Few, if any, institutions have comprehensive strengths in all areas of translational research. Therefore, 7 CTSA hubs (MUSC, Duke, UNC, Children’s National, U Florida, Virginia Commonwealth and Emory) have committed to provide reciprocal externship opportunities for KL2 scholars. The table below lists training and mentoring opportunities in areas of strength at each participating CTSA that are available to KL2 scholars at other CTSAs. The KL2 directors will help find training opportunities for KL2 scholars from any of our centers who may be interested in an area that is not yet available at any of our centers.
Externship Opportunities at the Medical University of South Carolina
There are other externship opportunities available. The table shows representative programs but many more are available to KL2 scholars.
Medical University of South Carolina SCTR Institute
PI: Marc Chimowitz
Contact: Diana Lee-Chavarria
- Clinical trials design and implementation
- Biomedical Imaging
- Medical informatics
- Therapeutics Translation
- Health Technology Solutions (eg. Mobile Apps)
Clinical Trials Design & Implementation
To meet the needs of investigators on the MUSC campus who are planning multicenter trials and to serve as a resource for investigators with similar interests at other CTSAs who may not have access to experienced clinical trialists, SCTR is developing a Clinical Trials Design Center (CTDC) led by Drs. Chimowitz and Palesch. Drs. Chimowitz and Palesch and CTDC staff will meet with investigators to help design trials and consult on statistics and data management. Additionally, Drs. Chimowitz and Palesch and SCTR staff will advise investigators on how to navigate the agencies involved (e.g., NIH, CMS, FDA), interact with industry partners, and prepare the trial budget. These activities will provide a unique opportunity for KL2 scholars and other K awardees at MUSC and other CTSAs to participate in a 1-3 month elective that would include attending the meetings between investigators planning trials and CTDC personnel helping them design the trials, as well as operations committee meetings led by Drs. Chimowitz and Palesch in ongoing NIH-funded trials that they lead. This real-life exposure will provide unique hands-on experience regarding various aspects of clinical trial design including adaptive vs. conventional designs, choosing appropriate primary endpoints, deciding on a clinically meaningful effect size, minimizing various forms of bias (selection, performance, detection, attrition, reporting), recruitment challenges, site performance and monitoring, data completeness and quality, and clinical trial leadership.
MUSC has made significant investments to develop the MUSC Center for Biomedical Imaging, which provides state-of-the-art resources to support clinical and research activities, disseminate new technologies and approaches, and train and mentor early stage investigators, including KL2 Scholars, in developing and applying biomedical imaging to clinical and translational science problems.
The Center for Biomedical Imaging is actively conducting research with teams of investigators in several departments (Neurosciences, Psychiatry, Radiology, Rehabilitation, Cardiology, Pediatrics, Surgery, Oncology). KL2 scholars with an interest in developing and refining imaging techniques for their research projects will have ample opportunities for externships.
Health Sciences of South Carolina (HSSC) is SCTR’s primary partner, sharing in the leadership and governance of SCTR and ensuring statewide reach in SCTR initiatives. HSSC goals are to expand biomedical research infrastructure, foster economic growth, and improve health and Health care through statewide integration. HSSC hosts a CDW externship for KL2 Scholars.
The South Carolina Efficient & Effective Delivery of Care Externship is another new training opportunity, providing KL2 scholars with an option to work with established industry and state partners (e.g., Blue Cross Blue Shield of SC, SelectHealth, SC Office of Research & Statistics) for health systems research training utilizing payer databases that assess efficient and effective delivery of prevention and care strategies. Primary topics and methodologies include outcomes assessment (utilization, functional status), process engineering and informatics, payment reform analyses, and system re-design.
The Therapeutics Translation Program is unique at MUSC in its ability to provide on-campus industry experience for faculty, staff and students. Under co-discovery partnership agreements, pharmaceutical companies support industry-directed research in labs on campus. An example of this is in the laboratory of Dr. Carol Feghali-Bostwick, Profesor of Medicine at MUSC, who currently supports multiple junior faculty and postdoctoral fellows with funding from industry partners, including GlaxoSmithKline, Biogen and iBio. KL2 scholars have externship opportunities with industry through these “co-discovery partnership agreements.”
Health Technology Solutions
Scholars have opportunities to participate in telehealth-focused research through the MUSC Center for Telehealth and through research on mobile technologies to improve study recruitment efforts.
Clinical & Translational Science Institute at Children’s NationalPI: Naomi L.C. Luban, M.D.
