Surgical Therapeutic Advancement Center (STAC)
“To promote therapeutic advancements through research, development, and education in order to improve the clinical care of surgical patients.”
The Surgical Therapeutic Advancement Center (STAC) at the University of Virginia (UVA) is an academic research center dedicated to the development of innovations in the field of surgery in order to improve the clinical care of patients. Our collaborators include some 30 UVA faculty members whose efforts are coordinated through one central office under the direction of Rachel Simon. The program was kick started by Dr. William Spotnitz.
Our clinical expertise in protocol development, implementation, execution, and publication extends throughout the surgical departments at the University of Virginia. Experience has been obtained in a wide variety of clinical trials (single and multi-center, including international) with many surgical specialties and related fields, including: general surgery, plastic surgery, breast surgery, pediatric surgery, surgical oncology, dermatology and radiology. The Center has particular strengths in the areas of cardiac surgery, thoracic surgery, and vascular/endovascular surgery. STAC is experienced with Phase I, II, III, and IV studies, and conducts all research with adherence to Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) guidelines. The Center boasts Certified Clinical Research Coordinators and trained support personnel dedicated to the efforts of clinical research.
STAC exists through the nurturing support of a large number of industrial collaborators as a result of unrestricted grant funding and specific contractual agreements. Proprietary interests of individual sponsors are carefully protected. Intellectual property developed at the University of Virginia may be patented through the University Patent’s Foundation.
Services Available Through STAC Include:
- Regulatory strategy advice and assistance
- Protocol development and revision
- Clinical steering committee leadership
- Site selection support and maintenance
- Source document review and editing
- Case Report Form review and editing
- Clinical trial support by certified Clinical Research Coordinators with strong clinically based nursing backgrounds
- Subject enrollment and data collection according to GCP/ICH standards
- Data management and analysis by UVA Department of Health Evaluations Sciences
- Scientific publication preparation
- Organization of Continuing Medical Education conferences, workshops and guest speaker appearances
- Formatting presentations to optimize learning for multidisciplinary/international groups including physicians, nursing, and allied health personnel as well as industry professionals
- Creation of didactic, small group, and laboratory events
- Facilitating Speakers’ Bureau/Guest Lecturer series
- Preparation of peer-reviewed journal manuscripts
- Authorship of chapters/books
- Providing Visiting professorships/fellowships
In keeping with the mission of the Surgical Therapeutic Advancement Center to “promote therapeutic advance-ments through research, development, and education in order to improve the clinical care of surgical patients,” an additional effort is being made by STAC to expand consultation services to industry. These services are specifically designed to help new and medium sized companies with an entire support package for new product development and larger companies with particular areas of interest. Consultation services include:
- Determination of surgeon needs
- Device design
- Device testing in bench and clinical environments
- Financial sponsorship
- Clinical trial execution
- Regulatory approval
- MSL and sales personnel organization and education
- Post market clinical trials
- Advisory board participation
- Market assessment and strategy
Services can be performed off site as well as at the University of Virginia and allow STAC to provide flexible degrees of support that are tailored to each individual company’s needs. STAC has a proven track record of successful support in these areas.

Rachel Simon, RN, BSN, CCRC
Manager
Rachel Simon, RN, BSN, CCRC
Rachel Simon received her Bachelor of Science Degree in Nursing from George Mason University. She came to the University of Virginia in 2004 as a staff nurse in the Thoracic Cardio Vascular Postoperative ICU. Rachel functioned as a Clinician III and Quality Team Lead in this unit which cared for highly complex and critically ill patients. In 2011, Rachel joined the Surgical Therapeutic Advancement Center as a Clinical Research Coordinator. Her early work as a CRC focused on cardiac surgical device trials and Cardio-Thoracic Surgical Network funded studies. Over time, Rachel expanded her knowledge and managed a variety of surgical trials which have included: device and drug, adults and pediatric populations, multi-site, investigator-initiated, industry funded, and NIH funded trials. In 2019, Rachel took the position of Research Manager for the Surgical Therapeutic Advancement Center. As the manager Rachel oversees administrative functions and coordinates the research efforts for the Department of Surgery.

Mike Cosner, RN, BSN, CCRC
Senior Clinical Research Coordinator
Mike Cosner, RN, BSN, CCRC
Mike received his Bachelor of Arts in Anthropology and a Minor in Chemistry from the College of William and Mary in 2004. He worked as a lead flight instructor for the world’s largest hang gliding school and volunteered as an Emergency Medical Technician prior to pursuing his nursing degree. Mike received a Bachelor’s of Nursing from Virginia Commonwealth University in 2009 and while there, worked as a Research Assistant on the Sedation and Ventilation Effects (SAVE) Study. He began his nursing career at the University of Virginia Health System as a registered nurse in the Thoracic Cardiovascular Post-operative Intensive Care Unit in 2010, specializing in the care of critically ill patients following major heart, lung, and vascular surgeries. In this role, Mike advanced to Clinician 2, gained CCRN certification, and “super-trained” staff members on new devices and bedside technologies. Continuing his work with cardiovascular surgery patients, Mike joined the STAC team in January 2014 and is active in clinical drug and device trials targeting stroke prevention in cardiovascular surgery patients.

