Leadership
Daniel F. Hanley, MD
- Director, BIOS Clinical Trials Coordinating Center
- PI, Johns Hopkins University Trial Innovation Center
- Deputy Director for Support and Innovation in Multicenter Trials, Johns Hopkins Institute for Clinical and Translational Research
- Jeffrey and Harriet Legum Professor of Acute Care Neurology
- Professor of Neurology, Neurosurgery, and Anesthesiology/Critical Care Medicine, Johns Hopkins University School of Medicine
A leading expert on brain injury, Dr. Daniel F. Hanley is a professor of neurology, neurosurgery, and anesthesiology/critical care medicine at the Johns Hopkins University School of Medicine and a professor at the School of Nursing. In 1999, he was named the Jeffrey and Harriet Legum Chair of Acute Care Neurology. He leads the BIOS Clinical Trials Coordinating Center (BIOS CTCC), previously named the Division of Brain Injury Outcomes, which he founded in 1999. BIOS CTCC is an academic research organization (clinical trial data management center, imaging reading center, and enrollment center) within the Department of Neurology. Although BIOS CTCC still is embedded in neurology, it has expanded beyond support for neurology trials. The center has extensive clinical trials experience in cardiac disorders and devices, vascular, infection, opiates, and aging, as well as Dr. Hanley’s personal areas of interest: stroke, traumatic brain injury, brain hemorrhage, and brain infection.
Dr. Hanley’s 40 years in medicine have centered on the areas of clinical trial design, organization, and interpretation of drug and device trials, development of strategic research plans, and FDA regulatory compliance. He was the principal investigator for the NIH-sponsored MISTIE III and CLEAR III trials investigating minimally invasive neurosurgical techniques to treat hemorrhagic stroke. As a current principal investigator for the National Center for Advancing Translational Sciences (NCATS) Johns Hopkins University Trial Innovation Center, Dr. Hanley leads collaborative efforts to advance education and therapeutics via well-designed and innovative CTSA clinical trials.
Continuously funded by the National Institutes of Health since 1984, Dr. Hanley has received more than 70 clinical and basic research grants, predominantly from the NIH and the FDA Orphan Products Grants Program. He has published more than 400 peer-reviewed articles and book chapters and has received the Humboldt Research Award for his accomplishments in brain injury research. Of the nearly 100 researchers he has mentored, his trainees have led 25 brain intensive care units across the United States and worldwide, and more than 40 have been named full professors, program leaders, or department chairs. Dr. Hanley received the 2018 Distinguished Investigator Award from the American College of Critical Care Medicine. He is a graduate of Williams College and Cornell University Medical College and has board certification in internal medicine, neurology, and psychiatry.
Karen Lane, CCRP
- Assistant Professor of Neurology
- Deputy Director, BIOS Clinical Trials Coordinating Center
- Director, Multicenter Study Operations Training Program, ICTR
- MPI, Johns Hopkins University Trial Innovation Center
Karen Lane’s academic focus is the art and business of clinical trial science. She is a co-founder of the BIOS Clinical Trials Coordinating Center, an academic research organization approaching its 25th year, and helped organize the Johns Hopkins University Trial Innovation Center, one of three U.S. centers of excellence in the National Center for Advancing Translational Sciences-sponsored Trial Innovation Network. Her research and training programs include universal lean management principles and methodologies aimed at improving clinical trial operations through innovations that address the inefficiencies and practical challenges of performing clinical trials. Her program building includes mapping trial administrative (e.g., recruiting) and regulatory workflows (e.g., consenting) and developing ways to measure and draw conclusions on how to improve them. One example is an accelerated start-up program that reduces site activation time by two-thirds compared to industry reporting.
She is a recognized expert on a wide range of lean management trial practices: standardizing site feasibility and selection practices by building automated systems for transparent scoring and ranking trial site readiness; remapping multicenter trial activation cycles with leaner flow pathways that improve productivity and efficiencies; creating cost-efficient, novel research roles, such as the site navigator role dedicated to helping sites succeed; training how to automate and monitor recruitment performance—encouraging trial teams to be more responsive to goals and succeed; and gamifying the activities of clinical trials—transforming trial metrics into game themes to engage sites and prevent isolation and underperformance. Across all these new models is embedded continuous improvement by repeatedly collecting metrics on performance and frequently meeting to ensure trial personnel on all levels are involved in performance improvement, analyzing progress in group formats weekly.
To address the common delays in preparing clinical research sites for patient enrollment, she has developed an innovative educational program that accelerates the start-up process for study sites. This program has been implemented in 12 NIH-funded multicenter trials that comprised more than 200 sites across the nation. This expertise was critical to the recent success of two multicenter COVID-19 convalescent plasma trials executed from site selection to peer review for publication in less than 24 months. These two exceptionally difficult projects involved leading a team of 20 clinical research associates coordinating study teams at 27 clinical centers. As public engagement and participation is critical to the success of any clinical research enterprise, particularly clinical trials, her most recent work has been the dissemination of study findings to the public and the medical community, using both academic-based public media departments and data-driven marketing communications—work critical to ensuring that the findings from the convalescent plasma trials had immediate impact not only on public health but global policy. A faculty mentor for the Ann Dana Kusch Predoctoral Fellowship in Clinical Research and Innovation, she mentors individual investigators, both at Hopkins and at other Clinical and Translational Science Awards (CTSA) Program hubs, on implementing lean and effective methodologies for performing clinical trials.
