Faculty – 11th Annual Clinical Trial Billing & Research Compliance Conference 


Kelly Anastasio
Associate Director of Clinical Trial Resources, YALE CENTER FOR CLINICAL INVESTIGATION

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Kelly Anastasio is the associate director of clinical trial resources and oversees recruitment and development. Prior to joining YCCI, she spent six years as a Clinical Research and Reimbursement Manager in the Department of Orthopaedics, where she was responsible for managing clinical trial activity, including budget development, contract negotiations, the clinical trials matrix and operational flow. Her outstanding contributions had a positive impact on the department’s performance, contributing to record levels of accomplishment and she was awarded the Leadership in Research Billing Compliance Award by Yale Medical Group Compliance in 2010. Ms. Anastasio is a certified Professional Medical Coding Curriculum instructor whose previous experience includes teaching for the Medical Coding Academy in Branford, CT and at The Coding Center of Connecticut.

Ms. Anastasio’s experience provides the ability to oversee the OnCore project, which includes many aspects of Yale’s institutional clinical research program, including determining the feasibility of research projects, allocating resources, budgeting for resource needs, and communicating and providing support to research teams. Her organizational and managerial skills have been an asset to YCCI as it seeks to broaden its ability to provide these critical services to investigators across the health campus.


Rick Arlow, Founder, CEO, COMPLION

Rick Arlow
Founder and CEO, COMPLION

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Complion founder Rick Arlow was immersed in clinical research during an NIH-funded M.D./Ph.D. medical scientist training program at Case Western Reserve University, which resulted in publications with several leading journals, including Neuroscience. Although he loved the work, he was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders.

Inspired by his experience and drawing on his engineering background, Rick put together a world-class team experienced in clinical research and enterprise content management to build Complion, a document management and workflow platform. Built specifically around the needs of clinical research sites, Complion helps reduce regulatory burden, improve compliance and streamline operations. Since its founding, Complion has grown to be the industry-leading solution used by physicians, hospitals, academic medical centers, health systems and cancer centers around the country.

Rick is a frequent lecturer for several professional research organizations, including ACRP, MAGI and SCRS. He was involved with a biotech business resulting in several patents and was recognized in Business Week’s “Top 25 Under 25 Entrepreneurs.” Rick takes great pride in Complion’s contributions to the research community and their mission to improve patient outcomes and expand medical knowledge.


Olatokunbo Awodele, M.D.
Contractor Medical Director, WPS

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Dr. Olatokunbo Olufunmike Awodele is currently one of the Contractor Medical Directors at Wisconsin Physicians Service (WPS) with oversight of Medicare Jurisdictions J5 and J8. She is a graduate of the University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School (now Rutgers Robert Wood Johnson Medical School), and the Rutgers University School of Public Health, where she earned a combined M.D./MPH. She completed her Family Medicine residency at the JFK Medical Center Family Medicine Residency in Edison, New Jersey. She is board certified by the American Board of Family Medicine. Prior to working with WPS, she was a physician reviewer with BCBS of Nebraska for four years and owned her own family medicine practice for nine years.

Dr. Ola has been married for more than 22 years and has three children.


Candida Barlow, MSN, RN
Director of Clinical Research, ST. JOHN CLINICAL RESEARCH INSTITUTE

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Candida Barlow has proficiency in creating and overseeing clinical research guidelines and regulation. During her tenure as an intensive care nurse, Barlow began her focus in clinical research in 2008. Barlow implemented multiple nursing research studies to improve patient outcomes within a critical care unit. Her service includes four years of experience as a nurse manager in a clinical research department. Her initial area of clinical research service was with cardiovascular trials. Today, she serves as the Director of Clinical Research for St. John Clinical Research Institute.

Barlow holds a Bachelor of Science degree in nursing from the Langston University and a Master of Science degree in nursing with advanced specialty in clinical research from Drexel University. Barlow is a 2012 recipient of the Lifelong Achievement Award from Drexel University School of Nursing for her continued education in clinical research.


Deena Bernstein, MHS
Director of Clinical Research, SHERIDAN CLINICAL RESEARCH, INC.

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Deena Bernstein is a graduate from Seton Hall University in South Orange, New Jersey with a B.A. in English. She received a Certificate in Clinical Research Administration in 2005 from George Washington University, Washington, DC and a Master in Health Sciences in Clinical Research Administration from George Washington University, Washington, DC in 2006.

Deena is Vice President, Site Services at Qcare a QuintilesIMS company. She is directly responsible for the site operations of the Qcare affiliated sites. Qcare is a site services provider that partners with sites to deliver operational efficiencies in the clinical trial process and provides full-service site support. Qcare sites are multi-therapeutic and conduct pharmaceutical sponsored studies Phase II-IV.

Her prior role was the Director of Clinical Research at Sheridan Clinical Research, Inc. Ms. Bernstein worked for the parent organization Sheridan Healthcare, Inc. from 1996-2016. The organization employed more than 6,000 physicians and allied healthcare providers for hospital contracts that the organization acquires. In 2000, Deena created Sheridan Clinical Research the research entity within the organization that facilitated and managed pharmaceutical sponsored clinical trials Phase II-IV for their employed physicians.

Deena serves on the Leadership Council of SCRS since its inception. Through her activity with SCRS she is on the Site Advisory Group (SAG) for TransCelerate’s Investigator Global Platform.

Deena is co-Leader on the CLEAR charter project, an SCRS initiative that’s remit is to make transformational change in the Clinical Trial Agreement negotiation process and improve cycle times for all stakeholders.

She is the founding Vice President for the SE FL ACRP Chapter.

Deena had served Sheridan Healthcorp on a Base Business Lean Transformation Team (BB LETT). She has participated in six Kaizens and led or championed five of them.


