THE INVESTIGATOR

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

We’ve made great strides in expanding the Office of Clinical Research and its resources. From launching a Biostatistics program, to working with the University to expand Regulatory & Compliance oversight, and a push to house all clinical trials in OnCore as a means of tracking and documenting the incredible scope of our research. We continue to be in an exciting time of growth and innovation. As a team, we are committed to helping each of you achieve your research goals and objectives. We are always open to new ideas and suggestions, as we recognize the value of everyone’s contributions to the success of this office. Your hard work and dedication is at the center of it all. I am proud of all that we have accomplished together and look forward to what we will continue to do in the coming years.

Dr. Sean Lee, Lead Biostatistician

Sean joined us in June as our lead Biostatistician. In his role, Sean leads and ensures the quality of all statistical and informatics aspects of the clinical studies undertaken by the GW SMHS Researchers, Scientists, residents, and students. His work focuses on clinical epidemiology and retrospective data analysis, clinical trial design, methodologies grant, and manuscript writing. Sean interacts directly and independently with principal investigators to coordinate all facets of their projects, provide statistical input in the study design and analysis phases, carefully review the end product, and focus on the appropriateness of statistical methods and validity of conclusions.

India Johnson, Sr. Financial Analyst

India joined us in August as our Sr. Financial Analyst. She is responsible for budget negotiations on clinical trials and CTMS financial builds, among other duties, in the OCR. India has obtained nearly a decade of finance related experience at a highly ranked international law firm headquartered in Philadelphia where she interfaced with Fortune 100 companies to smaller local organizations on a regular basis and managed complex financial arrangements. As a graduate of Carnegie Mellon University she earned a Bachelor of Science in the school of Humanities and Social Sciences.

VersaTrial is a free Google extension that serves as a bookmark. It's a dashboard used to store links and contact information for all vendors on a specific trial. When a new coordinator starts, you can easily share the list with them so they know who they'll need to reach out to for access. It also integrates with OnCore so you can click the OnCore link in VersaTrial and be taken directly to the study. There are no BAA issues and HIPAA compliance is not required, as there is no storing of PII. You can use this link to login and get started.

As a reminder, we recently began using Florence e-Consent as a way for electronically consenting subjects.

Florence e-Consent is a 21 CFR Part 11, HIPAA, CCPA, and GDPR compliant system that is easy to use for researchers, subjects, and research monitors. With Florence you can easily invite participants into the e-Consent platform, monitor the status of participants’ informed consent in real-time, update to latest consent versions for new protocol amendments, distribute and track re-consenting in the same application, and more!

If you are interested in utilizing e-Consent for your future studies, please follow the steps below: 

The hospital, in collaboration with the OCR, has launched a few new processes:

The Office of Vice Provost for Research, Office of Research Integrity has announced the appointment of Interim Director: Jennifer Christensen. Jennifer has over 15 years of experience in research, ethical and regulatory compliance, and strategic planning. Her background in application of evidence-based medicine combined with pre-clinical and clinical research experience supports successful collaboration with leaders, administrators, and researchers during every step of the research pathway.

She can be reached at jennifer.christensen@gwu.edu.

“It doesn’t matter how slowly one goes as long as one does not stop”. Tremaine’s career in clinical research has been a continuous, rewarding journey for the past 11 years.  Her first taste of research started at MD Anderson Cancer Center in Houston, Tx and she has not looked back.  She has worked on numerous clinical trials in many different realms and the patients have always come first. Since joining the MFA in 2019, Tremaine has been working with amazing physicians and support staff.  She is the type that if she doesn’t know something, has no problem reaching out for help.  Being the only coordinator for the Department of Surgery and the Transplant Institute, Tremaine has maintained her professionalism and sanity with a smile and no complaints.     
 
In her time, Tremaine enjoys traveling, dining, and shopping. Her personal shopping habits have led her to become quite the shoe “connoisseur”. Treat yourself to a glance at her shoes as she strolls by daily doing what she loves the most-research.

Thank you to everyone who donated their expired supplies to the Leave No Trace of Clinical Research Waste (LNTCRW) project! They catalogued over 4000 items - 76 pounds of usable lab collection supplies. These student volunteers are working tirelessly to ensure no supplies go to waste. So far, your donations have gone to: Bread for the City and 2 locations of La Clinica del Pueblo, along with a pipette donation to a GW freshman biology lab. Additional donations are planned for Medstar's low income clinics and the GW Healing Clinic.

If you would like to donate expired supplies to LNTCRW, please email clinicalresearch@mfa.gwu.edu for additional information. Right now the need is for butterfly needles, vacutainers, lab testing tubes, tourniquets, gauze/ bandages, paper tap, castille wipes, urine sample cups, and any other disposable materials. LNTCRW is planning another pickup for later in the fall.

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.