With more than 50 publications in the areas of clinical trials and brain injury treatments, she has developed technical and organizational trial innovations including processes integral to web-based electronic data collection systems, trial performance metrics and summaries, trial management techniques resulting in site and subject retention, websites for investigators and the scientific community, an online training facility for skill certification, and electronic regulatory depositories.
Nichol McBee, MPH
- Research Associate, Department of Neurology
- Executive Director, BIOS Clinical Trials Coordinating Center
- Faculty Program Lead, JHU ICTR Trial Innovation Unit (TIU)
- Director, Johns Hopkins University Trial Innovation Center (JHU TIC)
Nichol McBee has been an integral part of the BIOS Clinical Trials Coordinating Center since its inception. Her expertise is in the management of clinical trials, specifically in the areas of protocol compliance, adverse events monitoring, serious adverse event reporting, follow-up and documentation of potential outcome events. As executive director, she has direct oversight of day-to-day operations and human resources, and she provides input into overall project forecasting and staff capacity needs. She also serves as the project administrator of the Johns Hopkins University Trial Innovation Center, an NIH/NCATS program award to develop, demonstrate, and disseminate innovations for clinical trial efficiency.
In addition to these leadership roles, Nichol supervises the data management core, medical monitoring processes, central adjudication of safety endpoints, and regulatory documents specialists. She is an on-call resource to site managers and clinical teams during randomizations, and she serves on multiple protocol development committees. Nichol is responsible for implementing and maintaining quality assurance and quality control systems by managing SOP production to ensure BIOS CTCC trials are documented and reported in compliance with each protocol and the applicable regulatory requirements in a timely and correct manner. She has been a vital part of the BIOS CTCC program responsible for the FDA IND applications and the management of the Brain Hemorrhage Thrombolysis clinical trial program since 1995.
Lindsay Eyzaguirre, MS
- Research Associate, Department of Neurology
- Associate Director of Operations, BIOS Clinical Trials Coordinating Center
- Assistant Director, Johns Hopkins University Trial Innovation Center (JHU TIC)
With 17 years of research experience and a master’s in epidemiology, Lindsay Eyzaguirre’s primary role is to conduct initial and comprehensive consults from start to finish for the JHU TIC. She serves as the liaison between investigators, research staff, and experts. An author of 30 peer-reviewed scientific manuscripts, Lindsay’s expertise is in managing and coordinating research projects, leading collaborations with internal/external collaborators, communicating with sponsors (e.g., NIH, CDC, private foundations), producing reports and scientific publications, preparing presentations for scientific meetings, and providing guidance and technical expertise in grant writing. She also has experience training personnel in resource-limited settings in areas such as viral diagnostics and monitoring techniques, molecular virology techniques, biological sample management, and human research compliance.
Andrew Mould, MPH
- Research Associate, Department of Neurology
- Associate Director of Business Administration, BIOS Clinical Trials Coordinating Center
- Assistant Director, Johns Hopkins University Trial Innovation Center (JHU TIC)
As a project administrator, Andrew Mould supports investigators through the entire project cycle, from grant writing and development through trial implementation and closeout. Andrew has managed several NIH- and industry-sponsored trials focusing on neurological disorders. With his background in neuroimaging, he also manages the Brain Injury Outcomes NeuroImaging Center. His team assesses all CTs and MRIs for qualitative and quantitative metrics across BIOS CTCC brain hemorrhage and traumatic brain injury studies. He has a specific research interest in perihematomal edema and has presented his work at multiple international conferences.
Advisory Group
David Newman-Toker, MD, PHD
- Professor of Neurology, Ophthalmology and Otolaryngology, Johns Hopkins University School of Medicine
- Director, Division of Neuro-Visual and Vestibular Disorders, Department of Neurology
- Director, Armstrong Institute Center for Diagnostic Excellence
- Core Faculty, BIOS CTCC Clinical Trials Unit; Co-Investigator, Johns Hopkins University Trial Innovation Center
Dr. David E. Newman-Toker is an internationally recognized leader in neuro-otology, acute stroke diagnosis, and the study of diagnostic errors. He completed his undergraduate studies at Yale University, his medical degree at University of Pennsylvania, his residency training at Harvard University, and his doctoral degree in clinical research methods at the Johns Hopkins Bloomberg School of Public Health. He has served as a full-time faculty member at the Johns Hopkins University School of Medicine since 2002. He is a professor of neurology, otolaryngology, and ophthalmology, with joint appointments in emergency medicine, acute care nursing, health sciences informatics, epidemiology, and health policy and management.
Dr. Newman-Toker’s clinical and research focus is in diagnosis of acute disorders affecting the brainstem and cranial nerves, particularly stroke. He leads the Division of Neuro-Visual and Vestibular Disorders in the Department of Neurology. He also directs the Armstrong Institute Center for Diagnostic Excellence, whose mission is to catalyze efforts to improve diagnostic performance, develop the science of diagnostic safety, and enhance diagnostic research. He has been the principal investigator for multiple NIH, AHRQ, and foundation grants. Dr. Newman-Toker has published over 100 journal articles and given more than 200 invited lectures on dizziness and diagnostic errors. He is a leader in the national and international movements to eliminate patient harms from diagnostic error. He has served as an expert consultant on diagnostic safety and quality to AHRQ, the National Quality Forum, and the National Academy of Medicine. He is the 2018-2020 president of the Society to Improve Diagnosis in Medicine (SIDM).
