CLINICAL RESEARCH NAVIGATOR

A quarterly newsletter brought to you by the GW Office of Clinical Research

The Office of Clinical Research recently hosted our annual retreat. As part of this retreat, we discussed many new and exciting ways to move forward and better serve our research teams. We recently rolled out single sign-on for all OnCore users and updated our preaward intake process for federal foundation grant submissions. We will also be launching a new intake form system to streamline the contract intake process, storing all forms electronically in one location. Additional details will be provided at a later date along with information on how to access the new system.

Robert Miller, Vice Dean
Radwa Aly, Chief/Executive Director, Clinical Research Administration & Operations
Mardi Gomberg-Maitland, Chief Clinical Research Officer

Haneefa Willis-Johnson, OnCore Project Manager
Alice Pascalev, Sr. Applications Administrator, Clinical Research Applications
Sean Lee, Lead Biostatistician
Amanda Kohn, Research Program Associate

Eric Cannon, Manager, Sponsored Projects
Courtney Creekmore, Contracting Officer
India Johnson, Sr. Financial Analyst
Michelle Van Fossen, Research Grants Manager, Pre-Award

Melissa Vliet, Sr. Manager, Regulatory and Compliance

Our Operations team handles a variety of different tasks. As OnCore Project Manager, Haneefa oversees all data and reports in OnCore, ensuring compliance with OCR policies and maintaining OnCore as our source of truth.

Alice Pascalev maintains OnCore and Florence on the backend. For technical support in either system, you can reach her via the System Assistance Request Form. She will respond to all requests in the order in which they were received.

Sean Lee provides biostatistical support for non-grant and pre- and post-award clinical research projects. Sean’s support can be requested via the Biostatistics Support Request Form.

The 3rd Party Onboarding process allows for the onboarding of unpaid 3rd party individuals providing research support to MFA staff or those individuals who need access to MFA systems to support their research. You can find more information in the Onboarding and Training 3rd Party Individuals SOP or reach out clinicalresearch@mfa.gwu.edu to get the process started.

The Business Operations team supports clinical research by negotiating clinical trial contracts and budget. All new CTAs to be reviewed by the contracting team must be submitted with an Intake Form for New Studies. The intake form, along with other study start-up forms can be found on the OCR website. You can review the Study Contract Intake Process and Contract Timelines in our Business Operations SOPs.

If you are planning to submit a grant for contact proposal to a federal, foundation, association or other non-profit sponsor, a dedicated team of pre-award specialists housed in GW's POD3 Team will facilitate your proposal routing and submission through the myResearch portal.  You can complete the Notice of Intent Form here.

Regulatory & Compliance conducts Internal Monitoring Visits and oversees and supports compliance in clinical research activities. In addition, they are responsible for the SOPs & Guidance Documents, providing guidance and expectations while conducting research. Regulatory & Compliance also oversees clinical trials entered into the Protocol Registration and Results System. Keep an eye out for emails regarding upcoming information sessions for this system.

KUDOS TO ALL TEAMS! We’ve been able to keep our Epic billing review under 7 days. Let’s try to get to our goal of having all billing charges reviewed in 3 days!!! 

The Freezer Farm is located in Ross Hall and is available to GW MFA research teams who need freezer storage space for their samples. Please review the Freezer Farm SOP for further guidance. Each Freezer Farm request must come with a request form, inventory sheet, and signed agreement. You can reach out to clinicalresearch@mfa.gwu.edu with any questions.

We are excited to announce the launch of the OCR Proposal Intake Form to streamline the submission of funding applications. Effective immediately, please use the link or QR Code below to complete the form to indicate your intention to submit an application for funding.

OCR/GWCC Proposal Intake Form

This new tool simplifies the proposal workflow by providing a centralized point of contact for all clinical proposal submissions. Michelle will offer expert support in submitting a Notice of Intent to RST3, developing grant budgets, and navigating Sponsor and OSP/OVPR guidelines to ensure the best possible outcome for your funding application.

For any questions or if you would like to discuss expanding your research funding portfolio, please reach out to Michelle at:

Email: mvanfossen@mfa.gwu.edu

Phone: 202-994-2924 or 740-248-2868

We look forward to assisting you through this streamlined process.

The Office of Clinical Research recently welcomed a new group to the Advisory Committee. This committee oversees operations, finance, education and provides strategic guidance to the leadership team. It is composed of members with various areas of expertise from across SMHS.

Dr. Sora Ely 
Dr. Christopher Payette 
Dr. Sumona Bhattacharya 
Dr. Megan Quintana 
Dr. Ameer Abutaleb 
Preethy Feit, MHS, MS, CCRP

Welcome to our new members! We are grateful for your guidance and feedback as we continue to grow and improve our processes within the OCR.

The committee will continue to be chaired by Dr. Mardi Gomberg-Maitland while Radwa Aly serves in an ex officio capacity.

For the most accurate and up-to-date information, please be sure to check out the OCR website. As we continue to grow, we will continue to add more information and resources. If you have any feedback on the OCR website, please email clinicalresearch@mfa.gwu.edu.