CTSA Services

The CTSA Administrative Core provides oversight, leadership, integration, and coordination for all Duke CTSA programs and activities. This Core acts as a central collaborative platform to catalyze discoveries across Duke’s academic health center and entire University campus. It is directly integrated into the central administrative structure of the broader CTSI, facilitating full alignment of both NCATS and Duke's clinical and translational science objectives.

Core Aims

Aim 1. Facilitate nimble and responsive CTSA leadership.

Aim 2. Implement and evaluate programs, and then disseminate best practices.

Aim 3. Improve the quality and efficiency of clinical and translational studies.

Major Activities

• Provide tiered governance and collaborative leadership

• Administer, coordinate, and facilitate Duke CTSA activities and communication at the local, regional, and national levels

• Foster diverse voices and respond to stakeholder needs

• Apply a structured program quality improvement framework

• Study practices and provide evidence for sustained implementation

• Disseminate best practices within Duke and beyond

• Improve investigators’ awareness of programs facilitating high quality studies

• Facilitate rigorous study planning and monitor study quality

• Further decrease administrative inefficiencies

Leadership

Housed in the Department of Biostatistics and Bioinformatics (B&B) and the CTSI, BERD helps investigators identify quantitative/qualitative collaborators. As appropriate, they connect investigators with quantitative and qualitative partners across Duke and partner institutions. When there are not sufficient collaboration resources available, BERD builds and house teams of collaborative methodologists who work on long term collaborations with clinical and translational investigators.

David Page, PhD
Co-Director, Biostatistics, Epidemiology, and Research Design
Professor and Chair, Biostatistics & Bioinformatics
david.page@duke.edu

Gina-Maria Pomann 
Co-Director, Biostatistics, Epidemiology, and Research Design
Associate Professor in Biostatistics & Bioinformatics
gina-maria.pomann@duke.edu

Grounded in a health equity perspective, CERI seeks to improve relevance and uptake of scientific discoveries through stakeholder engagement. Programs and services promote community-engaged research through cultivating meaningful and equitable research-community stakeholder partnerships, enhancing capacity to conduct stakeholder-engaged research, and fostering trust and transparency in research via improved knowledge, information sharing, and power sharing.

Julius Wilder 
Director, Community Engaged Research Initiative
Department of Medicine
julius.wilder@duke.edu

Supports the development of novel methods and proof-of-concept evaluation of therapeutic agents, biomedical devices, diagnostic tests, and technologies. The goal is to transform translational research by promoting basic and clinical investigator collaboration, offering funding, providing project management support and technical knowledge, and facilitating access to resources and expertise within and outside Duke University.

Jennifer Li, MD
Co-Director, Pilots Program

James McNamara, Sr., MD
Co-Director, Pilots Program

Vonda Rodriguez
Duke CTSI
vonda.rodriguez@duke.edu

Eman Ghanem
Duke CTSI
eman.ghanem@duke.edu

Provides a basis for data science discovery and engineering of translational biomedical informatics applications. Aims are to form and fund teams to address new health data science questions through an incubator program; develop new data science methods and informatics applications and implement and disseminate data science tools.

Michael Pencina
Director, Data Science Core
Duke Biostatistics & Bioinformatics
Vice Dean for Data Science and Information Technology
michal.pencina@duke.edu

Shelley Rusincovitch
shelley.rusincovitch@duke.edu

Provides infrastructure support for research teams and CTSA Cores to promote equity, anti-bias, and anti-racism across all aspects of the research process and environment. Services include curriculum development and training, consultations to support the development of intentional and strategic diversity recruitment plans, and resources and tools to promote an anti-racist and anti-bias research environment.

Keisha Bentley-Edwards, PhD
Director, Equity in Research (EIR) Core
Department of Medicine, Duke Cancer Institute, Duke Global Health Institute
keisha.bentley.edwards@duke.edu

Dane Whicker, PhD
Director, Equity in Research (EIR) Core
Psychiatry and Behavioral Sciences
dane.whicker@duke.edu

As part of the CTSA Administration core, Evaluation and Continuous Quality Improvement applies principles of continuous quality improvement and evidence-based decision-making throughout and across CTSA functions. Evaluation and Continuous Quality Improvement aims to advance CTSA opportunities for organizational learning and understanding of impact. The primary focus is on the Duke hub but Evaluation and Continuous Quality Improvement also contributes to CTSA nationally, including participation in the CLIC-CTSA Program Evaluators Group.

Joe McClernon
Director, Evaluation & Strategic Planning Core
francis.mcclernon@duke.edu

Jessica Sperling
Co-Director, Evaluation & Strategic Planning Core
jessica.sperling@duke.edu

Focuses on innovative approaches that accelerate and transform scientific discoveries through data and applications that fuel translational research, data science and precision health; expand capacity for conducting collaborative network research and sharing network best practices; and provide access to opportunities for informatics training and professional development.