James F. Casella, MD
- Rainey Professor of Pediatric Hematology
- Chief, Division of Pediatric Hematology
The chief of pediatric hematology at Johns Hopkins Children’s Hospital since 1997, Dr. James Casella is director of the Basic and Translational Research Program in Sickle Cell Disease, Comprehensive Sickle Cell Center and the Maryland Hemophilia Treatment Center at Johns Hopkins. He co-founded and co-directs the JHU/NCI Pediatric Hematology and Oncology Fellowship Program and is an adjunct senior investigator at the National Cancer Institute. He is the director of the NHLBI-funded K12 Career Development in Benign Hematology program at Johns Hopkins, which trains young investigators. Early in his career, he discovered and characterized the actin-capping protein Cap Z, which plays a fundamental role in cell biology.
Dr. Casella is involved in basic and translational research to understand neurologic injury in sickle cell disease, and has participated in the development of numerous clinical trials to test treatment to prevent its complications, including BABY HUG, SIT, STOP II, and the EPIC Trial. He is the PI for the NHLBI-funded HU Prevent (Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease) trial.
Statisticians
Richard Thompson, PhD
- Biostatistician, JHU Trial Innovation Center
- Senior Scientist, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health
Dr. Rick Thompson’s expertise is in biostatistics and data analysis. A senior scientist in the Department of Biostatistics at the Johns Hopkins Bloomberg School of Public Health, he has served in leadership roles in the Johns Hopkins Biostatistics Center and the Johns Hopkins Institute for Clinical and Translational Research.
During his 21-year tenure as a faculty member at Johns Hopkins, Dr. Thompson has co-authored over 140 peer-reviewed papers in several fields of clinical and translational research, including neurology, surgery, pediatrics, cardiology, radiology, gastroenterology, and medical genetics. In addition, he was the PI of the data coordinating center for the MISTIE III study, an international multisite phase 3 clinical trial testing the effect of novel, minimally invasive surgical techniques for the treatment of hemorrhagic stroke. In this capacity, Dr. Thompson provided oversight and guidance on all statistical aspects of this trial, from study design to publications. In addition, he was the lead statistician for the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) phase 3 trial.
Gayane Yenokyan, MD, MPH, PhD
- Executive Director, Johns Hopkins Biostatistics Center
- Associate Scientist, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health
Dr. Gayane Yenokyan has a diverse background in medicine, health policy, epidemiology, and biostatistics. Since joining the Johns Hopkins Biostatistics Center in 2007, she has been the lead statistician on varied research collaborations with Johns Hopkins investigators from public health, medicine, and nursing, as well as external organizations. These projects range from large observational studies to clinical trial design and analysis.
Dr. Yenokyan’s key research interests include modeling patient-centered outcomes post-hemorrhagic stroke, relationship between cerebral blood flow autoregulation and neurocognitive outcomes after cardiac surgery, longitudinal disease trajectory in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD), bipolar disorder, and eating disorders, and, most recently, single-case designs for behavioral interventions in children with self-injury. She is proficient in STATA, SAS, SPSS, and R.
Constantine Frangakis, PhD
Professor of Biostatistics, Johns Hopkins Bloomberg School of Public Health
Dr. Constantine Frangakis develops designs and methods of analyses to evaluate treatments in medicine, public health, and policy (causal inference). The increased quality and number of available treatments, and increasing ethical and practical constraints, are transforming the field of intervention research: The factors of research interest in humans are no longer (and correctly so) the same as the factors in which we can intervene. To address this, Dr. Frangakis and colleagues are developing new designs and methods for partially controlled studies, studies that explore the factors that can be controlled, in order to investigate the effects of the factors of research interest.
Staff
Oona Abban, MS
Research Assistant
Oona Abban joined BIOS CTCC in October 2022 after earning her MSc in global public health, chronic and infectious diseases from University of Greenwich in London. Prior to working at Johns Hopkins, she interned for the Wellness in Stroke and Head Injury (WISH) Program at Towson University where she gained hands-on experience helping rehabilitation participants recovering from brain injuries. In her role, Oona supports consultations for the JHU TIC, TAP, and BIOS CTCC and provides project support for the Oral Antibiotics Trial as well as the biosketch team. In BIOS CTCC consults, she enjoys hearing about the many diverse diseases and hopes to gain further experience in clinical trial management prior to obtaining her PhD.
Ahmed Al Khafaji
Research Assistant, BIONIC
Ahmed joined the BIONIC team in April 2024. He works in the reading center, where he focuses on quantifying hemorrhages and processing MRI/CT scans for BEACH, MAP, and other ongoing clinical trials. Ahmed graduated from Towson University with a dual degree in biology and behavioral neuroscience. He then completed a postbaccalaureate fellowship at NHLBI, specializing in high-resolution cellular imaging techniques in endocytic processes. Additionally, Ahmed has conducted research in viral production/gene therapy and clinical study procedures in Phase 1 clinical trials.
Amy Andrelchik
Research Assistant, Data Core
Amy joined BIOS CTCC in June 2024. Her primary responsibilities include database management, enrollment reporting, and survey creation, among other data-related tasks. Additionally, she contributes to the publications team and is involved in peer-review processes. Amy has a BS in chemistry with a concentration in biochemistry and a minor in philosophy from Georgia State University. They are currently pursuing their MPH in epidemiology and are interested in utilizing advanced biostatistical methods to approach the areas of environmental epidemiology, toxicology, and climate and health. Their previous experiences include working as a bench chemist performing R&D analytical method development for small molecules detection, data collection, cleaning, analysis and quality control, survey development, systematic literature review, and technical report writing.
