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Clinical Studies
About Clinical Studies

MEET OUR STAFF

Margaret M. McCluskey, RN, MPH, CCRC
Manager of Clinical Operations, Clinical Trials Core

Pamela Edmonds, RN, BSN, MSA
Research Nurse/Study Coordinator

Ingelise Gordon, RN
Research Nurse/Study Coordinator

Sarah Hubka, RN, MSN, NP
Senior Nurse Practitioner

Brenda Larkin, RN, BSN, CCRC
Nurse Manager, VRC Clinic, Clinical Trials Core

 

Laura Novik, RN, BSN, MA
Research Nurse/Study Coordinator

Steve Rucker, RN
Research Nurse/Study Coordinator

Michael Scott, RN
Research Nurse/Study Coordinator

 


Margaret M. McCluskey
Margaret M. McCluskey, RN, MPH, CCRC is the Manager of Clinical Operations for the VRC Clinical Trials Core. Formerly directing the VaxGen Phase III Trial of AIDSVAX for Johns Hopkins University's (JHU) Center for Immunization Research, she brought five years of experience in managing HIV vaccine clinical trials to the VRC. Most notably, Ms. McCluskey led the JHU site to reach the highest volunteer enrollment among the 78 trial sites in North America, The Netherlands and Thailand. Additionally, the Washington D.C. site has an impressive 96% volunteer retention rate in this first, Phase III study of an HIV vaccine. Ms. McCluskey is a certified clinical research coordinator through the Association of Clinical Research Professionals.

Since 1981, Ms. McCluskey has worked with HIV and AIDS, first in conjunction with her ICU beginnings at Northwestern University in Chicago, then throughout her years in oncology and hospice nursing. Ms. McCluskey was Nursing Coordinator for The Women and Children's HIV Program at Cook County Hospital in the early 90's before working in Rwanda with the American Refugee Committee. Her passion has been her humanitarian work in Central and East Africa, and then later in Kosova with the International Rescue Committee. When asked why she joined the VRC rather than going back to relief work in the field, she responded: "In short, it'll have to wait... until we have something in the way of a decent vaccine to accompany us on the trip back.

"When I first returned from Africa, I was focused on the notion that nothing short of even a partially effective vaccine can begin to contain the magnitude of devastation and suffering wrought by HIV worldwide. Considering the lives lost to this virus, now exceeding 7,000 everyday, I can't see categorizing this pandemic as anything less than a humanitarian emergency. Now we have to add to our work the all-important protection of the public from potential bio-terrorist uses of pathogens. And so, despite being stuck this far north of the equator, I'm happy and privileged to do the work with the serious support of the U. S. government through the VRC. When we accomplish our tasks, daunting as they may be, I will be proud to have used our national resources to this end."
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Pamela Edmonds
Pamela Edmonds, RN, BSN, MSA is a Clinical Research Nurse/Study Coordinator for the VRC. Formerly a Research Nurse Case Manager for NIAID outpatient department, she managed care of volunteers on Phase III HIV, Hepatitis B and Hepatitis C protocols. Prior to employment at NIH she worked on the HIV/AIDS unit in a community based hospital providing care for patients with AIDS-related opportunistic infections. Ms. Edmonds has a shown evidence of her desire and ability to advance the research that promises to slow the spread of HIV, and is pleased to be doing so with the VRC.
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Ingelise Gordon
Ingelise Gordon, RN, has joined the VRC as a Research Nurse/Study Coordinator. Mrs. Gordon has been at the National Institutes of Health since 1991. She has supported NIAID in many capacities and has worked in many of their patient care units (inpatient, outpatient and Day Hospital nursing units). As a Case Manager for HIV protocols in two different HIV clinics within the NIAID, Ingelise demonstrated her well-known skill in combination with her compassionate, thorough approach to patient care.

Mrs. Gordon worked in a dual role as both the Clinic Coordinator for NIAID's Outpatient 11 clinic, while also serving as a Case Manager for NIAID’s HIV primary care clinic. Mrs. Gordon had a caseload of HIV-infected, uninsured patients who lived within 50 miles of the NIH campus, and displayed her deep satisfaction in working with these individuals while showing great empathy to her patients. The problems wrought by HIV are abundantly familiar to her.

When asked why she chose to join the VRC, Ms. Gordon stated, “Something needs to be done soon to prevent HIV altogether. Every second someone becomes infected with HIV, and it does certainly not discriminate. I think I am fortunate to be a part of an organization that will be instrumental in finding effective prevention against HIV. I want to give something to my daughter, and the other children of the world for that matter, so that they have good things to look forward to. I want to be able to say to my grandchildren, ‘Once a upon a time, a very, very long time ago, there was a deadly disease called AIDS.’ ”
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Sarah Hubka
Sarah Hubka, RN, MSN, NP is a senior nurse practitioner who has joined the VRC from Boston. Ms. Hubka managed Phase II, III and IV HIV clinical research trials for the Community Research Initiative of New England, a small, non-profit research organization. While there, she successfully facilitated the testing a new class of investigational, injectable HIV medications known as fusion inhibitors. For the past three years, Sarah has worked exclusively in nursing research, and has been responsible for all levels of conducting complex HIV clinical trials. This focused experience is sure to enhance the work of the Clinical Trials Core of the VRC.

