CLINICAL RESEARCH NAVIGATOR

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

A Message from Dr. Mardi Gomberg-Maitland, Chief Clinical Research Officer

Welcome to the March edition of our newly branded Office of Clinical Research newsletter, ‘Clinical Research Navigator’. This past year proved to be quite productive for the OCR. We’ve added multiple staff to support our growing portfolio, ramped up our regulatory and compliance monitoring, and fully transitioned to OnCore as our clinical trials management system, among many other wonderful milestones. My hope is that as we expand our existing processes, we may continue conducting impactful research and compete with neighboring institutions, making us the premier site for novel research.

As always, you can reach our office easily by email or phone and you can reach me individually with any concerns.

 

Warm Welcome

Courtney Creekmore, JD
Contracting Officer

Courtney’s professional experience includes over 6 years in industry contracting, including managing a complex, senior-level portfolio at the University of North Carolina at Chapel Hill. She earned a Bachelor’s of Arts in Political Science from the University of North Carolina at Charlotte and a Juris Doctorate from Marquette University Law School. She also obtained a Sports Law Certificate from the National Sports Law Institute at Marquette University Law School.  When Courtney is not attending college sporting events, she enjoys spending time with her loved ones and exploring the latest new restaurants in town.

Courtney will be supporting our Business Operations division with Clinical trial agreements, agreement amendments, data sharing agreements and material transfer agreements. Please join us in welcoming Courtney to our team!

 

Introducing Florence e-Binders – NOW LIVE!

We are now live with Florence e-binders to digitize, automate, and integrate our electronic investigator site files, participant binders, SOPs and study site logs.

Benefits of Florence e-Binders:

  • Go digital from start-up to close-out
  • Flexible workflows
  • Easy-to-use interface
  • Automated compliance
  • Enable remote monitoring
  • Customizable electronic logs

Follow this link to learn more! If you are interested in utilizing Florence eRegulatory solution for your study, please reach out to clinicalresearch@mfa.gwu.edu

ICYMI: We also have Florence eConsent. Check out the Research Toolbox for more information!

 

Coordinator Spotlight: Joaquin Calderon 

I earned my medical degree from Universidad del Norte in Barranquilla, Colombia, and after working as a general practitioner for several years, I joined MFA in 2022 as a Research Coordinator. Engaging in and leading various clinical trials and studies has been an enriching experience, allowing me to connect with remarkable individuals and interact with a diverse array of patients, which has been my favorite part. I’ve witnessed firsthand the potential for research to bridge social gaps and the power to outreach underserved populations. As an immigrant my desire is to train myself with the highest standards to advocate for healthcare equality, not just for Latino/Hispanic community, but in general for those patients who face barriers to accessing the health system.

In my spare time I enjoy dining, working out and simply exploring the multi-cultural aspects of the DMV area with my wife. As a passionate sports enthusiast, I particularly enjoy soccer and tennis, both as a spectator and a participant.

 

Helpful Reminders

  • If you have IRB related questions, please reach out to ohrirb@gwu.edu.
  • During the CTA intake process, we are unable to accept incomplete CTA packets. If you are not sure what should be included in your packet, please email researchcontracts@mfa.gwu.edu for further assistance.
  • We recently rolled out a new Amendment Intake Form as a means of streamlining our processes. This form will now be required for all amendment submissions. 
  • If you or your PI would like to advertise your clinical trials around the MFA, please make sure that all patient facing material is IRB approved (for digital and print) and reach out to the Office of Clinical Research. We will help connect you with the communications and marketing team who can create digital advertisements or help post around the building. Any flyers must be approved by the communications team before posting.

Regulatory & Compliance
  • The organization for ct.gov is GWUniversity.
  • When preparing for a Study Monitor and completing an Epic Access Request Form, please keep in mind that the inspector key is required before submitting the form. A batch release must be completed to generate the inspector key.
  • All SOPs & Guidance Documents are located on the OCR website.
 

Visit Our Website!

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.

 

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