Dorothy M. Anika
Research Program Coordinator
Dorothy Anika joined BIOS CTCC in June 2022 after earning a Bachelor of Science in neuroscience from Trinity College in Hartford, Connecticut. Throughout her entire undergraduate experience, she gained research experience. Her main responsibilities include managing clinical trials, site activation, enrollment, submitting IRB protocols and consent forms, and interfacing with other roles. She is currently coordinating site activation and enrollment for NIH/NINDS StrokeNet; ASPIRE, and is assisting the study start-up team on the REASSESS ICH trial, among other tasks. Prior to enrolling in medical school, she desires to obtain experience in clinical trial coordination, interventions, and brain imaging. The human brain fascinates her, and she hopes to contribute to the discipline of medicine.
Alexis Archer
Clinical Research Site Manager
Alexis started her career at BIOS CTCC in March of 2023. As a graduate of Florida International University, her academic path led her to obtain a Bachelor of Clinical Psychology with honors. Since then, she has grown to become an expert in clinical trial management from start to finish in academic settings, regional hospitals, and private practices. Alexis has over 8 years of extensive experience working with all phases of clinical research, specializing in cardiology, psychiatry, neurology, gastroenterology, and investigational device (IVD) trials. At BIOS CTCC, she provides site navigation services for multiple trials including site selection, accelerated start-up, enrollment and close out activities. Alexis is eager to grow her career at BIOS CTCC and pursue the MPH program at Johns Hopkins University.
Jessica Baird, PhD
Research Navigator
Dr. Jessica Baird, who joined BIOS CTCC in March 2021, has a BS in exercise science from Ithaca College and an MS and PhD in exercise science from the University of South Carolina. As an NIH T32 postdoctoral trainee at the University of Alabama Birmingham Center for Exercise Medicine and the Exercise Neuroscience Research Lab, she conducted research related to exercise and physical activity in persons with multiple sclerosis. She has experience in the design and implementation of clinical trials, data management and analysis, and writing and disseminating scientific research. She ensures timely, accurate submission of regulatory documents to IRBs, works with participating sites to compile required documentation, and coordinates with stakeholders and TIC leadership to maintain required regulatory documentation.
Emily Ann Blair, LVN, CCRA, PMP
Research Navigator
Emily Blair has 20 years of clinical research experience. Her experience includes early and late phase research from study start up to end of study services. She is located centrally in Lockhart, Texas, providing extended hours of availability to study teams. Prior to joining BIOS CTCC, she has worked as a project manager, CCRA, LVN, and IVRS/CTMS consultant, and in quality assurance and regulatory affairs. She is dedicated to patient safety and the enrichment of community knowledge related to the ideas surrounding clinical research for the greater good. Emily prides herself on providing personalized care to each site to ensure the success of all participants, sites, and research.
Jamie Braun
Administrative Manager
Jamie Braun provides administrative support for Dr. Daniel Hanley and Karen Lane, as well as the JHU TIC. She was an integral part of the organizing committee for the World IntraCranial Hemorrhage (WICH) conference in 2017. Prior to joining BIOS CTCC in 2014, she maintained support roles in the travel management program for a global marketing services and consulting firm in the Washington, D.C., area. Jamie received her certification in professional travel management from Florida Atlantic University and a professional administrative assistant certificate from Johns Hopkins University. Outside of BIOS CTCC, her life revolves around family and community. When not attending her children’s sporting and school events, she volunteers and serves on the board of a local youth sports organization and community association.
Dylan Burbee
Sr. Compliance Monitoring Specialist
Dylan Burbee joined BIOS CTCC in August 2022 following a 10-year research career at the University of Pittsburgh. While completing a BSc in neuroscience at the University of Pittsburgh, Dylan worked in neurobiology research before transitioning to critical care clinical research. His research interests include post-resuscitation care and post-cardiac arrest neuroprognositication. At BIOS, Dylan serves as a study monitor where he works to assure participant safety and obtain optimal study data quality.
Cristina Camayd-Muñoz, MS
Research Program Manager
Cristina Camayd-Muñoz is a graduate of Tufts School of Public Health with a background managing clinical trials and public health research primarily in pediatric neurology. She has published on strategies to reach high health disparities populations at safety net hospitals, and cultural and linguistic factors impacting patient engagement. She has worked extensively in telehealth and telemedicine implementation and quality improvement for complex care coordination. Cristina has managed relationships between studies and stakeholders including funders, advocacy groups, and directing patient advisory boards. Since joining BIOS CTCC and the JHU TIC in May 2021, Cristina has served as manager of the Data and Safety Monitoring Board Unit and project manager to TIC multisite trials.
Jack Chally
Senior Project Manager
Since joining BIOS CTCC, Jack has been managing two HEAL research projects, working on grant production, and supporting various projects. Jack comes to BIOS after over 11 years managing a grant from NIDA and leading and supporting many multisite clinical trials. Previously, he worked as the lead protocol specialist at a CRO for 5 years. Jack is a Navy veteran who brings 30 plus years of leadership and management experience to BIOS. Jack has a MBA with an emphasis in hospital administration and management and spends his off time with his wife and two children.
