The CTTI staff supports the development and execution of projects and dissemination of project results. In addition, staff members organize and support activities of the Executive and Steering Committees. Below, you will find a list of our staff members:
Dr. Tenaerts works closely with the CTTI Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations of CTTI and orchestrates efforts to effectively engage all interested stakeholders to improve the conduct of clinical trials. She is a member of PCORI's CTAP expert post-award subcommittee and MIT’s Collaborative Initiatives Clinical Trials Process Expert Advisory Board, a Member of the Advisory Council North America, DIA.
With more than 20 years’ experience in the conduct of clinical trials across a number of sectors, she practiced medicine in both the emergency department and private practice setting for several years before embarking on a career in research. Most recently Dr. Tenaerts oversaw European operations for CoAxia, a medical device company focused on cerebral ischemia. She received her MD from Catholic University of Leuven, Belgium, and a MBA from the University of South Florida. She speaks five languages and has obtained Six Sigma Green Belt certification.
Ms. Madre advises and supports the executive director in setting and carrying out organizational strategies in support of CTTI's mission. She provides senior leadership on communication and membership strategies and programs and is responsible for maintaining awareness and assessing related efforts of government and private sector organizations, developing and implementing appropriate plans for CTTI in light of those initiatives.
Ms. Madre has more than 15 years experience working on clinical and translational research issues. She previously served as program director of the Centers for Education and Research on Therapeutics (CERTs) Coordinating Center, where she played an instrumental role in creating and managing the CERTs program organization, including the creation of a model for public-private partnership. While at Duke University, Ms. Madre also served as manager of strategic relations and client services for the DCRI. Prior to joining Duke, she served as an attorney for Sentara Health System. Ms. Madre received her JD from the University of Richmond, her MHA from the Medical College of Virginia/Virginia Commonwealth University, and her BS (biochemistry) from North Carolina State University.
Ms. Forrest provides senior operational leadership for core activities such as project management, site management, personnel management, financial performance, regulatory compliance, information systems, and process improvement.
Ms. Forrest has more than 15 years of experience in the clinical research industry. For the last three years she has served as a Senior Clinical Project Manager at CTTI. Previously she served as director of field clinical operations for CoAxia, Inc., where she led site management for 50 centers in a study of a novel ischemic stroke therapy. Prior to CoAxia, Ms. Forrest worked as a clinical research associate for Westat, a Maryland-based contract research organization, and as a research nurse specialist at the National Institute of Neurological Disorders and Stroke (NINDS) in its section of stroke diagnostics and therapeutics. Ms. Forrest began her research career at Rush University Medical Center (Chicago, IL) where she managed an Illinois-wide stroke registry. Ms. Forrest received her BS in Nursing from the University of Michigan, and her MPH and MS (with focus on community nursing) from the University of Illinois at Chicago.
Dr. Calvert is responsible for managing the development and implementation of CTTI projects. In collaboration with team leaders, she leads the creation of project plans and budgets, as well as the implementation of those plans.
Prior to joining CTTI, Dr. Calvert was a clinical pharmacist and project leader in the Outcomes Group at the Duke Clinical Research Institute. She has eight years of clinical research experience at the DCRI, which included managing projects, conducting a randomized intervention to improve medication adherence, and serving as the anticoagulation monitor for a multi-center clinical trial. She also practiced as a clinical pharmacist at the Duke Outpatient Clinic from 2007-2015. Her therapeutic experience includes cardiology, diabetes, hypertension, and anticoagulation. Dr. Calvert received her doctor of pharmacy from the University of Pittsburgh and completed a specialty residency in primary care pharmacy practice at Duke University Medical Center and Health System.
Jen Goldsack manages the development and implementation of CTTI projects. In collaboration with team leaders, she creates project plans and budgets, and manages the implementation of those plans.
Ms. Goldsack spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, Ms. Goldsack helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Ms Goldsack earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms. Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian and World Championship silver medalist.