Ms. Hubka has cared for long-term, infected HIV-positive adults, and so, has seen the devastation wrought by HIV and AIDS. Recognizing this experience as what drives her VRC colleagues, Ms. Hubka is thrilled to be working with a team of people who she identifies as committed toward prevention, and ultimately, the eradication of HIV. When asked about her decision to join the VRC, Ms. Hubka states "I feel like I have found my niche in this phenomenally dedicated group. I am proud to be part of an endeavor likely to provide the world with the hope of a tangible solution to effectively prevent HIV. I look forward to the challenges ahead of us."
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Brenda Larkin
Brenda Larkin, RN, BSN, CCRC is the Nurse Manager for the VRC Clinic on 12 West of the Clinical Center, Building 10. Formerly, Brenda worked with the Johns Hopkins University, Center for Immunization Research, where she coordinated Phase I, II and III preventive HIV vaccine trials since 1997. Ms. Larkin was instrumental in developing the infrastructure upon which the VaxGen study of AIDSVAXÔ was conducted, receiving accolades due to its premier enrollment and retention status among sites worldwide.

Being on the preventive end of HIV is important to Ms. Larkin, after years of witnessing the ravages of HIV/AIDS while caring for adults, especially pregnant women, in an economically depressed area 40 miles north of Boston. She is sensitive to the plethora of issues that arise due to this disease; this was key to her successfully assisting patients in finding housing, transportation and food, or while giving HIV positive results to youths in Massachusetts. Ms. Larkin helped women through the maze of barriers that exist while seeking testing and treatment. In her role as the MassCap Nurse for the northeastern part of Massachusetts, she was responsible for HIV training and education of providers in the area. Ms. Larkin is a certified clinical research coordinator through the Association of Clinical Research Professionals.

When asked why she joined the VRC, Ms. Larkin stated, "I am excited to be joining the Vaccine Research Center and hopeful that, in collaboration with others, we will find a way to stop the disproportionate destruction and unspeakable suffering caused by HIV/AIDS."
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Laura Novik
Laura Novik, RN, BSN, MA has joined the VRC as a Research Nurse/Study Coordinator. Ms. Novik began working as a Research Nurse at the National Institutes of Health in 2000 at the National Cancer Institute/ National Naval Medical Center, where she coordinated Phase II prostate cancer vaccine trials. Prior to that, she spent 18 years in nephrology nursing working in varying roles as a primary care nurse, quality management coordinator, and administrator. Beginning in the early 1980's, Ms. Novik was involved with HIV and AIDS in the clinical setting and after experiencing an HIV-related, personal loss, felt a growing need to contribute in a more meaningful way.

Upon arrival to the VRC in January of 2003, Laura stated: "I feel privileged to be a part of this amazing group of dedicated staff and volunteers. I realize that a great deal of time and effort is needed to produce a serious vaccine, but I am confident that it will happen, and that it will happen here." Ms. Novik's clinical trials management experience enhances the skills of the VRC Clinical Trials Core.
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Steve Rucker
Steve Rucker, RN is a Research Nurse/Study Coordinator. Steve has a rich variety of experience in nursing and clinical trials, principally in HIV. Prior to joining the VRC, he was at the National Cancer Institute coordinating a variety of Phase I and II, therapeutic cancer vaccine trials for prostate, colon, ovarian and breast cancer. Beginning in 1998, Mr. Rucker coordinated a variety of HIV clinical trials, working on many of the drugs that are now standard treatments for HIV/AIDS. Steve's initial experience in HIV research was at the Whitman Walker Clinic, the renowned, community clinic in Washington, DC. He then moved to Dupont Circle Medical Group. Steve adds a special set of strengths from his experience as a consultant on VaxGen's Phase III Trial of AIDSVAX® for the Johns Hopkins University's (JHU) Center for Immunization Research.

Steve brings to the VRC a passionate dedication to reduce the devastating effects of HIV/AIDS. Both in his work, and in his personal life, he has seen the ravages of the disease, contributing to a desire to be part of the solution. "I had temporarily left HIV work partly because I knew the drugs, while miraculous to so many people, would never be fully available to all people with the infection. The effort to develop a vaccine is really where my heart lies, because it has the potential to dramatically reduce the suffering worldwide."
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Michael Scott
Michael Scott, RN joins the VRC as a Research Nurse/Study Coordinator. Michael most recently was a Research Nurse at the University of Texas Southwestern Medical School in Dallas. There, he coordinated trials for the Adult AIDS Clinical Trials Group. He led two-phase III treatment protocols for Hepatitis C in subjects co-infected with HIV. Michael enjoyed an outstanding reputation for over-enrolling these protocols. He also coordinated a large phase III protease-inhibitor sparing treatment trial for HIV treatment naïve individuals. Additionally, he coordinated adjunct studies involving SPECT scans, longitudinal observational study, and a neurological assessment study.

Prior to his tenure in research, Michael worked within the Parkland Health and Hospital System's HIV/AIDS outpatient clinic. His responsibilities included triage, assessment, discharge, medication education and administration, infusion therapy, transfusions, and as a sensitive and effective advocate.

Michael muses, "I have often wondered where I would be when they announce the end of HIV. I am honored and humbled to have the opportunity to work for the day when HIV will be no more than a bad memory because of an effective vaccine."
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