Contact: Amanda Kasper, MPH
- Diseases/disorders of infancy/childhood that impact adult health
- Neurosciences, including imaging
- Health policy
- Device development and innovation
- Genomics/metabolomics of rare diseases
Diseases/Disorders of Infancy/Childhood that Impact Adult Health – Center for Translational Science
To foster broad collaborative investigation that accelerates discovery across the continuum of the bench, the bedside, and the community. To accomplish its mission, the Center emphasizes: Studies on molecular pathogenesis; Development and validation of experimental therapeutics; Outcome-oriented patient research; Novel, innovative projects and product development; Collaboration within the research community and between researchers and the larger community; Service to communities of diverse populations.
- Patient Oriented Research
- Behavioral and Community Research
- Molecular Pathogenesis and Experimental Therapeutics
- Health Services Research to Improve Health care for Children and Adolescents
- Improving Disparities in Health and Health care
- Federally Funded Consortia
Neurosciences, Including Imaging – Center for Neuroscience Research
The Center for Neuroscience Research comprises an expanding group of highly productive lab-based developmental neuroscientists and clinical investigators who have established strong research programs and collaborations in the area of neurodevelopmental disorders. While these investigators have distinct expertise and research programs, their research as a whole is focused on childhood neurological disorders, from early stages of when the nervous system is first established, to postnatal stages that include the formation of neuronal connections and the wrapping of neuronal processes by the myelin insulator. The unique and exciting setting of the center has supported and promoted a large number of research projects that span basic, translational and clinical research in neurodevelopmental disorders.
The Advanced Pediatric Brain Imaging Research Laboratory is housed in the department of Diagnostic Imaging and Radiology and affiliated with the Fetal and Transitional Medicine Program at Children’s National Health System. Our research focuses on the developing brain, both in utero and in the newborn stages of life. We are developing advanced MRI (magnetic resonance imaging) techniques to examine the structure, connectivity, and metabolism of the brain in ways that cannot be done with conventional MRI studies. It is our long-term goal to be able to identify babies with impaired brain growth as soon as possible, so that the proper interventions and clinical planning can take place.
Health Policy – GW Department of Health Policy & Management
The mission of the Department of Health Policy and Management—a practice-oriented academic community in Washington, DC—is to improve health and health systems locally, nationally, and globally through: excellence in education, innovative scholarship and applied research that is translated into practice and policy, and the promotion of transformational leadership that advances health policy and health services management.
Device Development & Innovation – Sheikh Zayed Institute for Pediatric Surgical Innovation
The mission of the Sheikh Zayed Institute for Pediatric Surgical Innovation (SZI) is to make pediatric surgery more precise, less invasive, and pain free. In its very short existence, the Institute lists among many achievements creating a strong infrastructure for R&D and a network of product and medical device development experts, and seasoned veterans in venture capital, technology commercialization, and intellectual property. The institute is process-driven and outcome-focused. It is comprised of multi-disciplinary teams that apply rigorous process management from conception to marketed product through creative partnerships in academia and industry. The Institute was founded with four major clinical themes to transform pediatric surgical innovation and intervention.
These are in:
- Pediatric pain and anesthesia
- Systems biology
Genomics/Metabolomics of Rare Diseases – Center for Genetic Medicine Research
Focusing on common health problems in Washington, DC, as well as serving as an international referral site for rare disorders, faculty and their laboratories are encouraged to be collaborative, and many of the Center’s projects bring together multiple clinical and scientific disciplines. The Center strives to provide faculty easy access to the latest technologies in genomics, proteomics, microscopy, bioinformatics, pre-clinical (murine) drug trials, and multi-site clinical trial networks. The Center provides services in these technologies to laboratories throughout the District, and internationally, through a series of NIH Core grants. Drug development and experimental therapeutics has increasingly become the focus, resulting in a technology transfer to an early-stage biopharmaceutical company, ReveraGen BioPharma, Inc.
We use data from interdisciplinary studies of molecules and pathways to create interactive physiological models of human health and disease that provide novel insights about potential strategies for disease prevention and treatment.
Duke University Clinical & Translational Science Award
PI: Laura Svetkey, M.D.