Tracie Bistany
Post-Award Financial Specialist, CAROLINAS MEDICAL CENTER

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Tracie Bistany has been with Carolinas HealthCare System, the largest healthcare system in North and South Carolina and the second largest public, multi-hospital system in the nation for nine years. She has been involved in the research side of the organization for five years. She started her research experience in the Sponsored Programs Administration as a Grant Accountant and moved to the Oncology Research Administration Department as a Post-Award Financial Specialist. In her current role, she is responsible for the training of and assistance for new clinical trial financial counselors, patient billing issues, reconciliations, and sponsor invoicing.


Reg Blynn
Vice President of Client Services, Site and Patient Networks, QUINTILESIMS

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Reg Blynn has more than 15 years of sales and business development experience. Reg Blynn started his career in clinical research in 2005 with the eCast Corporation. eCast was an EMR company that changed its business model to offer clinical research opportunities based on collected and de-identified data. As Vice President of Sales, Reg grew that team from 10 to more than 140 people. From there, Reg took over as Business Development Director for a Dedicated Research Site in Charles ton, SC. From that role, Reg created a 30-site network of research sites called Medical Research Alliance, which still runs today. During his time as President and Founder at Medical Research Alliance, Reg went on to conceive, develop and build the first turnkey CRM program for research sites called Devana Solutions, which is also still running. In early 2016 Reg joined QuintilesIMS as Vice President of Client Services and helps run a division there known as Qcare. Qcare is a new partner program QuintilesIMS offers to select sites that involves full integration and help with staffing, efficiency, profitability and expansion.


Candice Brown-Bishop
Research Billing Manager, UF HEALTH

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Candice Brown-Bishop is the Research Billing Manager at UF Health. Two campuses, six health colleges, two major teaching hospitals, two specialty hospitals, and nine major research centers and institutes comprise the University of Florida Health System. Candice also serves as UF Health’s Principle Trainer for Research Workflows. She has led UF Health’s implementation of Epic’s Research Module and launched the UF Health Centralized Research Billing Office. Candice received her Epic Research Billing Certification in 2015 and is currently working on her Principle Trainer certification through Epic. Candice’s 16 years of healthcare experience includes utilization management, patient access/registration, physician practice operations, academic physician group practice revenue cycle and billing operations, academic hospital revenue cycle and billing operations, training/education, and physician reimbursement analysis. Candice continues to be a leader in improving UF Health’s research-related workflows and serves on various UF health leadership, finance and research billing compliance committees.


Leigh Burgess, MHA, MEd, M.A.
Chief Research Operations Officer, DUKE CANCER INSTITUTE

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Leigh Burgess, MHA, MEd, M.A., is the Chief Research Operations Officer of the Duke Cancer Institute (DCI). In her role, she and her colleagues at the DCI work together to effectively lead and forward the mission of Duke Medicine by developing and implementing strategic initiatives within basic, translational and clinical research. Leigh is a member of the senior team responsible for providing guidance, support and assistance to the multidisciplinary administration and leadership cross-institutionally at Duke. She currently supports a team of more than 150 clinical research operations and administration staff and directs the administrative and operational functions of the CCSG P-30 nine Research Programs and 13 shared resources and associated cores. As a current example of a key area that Leigh supports and leads, she is focused on supporting and planning for the development, implementation and improvement of clinical trials management, scientific and feasibility review, and quality data capture. This work includes tracking protocol throughput and reviewing and projecting clinical trial accruals with a specialized effort to understand how to utilize organizational and human systems theory to impact and improve clinical trial activation and overall efficiency. She oversees the work of key areas of clinical research operations for oncology, included but not limited to data, safety and monitoring, cancer protocol committee, scientific review, regulatory, compliance, informatics, reporting, biobanking, biostatistics, accrual tracking/metrics, activation cycle time, and strategic growth opportunities. In concert with DCI Senior Leaders, she develops and implements plans for financial, operational and administrative priority setting and strategy deployment outlining needs, improvements, opportunities and relationship building. She identifies/addresses/strategizes and directs the improvement of operational areas of opportunity at the organizational level based on metrics data.


Kyle Byron
Senior Account Manager, CLINICAL CONDUCTOR CTMS

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Kyle is a Senior Account Manager for Clinical Conductor CTMS, and he has worked with large research institutions for more than three years deploying clinical trial management systems. In this time, he has developed expertise in deploying CTMS technology at multi-location institutions around the world, each with unique configurations. Kyle has also mastered how to adapt research technology to the workflows of research teams, and he regularly works with billing teams to adequately establish simple, effective and compliant billing best practices that promote quality, consistency and communication. Kyle has a B.A. from the State University of New York at Geneseo, and has spoken at multiple conferences on billing and other operational areas in clinical research.


Nancy L. Clinton, RN, BSN, CCRP
Manager, Research Clinical Coverage, NORTON HEALTHCARE RESEARCH OFFICE

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Nancy L. Clinton, RN, BSN, CCRP, is the Manager of Research Clinical Coverage at Norton Healthcare, Inc. in Louisville, Kentucky. Nancy leads the coverage team, which is responsible for creating Medicare Coverage Analysis Documents and processing research patient claims. Nancy has been in healthcare for more than 10 years with experience in healthcare finance, as a pediatric RN and as a research coverage analyst.


Kelly Colucci, M.A.
Manager of Grants and Contracts, ATLANTIC HEALTH SYSTEM

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Ms. Colucci is the Manager of Grants and Contracts in the Atlantic Center for Research at Atlantic Health System. She is responsible for all grants and research contracts related to research conducted at this six-hospital system. This includes more than 150 active sponsored research studies and all phases of contracts, budgets, negotiation and financial management.

Ms. Colucci is an experienced manager focused on advancing clinical research and building partnerships. She and her team are focused on continually building customer satisfaction for research participants, physicians, the community and departments served.

