Clinical Research Office

Clinical Research Office

The Department of Obstetrics and Gynecology Clinical Research Office provides faculty and staff with the necessary infrastructure and resources to support a wide variety of clinical research studies.

Regulatory Services

  • IRB submission of new protocols and amendments to local and central IRBs
  • Preparation of research authorization and informed consent documents
  • Assembly of regulatory binders
  • Support for Investigational New Drug/Investigational Device Exemption applications

Study Administration

  • Initial study feasibility analysis 
  • Development of electronic case report forms (eCRFs) 
  • Participation in site initiation visits and investigator meetings 

Subject Recruitment

  • Development of recruitment plans materials
  • Pre-screening potential participants via multiple electronic medical record systems

Study Coordination

  • Obtains and documents informed consent
  • Conducts study visits according to protocol
  • Collects and enters data into CRF
  • Participation in study monitor visits

Financial Support

  • Develops and negotiates budget based on study protocol
  • Monitors expenditures against approved budget
  • Submits invoices and collects payments from sponsor

Our clinical research office is located just steps away from UnityPoint Health-Meriter hospital and a short drive from University of Wisconsin Hospital, which provides staff with easy access to the inpatient, general and ambulatory clinics. This ideal location has facilitated the development of well-established, research-focused partnerships between clinical and research staff as well as the ability to connect easily and promptly with a diverse, research-receptive cohort of potential subjects. The clinical research office itself is well equipped with dedicated, limited access storage for physical records, private meeting rooms and technology to support web conferences.

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Dr. Kushner is the Vice Chair of Clinical Research for the Department of OB/Gyn and provides leadership to the clinical research office. He has built an infrastructure across the department to support and grow clinical trials. Previously, he directed the Gynecologic Oncology program from 2006-2017 and is the principal investigator on multiple studies evaluating sexual health among gynecologic cancer survivors. He has acted as the PI for NRG Oncology at UW-Madison and is currently the Co-PI on the UWCCC institutional NIH Lead Academic Performance Site (LAPS) U10 grant.

David Kushner, MD
Flesch Professor of Gynecologic Oncology; Vice Chair of Clinical Research
Administrative Assistant: Cortney Wood
Phone: (608) 263-1210
Email: cwood3@wisc.edu

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Jennifer started her research career over 10 years ago at UW-Madison as a study coordinator and health technologist for the Beaver Dam Eye Study and the WI Epidemiologic Study of Diabetic Retinopathy (WESDR). She continued to work in clinical research as a study coordinator for the Alzheimer’s Disease Research Center in the neuroimaging core. She has coordinated numerous NIH-funded multidisciplinary and investigator-initiated trials and assisted with the startup of sponsor-initiated clinical trials. In addition, she has experience managing regulatory requirements throughout the life of a clinical research study, including data safety monitoring, IRB and Investigational New Drug (IND) applications.

Jennifer Poetter
Clinical Research Administrator
Phone: (608) 417-6941
Email: jennifer.poetter@wisc.edu

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Rosalina has been in the Department of Ob/Gyn for over 7 years, where she completed a PhD in Endocrinology and Reproductive Physiology. She joined the CRO in the spring of 2018 as the lead research coordinator for reproductive sciences and reproductive endocrinology & infertility research studies. In June 2019, she became Research Program Manager. Using her skills and experience from her PhD, Rosalina has played a critical role in establishing relationships between research technicians, clinical care staff, hospital administrators and principal investigators.

Rosalina Villalon Landeros
Research Program Manager
Phone: (608) 417-4232
Email: villalonland@wisc.edu

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Prior to joining the Department of Ob/Gyn in 2018, Sharon spent 16 years in the Department of Pediatrics as a laboratory manager, managing clinical and animal research projects in the area of neonatology. In this role, she had the opportunity to work on many different projects, including investigator-initiated research funded by private foundations and federal sponsors, such as the National Institutes for Health (NIH). Sharon has a passion for guiding learners through complex regulatory requirements to ensure the safety of human subjects.

Sharon Blohowiak
Regulatory Specialist
Phone: (608) 417-6957
Email: sblohowiak@wisc.edu

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Amy Godecker, Ph.D., M.S., is a Reproductive Health Research Scientist working to enhance research in the Department of Obstetrics and Gynecology. Her work includes consulting and collaborating with residents, fellows, and faculty with research design, data collection, data analysis, and publication. Dr. Godecker completed her graduate work in Sociology at the University of Wisconsin – Madison, with an emphasis in social demography and health. She also holds a B.A. in Psychology from the University of Chicago. Research areas of interest include reproductive health, maternal and child health, public health, and health equity. Prior to joining Ob-Gyn, Dr. Godecker worked for over 16 years as an epidemiologist, researcher, and evaluator for universities and state and local governments in California, Minnesota, and Wisconsin. At UW-Madison, she has been Director of the UW Carbone Cancer Center’s Cancer Prevention and Outcomes Data (C-POD) Shared Resource and an evaluator with the UW Population Health Institute, where she was the lead evaluator for the Lifecourse Initiative for Healthy Families (LIHF).

Amy Godecker, PhD, MS
Phone: (608) 417-4251 
Email: godecker@wisc.edu

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Robin has over 24 years of clinical research coordination experience in a variety of studies including phase II – phase IV industry sponsored studies, NIH investigator-initiated studies and medical device trials. While the primary focus of her experience has been in the subspecialty of urogynecology, Robin is well versed in conducting clinical research across the entire field of obstetrics and gynecology. Robin serves as the most senior clinical research coordinator and has held a Clinical Research Coordination Certification (CCRC) through the Association of Clinical Research Professionals (ACRP) since March 2007.

Robin Wasielewski
Research Coordinator
Phone: (608) 417-4230
Email: rwasielewsk2@wisc.edu

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Melissa began her clinical research career providing recruitment and publicity support from the Beaver Dam Hearing Study and the Beaver Dam Offspring Study within the Department of Ophthalmology. She has been a clinical research coordinator within the Department of OB/Gyn since 2017 and has been able to provide support for a variety of studies, many of which have a focus on hypertension and pregnancy. Melissa has a MS in Industrial Relations and Human Resources from Loyola University of Chicago.

Melissa Zernick
Research Coordinator
Phone: (608) 417-4218
Email: mmzernick@wisc.edu

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Maria graduated from the University of California San Diego with a bachelor’s degree in Human Biology. She has previous experience working as a research assistant at the Salk Institute in La Jolla, California and has also worked as a Medical Assistant at an Orthopedic surgical office. Since 2018, Maria has been working as a Research Intern with Dr. Heidi Brown and as of July also supports Dr. Makeba Williams and the ASOG Division. 

Maria Villalon Landeros
Research Intern
Email: mvillalonlan@wisc.edu

Interested in conducting your clinical research study with the Department of OB/Gyn? Contact:

Jennifer Poetter
Clinical Research Administrator

Phone: (608) 417-6941
jennifer.poetter@wisc.edu

McConnell Hall
1010 Mound Street
Madison, WI 53715