Contact: Stephanie Molner
- Multi-center clinical trials coordination
- Human systems biology studies
- TL1 Translational Research
- Community-based research
- Minority health and health disparities
Duke is proud to offer several exchange programs for KL2 scholars from other CTSA institutions. Duke has a number of unique opportunities that will give scholars experience in research activities that will supplement their experience at their home institution. Each of the exchange programs will be overseen by a pre-identified faculty member who will serve as a “host” for the scholar. Specific opportunities include:
Coordinating Multi Center Clinical Trials - Duke Clinical Research Institute (DCRI)
Serving as a clinical trial coordinating center requires substantially different infrastructure and activities than enrolling research participants into clinical research locally. In this exchange program opportunity, scholars will learn about the scientific and operational aspects of managing large multi-center clinical trials by spending time at the DCRI(link is external), which, at any given time is coordinating approximately 60 multi-center clinical trials around the world. Scholars will shadow investigators and project leaders, participate in study team meetings, attend meetings or conference calls with sponsors (both industry and NIH), and observe the creation of multi-million dollar study budgets and operational plans.
Conducting Human Systems Biology Studies – Duke Clinical Research Unit (DCRU)
In this exchange program, scholars will shadow investigators and project leaders conducting first in human, proof-of-concept research. Scholars will observe sponsor meetings, the start up process, translating study protocols into orders, management of the research portfolio, and study-specific procedures with research volunteers. The DCRU is a 30-bed state-of-the-art facility with six well equipped examination rooms, a metabolic kitchen, and processing laboratory.
Managing T1 Translational Research – Duke Translational Research Institute (DTRI)
Overcoming the Valley of Death is difficult, but with specific management strategies and technical knowledge, the steps to bring a new discovery to the point of first-in-human testing can be managed. In the DTRI exchange program, scholars will spend time with the investigators, project managers, regulatory staff, and commercialization experts involved in T1 research at Duke. Scholars will participate in team meetings, observing the creation of strategic management plans to move new technologies along the pipeline.
Practicing Community-Based Research
Scholars in this exchange program will observe the Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) study. Set in a small town in rural North Carolina, the MURDOCK study is a 50,000 participant, longitudinal health study working to reclassify health and disease. Scholars will spend one week in Kannapolis, participating in recruitment events, meeting with local health care providers, observing volunteers enrolling in the study, and meeting with investigators who are conducting analyses from the study data.
Research in Minority Health & Health Disparities: Racial and ethnic disparities in health and Health care are widely documented across a range of diseases and care settings. In this externship, scholars will pair with a senior investigator conducting health disparities research based on their interest in a specific discipline, (medicine, OB/GYN, psychiatry, surgery), focus on the translational spectrum (T1 to T4) , or research methodology (observational research, RCT, etc.). Scholars will attend meetings of studies in progress, interact with study staff, and receive specific feedback on their own project in progress or development.
In addition to the externship, scholars at institutions in the consortium will have the opportunity to access the Duke CTSA KL2 Health Disparities Research Curriculum. The goals of the curriculum are to increase knowledge among KL2 Scholars about the impact of racial and ethnic health disparities and to develop the skills needed to conduct research in minority health and health disparities. The curriculum content will be available on-line for interested scholars. Each module will include a didactic session and small group activity.
The North Carolina Translational & Clinical Sciences Institute
PI: Morris Weinberger, Ph.D.
Contact: Susan Pusek
- Comparative effectiveness research
- Biostatistics methodologies
- Practice-based research networks
- Community Engagement
- Rare disease registries (with Research Triangle Institute)
Comparative Effectiveness Research (CER): CER is a major initiative for UNC. Externships may be established through UNC Centers, for example, the Sheps Center for Health Services Research (Director: Tim Carey; Sheps Center) and the Center for Pharmacoepidemiology (Director: Til Sturmer; (Pharmacoepi). In addition, externships can be established with individual investigators from the Schools of Medicine, Pharmacy, and Public Health.
Biostatistics Methodologies: Biostatistical methodology for addressing pressing issues and ensuring reproducible and replicable research in the biomedical and public health sciences, is a recognized strength and high priority of the Department of Biostatistics (Chair: Michael Kosorok; Biostatistics ) and the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. Areas of expertise include general biostatistics, clinical trials, precision medicine and machine learning, design and analysis of observational and laboratory studies, causal inference, survey sampling, survival analysis, longitudinal data, missing data, Big Data, Bayesian methods, and many other areas.
Practice Based Research Networks (PBRN): PBRNs are organizations that partner research investigators with clinical practices to answer questions central to pediatric, adolescent, and adult primary care. The North Carolina Network Consortium (NCNC - see www.ncnc.unc.edu), housed at the Cecil G Sheps Center for Health Services Research, includes investigators and practices associated with Duke University, the Carolinas Medical Center, East Carolina University as well as UNC Chapel Hill. Externships can be established with our lead UNC Chapel Hill PBRN investigators: Jacqueline Halladay, Katrina Donahue, and Tamera Coyne-Beasley.