Matt Kime, BS, CCRC
Senior Clinical Research Coordinator
Matt Kime, BS, CCRC
Matt received his Bachelors degree in biology with concentrations in microbiology and immunology from Virginia Tech in May 2013. During his undergraduate studies, he worked as a nurse aide at LewisGale Hospital Montgomery in Blacksburg, VA and as a research assistant for the UVA Clinical Trials Office. After graduating, Matt moved back to Charlottesville and became a Data Technician for the UVA Transplant Center Quality Department in 2013. He then became a Clinical Research Coordinator for the Department of Surgery’s Transplant Division in 2015, where he coordinated drug and device trials related to liver, kidney, pancreas, and lung transplantation and became the division team lead until August 2018. Matt spent a year as the Regulatory Specialist for the UVA Center for Diabetes Technology before joining the Department of Surgery’s Surgical Therapeutic Advancement Center in July 2019 as a Senior Clinical Research Coordinator, where he coordinates the cardiac surgery studies.

Kaitlyn Vecere, BS, RN, CCRC
Clinical Research Coordinator
Kaitlyn Vecere, BS, RN, CCRC
Kaitlyn received her Bachelor of Science in Immunology and Infectious Disease and a Minor in Biology from The Pennsylvania State University in 2016. During her time at Penn State, she was first introduced to clinical research as an intern at the University of Virginia, as well as Cancer Treatment Centers of America in Philadelphia. While working as an intern with the Radiation Oncology department here at the university, she supported research efforts to evaluate the effects of dose sparing of cardiac structures by implementing the Voluntary Deep Inspiratory Breath Hold (VDIBH) protocol in patients receiving left breast radiation. While working at Cancer Treatment Centers of America, she retrieved, organized, and prepared a variety of documentation for the Stem Cell Transplant and Cellular Therapy Unit, in order to prepare for audit and accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). Continuing her work with research, Kaitlyn joined the STAC team in June 2017, working on a variety of clinical trials coordinated in the office.

Christine Bernat, RN, BSN
Clinical Research Coordinator
Christine Bernat, RN, BSN
Christine earned her Bachelor of Science in Nursing from the University of Virginia in 2014. She gained experience with cardiothoracic surgical patients working on 4 West and the Thoracic Cardiovascular Post-operative Intensive Care Unit. As a bedside nurse, Christine advanced to Clinician 2 and obtained her CCRN certification. Christine joined the STAC team in April 2019 and coordinates clinical drug and device trials in the cardiac and thoracic surgery populations.

S. Afua Owusu, BS, PhD
Clinical Research Coordinator
S. Afua Owusu, BS, PhD
Afua attended Southern Illinois University-Carbondale (SIUC) where she earned a B.S. in Physiology with a minor in Chemistry in 2009. During her time at SIUC, she had the opportunity to conduct undergraduate scientific research in endocrinology as a Ronald E. McNair and Louis Stokes Alliances for Minority Participation scholar. Afua then participated in an NIH funded Post-baccalaureate Research Education Program at the University of Alabama at Birmingham—where she studied cardiac mitochondrial respiration redox cell signaling in the Department of Pathology. In 2015, Afua received her PhD in Physiology at Pennsylvania State University, as a Bunton-Waller Fellow and an Alfred P. Sloan scholar, investigating vitamin A metabolism in neonatal lung development and lung injury. In 2018, she completed her NIH T32 funded postdoctoral fellowship at Weill Cornell Medicine/New York Presbyterian Hospital in the Department of Genetic Medicine specializing in the areas of Personalized Medicine and Gene Therapy, elucidating vitamin A metabolism and genetic variation in the human airway epithelium of cigarette smokers. During her post-doctoral training, she earned an Advanced Certificate in Clinical & Translational Investigation and received trainee development scholarships through the American Thoracic Society. Afua joined the STAC team in June 2019 and coordinates a variety of clinical research conducted in the Department of Surgery.

China Green, BS, CCRC
Clinical Research Coordinator
China Green, BS, CCRC
China received her Bachelor of Science in Biochemistry from the University of Virginia in 2014. Her interest in research began during her undergraduate fourth year when she participated in a research lab performing enzymatic assays on a protein isolated from L. delbrueckii to determine its function. After graduating, she worked as a pharmacy technician for CVS in her hometown of Covington, VA then returned to Charlottesville to work in the clinical labs at the UVA Health System. In 2016, China joined the STAC team and is active in cardiac and vascular surgery trials.

Caroline Keller
Clinical Research Coordinator Trainee
Caroline Keller
Caroline received her bachelor’s degree in Biology and Bioethics from the University of Virginia in 2019. She has worked as a surgical assistant for a private oral surgery clinic in Charlottesville for the past four years. She additionally volunteers in UVA’s department of anesthesiology research labs investigating the neurological and developmental effects of early exposure to general anesthesia. In her spare time she enjoys running and coaching her U-6 soccer team. She plans on continuing her education in the medical field in the near future. She works mainly with the Cardiac Surgery Trials for the UVA STAC office.