Zachary Hallinan manages the development and implementation of CTTI projects. In collaboration with team leaders, he creates project plans and budgets, and manages the implementation of those plans.
Prior to joining CTTI, Mr. Hallinan directed the patient communication and engagement programs at the nonprofit Center for Information and Study on Clinical Research Participation, where for five years he led efforts to help the research enterprise better understand and meet the needs of the participants who make research possible. Among other initiatives, he worked with leading industry sponsors to implement programs for routinely providing plain-language summaries of clinical trial results to research participants in more than forty countries. Mr. Hallinan's experience also includes science curriculum development at the Education Development Center, as well as basic research in organic chemistry and biology. A graduate of the University of Pennsylvania, he has been recognized by CenterWatch as an innovator changing the face of the clinical trials industry, and has also been a National Science Foundation IGERT fellow, as well as an AmeriCorps volunteer.
Mr. Hamre manages the development and implementation of CTTI projects. In collaboration with team leaders, he creates project plans and budgets, and manages the implementation of project plans.
Mr. Hamre has more than ten years of experience in the pharmaceutical industry, including regulatory, legislative, and business management work. Four years prior to joining CTTI, he worked in the Food and Drug Administration’s (FDA) Office of Legislation, followed by the FDA’s Center for Drug Evaluation and Research, Office of Policy for Pharmaceutical Quality. His primary areas of focus at the FDA were the drug approval process, antibacterial drug development, manufacturing quality, and generic drugs. Before joining the FDA, Mr. Hamre worked on pharmaceutical science or healthcare delivery administration issues in corporate, federal government, and non-government organization (NGO) sectors, domestically and internationally. Mr. Hamre is also a returned Peace Corps Volunteer; he served in South Africa from 2004 to 2006.
Laura Shannon oversees CTTI’s communications strategy with the goals of increasing visibility of CTTI’s work and driving adoption of our recommendations. Coordinating closely with project teams, members, stakeholders, and CTTI staff, she leads our digital channels, public relations outreach, collateral development, and additional communications activities.
Prior to CTTI, Mrs. Shannon was an associate director of development communications at Dana-Farber Cancer Institute, where she played a key role in developing and executing marketing campaigns that helped raise more than $225 million, annually, for cancer research and patient care. Previously, she also led U.S. communications efforts for the World Society for the Protection of Animals and worked at Lois Paul & Partners, a healthcare and technology public relations agency. Her communications work has earned her accolades including a New England Society for Healthcare Communications - Gold Lamplighter Award and a Publicity Club of New England - Gold Bell Ringer Award.
Mrs. Shannon earned her MA in Mass Communications and her BS in Public Relations from the University of Florida.
As CTTI’s lead social scientist, Amy oversees the work of the CTTI social science team and works closely with the CTTI project teams to provide guidance on the design, implementation, analysis, and write up of CTTI’s quantitative and qualitative research studies. She is an Associate Professor in the Division of General Internal Medicine, School of Medicine, at Duke University. She is also a faculty member of the Duke Clinical Research Institute.
Over the past 20+ years, Amy has conducted research in health and empirical bioethics in multiple countries in sub-Saharan Africa, the Middle East, South and Southeast Asia, and North America through her positions at Emory University, the Centers for Disease Control and Prevention, the University of North Carolina at Chapel Hill, and FHI 360. Since 2001, she has been involved with multiple HIV prevention drug trials, and most recently served as the behavioral principal investigator for the FEM-PrEP clinical trial, a multi-site, phase III, placebo-controlled trial of emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV prevention among women in sub-Saharan Africa. She had led NIH-funded research on topics related biomedical HIV prevention and research ethics, and has numerous publications from her involvement in clinical research, including manuscripts on informed consent and assent, participant product adherence, reasons participants enroll in clinical trials, community involvement in clinical trial design, and the functioning of research ethics committees. Amy received her PhD from the University of North Carolina at Chapel Hill and her MPH from Emory University.
