Clinical Research Group

The team is comprised of Study Coordinators (registered nurses, licensed vocational nurses), Research Assistants/Associates (RAs), Clinic Coordinator, Regulatory Manager, Project Administrator, Team Manager/Research Liaison and Scientific Director. This experience and expertise is in addition to the many physicians who spend countless hours filling the roles of Principal Investigator (PI), Local Site Investigator (LSI) or Sub-Investigator, including the CRG Medical Director, Dr. Ronald Fernando.

Since its inception in 2008, the CRG has had the opportunity to work with many industry sponsors and participate in over a dozen VA Cooperative Studies Program (CSP) studies covering many different disease states including but not limited to anticoagulation point-of-care testing, anticoagulation bridging therapy, PTSD, depression, heart disease, arrythmias, prediabetes, diabetes, autoimmune disorders, diabetic kidney disease, osteoarthritis, esophageal reflux disorder, gout, flu vaccine, clostridium difficile (C. diff), Crohn’s disease, osteomyelitis, heart failure, cardiovascular disease, pain treatment/management, Parkinson’s disease, PTSD related insomnia and end stage renal disease.
The CRG employs a team approach to every research project and, prior to initiating a trial, the Scientific Director, with the support of the Project Administrator, performs a comprehensive feasibility assessment (consulting with VA and CRG staff as needed regarding anticipated study logistics), reviews and/or negotiates the study budget and provides input for CRADA/contract as needed by LLVARE (non-profit corporation) for industry sponsored studies. Once these processes are complete the project is forwarded to the Regulatory Manager who works closely with the sponsor/CSP to prepare and submit the initial application to the Local or Central Institutional Review Board (C/IRB) and Research and Development Committee (R&DC). Meanwhile, the Study Coordinator is assigned and begins protocol review and preparations for study initiation.

Upon C/IRB and R&DC approval the Study Coordinator works with the Team Manager to schedule the Site Initiation Visit or attend the kick-off meeting, prepares for receipt of study materials, completes any necessary training, and ensures other staff, such as RAs, receive training to the applicable portions of the protocol. In the CRG team approach, the RAs are responsible for clinical tasks such as vital signs measurement, phlebotomy, and sample processing/shipping. Further, the RAs hold primary responsibility for completing data entry into any electronic data capture system, under the supervision of the Study Coordinator and Team Manager.
During the pre-initiation phase, the Study Coordinator meets with the Team Manager, Scientific Director, Medical Director, and PI/LSI(s) to discuss and finalize the best methods for recruitment, enrollment, and long-term retention with the end goal of enrolling the target number of qualified study subjects and providing quality data. This group will meet as needed for the duration of the enrollment period to evaluate and refine processes to ensure enrollment goals are met.

Although the recruitment strategy is customized to the trial and its budget, it may include attending section meetings to solicit physician involvement, identifying potential candidates in advance of clinic appointments, contacting their providers for referrals, and sending letters to potential subjects so they may follow-up at their clinic appointment. In addition, these efforts may be supported by a customized, refreshable database of potentially eligible candidates with upcoming appointments which is extracted from the VA Data Warehouse based upon study specific inclusion/exclusion criteria. Further, advertisements may be created, approved by the C/IRB, and placed on the digital displays throughout the main facility and nearby Ambulatory Care Center.

In the years working within the VA system, the CRG team has fostered good working relationships with many different services within the facility including hospital administration. The team has the full support of the Associate Chief of Staff for Research and works to maintain a good working relationship with the IRB and R&DC chairpersons. And, after participating in multiple CSP studies, the CRG has extensive knowledge of CSP processes and requirements and a reputation for being an excellent site in every respect.

For more information or to connect with the CRG please contact us at extension 6361 or email the Scientific Director at Rebecca.Ruybalid@va.gov.