Ms. Colucci has been with Atlantic Health System for 18 years, 12 of which have been dedicated to the area of research administration. She is a member of the Association of Clinical Research Professionals and the Society of Clinical Research Associates. Her expertise is in the area of project management and performance improvement.


Carolyn Cunningham
Contractor Medical Director, NATIONAL GOVERNMENT SERVICES

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Carolyn Cunningham, M.D., is a board-certified internist and serves as a contractor medical director with National Government Services, a Medicare Administrative Contractor. Dr. Cunningham is based in Indianapolis, Indiana.


Christine de Leon, RN, CPC
Advanced Clinical Trials Specialist, SHARP HEALTHCARE

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Christine de Leon is a Registered Nurse and AAPC Certified Professional Coder. She has five years of experience working in healthcare compliance at an academic institution in Manhattan, NY which includes documentation review and auditing, coding/reimbursement, and education and training for physician and non-physician practitioners. Specifically related to research and clinical trials, Christine assisted with implementation of an Epic CTMS system and initiating/providing extensive training on a process flow for streamlining the identification of research-related services. Since then, she has relocated to a community-based hospital system in San Diego, where she assisted in the development of integrating coverage analysis into the complete review of clinical trial submissions. Her current position as Advanced Clinical Trials Specialist allows her to continue educating and training those involved with compliance in clinical trial billing and overall conduct.


Andrea M. Denicoff, M.S., RN
Head, NCTN Clinical Trials Operations; Scientific Liaison, Patient Reported Outcomes (PROs), NATIONAL CANCER INSTITUTE

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Andrea Denicoff is a Nurse Consultant in the Clinical Investigations Branch within the Cancer Therapy Evaluation Program (CTEP) in the Division of Cancer Treatment & Diagnosis at the National Cancer Institute (NCI). She serves as the Head of Clinical Trials Operations for the NCI’s National Clinical Trials Network (NCTN). In this role, she also works with the NCTN Lead Academic Participating Sites (LAPS) grantees on enhancing their efforts within the NCTN. She directs, manages and coordinates several projects to reduce barriers to clinical trials accrual and increase participation of diverse populations into cancer trials, including racial and ethnic minorities, the elderly, and adolescent and young adults (AYA). She directs components of the Cancer Trials Support Unit (CTSU) that deal with accrual to NCTN trials and national coverage analyses. She provides scientific review, leadership and coordination for patient-reported outcomes (PROs) and health-related quality of life (HRQoL) research in cancer treatment studies, serves on NCI’s Symptom Management and HRQoL Scientific Steering Committee, and is a member of the NCI PRO-CTCAE Study Group. In addition, she is a Contracting Officer Representative for the NCI Clinical Trials Information and Management Support contract, serves as the CTEP representative to the Patient Advocate Steering Committee, and provides direction from CTEP’s perspective on NCI research in palliative care in cancer. She serves as an Associate Editor for Clinical Trials: Journal of the Society for Clinical Trials. Before coming to the NCI, she was on the faculty at Georgetown University in the Department of Medicine, Division of Hematology/Oncology as an oncology nurse practitioner and was active in the breast cancer clinical research program. Prior to that, she was the research nurse coordinating early phase breast cancer trials for the Medical Breast Cancer Section in NCI’s intramural program.


Debbi Gilad, J.D.
Director, Office of Research, BON SECOURS HEALTH SYSTEM

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My professional work began as an International Intellectual Property Attorney practicing law in Israel. After relocating back to the United States, I entered the world of research administration as the research compliance and integrity officer at UC Davis and then worked at the University of Penn School of Medicine as the executive director for the Office of Research Compliance and Integrity. I currently work at Bon Secours Health System as the director of the Bon Secours Office of Research and am responsible for the implementation and oversight of research. This includes extensive building of an infrastructure from policies and procedures to best practices and the implementation of electronic systems to advance efficiency and sophistication, increase accountability, and ensure greater compliance. I have a J.D. from Pace University School of Law and am a member of the Bar in New York and the State of Israel.


Fred Herman, CHRC
Director, Corporate Research Compliance, UMMS Finance, UNIVERSITY OF MARYLAND MEDICAL SYSTEM

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Fred is the Director of Corporate Research Compliance for the University of Maryland Medical System, a 13-hospital group located in Baltimore and Eastern Maryland.  The focus of Fred’s more than 40 years in healthcare and higher education administration has been in practice management, accounts receivable and, for the past 14 years, research compliance.  Fred spent more than 10 years as an independent management consultant to large group practices at academic medical centers on the East Coast and in the Midwest covering a variety of areas relevant to operational improvement and systems integration to effectively manage accounts receivable.  Fred is Certified in Healthcare Research Compliance (CHRC) by the Health Care Compliance Association (HCCA) and has previously presented on the topic of research compliance at conferences sponsored by ExL Pharma, HCCA, ACUA and NCURA.  Fred was also a contributor to the “Clinical Trials Administration Toolkit” published by the Association of Academic Health Centers (AAHC).


Emily Hoyle, MBA, B.A., CCRC
Clinical Research Administrator, MULTICARE INSTITUTE FOR RESEARCH AND INNOVATION (MIRI)

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Emily Hoyle, MBA, B.A., CCRC, is the Clinical Research Administrator at MultiCare Institute for Research and Innovation (MIRI) at MultiCare Health System in Washington State. MIRI has approximately 900 active subjects participating in more than 240 active trials. Emily has more than 10 years of experience in research conduct and administration. In her current position, Emily manages the business operations of the Institute, including contract and budget negotiation, research billing, accounts payable, and accounts receivable. Emily earned her MBA in management and strategy from Western Governors University-Washington, her B.A. in psychology at Northwest University, and her CCRC certification through the Association of Clinical Research Professionals.