Eric Christensen, MS
Research Navigator
Eric Christensen is a graduate of the George Washington University School of Public Health. He began coordinating clinical research trials in the Rehabilitation Medicine Department at the NIH Clinical Center in 2012. From 2014-2020, he was a lead clinical research specialist within the University of Maryland School of Medicine, leading various clinical research trials. He has over 10 years of experience leading clinical research trials from study concept through implementation and study close-out. A native of New Hampshire, he joined BIOS CTCC and the JHU TIC in 2021 as a research program manager/site manager. In 2023, he transitioned to research navigator overseeing the BIOS CTCC DSMB Unit while continuing to serve as project manager for multisite trials.
Noah Choe
Research Assistant
Noah Choe joined BIOS CTCC in June 2024 as a research assistant. He provides project and data support for the MAP and REASSESS ICH trials. As a member of the data core, Noah contributes to database management, enrollment reports, and survey creation. During his time at BIOS CTCC, Noah plans to explore how statistical analysis and programming apply to clinical trials.
Amy Collinsworth, PhD
Clinical Research Site Manager
Amy Collinsworth joined BIOS CTCC in October 2024 as a part of the site navigation team. She has a BS and an MS in Radiology Sciences from Midwestern State University. She also completed her PhD in Learning Technologies from the University of North Texas. Her background involves research experience in the areas of pediatrics, radiology, cardiology, and medical devices. She is a licensed medical imaging professional with recent work in coronary CT angiography and AI. Amy is looking forward to learning new processes and developing her research skills at BIOS CTCC.
Brittany Daley
Research Program Manager
Brittany Daley joined BIOS in October 2024 with over 10 years of experience. She began her research career at Brooke Army Medical Center in San Antonio, Texas working on studies that supported the advancement of military medical research within the field of trauma and pulmonary/critical care. She received a Bachelor of Science from Northern Arizona University in Public Health and a Master of Public Health from University of California Berkeley. She currently lives in Maine with her husband and two sons.
Molly Dellinger, CRA
Grants and Contracts Manager
Molly Dellinger joined BIOS CTCC in November 2021. She has a BS in biology from Penn State University and an associate’s degree in computer information technology. She has over 14 years of experience in research administration and received her certification as a research administrator in 2014. She oversees various pre- and post-award activities, monitors budgetary matters, and monitors sponsored and non-sponsored financial activities. She also provides guidance, assistance, and support as needed to the department faculty and staff.
Darcy DeVance
Senior Administrative Coordinator
Darcy DeVance joined the BIOS CTCC team in November 2021 and provides administrative support to Nichol McBee, Lindsay Eyzaguirre, and Andrew Mould. Prior to joining BIOS CTCC, Darcy worked at Aetna in Harrisburg, PA, where she supported an executive director and her team in provider data services and credentialing. Darcy brings with her over 25 years of administrative experience in the legal community and medical insurance field.
Sara Dolen
Sr. Grants & Contracts Analyst—Post-Award
Sara Dolen has a BS in exercise and sport science (EXSS) and a BA in international studies of EXSS from Oregon State University. She has been a Certified Clinical Research Professional since 2008. Sara worked in clinical research from 2000-2016, focusing on Alzheimer’s disease, TBI, PTSD, health promotion, and orthostatic hypotension. From 2017-2023, she was the grants and contracts accountant for a small non-profit working with the Veterans Health Administration in Portland, OR. She also led all pre-award activities from 2022-2023. She joined BIOS CTCC in 2024, where she focuses on all things finance for current grants and contracts.
Tracey Economas, LPN, CCRP
Research Program Manager
Tracey K. Economas is a research program manager with 15 years of research experience with BIOS CTCC. She began as a study coordinator, managing NIH- and industry-sponsored drug and device trials. She transitioned to a site startup specialist in the NIH-funded CLEAR III trial, for which she trained and initiated over 100 sites in the U.S. and internationally. She continued this role for the MISTIE III trial and transitioned into site management, working with U.S. and international sites, and also served as a safety event officer. Her primary role at the JHU TIC is managing site startup activities.
Joye Anne Gerald
Sr. Compliance Monitoring Specialist
Anne Gerald joined the BIOS Clinical Trials Coordinating Center at JHU in July 2022. She is responsible for preparing monitoring plans, monitoring the clinical data, and reporting on data findings for several clinical trials. She has vast clinical trial experience including monitoring all study visits, query resolution, training site staff, and mentoring coworkers. Her most recent experience includes remote study monitoring via site electronic medical records (EMRs), as well as on sponsor approved systems with uploaded source documentation for fast-paced COVID-19 clinical trials.
Shayne Gutzmore
Research Assistant
Shayne Gutzmore joined the BIOS CTCC team in July 2021. In his role at BIOS CTCC, Shayne provides support for TIC, TIN, and BIOS CTCC research projects in which the JHM IRB serves as the single IRB of record. He assists with the preparation of IRB protocols and the maintenance of project databases. Shayne also tracks agreements and execution statuses, uploads documents to online repositories, develops and maintains records of research activities, and assists with inquiries from study sites. Before joining the BIOS CTCC team, Shayne earned a Bachelor of Science in psychology and a Master of Research Administration from the University of Central Florida.
Kassondra Guzman
Clinical Research Site Manager
Kassondra joined BIOS CTCC in December 2023 as a research site navigator. She has a Bachelor of Science in health services administration with a minor in health information and informatics management from the University of Central Florida. Kassondra brings over 5 1/2 years of experience with federal grants and industry-sponsored trials. Her background includes program coordination, site selection through close-out, charging recruitment initiatives, as well as developing study-wide reports and procedures. Kassondra is excited to implement her knowledge at BIOS as a research site navigator.