Linda Yeboah, BA, CRC
Clinical Research Coordinator
Linda Yeboah, BA, CRC
Linda earned her Bachelors of art in psychology from the University of Virginia in 2012. During her times at UVA, she was a research assistant in the Dodson’s memory and cognition lab with focus on examining the cause of false memories and strategies to preventing them. After graduating, Linda worked for two years as a scribe emergency department at St. Mary’s hospital in Richmond, Virginia. She later moved back to Charlottesville where she worked with the access team at the Emily Couric Cancer Center at the University of Virginia Health system. She joined the STAC team in June of 2017 and has worked on various trials in the office but currently coordinates breast oncology trials.

Dena Snyder, RN, BSN, CCRC
Clinical Research Coordinator
Dena Snyder, RN, BSN, CCRC
Dena attended the University of North Carolina Wilmington where she earned her Bachelor of Science in Biology. After moving to Charlottesville, she began working at Martha Jefferson Medical and Surgical Associates. While there, she pursued her nursing degree and received her Bachelors of Science in Nursing from Old Dominion University in 2014. She gained experience as an RN working at Martha Jefferson Hospital before joining STAC in 2017. She is currently working on the surgical oncology team with clinical trials focused on breast cancer and benign breast disease.
Studies managed by STAC that are open to enrollment (updated 04/21/20):
IRB #15966-The (IRAD) International Registry for Acute Aortic Dissection (PI: Lori Conklin)
IRB #16965- A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy (PI: Shayna Showalter)
IRB #16966- A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (PI: Shayna Showalter)
IRB #17042- Understanding Aortic Aneurysms (PI: Gorav Ailawadi)
IRB #17415- On-X Prosthetic Heart Valve: 17 mm Aortic & 23 mm Mitral Study. NCT01812174 (PI: James Gangemi)
IRB #17933- A Randomized Clinical Trial Comparing The Overall Adverse Event Rate of Inguinal Hernia (IH) Repair Prior to NICU Discharge Versus IH Repair After NICU Discharge And Beyond 55 Weeks Post Conceptual Age In Premature Infants. NCT01678638. (PI: Jeffrey Gander)
IRB #18004- A Prospective Multi-site Single- Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early -Stage Breast Cancer. NCT02400658. (PI: Shayna Showalter)
IRB #18445- Partners in Discovery for Total Cancer Care at UVA (PI: Christopher Moskaluk)
IRB #18734- Assessment of the Gore Excluder Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. NCT02489539. (PI: W. Darrin Clouse)
IRB #19044- Endothelial TRPV and IP3 Receptor Channels. (PI: Swapnil Sonkusare)
IRB #19192- SSB 11-02 Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta. NCT02777528. (PI: John Kern)
IRB #19437- Treatment of Breast Fibroadenoma targeted tissue with High Intensity Focused Ultrasound (HIFU): A Pivotal Multi Center Prospective Study. NCT03044054 (PI: David Brenin)
IRB #19564- Pulmonary Artery Banding in Dilated Cardiomyopathy (PI: Mark Roeser)
IRB #19773- Surgical Implantation of TRAnscatheter valve in native mitral annular calcification (SITRAL) study. NCT02830204. (PI: Gorav Ailawadi)
IRB #19930- Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis: EARLY TAVR trial.NCT03042104. (PI: Gorav Ailawadi)
IRB #21515- Mechanical Circulatory Support- Product Surveillance Registry Platform Base Clinical Investigation Plan (PI: Leora Yarboro)
HSR180025- A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 For the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery. NCT03510897. (PI: Nicholas Teman)
HSR180035- A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery. NCT03779841 (PI: Gorav Ailawadi)
HSR190013- Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence (SECURE STUDY). NCT03709693. (PI: John Kern)
HSR190033- A Multicenter, Prospective, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of ANG-3777 (formerly BB3) to Assess the Safety and Efficacy of ANG-3777 in Patients Developing Acute Kidney Injury After Cardiac Surgery. NCT02771509. (PI: Nicholas Teman)
HSR190034- Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG. NCT04045665 (PI: Gorav Ailawadi)
HSR190049- A pragmatic study of home versus office-based narrow band ultraviolet B phototherapy for the treatment of psoriasis NCT03726489 (PI: Richard Flowers)
HSR190050- Analysis of Patient Recovery after Breast Cancer Surgery using Patient Worn Actigraphy Devices (PI: Christopher Campbell)
HSR200100- Mesenchymal Stem Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome (PI: Jeffrey Sturek)
Contact Surgical Therapeutic Advancement Center (STAC)
Fax (434) 243-0318
uvastac@virginia.edu
University of Virginia Health System
Surgical Therapeutic Advancement Center
P.O. Box 801370
Charlottesville, VA 22908-1370
University of Virginia Health System
Surgical Therapeutic Advancement Center
135 Hospital Drive, Cobb Hall,
Suite 1010
Charlottesville, VA 22908