Rare Disease Registries: Patient and Caregiver Outcomes in Rare Disease (PCORD) is an RTI-based UNC CTSA resource. PCORD helps investigators develop registries and surveys to collect data on patient and caregiver outcomes in rare diseases. Externships may be established with investigators from the UNC Schools of Medicine or Public Health.
Community Engagement: UNC provides technical support to enhance community engagement throughout all phases of translational research from planning through dissemination. Externships can be adapted around existing research projects which meaningfully engage appropriate stakeholders such as patients, Health care providers, primary care practices, English- and Spanish-speaking community members, and community advisory boards (NC TraCS CARES). Externships can also be established with individual investigators from the Schools of Medicine, Public Health, Nursing, and Pharmacy.
University of Florida Clinical & Translational Science Institute
PI: Thomas Pearson, M.D., Ph.D.
Contact: Maria Gavidia
- Neuromuscular disease
- Type 1 Diabetes
- Pain research and therapeutics
- Pharmacodynamic modeling
The University has recently organized a multidisciplinary Diabetes Institute drawing upon the participation of more than 100 faculty, conducting both basic research to clarify the mechanisms causing diabetes and translational research to transform their research findings into clinical solutions. Multiple collaborations especially focus on the etiology and pathogenesis of Type I diabetes including development of therapeutic trials.
The UF Southeast Center for Integrated Metabolomics is supported by one of five national awards to create a national metabolomics consortium to promote the development of analytical methods and applications for diagnosis and monitoring of human conditions. The program has close collaborations with the UF Department of Chemistry, the Sanford Burnham Prebys Research Institute, and several universities in the Southeast U.S.
The UF Pain Research and Intervention Center of Excellence (PRICE) is a multidisciplinary center including investigators from Medicine, Nursing, Pharmacy, and Dentistry examining the neurophysiology and genetics of pain as well as novel therapeutic approaches. Mechanisms of pain studied include inflammatory processes and their potential influence on pain-related brain structure and function.
Virginia Commonwealth UniversityPI: Arun Sanyal, MBBS, M.D.
Contact: Teraya Donaldson
- Responsible conduct of research and research ethics
- Repurposing Medicinal Compounds
- Regulatory Sciences
- Transparency in science
Lipidomics/ Metabolic Studies:
The Lipidomic/ Metabolic research group at VCU is focused on the understanding, early diagnosis, and evidence-based treatment of critical illness and injury. To this end, the group utilizes a complete qualitative and quantitative analytical workflow investigating the changes to the lipidome/ metabolome with respect to various disease states. Scholars will have the opportunity to take part in discovery of preclinical biomarkers that will serve as molecular guideposts to direct protocolized medical interventions.
Traumatic Brain Injury:
Traumatic brain injury (TBI) research and clinical services in the VCU Department of Physical Medicine &Rehabilitation have been aimed at better understanding the mechanisms underlying damage to the brain and factors influencing short and long-term durable recovery. We have extensive clinical and research experience relating to civilian, veteran, and military populations. For example, we are national leaders in the longitudinal study of military service members and veterans from the Iraq and Afghanistan conflicts with a large ongoing set of data being collected on multiple parameters of health and disability. We have recently completed a major study examining the efficacy of hyperbaric pressure on TBI outcome with several journal publications reporting out results.
We are an important player in three large multi-institutional clinical research networks recently established to study TBI; i.e. the Chronic Effects of Neurotrauma Consortium (CENC), the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) Program, and the TBI Endpoints Development (TED) Program. While these three consortia have non-overlapping aims, they do share goals and priorities related to better understanding the biology and consequences TBI as well as optimizing treatment. As part of the TED Program, we help collect a broad range of long-term data from existing studies and databases for integration into a dataset that can be interrogated for TBI associations and causes in such a way that has never before been possible. The hope of the TED Program is to determine better methods for selecting patients for clinical trials and improve measures of patient outcomes that together may lead to the identification of effective TBI treatments.
Thus, participants in the Externship would be able to conduct disability and rehabilitation research with a collaborative group from a variety of scientific disciplines. Areas of research can include; Veterans, active duty service members, athletes, employment, health disparities, human performance, musculoskeletal and pain, pediatric, engineering, and family involvement.