Shannon Hillery
Accelerated Start-Up Unit Manager
Shannon Hillery came to BIOS CTCC in October 2017 as a Towson University graduate with a BS in psychology and experience conducting biopsychology research. Her responsibilities include project management and support as well as performance tracking across multiple multicenter trials. She also pilots and contributes to multiple systemic innovations and working groups. Shannon holds a leadership role in the Accelerated Site Start-Up management team for various multicenter clinical trials. She completed the Science of Clinical Investigation Training Program at JHU in May 2019.
Elizabeth Holthouse, PhD
Science Writer
Dr. Elizabeth Holthouse, who joined BIOS CTCC in October 2023, has a BS in biological sciences from North Carolina State University and a PhD in neuroscience from Virginia Commonwealth University. As a PhD candidate, she conducted research understanding mechanisms relating to the onset of multiple sclerosis. She has experience in grant production, manuscript writing, and scientific communication. She provides writing, editing, and design expertise for BIOS CTCC projects, including scientific manuscripts, grant applications, and recruitment materials.
Emily Honeycutt, MS
Statistical Programmer Analyst
Emily joined BIOS CTCC in March 2024. With a BS in computer science and MS in bioinformatics from North Carolina State University, she has a multidisciplinary background in statistics, life sciences, and software development. She has over 20 years of experience as a biostatistician and statistical programmer in both academic and clinical research organizations, working on observational studies, Phase I-IV clinical trials, and clinical registries. She is a statistical co-author on over 40 peer-reviewed manuscripts. She has worked in the clinical research areas of cardiology, pelvic floor disorders, contraception, diagnostic testing, and oncology. Her background positions her well to contribute to research at BIOS across a range of clinical areas. In her free time, Emily enjoys watching NC State University sporting events, playing pickleball, traveling with her husband, and spending time with their dog.
Sabrina Hounshell
Senior Grants and Contracts Analyst
Sabrina Hounshell joined the BIOS CTCC team in December 2023 and brings over 10 years of research administration experience including pre-award budget development and proposal compliance guidance, and post-award grant administration. She holds a master’s degree in public administration from Eastern Kentucky University. As part of the BIOS CTCC team, she provides high-quality, customer service-focused, and compliant research administration support for pre-award and post-award activities.
Komal Hunagund
Research Assistant
Komal Hunagund joined BIOS CTCC in May 2024. While working towards her BS in psychology at University of California, San Diego, she worked 1:1 with at-risk youth from various school districts throughout San Diego. After graduating, she gained clinical experience while working in healthcare as a youth advocate at Stars Behavioral Health Group, providing level 4 outpatient mental health services to young people throughout the county of Sacramento. In her current role as a research assistant, Komal provides specialized support to the consultation and grant production teams of the JHU TIC, TAP, and BIOS CTCC. She is eager to grow her career at BIOS CTCC and pursue an MS in biotechnology at Johns Hopkins University.
Bahiyyah Jackson
Research Services Navigator
Bahiyyah Jackson, who joined BIOS CTCC in July 2019, oversees research events for BIOS CTCC projects receiving single IRB and assists with the JHU TIC sIRB standard agreements services and project workflow between principal investigators, participating sites, IRB, and research administration. She has a colorful research background starting on the bench after receiving her bachelor’s degree and working every angle of the spectrum since. She has over 13 years of clinical research management experience. Prior to working at BIOS CTCC, she worked as a research specialist at the University of Maryland Department of Radiation Oncology spearheading the GammaPod project from draft to FDA clearance. She managed the radiation oncology medical device clinical trials, overseeing eight active studies and the department’s retrospective library (>200 studies). She also served as a research coordinator in the pediatric emergency department at the University of Maryland Medical Center, Children’s National Medical Center in Washington, DC, and Johns Hopkins Children’s Hospital with Dr. Jen Anders.
Kaley Kildahl, MRA
Research Site Navigator
Kaley Kildahl came to BIOS CTCC in March of 2023 as a University of Central Florida graduate with a Bachelor of Science in psychology and a Master of Research Administration. Her previous experience includes more than 8 years working as a site manager providing direct oversight of various central nervous system (CNS) investigational drug and device clinical trials. As part of the BIOS CTCC team, she provides site navigation services for multiple trials from site selection and accelerated start-up to enrollment and close out activities.
Ryan Majkowski
Data Manager and Regulatory Documentation Specialist
Ryan Majkowski joined BIOS CTCC in 2010 as a research program assistant and regulatory documentation monitor. Within both BIOS CTCC and the JHU TIC, he provides expertise in the development of the multicenter trial startup/execution team by creating regulatory document requirements, structures, and processes. A member of the BIOS CTCC data management team, he works to better standardize regulatory and site startup data metrics for analysis.
Savanah Maldonado
Research Assistant
Savanah Maldonado joined BIOS CTCC in March 2023 as a research assistant. She graduated from the University of Florida with bachelor’s degrees in psychology and sustainability studies. Her past experience includes project development, data collection, and teaching assistance. In her current role, Savanah provides research support for the REST trial and the BIOS CTCC DSMB unit by implementing project related procedures and tasks. She hopes to expand on her clinical research experience and further her education.
Raveena Munnangi
Clinical Research Monitor
Raveena Munnangi joined BIOS CTCC as a senior staff member in July 2024. She manages site and study progress by tracking regulatory submissions, recruitment, case report form completion, and data query resolution. She regularly schedules monitoring visits to assist staff in order to evaluate the quality and integrity of compliance when conducting research. Raveena graduated from Michigan State University with a degree in human biology and health promotions. She has numerous years of research experience working in all phases and several therapeutic areas of clinical research. Raveena is eager to grow her career at BIOS CTCC.