Kathleen Hurtado, R.Ph.
Consultant, KELLY WILLENBERG & ASSOCIATES

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Kathleen Hurtado was named Chief Executive Officer of Health Research Association, a University of Southern California subsidiary dedicated to providing full-service clinical trial support to USC faculty, in August 2004. An experienced senior executive in the pharmaceutical and biotechnology industries, Ms. Hurtado has spent her career successfully developing, marketing and selling ethical pharmaceuticals. Prior to joining HRA she served as the Director of Operations at the American College of Surgeons Oncology Group at Duke University. Kathleen began her career as a pediatric oncology pharmacist at the MD Anderson Cancer Center in Houston, Texas.  Ms. Hurtado was educated at the University of Houston, where she earned her B.S. in pharmacy.  Ms. Hurtado is affiliated with numerous organizations, including the American College of Healthcare Executives, Board of Councilors the University of Southern California School of Pharmacy, Board of Directors of Priority Healthcare Corporation, Board of Directors for the Westside Family Center and a volunteer at the Downtown Women’s Center.  In her spare time she enjoys hiking, biking, reading, and spending time with her dogs and family.


D. Marie Jackson, Ph.D., MBA
Revenue Cycle, Director, Clinical Research Billing, UC SAN DIEGO HEALTH

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As a native Pittsburgher, Dr. Marie Jackson fell in love with medical research nearly 30 years ago while working at the University of Pittsburgh. Inspired by the possibility of being part of medical discoveries that help people, Marie’s journey includes stops at Emory University, Harbor-UCLA, City of Hope, Amgen, Allergan, and most recently Parkland Health System in Dallas, Texas. Marie is known for tackling difficult problems and establishing lean business processes to increase efficiencies in the research process. Dr. Jackson holds an MBA from CSUDH and her doctorate is in the area of health sciences from TUI in Cypress, CA. In her spare time, Marie enjoys kayaking, ballroom dancing, and spending time with family and friends.


Scott P. Jensen, Strategy and Transformation Leader, Global Clinical Budgeting and Contracting, ELI LILLY AND COMPANY

Scott P. Jensen
Strategy and Transformation Leader, Global Clinical Budgeting and Contracting, ELI LILLY AND COMPANY

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Scott Jensen is a Global Clinical Trial Strategy and Enterprise Risk Management Leader at Eli Lilly and Company in Indianapolis, Indiana. In this capacity, he is responsible for Lilly’s clinical trial budgeting, contracting, payment and reporting activities in more than 75 countries. He has 26 years of domestic and international pharmaceutical management experience and has held a variety of leadership positions spanning strategic planning, operations management, financial management and risk management. Scott holds a master’s in business administration and general management from the University of North Carolina at Chapel Hill. He is also a former officer and paratrooper in the United States Army’s elite 82nd Airborne Division.


René Jooste, M Pharm, CCRP
Director, Clinical Trials Finance Office, ST. JUDE CHILDRENS’ RESEARCH HOSPITAL

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René Jooste joined the St. Jude Children’s Research Hospital in 2016 as Director of their newly established Clinical Trials Finance Office. René started her professional career as a pharmacist in South Africa and was recruited to the University of Alabama at Birmingham in 2002 where she initially served as Program Director of Cooperative Group studies. When leaving UAB after 14 years, she was Manager of their Clinical Billing Review Office. Since coming to St. Jude, she continues to grow a centralized successful clinical trial billing initiative. She serves on various committees, one of them a task force evaluating clinical trials management systems. René holds a Master of Pharmacy Degree from the University of Pretoria and is also a member of the Society of Clinical Research Associates, where she holds her certification (CCRP). She is a Ph.D. candidate in the UAB School of Health Professions, completing a degree in Administration of Health Services.  René has been an IRB member and participated as co-auditor in NCI audits. She received an award of excellence from the Eastern Cooperative Oncology Group where she served as CRA chair from 2002-2005.


Melissa Kadar
Director, Clinical Operations - Industry Studies, OHIOHEALTH RESEARCH & INNOVATION INSTITUTE

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Melissa Kadar is a national speaker and executive in research administration whose mission is to help research leaders more effectively use their energy, influence and resources to create a structured process to enable them to manage the performance of their organizations. In her role as Director, Clinical Trials at University Hospitals Seidman Cancer Center, she has developed a strategic business plan to enhance the clinical trial program monitored by a scorecard-based, metric-driven process.


Anna Kowal
Research Compliance Manager, ATLANTIC HEALTH SYSTEM

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Anna Kowal is currently a Research Compliance Manager at Atlantic Health System where she provides compliance and regulatory guidance to the research administration staff, the entire research community at Atlantic Health System and the IRB. She has more than 10 years of clinical research experience with an extensive background in quality assurance and good clinical practices. Anna is working on her master’s degree in clinical research organization and management and is certified through SOCRA and HCCA.


Sunil V. Lalla, M.D., FACS
Medical Director, Jurisdictions H & L, NOVITAS SOLUTIONS, INC.

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Dr. Sunil V. Lalla is a Medical Director with Novitas Solutions, Inc. He serves as the Medicare Administrative Contractor (MAC) Medical Director for Jurisdiction H (Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma and Texas) and Jurisdiction L (Pennsylvania, Maryland, New Jersey, and Delaware and the District of Columbia).

Dr. Lalla grew up in Georgia and completed his undergraduate studies at Emory University. He chose to remain in Atlanta and is a 1988 graduate of the Emory University School of Medicine. He completed his residency in General Surgery at the University of Tennessee Health Science, Memphis and served as Chief Resident.

After completing his training, Dr. Lalla founded his private practice of General Surgery in South Carolina and remained in private practice for almost two decades. He has served in many leadership roles during that time, including Chief of Surgery and Chair of Quality Improvement Council, in addition to serving on the Board of Trustees of the South Carolina Medical Association. He then was recruited to found and establish a hospital-based surgery group at the South Carolina coast, where he remained until he accepted his present position with Novitas Solutions, Inc. Dr. Lalla has considerable experience with billing and coding and is a Certified Professional Coder (CPC).

