Regulatory Affairs Team

 

Audrey Perry
Regulatory Document Specialist

Email: audrey.perry@duke.edu
Phone: (919) 668-4623

Audrey Perry is the Regulatory Document Specialist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. She supports investigators and the ORAQ staff/faculty in all aspects of regulatory document preparation and submission, including technical document preparation, compilation, review, and shipment.  Audrey manages the office databases and tracks all regulatory submissions and sponsor training.  Significantly, she maintains a database of regulatory applications within the institution and sends annual report reminders to study teams and quarterly reports to the Duke Institutional Review Board (IRB).  Audrey has worked at Duke for almost 27 years and has spent 16 of those years supporting clinical research efforts. She has worked in regulatory since 2001 and has applied her advanced technical skills across the institution. Audrey has completed extensive coursework in nursing, participates in ongoing regulatory education, and holds a Technical Excellence Certification from Learning and Organization Development, all of which have contributed to her success in her specialized role.
 

Daniel Tonkin, PhD, RAC
Regulatory Affairs Scientist

Email: daniel.tonkin@duke.edu
Phone: (919) 681-2053

Daniel Tonkin, PhD, RAC is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Tonkin is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. Although his role is primarily focused on providing regulatory support to the Duke Human Vaccine Institute’s portfolio of clinical trials and GMP manufacturing, Dr. Tonkin also performs a variety of extended services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Tonkin is also involved in the implementation of educational initiatives within ORAQ.

Dr. Tonkin received his undergraduate degree from Duke University, and his PhD in Immunology from the University of Colorado. After his graduate studies, Dr. Tonkin worked as a staff scientist at Global Vaccines Inc. where he supported the preclinical development of a virus-based adjuvant. While at Global Vaccines, he was awarded a Ruth L. Kirschstein NRSA Postdoctoral Fellowship. Following his work at Global Vaccines Inc., he spent a year at the Preston Robert Tisch Brain Tumor Center at Duke University as a Regulatory Coordinator and Clinical Protocol Writer. Dr. Tonkin holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
 

David Jensen, PhD, RAC
Regulatory Associate, Senior

Email: david.jensen@duke.edu
Phone: (919) 668-8914

David Jensen, Ph.D., RAC is a Regulatory Associate, Senior in the office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. David uses his 15+ years of experience in US FDA-regulated medical product development to advise Duke Faculty and project teams, primarily at the Duke Clinical Research Institute (DCRI), on regulatory strategy development, FDA meetings, regulatory submissions, product manufacturing, and preclinical testing. He assists project teams with the development, coordination, and implementation of complex regulatory projects involving drugs, biologics, devices (including Software as a Medical Device), and dietary supplements.

David is also a patent-holding cell & molecular biologist with broad experience in drug discovery and development and with significant scientific knowledge in a variety of therapeutic areas.

Prior to Duke, David held regulatory positions at a major CRO and at a biotechnology company (focused on nanotechnology) and he was a project leader for oncology, osteoarthritis, and virology programs at a major pharmaceutical company.

David has an undergraduate degree in Chemistry from California State University at Fullerton, a master’s degree in Medicinal Chemistry from Duquesne University, and a doctoral degree in Pharmacology from the University of Virginia. He also holds the US regulatory affairs certification (RAC) from the Regulatory Affairs Professional Society.

 

Jessica Chapman, PhD, RAC
Senior Regulatory Affairs Scientist

Email: jessica.chapman@duke.edu
Phone: (919) 668-7962

Jessica Chapman, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Chapman is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Chapman is also involved in the implementation of operational initiatives within ORAQ.

Dr. Chapman received her undergraduate degree in biology from the University of Illinois, Champaign-Urbana. She conducted her graduate research at Wake Forest University, where she earned her PhD in Molecular Genetics and Genomics. Her research was focused on examining the role of adiposity loci recently identified in Europeans in multiple African American populations to elucidate the genetic differences between the two ethnicities. After her graduate studies, Dr. Chapman accepted a position with the Duke Translational Medicine Institute (DTMI) as a Quality Assurance Scientist. In this role, she spent two years providing quality and some regulatory support to the Carolinas Cord Blood Bank (CCBB) and the Clinical and Translational Cell Therapy Program (CT2).  Dr. Chapman holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

 

Kelly Lindblom, PhD, RAC
Senior Regulatory Affairs Scientist

Email: kelly.lindblom@duke.edu
Phone: (919) 668-9758

Kelly Lindblom, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Lindblom is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Lindblom is also involved in the implementation of educational initiatives within ORAQ.