Allison Newell-Sturdivant, MSN
Site Navigator
Allison Newell-Sturdivant joined the BIOS CTCC team in November 2022. She has a BS in chemistry from Appalachian State University, a Postbaccalaureate Certificate in biochemistry from Virginia Commonwealth University, and both a BSN and an MSN-Nurse Administrator from Queens University of Charlotte. Her previous experience includes more than 10 years as an RN with experience at the bedside and as a clinical research nurse. She has worked in the academic setting on multiple clinical trials focused on neurodegenerative diseases and neurosciences, most recently managing site-based operations. She provides site navigation services for multiple BIOS CTCC trials from site selection and accelerated start-up to enrollment and close out activities.
Jamilyn Nimo
Research Assistant
Jamilyn joined BIOS Clinical Trials Coordinating Center in March of 2022. In her role at BIOS CTCC, Jamilyn participates in project-related meetings to develop and implement necessary quality control procedures for the PENS, RAFT, and REASSESS ICH trials. She also holds a role in the DSMB unit, among various other responsibilities. Prior to joining the BIOS CTCC team, Jamilyn received her Bachelor of Science in psychology and Bachelor of Arts in political science at Pennsylvania State University. Through her research experience, she hopes to gain additional knowledge and plans to further her education at Johns Hopkins University.
Noeleen Ostapkovich, MS
Project and QA Manager
Noeleen Ostapkovich has 40 years of experience as a research coordinator, research manager, and regulatory specialist for neuroanesthesia and neurocritical care research. She began working with the CLEAR projects in 2000 and came to Johns Hopkins as a member of the BIOS CTCC team in 2012.
Craig Ou, MS
Biostatistician
Craig Ou graduated with a master’s degree in biostatistics. His experience includes statistical analysis and statistical programming, such as SAS, R, and Python with experience in conducting research. Mr. Ou supports BIOS CTCC projects by providing statistical analyses, statistical designs as well as statistical programming for various projects.
Cecilia Pessoa Gingerich
Communications Associate
Cecilia Pessoa Gingerich joined BIOS CTCC in April 2020. She graduated from Amherst College with a BA in geology. Cecilia previously worked in healthcare journalism—reporting on research results and regulatory decisions—and in nonprofit communications. Her experience includes writing and editing, managing websites and social media accounts, tracking communications-related metrics, video editing, and creating written and visual content for a variety of channels. Cecilia supports BIOS CTCC projects by providing communications services for the internal needs of multisite clinical trial teams as well as for participant recruitment and retention efforts.
Shaquetta Phillips
Navigator Program Coordinator
Shaquetta Phillips, who joined the BIOS CTCC team in March 2018, supports and coordinates meetings for projects assigned to the JHU TIC and for the Trial Advisor Program (TAP) that are approved for initial consultations. She also provides department human resources support, administrative support for leadership, and meeting coordination for inquiries for services/resources from BIOS CTCC. Ms. Phillips has a BA in human resources management from Temple University and hopes to pursue her MBA.
Malathi Ram
Associate Scientist
Malathi Ram has worked on several international collaborative research studies in India, Ghana, Peru, Guatemala, South Africa, Brazil, Bangladesh, and Cameroon and has provided training to in-country personnel in data management processes. She has over 30 years of experience in all aspects of data management, such as developing study instruments, developing and updating standard operating procedures, developing data entry screens, developing error-detection programs, ensuring data quality, and performing data analyses. She has worked with the BIOS CTCC team since 2013 providing support in data management, data quality assurance, developing standard operating procedures, and serving as a liaison between JHU statisticians and Utah statisticians for the HEAL studies.
Meghana Rao, MPH
Research Data Manager
Meghana Rao joined BIOS CTCC in December 2022. Her research experience encompasses a variety of roles such as study coordination, data management, and statistical analysis. Within BIOS CTCC, she is responsible for overseeing all aspects of data management activities and serves as a primary contact for multi-center study staff. Specifically, she oversees and provides data management support for CRF and database development, data collection, and data quality control. Additionally, produces reports showcasing study performance and quality assurance. She has a Master of Public Health with a focus on biostatistics from the University of Oklahoma Health Sciences Center and Bachelor of Science in biology from the University of Tulsa.
Paul Ryu
Clinical Data Programmer Analyst
Since joining BIOS CTCC in November 2019, Paul Ryu has become a part of the Brain Injury Outcomes NeuroImaging Center (BIONIC). He has been responsible for exportation and verification processes of multiclass segmentation of hemorrhages from the CLEAR and MISTIE studies for a machine-learning-based project as well as assisting with BIONIC’s role in the AVERT clinical trial. With a BA in chemistry from Goucher College, he seeks to gain more experience in research at BIOS CTCC and pursue further education at Johns Hopkins.
Kaneel Senevirathne, MS
Senior Programmer Analyst
Kaneel Senevirathne joined BIOS CTCC in April 2022 after earning his MS in biomedical engineering from the University of Delaware. He is a part of the Brain Injury Outcomes Neuroimaging Center (BIONIC) and the programming core at BIOS CTCC. He is mainly responsible for developing/deploying machine learning segmentation algorithms, developing algorithms to automate BIONIC workflows, and investigating methods to migrate clinical trial workflows to Google cloud platform. He aspires to gain more experience at BIOS CTCC and further his education.