He is a Diplomate of the American Board of Surgery and a Fellow of the American College of Surgeons.


Cynthie Lawson, BSBM, CHRC, CPC
Consultant, KELLY WILLENBERG & ASSOCIATES

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Cynthie Lawson works as an independent contractor with Kelly Willenberg, LLC and has over 15 years of experience in financial and revenue cycle. Cynthie’s expertise is in in research operations including billing compliance and financial management. She has a strong background and expertise encompassing study start-up to final closeout.  She has extensive experience with developing and improving process flows for revenue cycle and financial systems.  She has experience working with EMR and billing systems including EPIC, Cerner, Meditech and others. Her experience includes: Coverage Analysis, clinical trial budget forecasting and negotiations, claims processing, claim denial reviews and appeals, managing internal and external monitoring and audits, accounts payable and receivable, as well as grant management and SEFA reporting.  She is certified as a Healthcare Research Compliance Professional (CHRC) and a Certified Professional Coder (CPC).  Most recently, Cynthie was the Research Finance Manager at a large Health System.

Cynthie has presented on topics including: Developing a Coverage Analysis, Research Billing Compliance for the Investigator, Research Billing Compliance for the Site, Subject Injury Language, and Front to Back-End Research Billing Processes.

 


Jeanne Lewis
Research Billing Manager, ST. VINCENT OFFICE OF RESEARCH AND CLINICAL TRIALS

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Jeanne Lewis is a Research Billing Manager for St. Vincent Office of Research and Clinical Trials. Jeanne assists and supports researchers throughout the St. Vincent Health Care system with regulatory billing, coverage analysis, budgeting and compliance. Jeanne interacts with research organizations and study sponsors to facilitate the budget process. Along with this Jeanne manages research project accounts to track study income and expenses. In 2016, the St. Vincent Office of Research and Clinical Trials implemented a CTMS system, and Jeanne led this project as the Research Billing Manager. This CTMS project — along with the implementation of a new hospital billing system — allowed Jeanne to acquire two new positions; a Research Billing Auditor position to scrub and code research bills for St. Vincent Health Care Systems, and a Research Financial Compliance Analyst to manage CTMS implementation and training.


Chris Longspaugh, PharmD
Consultant, KELLY WILLENBERG & ASSOCIATES

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Dr. Chris Longspaugh, a pharmacist with a varied career, has more than 15 years of experience in multiple areas of clinical research, including billing compliance, clinical trial operations, information technology and project coordination. Most recently Chris served as Senior Manager of Medical Operations of a mid-sized biotech company where he was responsible for clinical trial budgeting and forecasting, strategic planning, and key opinion leader endeavors. Chris spent more than eight years at the University of Southern California leading a team conducting prospective clinical trial coverage analyses. As a member of the management team there, he produced operational, budgeting and financial trial reporting tools utilized by the institution. Chris has presented on topics including clinical trial policy/NCD 310.1, investigator-initiated research, clinical trial budgeting and billing processes, routine costs in clinical trials, and research compliance.


Molly Maurer, MSN, RN, OCN, CCRC
Nurse Educator, Oncology Research, ATLANTIC HEALTH SYSTEM

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Ms. Maurer attained her Master of Nursing in clinical leadership with a transcultural focus from Kean University, and her Bachelor of Science in Nursing from The University of Scranton. In addition to being a registered professional nurse, she holds certification as a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals and is an Oncology Certified Nurse through the Oncology Nursing Society. She is a member of both The Association of Clinical Research Professionals and The Oncology Nursing Society. Ms. Maurer has presented multiple topics in various settings, including Oncologic Emergencies and Bone Marrow Transplant, Research Basics, and Participating in Clinical Trials.

Ms. Maurer started her oncology nursing career in the Bone Marrow Transplant Unit at RWJUH in NJ in 1999. She was Head Nurse and then Nursing Director of the BMTU, Adult Hem-ONC Unit and Radiation Oncology from 2006-2010. Ms. Maurer joined the Oncology Research Department at Atlantic Health System in 2010 as Research Nurse Coordinator and became the Nurse Educator for Oncology Research in 2015. In this role Ms. Maurer supports the clinical staff and acts as the startup coordinator for all new clinical trials in oncology, pulmonary and urology for the system.


Ryan Meade, J.D., Director Regulatory Compliance Studies, LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW

Ryan Meade, J.D.
Director Regulatory Compliance Studies, LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW

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Ryan Meade is the Director of Regulatory Compliance Studies at Loyola University Chicago School of Law.  He focuses his work within the Beazley Institute for Health Law and Policy on courses addressing both long-standing and emerging regulatory challenges for healthcare organizations.  He supervises LLM student theses dealing with regulatory compliance and compliance programs, and he assists the Institute in outreach to healthcare associations supporting compliance programs.

Professor Meade focuses his legal practice on Medicare and Medicaid compliance, clinical research regulatory law, privacy and security of health information, and the organizational integration of compliance programs.

Professor Meade has been active within the healthcare industry promoting the adoption of compliance programs and educating industry leaders.  He serves on the faculty of the Health Care Compliance Association’s Compliance (HCCA) Academy, where he teaches “Stark/Anti-kickback, “Auditing & Monitoring,” and various research regulatory topics.  He co-chairs HCCA’s annual Research Compliance Conference.  He is a member of the advisory boards and an exam writer for the Compliance Certification Board’s Certification in Healthcare Compliance (CHC) and Certification in Research Healthcare Compliance (CHRC). He has served on the advisory board of the CMS Compliance Effectiveness Pilot Project.