Rishikesan Kamaleswaran, PhD. MS
Director, Informatics

1. Provides junior faculty scholars with fundamental transdisciplinary research skills required for successful translational research careers

2. Prepares junior faculty scholars to successfully employ fundamental team science approaches to enable innovation and impact

3. Promotes a highly diverse translational research workforce.

Laura Svetkey
Director, KL2 Core
Department of Medicine
laura.svetkey@duke.edu

Kimberly Johnson
Director, KL2 Core
Department of Medicine, Geriatrics
kimberly.s.johnson@duke.edu

Rasheed Gbadegesin
Director, KL2 Core
Department of Medicine, Pediatrics
rasheed.gbadegesin@duke.edu

Stephanie Molner
Duke CTSI
stephanie.molner@duke.edu

Run by the Duke Office of Clinical Research (DOCR), ensures rigorous and efficient conduct of clinical research while partnering with and protecting research participants. DOCR supports Clinical Research Units and Oversight Organizations with tools and training, and houses multiple research support services, including the Duke Early Phase Research Unit (DEPRU) and Duke Research at Pickett (R@P).

Susanna Naggie, MD
Co-Director, Participant & Clinical Interactions (PCI) Core
Vice Dean for Clinical Research
susanna.naggie@duke.edu

Shruti Raja, MD, MHS
Co-Director, Participant & Clinical Interactions (PCI) Core
Faculty Director, Duke Early Phase Research Unit (DEPRU)
shruti.raja@duke.edu

Denise Snyder
Duke Office of Clinical Research
denise.snyder@duke.edu

Stephanie Freel
Duke Office of Clinical Research
stephanie.freel@duke.edu

Catee Mullen, MS
Director, Research Operations, DOCR
catee.mullen@duke.edu

Marissa Stroo
Director, Research Operations - Data, DOCR
marissa.stroo@duke.edu

Donna Hammel
DEPRU
donna.hammel@duke.edu

Hub of our participation in several research networks and our recruitment innovation team, supporting Duke Research by ensuring our robust involvement in the Trial Innovation Network (TIN) and PCORnet. RIC provides guidance, tools, and training in effective outreach, engagement, recruitment, and retention to Duke research.

Ranee Chatterjee Montgomery
Director, Recruitment Innovation Center (RIC)
General Internal Medicine
ranee.chatterjee@duke.edu

Schuyler Jones
Director, Recruitment Innovation Center (RIC)
Department of Medicine, Cardiology
schuyler.jones@duke.edu

Assists clinical and translational researchers meet U.S. Food and Drug Administration (FDA) regulatory requirements. The Core provides full-spectrum regulatory and quality assurance support, including strategic development; preclinical testing and Good Manufacturing Practice (GMP) guidance; regulatory submissions and meetings with the FDA; and regulatory education and training.

Amanda B Parrish
Associate Dean of Regulatory Affairs and Quality and Executive Director of Regulatory Affairs and Quality
Office of Regulatory Affairs and Quality (ORAQ)
amanda.b.parrish@duke.edu

Enables equitable and effective boundary-spanning teams across Duke University, Duke Health, and our institutional collaborators by: (1) advancing our understanding of what factors contribute to effective team science by conducting research studies to advance the Science of Team Science; (2) promoting team science skills and concepts across the institution; and (3) developing intentional career paths for post-award support of team science.

Jonathon Cummings
Director, Team Science Core
Fuqua School of Business
jonathon.cummings@duke.edu

Kristine Glauber
Duke CTSI, Duke Office of Research Initiatives
kristine.glauber@duke.edu

Comprises 3 programs: a two-year master’s program in clinical research for medical students, a postdoctoral program supporting research training for outstanding junior scientists, and a pre-doctoral scholarship program offering clinical and translational research experience and training for predoctoral students in medicine.

David Edelman
Department of Medicine, General Internal Medicine
david.edelman@duke.edu

Kevin Thomas
Department of Medicine
kevin.thomas@duke.edu

Stephanie Molner
Duke CTSI
stephanie.molner@duke.edu

Ensures that our research workforce has the skills and knowledge necessary to advance translation of discoveries into improved health outcomes. Workforce Devlopment offers an evolving portfolio of training opportunities to enhance and diversify the workforce, addressing a range of learners—from students to staff to faculty.

Steven Grambow
Co-Director, Workforce Development
Biostatistics & Bioinformatics
steven.grambow@duke.edu

Kafui Dzirasa
Co-Director, Workforce Development
Psychiatry & Behavioral Sciences
kafai.dzirasa@duke.edu

Tracie Locklear
Co-Director, Workforce Development
tlock112@nccu.edu

Katie Dickerson
Associate Director, Workforce Development
Psychiatry & Behavioral Sciences
kathryn.dickerson@duke.edu

Amanda McMillan
Duke CTSI
amanda.mcmillan@duke.edu