to the Tufts CTSI I LEARN course site before the live session.

Seminars & Workshops
Obtaining Informed Consent: A Practical Approach

Are you a clinical research team member, obtaining informed consent from human research volunteers?

Could you or your team use information on best practices and strategies for obtaining informed consent?

Join Tufts CTSI for a blended synchronous/asynchronous workshop focused on providing hands-on practice consenting research participants. This training will take place in two parts.

Part 1 of this workshop will be offered online, self-paced through Tufts CTSI I LEARN.

Part 2 of the workshop will take place in a live Zoom meeting and provide an opportunity to practice obtaining informed consent with members of Tufts CTSI’s Stakeholder Expert Panel. Panel members are former research participants and individuals with experience as simulated patients. This is a learning and skill building opportunity for you and will not be evaluated in any way.

Participants must complete all of the pre-work on Tufts CTSI I LEARN in order to receive the Zoom link for the live training. While in the live workshop your active participation in the live role-play activity is required. You will also learn through providing feedback to others and engaging in group discussion. This will ensure that you get the most out of what this training has to offer.

Clinical research coordinators, investigators, research fellows, research nurses, and anyone involved in obtaining informed consent are encouraged to attend.

Learning Objectives

By the end of this workshop, participants of Parts 1 & 2 will be able to:

  • List the essential elements of informed consent.
  • Demonstrate (using plain language) in explaining the informed consent process, in a virtual setting.
  • Demonstrate multiple techniques to verify participants’ comprehension.
  • Identify 2-3 key considerations for obtaining informed consent in a remote or virtual setting.

Details

Live Session: Thursday, June 23, 2022
10:00AM-noon
Online via Zoom (a link will be sent to those who register and complete the I LEARN pre-work).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by Thursday, June 16, 2022.

Prerequisite: CITI basic human subjects protection training. Participants will be required to upload proof of CITI completion to the Tufts CTSI I LEARN course site before the live session.

Seminars & Workshops
Pfizer Investigator Training Program (iTP)

Acclaimed training program begins April 18, 2017

Tufts CTSI will host Pfizer’s acclaimed Investigator Training Program (iTP) on April 18-19, 2017.

This unique, two-day, free-of-charge program will empower clinicians to build critical skills required for the recruitment, management, conduct, and reporting of clinical trials. It will examine the entire trial process, from planning stages to trial close-out activities, and will provide practical recommendations for increasing the efficiency of clinical trial conduct at investigative sites.

Led by clinical trial experts, this interactive training will consist of didactic lectures, discussions, and group activities. The iTP is targeted to investigators and the entire clinical study team, including research fellows, coordinators, research nurses, data managers, regulatory, and IRB members. Clinical trial experience (even if limited) is encouraged, though not required.

Attendees will receive a certificate of attendance after completing this International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) program. This workshop is approved for 16.5 contact hours towards maintaining an Association of Clinical Research Professionals (ACRP) certification. Contact hours are applicable to CCRCs, CCRAs and CPIs at an entry-level knowledge base.

This is a popular training, and class size is limited, so please pre-register by no later than April 7. You will receive an official email invitation from Pfizer if you are admitted to the program.

Please note: registration is a two-step process. Once you pre-register with Tufts CTSI, you will receive a formal registration form from Pfizer. You must be registered with Pfizer in order to attend this training and receive certification.

Details

Tuesday, April 18, 7:30AM-5:00PM
Wednesday, April 19, 8:30AM-3:30PM
Registration and continental breakfast begin at 8:00AM.

Tufts Center for Medical Education, Room 114
145 Harrison Avenue, Boston MA

Contact

Questions? Please email info@tuftsctsi.org for assistance.