He has practiced as an associate at Mayer, Brown & Platt and as a partner at Katten Muchin & Zavis, and is one of the founding partners of Meade, Roach & Annulis, LLP and its affiliated consulting firm, Aegis Compliance & Ethics Center, LLP.  Since graduating law school he has also studied theology at the University of St. Mary of the Lake and philosophy at Oxford University.

Professor Meade’s academic interests focus on the role of the regulatory state in contemporary society, the interaction of ethics and civil law, the history of Anglo-American common law, and the organization of the healthcare system in the United States.  He also has interests in legal theory and language.  He taught in the Law School as an adjunct for 12 years and also served as an assistant professor at Rush University for more than 10 years.


Thomas R. Mitchell, M.D., FACEP, FACP, Senior Contractor Medical Director, CAHABA GBA, LLC

Thomas Mitchell, M.D., FACEP, FACP
Senior Contractor Medical Director, CAHABA GBA, LLC

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Dr. Mitchell grew up in Florida, Texas and Mexico. He attended Cornell University and pursued graduate work in Poultry Science at Cornell. He then attended Cornell University Medical College and subsequently trained in Internal Medicine at Vanderbilt University. Following a Chief Residency in Internal Medicine at the Nashville VA Medical Center he became the Director of Emergency Services at Metropolitan Nashville General Hospital. This was an active inner city ED experiencing around 40,000 visits per year staffed predominantly by house-staff. He has practiced Emergency Medicine for 25 years, most recently in a critical access Emergency Department in rural Tennessee. During that time he also served as the Market Medical Director for Aetna Health Plans of Tennessee and as the Assistant Medical Director for a startup Medicare Advantage plan based in Nashville. He joined Cahaba GBA two years ago as an Associate Medical Director and was promoted to the Senior Contractor Medical Director in February of this year. He continues to practice emergency medicine part time. He is Past President of the Tennessee Chapter of the American College of Emergency Physicians and serves on the steering and reimbursement committees of the American College of Emergency Physicians.


Carrie Nemke
Vice President, Business Development, FORTE RESEARCH SYSTEMS

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As Vice President of Business Development, Carrie helps define the sales strategy across the Forte and Nimblify family. With a background in healthcare and clinical research, she brings an understanding of research operations to the business development process. In line with Forte’s core values, the business development team focuses on a consultative approach to understand customer priorities, working with the Forte team to ensure we can fulfill commitments for all customers.


Mikki O'Neal, MBA, CCRP, CCRC, CHRC
Independent Contractor

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Mikki O’Neal has worked in healthcare for 20 years, with 16 years of clinical research experience. Her experience includes the coordination of clinical trials; clinical research operations management, including financial and regulatory; and clinical research compliance. She currently works as a clinical research billing compliance manager within the Institutional Compliance Office at MD Anderson Cancer Center. Her areas of specialty range from human research protections, clinical research compliance, clinical research education and clinical research billing.


Susie Owenby, RN, CCRP
Clinical Research Manager, CENTER FOR BIOMEDICAL RESEARCH

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Susie Owenby, RN, CCRP, is a Clinical Research Manager at the Center for Biomedical Research in Knoxville, Tennessee.  She has 31 years of oncology nursing experience with the last 26 years focusing on oncology clinical research.  In her current role, she is responsible for the oversight of all clinical research activity, daily operations, financial, regulatory and compliance.  Susie’s nursing and administrative experience in a variety of clinical settings has been advantageous in building a strong research department that can support an expanding portfolio of clinical research across multiple disciplines, including oncology, urology, pulmonary hypertension and proton therapy/radiation therapy.  A strong clinical background gives an important understanding of clinical processes and work flow that is crucial for the successful integration of research into private practice.  Susie received her diploma in nursing from Fort Sander’s School of Nursing.  She has been a member of SoCRA since 2009 and certified as a certified research clinical professional since 2010.


Rhonda J. Paz, Ph.D., CRCP
Chief Operations Officer, GUIDESTAR CLINICAL TRIALS MANAGEMENT

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In her role as Chief Operating Officer, Dr. Paz is responsible for strategizing and implementing new service lines and products as well as the formation of expert operational units to support the variety of service needs of client research sites. She oversees all staff units, ensuring that operating goals and performance metrics are achieved.

Dr. Paz has more than 25 years of leadership experience in clinical research. Before joining GuideStar, she was the Associate Center Director for Scientific Administration of the Louisiana Cancer Research Consortium, a joint effort between Tulane University, Louisiana State University, and Xavier University of Louisiana. In this capacity she was responsible for establishing a centralized administration to oversee and manage scientific programs; internal grant programs; research informatics; and basic, translational and clinical research core facilities. Prior to that she served as the Director of Clinical Research for two prestigious medical centers, where she was responsible for the implementation and operations of the clinical research programs. Her experience makes her uniquely adept at program development, start-up and re-engineering of research operations.

Rhonda holds a Ph.D. in health administration and a B.A. in business administration and management. Additionally, she has earned a designation of Certified Contract Research Professional.


Dawn N. Pittinger, B.S., CHRC, CRCP
Manager, Clinical Research Billing, SUMMA HEALTH

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Dawn Pittinger is the Clinical Research Billing Manager at Summa Health in Akron, Ohio. She has nine years of experience in scientific and clinical research, with five of these years focused in clinical research billing for all departments at her institution. Mrs. Pittinger has a Bachelor of Science in Management, is CHRC and CRCP certified, and will complete her MBA in healthcare administration in April 2017.

Summa Health is a community-based teaching hospital system that functions without the academic medical center infrastructure. The organization does its best to engage in quality research while maintaining compliance. We have limited resources and find efficient ways in carrying out the day-to-day operations required. We have implemented a centralized approach to handling our clinical trials operations with success and could help others accomplish the same thing.


