CLINICAL RESEARCH NAVIGATOR

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

Melissa Vliet
Sr. Manager, Regulatory and Compliance

Reporting to the Director of the Office of Clinical Research, Melissa will serve as a regulatory affairs and compliance resource, review IRB submissions, provide support in various quality assurance program functions, ensure implementation of research quality assurance programs and risk assessment and reduction strategies.  In addition, Melissa will be developing and revising internal monitoring plans, standard operating procedures as they relate to clinical research and will play an integral role in the oversight and management of clinicaltrials.gov and other systems. 

As a reminder, Epic billing review must be completed daily. Please be sure you are logging in at least once a day to clear your queue.

We now have a Master Agreement with Advarra. What does this mean for you?

Advarra utilizes a highly customized, cloud-based electronic platform to facilitate research study submissions, regulatory compliance, and e-processing and tracking of research studies. The electronic platform is called the Center for IRB Intelligence (CIRBI) and allows real-time communication among sponsors, research sites, institutional representatives, and Advarra staff and IRB members. All parts of the IRB process from initial submission to study close- out/termination are supported by CIRBI.

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:

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!

As a reminder, the Study Organizer 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 the Study Organizer 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.

I earned my Doctor of Pharmacy degree from the University of Maryland in Baltimore and I completed Clinical Pharmacy residency training with Johns Hopkins Medicine. After residency, I worked as an Oncology Clinical Research Pharmacist prior to joining the MFA in October 2021. I currently serve as the Research Pharmacy Operations Manager for The GW Medical Faculty Associates, overseeing all logistics for any investigational drug agents dispensed and administered within the institution. I was drawn to Research Pharmacy when I learned of the critical value that a clinical pharmacist adds to research, from protocol development all the way down to drug dispensing logistics and overall patient safety.

My clinical background and my research background have helped me to proactively anticipate ways to safely and efficiently practice Research Pharmacy for each and every clinical trial that we do. The Research Pharmacy serves 14 different clinical departments, managing an average of ~100 protocols at any given moment. My favorite part of my job is working closely with the practitioners, coordinators, and other support staff within each of the 14 departments to achieve our mutual goals together.  I am passionate about improving the lives of patients enrolled in clinical trials by optimizing the drug dispensation process for clinical trials to ensure a smooth workflow. Making the process easy and seamless from the inside always translates outward to the patient and enhances their overall experience here at GW, which brings me great joy. In my spare time, I enjoy exploring museums, art exhibitions, and theatrical plays in the local DC area.

As we strive to create standards across the organization we will be implementing a process for ALL new clinical research positions. The Office of Clinical Research (OCR) has identified inconsistencies in new position requests and onboarding before proceeding to the PJF stage. This has led to discrepancies in finances available to support the new hires. It is important that our leaders work with the OCR to verify grant/award funding is available to support the research position being requested. This will allow for better oversight, ensure financial visibility and provides an opportunity for the OCR to be privy of any open vacancies and anticipated new hires. Additionally, this will enable the OCR to ensure all research staff are onboarded and trained on all research policies

Please see the steps below. Effective immediately we will be implementing this process for ALL new clinical research positions. 

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.