Mr. Perry works closely with the CTTI project teams and other social science researchers to design, implement, analyze, and report CTTI’s evidence-generating research activities. Along with his role with CTTI, he is a Clinical Trials Project Leader at the Duke Clinical Research Institute (DCRI).
Mr. Perry has over 12 years of experience conducting social science research around the globe on topics such as stakeholder acceptability of innovations in treatment, patient engagement in the United States and Sub-Saharan Africa, and constructs of identity formation among marginalized populations in South Asia. Prior to joining CTTI, Mr. Perry’s research focused on investigating the cultural and social contexts surrounding clinical trials and how these may impact patient behaviors and trial outcomes. He has served as the study coordinator and lead analyst on over a dozen qualitative and mixed methods studies funded by the FDA, USAID, NIH, and NSF. He has expertise in social science research development, research project management, field work (including participant observation, in-depth interviews, focus groups, surveys, pile sorting, PhotoVoice), qualitative data analysis, and scientific writing. Mr. Perry received his MPH from the University of North Carolina at Greensboro.
Dr. Swezey works closely with the CTTI project teams and other social science researchers to design, implement, analyze and report CTTI’s evidence-generating research activities. Along with her role with CTTI, she is a Clinical Trials Project Leader at the Duke Clinical Research Institute (DCRI).
Dr. Swezey has ten years of experience specializing in qualitative research, focused primarily on the sociocultural aspects of HIV/AIDS in Sub-Saharan Africa. Her research expertise includes developing data collection instruments, conducting focus groups and in-depth semi-structured interviews, developing codebooks, coding and analyzing data, and writing up results for reports and peer-reviewed publications. She also has seven years of experience working on clinical trial–related research. Prior to joining CTTI, she combined her clinical trial and qualitative research skills as a research associate in the Department of Epidemiology and the Department of Social Medicine’s Center for Bioethics at the University of North Carolina at Chapel Hill. She was also a clinical research coordinator on dementia trials in the Department of Neurology at UNC. Dr. Swezey received her MA in Anthropology and her PhD in Sociology from Michigan State University.
Ms. Hamilton provides administrative support for the Steering Committee and for the Director of Strategy. She also supports CTTI’s internal and external dissemination activities, including maintenance of the website.
Ms. Hamilton has been with Duke University Medical Center for 14 years, working initially with the Centers for Education and Research on Therapeutics Coordinating Center. She has over 30 years of administrative experience in the health care field.
Ms. Royal provides administrative support for the Clinical Project Managers and the project teams.
Ms. Royal has been with Duke University Medical Center for 6 years, working initially with the department of Duke Orthopaedics.
Kristi Geercken manages CTTI’s websites, e-newsletters, and social media channels. Working closely with CTTI staff, she keeps CTTI’s websites dynamic and current, and works with the Communications Manager to coordinate the distribution of news and materials to members, staff, and external audiences via email, Twitter, LinkedIn, Vimeo and other platforms. She also plays an important role in measuring and analyzing CTTI’s online metrics, in an ongoing effort to improve and enhance CTTI communications.
Prior to CTTI, Ms. Geercken spent 18 years in digital media at The McClatchy Company, most recently as a social media specialist. During her tenure at McClatchy, she created compelling research presentations and collateral that drove revenue for a national advertising network, and worked closely with digital staff in newspaper newsrooms to help keep them at the forefront of digital change. In addition, she has served as a board member for a local Little League baseball organization, where she managed all communications for the league.
Ms. Geercken earned her BA in Journalism & Mass Communication from The University of North Carolina at Chapel Hill.
Ms. Smith manages the planning, execution and follow-up activities of meetings and events for the Clinical Trials Transformation Initiative (CTTI). Her responsibilities include maintaining awareness of national and international conferences, professional and trade meetings and multi-stakeholder meetings used by project teams to gain input or consensus on important issues being addressed by CTTI projects.
Ms. Smith brings over 10 years of experience of event coordination and management, project budgeting and coordination from concept to completion, as well as sales and marketing participation. She has also been involved in the harmonization and execution of public and privately held professional events.