Tracy Popp, MBA, CRCP, CCRP
Director of Research Financial Operations, NORTON HEALTHCARE

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Tracy Popp, MBA, CRCP, CCRP, is the Director of Research Financial Operations at Norton Healthcare, Inc. in Louisville, Kentucky.  Tracy oversees the wide spectrum of financial operations related to research, including contracting, budgeting, billing, accounting, coverage reviews and finance.  She has more than 14 years of experience in healthcare accounting, with the last seven focused on research finance.  Tracy received her MBA from Webster University and completed her B.A. in accounting at Valdosta State University.  Under her leadership, she has built the dynamic research finance team that exists today at Norton Healthcare.  She is a member of various accounting and clinical research groups.


Wendy Portier, MSN, RN, CCM, CHRC, CHC
Consultant, KELLY WILLENBERG & ASSOCIATES

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Wendy Portier has more than 25 years of experience in healthcare, including managed care, quality, healthcare compliance, clinical research compliance, clinical research, care management and critical care nursing. Having worked on the provider, researcher, payer and sponsor sides, Wendy has a unique perspective and extensive knowledge regarding clinical research compliance. Her specific research compliance experience includes process improvement, government inspections and responses, auditing, monitoring, the implementation of compliance programs, and research billing revenue cycle improvements — from coverage analysis, authorizations and claims review to denials management. Most recently, Wendy was the Medical Management Director at a health insurance cooperative startup and served as a consultant with a major consulting firm and contract research organization. Prior to that, Wendy served as a Corporate Compliance Officer and Chief Research Compliance Officer at a major academic medical center.

Wendy holds a Master of Science in Nursing in clinical research management from Duke University and completed the Health Care Corporate Compliance – Post Graduate Certificate Program at George Washington University. She also holds several healthcare-related certifications and has lectured locally, nationally and internationally on various topics related to clinical research, healthcare auditing, research billing and healthcare compliance.


Denise Quint, CPC, CHC, CHRC, Research Compliance Analyst, UNIVERSITY OF VERMONT MEDICAL CENTER

Denise Quint, CPC, CHC, CHRC
Research Compliance Analyst, UNIVERSITY OF VERMONT MEDICAL CENTER

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Denise Quint has more than 15 years of research billing compliance experience and worked clinically in CT, Interventional Radiology and the Cardiac Cath Lab at the University of Vermont Medical Center.  She is a seasoned certified coder and healthcare compliance professional.  Her responsibilities include Medicare Coverage Analysis of all studies using UVM Medical Center resources, and she audits both professional and hospital billing.  She creates and performs all research billing compliance training for principal investigators, research coordinators, and hospital and professional billing staff in the UVM Health Network. She assists the Chief Compliance Officer, the Compliance Program Staff and Corporate Counsel in their assessment of regulatory and contractual changes by payers and regulators and coordinates responses to government audits.  She has been working very closely with third-party payers in Vermont on research billing requirements and advises on policy for coverage of research items and services.  Denise is a member of the American Academy of Professional Coders and the Health Care Compliance Association.  She is a retired Radiologic Technologist and Cardiovascular Specialist.  Denise has presented both locally and nationally on research billing compliance.


Dr. Lawrence R. Ragard
Senior Study Director, CTSU/WESTAT

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Dr. Lawrence R. Ragard is a physician and Westat Senior Study Director with 15 years of experience in internal medicine and 16 years of experience in medical research.


Dr. Victor M. Santana
Vice President Clinical Trials Administration, Associate Director for Clinical Research at St. Jude Comprehensive Cancer Center, ST. JUDE CHILDREN’S RESEARCH HOSPITAL

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Victor Santana, M.D., is a pediatric oncologist and clinical investigator who has been devoted to developing new experimental treatment approaches for children with high-risk solid tumors, and to acquiring knowledge and expertise in clinical trial design and the regulatory aspects of clinical research for more than 25 years. His scientific interest and research has been in identifying promising new therapies for children with cancer. As a clinical investigator, Dr. Santana has participated as Principal Investigator and Sub Investigator in numerous clinical trials in children with solid tumors and specifically in neuroblastoma. He has successfully administered the clinical component of the peer-reviewed, NCI-funded clinical project of the St. Jude Solid Tumor Program Project grant for more than 15 years, and has been instrumental in translating key laboratory discoveries into the treatment approaches for children with solid tumors and providing direction for continued laboratory investigations. He is a past member of the FDA Pediatric Advisory Committee, and presently serves on the NCI Central Pediatric Institutional Review Board. Dr. Santana is also a scientific advisor to the NANT program project grant, as well as a member of the NCI Cancer Centers Review Committee. Dr. Santana brings specific expertise and experience in drug development and the application of laboratory findings to clinical trials, regulatory oversight and compliance with clinical trials involving children.  His interests in teaching the next generation of clinical investigators and staff is evidenced by his active participation as lecturer in SoCRA Clinical Science Course.


Maria Soliman
Director of Research Administration, CAROLINAS MEDICAL CENTER

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Maria Soliman has more than 20 years of experience in research administration, including proposal development, contract negotiations, budget analysis, advanced operations, clinical research, post-award operations and process improvement. Having worked at a large academic medical center, a research university and a medical innovation company and in healthcare, Maria has a unique perspective and extensive knowledge in a number of faucets of research administration, especially finance. Her specific research experience includes implementing financial management and clinical trial management systems and process improvements, auditing and implementing billing compliance programs, and improving the research billing revenue cycle process. Currently, Maria is the Director of Research Administration at the Levine Cancer Institute (LCI) part of Carolinas Healthcare System. LCI is a 25-site oncology network that spans throughout North and South Carolina providing access to cancer care where patients live. Prior to that, Maria served as the Research Director for the College of Computing and Informatics at University of North Carolina Charlotte, Senior Sponsored Program Officer at The Ohio State University, and Associate Director of the Center of Automotive Research at Ohio State.