Dr. Lindblom received her undergraduate degree in chemistry from the University of North Carolina-Chapel Hill. She conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. Her research focused on the regulation of cell death in the context of Non-Alcoholic Steatohepatitis and different types of cancer. During her graduate training, Dr. Lindblom was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. Dr. Lindblom was the Assistant Director of Research Initiatives in the Office of the Vice Provost for Research at Duke University before joining ORAQ.  Dr. Lindblom holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
 

Kristen Foss, PhD, RAC
Senior Regulatory Affairs Scientist

Email: kristen.foss@duke.edu
Phone: (919) 668-6612

Kristen Foss, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Foss is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Foss is also involved in the implementation of collaborative initiatives within ORAQ.

Dr. Foss received her undergraduate degree in biology from South Dakota State University and then worked as a research associate at the Translational Genomics Research Institute in Phoenix, Arizona. Dr. Foss conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. During her graduate training, Dr. Foss was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. She was also selected to participate in the Duke Scholars in Molecular Medicine Program in Oncology and Regenerative Medicine. Dr. Foss holds the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
 

Kylie Opel, JD
Regulatory Associate

Email: kylie.opel@duke.edu
Phone: (919) 668-0830

Kylie Opel, JD, is a Regulatory Associate in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine.  In this role, Kylie is responsible for providing support and guidance to investigators and clinical research study teams regarding the regulatory requirements relevant to their research study activities within the Duke Clinical Research Institute (DCRI).  Additionally, Kylie researches and advises on a variety of international data privacy regulations affecting clinical research activities conducted by the DCRI, such as the European Union’s General Data Protection Regulation.  Kylie maintains the “Country by Country” database providing information on global regulations and laws regarding drug and device studies, as well as global data privacy information.

Kylie received her undergraduate degrees in criminal justice and political science with a minor in international affairs from the University of North Carolina at Wilmington, and her Juris Doctor from Campbell University.
 

Rachel Johnson, PhD, RAC
Regulatory Affairs Scientist

Email: rachel.hesler@duke.edu
Phone: (919) 668-4635

Rachel Johnson, PhD, RAC is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine.  In this role, Dr. Johnson is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Johnson is also involved in the implementation of operational initiatives within ORAQ.

Dr. Johnson received her undergraduate degree in biochemistry from Clemson University.  She conducted her graduate research at Duke University, where she earned her PhD in Molecular Cancer Biology.    During her graduate training, Dr. Johnson was the recipient of a James B. Duke Fellowship, a Ruth L. Kirschstein-NRSA Predoctoral Fellowship, and a Robert J. Fitzgerald Scholar Award.  After her graduate studies, Dr. Johnson spent two years as a Regulatory Coordinator at the Preston Robert Tisch Brain Tumor Center at Duke University.  Dr. Johnson holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
 

Rose Beci
Manager Investigational Applications

Email: rose.beci@duke.edu
Phone: (919) 668-8632

Rose Beci, is the Manager of Investigational Applications in the office of Regulatory Affairs and Quality within the Duke University School of Medicine.  Rose Beci primarily serves as the regulatory lead for the Pediatric Trials Network (PTN) which is managed by Duke Clinical Research Institute faculty and project teams. Rose monitors and evaluates network activities, detects trends and opportunities, formulates and executes regulatory strategies and derives regulatory pathways essential to the successful management and outcome of clinical projects.   Prior to joining the DCRI Rose served as regulatory lead for many investigator-initiated and commercial studies conducted by Duke oncologists.   Rose had her start in clinical research with the Cancer and Leukemia Group B’s Statistical Center at Duke University.  

Rose has a Bachelor of Science degree in Microbiology from the University of Illinois, Champaign-Urbana.  Prior to joining Duke University she worked at the North Carolina Biotechnology Center as the Manager of Science and Technology Development, and at Abbott Laboratories as a researcher with the Cancer Diagnostic Division.

 

Stephanie PierceStephanie Fraser, PhD, RAC
Regulatory Affairs Scientist

Email: stephanie.fraser@duke.edu
Phone: (919) 668-8685

Stephanie Pierce, PhD, RAC is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Pierce is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Pierce is also involved in the implementation of collaborative initiatives within ORAQ.

Dr. Pierce received her undergraduate degree in biology from Central Michigan University while also completing the McNair Scholar Program. She conducted her graduate research at the University of Iowa, where she earned her PhD in Molecular Physiology and Biophysics. Her research focused on the role and regulation of the SK3 Channel in the myometrium throughout pregnancy. During her graduate training, Dr. Pierce was the recipient of an American Heart Association Predoctoral Fellowship. Dr. Pierce then accepted a position as a Postdoctoral Research Assistant at the University of North Carolina in the Cell and Molecular Physiology Dept. and was awarded the NIH Contraception and Infertility LPR through the NICHD.  Dr. Pierce then went on to complete her postdoctoral training at Duke University studying the role of Adrenomedullin in cigarette smoke-mediated protection from preeclampsia.  Dr. Pierce holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.