Research focuses on studying the neurobiology of addiction using Magnetic Resonance Imaging (MRI) as a tool for medication development. Imaging methods used include functional MRI (fMRI), Diffusion Tensor Imaging (DTI), and functional and effective connectivity imaging. This imaging work combines human behavior laboratory research and clinical trials in patients with addictions or other conditions where impulsivity plays a role. These projects are in collaboration with VCU Departments of Physical Medicine and Rehabilitation, Psychiatry, and Pharmacology and Toxicology.
Opportunities in Regulatory Sciences at the HIV-Forum & the Liver-Forum
To build workforce capacity by training clinician-scientists who already have content expertise in various bio-medical fields to gain experience and expertise in regulatory sciences to develop new paradigms applications relevant biomarker and surrogate marker development. The program will be of interest to individuals interested in careers with regulatory agencies, pharma, biotech and/or diagnostic industry, or health policy. The ultimate goal is to accelerate drug development and to bring safe and effective therapies to patients who need such therapies.
Nature of Training Opportunities:
- Participation in meetings of the HIV-Forum, HCV Drug Development Advisory Group, CMV in transplantation, HBV Therapeutic and Curative Strategies, Liver Forum. A wide range of topics such as the HIV cure initiative, NASH and Metabolic Syndrome to evaluation of drug toxicities are currently being worked on.
- Working on background data generation and reports to support the evidentiary burden required to accept and validate endpoints and definitions related to various conditions.
- Learn the regulatory science and requirements for validation of definitions, study designs and endpoints to approve various diagnostic and therapeutic strategies.
- Participate in working groups that are developing new paradigms in study designs and validation of various methods to accelerate therapeutic development.
- Interact with regulatory agencies to learn regulatory pathways and guidances as well as mechanisms to accept new paradigms for therapeutic development.
- Work in a multi-stakeholder setting to learn ways to integrate changes in clinical practice and methods of care-delivery to development processes to develop new paradigms in drug development.
- Participate in educational seminars and activities at the Forum in the University of California Campus in Washington, D.C.
Externships in Responsible Conduct of Research Training
Virginia Commonwealth University has been a national leader in the field of responsible conduct of research (RCR) education. A cohort of VCU faculty have created a university-wide platform for the delivery of RCR instruction to M.D.-Ph.D. students, graduate students, residents and fellows, faculty, and undergraduates. They have also been involved in offering train-the-trainer workshops in RCR instruction at VCU and at numerous other institutions such as Hampton University, Meharry Medical College, and Virginia Union University.
VCU faculty colleagues, coupled with VCU’s year-around offerings of 1 credit hour RCR courses, offer a variety of opportunities for visiting externs to explore teaching methods, content building, case development, and train-the-trainer methods. The availability of RCR course offerings and the instructional faculty at VCU provide flexibility in both timing and duration of externships that can offer a variety of opportunities for externs. These can be customized to address the objectives of interested externs in response to their level of prior experience.
- Opportunities include the following:
- Turnkey training in RCR course building, aimed at any level trainee, involving courses that meet the NIH expectations in terms of content, duration, and format.
- Mentoring in delivering train-the-trainer workshops aimed at recruiting and preparing RCR instructors at the externs’ institutions.
- Writing and testing of discipline-specific short case studies for use in small group discussions.
- Writing and development of complex case studies that progressively include multiple topic areas built around a common foundational scenario.
- Development and testing of interactive classroom tools including survey instruments in RCR topic areas, the results of which can be used to catalyze class discussion.
- Study and evaluation of resources that can be housed centrally at institutions to promote a culture of RCR; e.g., tools for quality control relative to reporting research findings, programs for monitoring of pre-published material including evaluating self-plagiarism and digital image manipulation.
Externs will hold copyright on any materials they develop during the course of their study at VCU, and we will freely share any materials we have developed for their use in instruction at their home institutions.
Community Engaged Research: The VCU community engaged research core is dedicated to connecting communities and researchers in an effort to improve community health and wellbeing. Activities focus on providing the infrastructure to broadly support the engagement of a diverse set of multidisciplinary and community stakeholders, developing and disseminating advanced methods to conduct community engaged research ad team science, promoting collaboration beyond traditional groups of homogeneous clinical scientists into diverse teams, and training the community engaged and team science workforce. Scholars can gain experifence working with residential communities in Richmond and Virginia or in the primary care practice based research network distributed throughout the state.
Atlanta Clinical & Translational Science Institute
PI: David Stephens, M.D.
Contact: Cheryl Sroka
- Externships with biotechnology companies
- Drug Discovery
- Metabolomics & Hercules Expansome Research Center
- Community Engagement and Health Disparities Research
Diana Lee-Chavarria, MA
Workforce Training and Development Manager