Maria holds a Bachelor of Science in business management and economics, with a minor in statistics from The Ohio State University. In her spare time, Maria enjoys watching her daughter play softball throughout the southeast and traveling with her husband.


Rosemary Stefiniw
Manager, Oncology, Pulmonary, Urology and Sports Health Research Data and Outcomes for the Oncology Service Line, ATLANTIC HEALTH SYSTEM

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Ms. Stefiniw attained her Master of Science from Drexel University with a concentration in Research Administration, Bachelor of Science in Business Administration from the College of St. Elizabeth and an Associate of Applied Science in nursing from the County College of Morris. In addition to being a registered professional nurse, she holds certification as a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals and is Certified in Healthcare Research Compliance through the Health Care Compliance Association. She is a member of the Oncology Nursing Society, The Association of Clinical Research Professionals and The Society of Research Administrators. In May 2006, she did a presentation to the Leukemia and Lymphoma Society titled “Participating in Clinical Research.” Additionally, Ms. Stefiniw did a book review for The Journal of Research Administration in August of 2006.

Ms. Stefiniw has worked at Morristown Memorial Hospital, one of the Atlantic Health campuses, for more than 30 years in various nursing capacities. Currently she is the Manager of Oncology Research, Data and Outcomes for Atlantic Health. In this position, Ms. Stefiniw is responsible for implementing and achieving oncology research standards and goals for the organization. She is responsible for making sure that the timelines are met and the staff are well-trained and knowledgeable regarding compliance and procedures. In addition, she provides oversight for all regulatory, nursing and data management activities for adult oncology research conducted with industry and cooperative group sponsored trials.


Theresa “Terry” Stone, BBA
Director, Clinical Trials Office, BOSTON MEDICAL CENTER

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Terry Stone is the Director of the Clinical Trial Office at Boston Medical Center.  She has 10 years of experience in clinical trial contracting (coverage analysis, budgeting, and contract terms and conditions) and billing compliance.  Terry was a senior analyst in the Partners Clinical Trial Office where she managed the training of financial analysts on healthcare billing and performed coverage analysis and budget negotiations for all Brigham and Women’s and Massachusetts General Hospital Cardiology and cardiology device trials.  Just prior to joining BMC she was the Manager of Research Billing Compliance at Brigham and Women’s Hospital where she developed and implemented a broad-based clinical trial audit policy and program.  Her extensive research operations experience was key to her leadership of the implementation of the research functionality in the Epic revenue and clinical system implementation at Brigham and Women’s, Dana Farber Cancer Institute and Faulkner Hospital, while also serving as a research billing subject matter expert for the entire Partners system.  She has 25 years of experience in healthcare billing and administration and is a national speaker on the topics of clinical trial budgeting and research billing compliance.


Candice M. Vance, MBA, CHRC
Senior Manager, Clinical Research Revenue Cycle, MEDSTAR HEALTH RESEARCH INSTITUTE

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Candice Vance is the Senior Manager of Clinical Research Revenue Cycle at MedStar Health Research Institute.  She oversees clinical research billing compliance, coverage analysis, budget negotiation and revenue recognition.  Candice has a background in auditing health systems for billing and coding compliance, and moved into the research realm eight years ago.  She has an MBA and is certified in healthcare research compliance.


David Vulcano
Assistant Vice President and Responsible Executive for Clinical Research, HCA HEALTHCARE

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David is a well-known leader and change agent in the clinical research industry. He was born and raised in New Orleans, Louisiana. He has a master’s degree in social work and business administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). He is the Responsible Executive for Clinical Research for Hospital Corporation of America (HCA). He is and has been in many industry leader roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP). He is also the President of the Nashville Angel Capital Group. He is married with two children and lives south of Nashville, Tennessee where he involves himself in work, family life, and other charitable and entrepreneurial opportunities. David was recently honored with the “Outstanding Speaker” award, presented at the 2015 MAGI West conference.


Kelly Willenberg, DBA, RN, CHRC, CCRP, CHC
President, KELLY WILLENBERG & ASSOCIATES

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Kelly Willenberg is the owner of Kelly Willenberg, LLC. Kelly has a vast array of knowledge and works with a variety of research compliance advocates to meet the needs of her clients. Kelly has an extensive background in clinical trials management and research compliance, including all aspects of billing compliance. She has nearly 30 years of clinical research experience, 15 of which are in billing compliance. She is an experienced oncology nurse and has presented at events held by HCCA, ONS, ASCO, AHLA, MAGI, ExL Pharma and other professional organizations. She helped write the Research Compliance Professional’s Handbook for the Healthcare Compliance Association (HCCA). She also is serving as an editor for the 3rd edition of the ONS Manual for Clinical Trials Nursing and is authoring a variety of chapters in that publication. She is certified in Healthcare Research Compliance (CHRC) and Healthcare Compliance (CHC), and is a Certified Clinical Research Professional (CCRP). For more than 12 years, Kelly worked at Vanderbilt University Medical Center as both the Director of Billing Compliance and as the Director of the Clinical Trials Office for the Cancer Center. She has owned her own consulting business for the past six years.


Marilyn Windschiegl
Director of Clinical Research Contracts and Compliance, PFS CLINICAL

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Attorney Windschiegl is the Director of Clinical Research Contracts and Compliance at PFS Clinical, a company that offers administrative solutions for research. Ms. Windschiegl has more than 30 years of experience in the health insurance industry, including both commercial health insurance and the Medicare and Tricare government benefit programs. Her areas of expertise include health plan operations, training, provider credentialing, health plan and benefit program laws and regulations, coverage mandates, and privacy and security requirements. She holds a B.S. in elementary education from the University of Wisconsin-Madison and a J.D. from the University of Wisconsin School of Law. She is a member of the State Bar of Wisconsin and the Dane County Bar Association, and is the President of the HIPAA Collaborative of Wisconsin.