Kevin Treine
Project Manager
Kevin Treine is a research program manager with 20 years of research experience with the Johns Hopkins University. His expertise is in management, monitoring, and ensuring compliance with FDA regulations when working with primary investigators conducting clinical trials. He also has experience coordinating NIH-funded and industry-sponsored research projects. His primary role at BIOS CTCC is to serve as program manager for research studies from start to finish. He coordinates research-related tasks between investigators, research staff, and medical experts to ensure compliance training for human subjects research.
Pranshu Trivedi, MPH
Statistical Programmer Analyst
Pranshu Trivedi graduated with a MPH from Boston University in May 2023 and joined BIOS CTCC in August 2023. He supports the REACT-AF, BEACH, and RAFT studies as statistical programmer analyst. He is proficient in SAS, SQL, and R. In his free time, Pranshu loves playing chess and soccer.
Nathan Walborn
Senior Research Assistant
Nathan Walborn joined the Brain Injury Outcomes NeuroImaging Center (BIONIC) in December 2019. His primary responsibilities involve qualitative and volumetric calculations of brain hemorrhages, as well as perihematomal edema segmentation for the CLEAR and MISTIE clinical trials. He also assists in the progress of the AVERT clinical trial. Nathan received his BS in neuroscience from the Pennsylvania State University and has conducted research in psychology and linguistics. He has aspirations of furthering his education through Johns Hopkins University and hopes to earn a PhD in cognitive science.
Shannon Watson, MHSA
Research Navigator
Shannon Watson has over 5 years of clinical research experience and has served in various roles in the clinical trial implementation process. She began her research career in her hometown of New Orleans, Louisiana, working on community-based epidemiological research with underserved and historically neglected populations. Prior to joining BIOS CTCC, she also worked at the Kennedy Krieger Institute as a liaison between study sponsors, principal investigators, and research participants. She received a Bachelor of Science from Tulane University in public health & tropical medicine, and a Master of Science in health systems administration from Georgetown University.
Cailin Whisler Brady, MPH
Research Program Manager
Cailin Whisler Brady joined the BIOS CTCC team in May of 2022 as a site navigator. She currently serves as a research program manager for TIC multicenter trials. As a site navigator, she provided site navigation services for multiple BIOS CTCC trials from site selection and accelerated start-up to enrollment and close out activities. She has a BA in psychology from Northwestern University and an MPH focused on community health research from the Feinberg School of Medicine. Her previous experience includes more than 5 years working in both academic and industry settings as a clinical research coordinator on investigational drug and device trials, primarily in the therapeutic areas of cardiology and COVID-19 immunotherapy.
Esther Woo
Research Assistant
Esther Woo joined BIOS CTCC in February of 2023. While earning a BS in biology at Georgia Institute of Technology, she gained research and data analysis experience through independent ecological lab work. Prior to joining BIOS CTCC, she provided technical support for electronic medical record (EMR) software for several hospital systems across the Midwest. She now provides project support for the REACT-AF trial and RA support for the consultation/grant production teams of the JHU TIC, TAP, and BIOS CTCC. She also leads training for new research assistants.
Liesa Wyman
Project Specialist
Liesa Wyman joined BIOS CTCC in October of 2022 and is a member of the administrative team. She holds a BS in business from West Chester University and brings over 25 years of administrative and management experience in higher education, healthcare, and community arts.
Anusha Yarava, PharmD, MPH
IDS-Pharmacist Manager / Biostatistician
Dr. Anusha Yarava joined BIOS CTCC as IDS-pharmacist manager/biostatistician in November 2020. Dr. Yarava graduated with a Doctor of Pharmacy degree from Kakatiya University, India, and previously worked in a hospital pharmacy setting as a clinical research pharmacist. Her experience includes delivering investigational drug service for clinical trials and regulatory documentation. In addition to her pharmacy degree, Dr. Yarava has a Master of Public Health, with a biostatistics major, and she has previously worked with various statistical models such as survival analysis, longitudinal data modeling, and regressional analysis of the retrospective data CDC-BRFSS, NHANS, and MEPS databases. Dr. Yarava supports BIOS CTCC projects by running the plasma inventory management, assisting with regulatory documentation, providing pharmacological and clinical expertise, and sharing her statistical knowledge for the design and analysis of projects.
Taylor Young
Research Assistant
Taylor Young joined the BIOS CTCC team in July 2024. She has a BA in Cognitive Science and Spanish from Johns Hopkins University and a diverse professional background with experience in publishing, policy research, and scientific research. These varying past roles have allowed her to develop particular skills within communications and data management, and she hopes to expand and refine her skillset with this present role. Currently as a research assistant, she provides support for the consultation and grant production teams of the JHU TIC, TAP, and BIOS CTCC.
Wen Da (Vincent) Zhan
Research Assistant—Data Core
Wen Da (Vincent) Zhan joined BIOS CTCC in March 2022 as a research assistant—data core, after graduating from the University of Maryland, College Park, studying psychology and neuroscience. Vincent’s research responsibilities include working with a wide variety of administrative, regulatory, and analytical data tasks (BEACH, RAFT, MAP, REASSESS ICH), in addition to supporting active clinical trials in non-data roles (Kids MoD PAH, BEACH). He has prior research interests in neuroscience, neuro-electrography, and clinical trial research design, and is looking to pursue a Master of Public Health at Hopkins.