Faculty – 13th Clinical Trial Billing & Research Compliance Conference


Kelly Anastasio, COC, CPC, CPCO, CPC-I, CLSSGB
Associate Director of Clinical Trial Resources, YALE SCHOOL OF MEDICINE

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Kelly Anastasio is the Associate Director of Clinical Trial Resources, the out-patient research unit, coordinator pool, and recruitment and development. 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, financial management for all industry activity, 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 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, NATIONAL GOVERNMENT SERVICES

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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.


Jenni Bachhofer, CHRC
Research Manager, CANCER SPECIALISTS OF NORTH FLORIDA

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Jenni is the Research Manager at Cancer Specialists of North Florida (CSNF) – a physician owned private practice in Jacksonville, FL and has been with the company collectively for eight years. She received her Healthcare Research Compliance certification in 2015 which jumpstarted her interest in clinical trial billing and overall patient financial toxicities.

In her free time, Jenni can be found spending time with family and her dog, volunteering in the community or traveling.


Chris Bilamu, CPC
Research Coordinator, Revenue Cycle, BON SECOURS MERCY HEALTH

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Chris is the Clinical Research Billing Coordinator, primarily handling all research billing to both payers and sponsors for Bon Secours Health System, Inc. Assisting in all aspects of the revenue cycle, he is the link between the clinical research community and financial operations, including general accounting and finance. With 4 years of healthcare experience and an active member of his local AAPC chapter, he has been an integral part of implementing the clinical trial billing and compliance process at his healthcare system. Chris is a certified professional coder (CPC) and currently seeking to obtain more certifications.


Cynthia E. Boyd, M.D., MBA
VP, Corporate Compliance and Chief Compliance Officer, RUSH UNIVERSITY MEDICAL CENTER

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Dr. Cynthia Boyd serves as Vice President of Corporate Compliance and Chief Compliance Officer for Rush University Medical Center, a role she has held for the past fifteen years. She is responsible for providing direction and oversight of the institution’s Corporate, HIPAA and Research Compliance Program as well as the medical center’s other subsidiaries. Dr. Boyd’s responsibilities include providing awareness, education, direction and support to the Board of Trustees, the Audit Committee of the Board, senior management and Rush staff regarding the prevention and resolution of compliance issues.

In addition to many speaking engagements, Dr. Boyd is nationally recognized in the compliance arena and academic medical institutions for her expertise and knowledge of clinical trial billing compliance. In addition to her speaking engagements, she has published in peer-reviewed journals on compliance related topics. In past years, she has served the Health Care Compliance Association on the Board of Directors and as Chair of the Governance and Ethics Committee. She has also served as a previous Chair of the Forum on Regulation of the Association of Academic Health Centers.

She is a longstanding member of the faculty at Rush University Medical College and currently serves as the dean for admissions and recruitment for Rush Medical College. Dr. Boyd received her undergraduate degree in Biology from the University of Colorado, Boulder and her medical degree from the George Washington University School of Medicine and Health Sciences. She holds an MBA degree from the University of Chicago Graduate School of Business with certification in health administration and policy. She is an associate professor of medicine, a fellow of the American College of Physicians and an inaugural, past fellow of the Carol Emmott fellowship program for women leaders in health.


Michael Brechbuhler
Director — Research Business Services, OHIOHEALTH

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Michael is the Director of Research Business Services for OhioHealth and has been with the institution for the past 2 years.  He has over 16 years of experience in clinical research starting as a clinical research coordinator conducting family practice studies (diabetes, hypertension, acne, etc.). He then moved into research finance with The Ohio State University 2 years later and grew his experience in pre-award, post-award and federal grant finances for all types of trials and projects (oncology, cardiology, neuro, pulmonary, etc). The Research Business Services office currently handles all budget/contract development for industry and IIT studies, pre and post-award finances, billing compliance, federal grant awards as well as research IT for the OhioHealth Research Institute.

Michael enjoys spending time with his family, relaxing on the beach, hiking in the mountains and is an avid bike rider.


Quincy Byrdsong, Ed.D., CIP, CCRP
Executive Director of Research Administration, WellStar Research Institute, WELLSTAR HEALTH SYSTEM

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Dr. Quincy J. Byrdsong is the Executive Director for Research Administration at the WellStar Research Institute for WellStar Health System, the largest Health System in the State of Georgia. Dr. Byrdsong has extensive expertise in providing strategic vision, operational organization and programmatic infrastructure to complex institutions of higher education and healthcare systems. Currently, he functions as the Chief Research Administration Officer with operational oversight of all research administration activity and serves as the liaison to pharmaceutical sponsors and other funding agencies. In his role, Dr. Byrdsong analyzes, evaluates, and develops metrics for all research activity for mission alignment and productivity as well as informs the organizational agenda for research to include areas of strength, areas of opportunity, and areas of growth. He continues to speak to national audiences in the areas of executive research administrative oversight and the establishment of dynamic education programs and curricula for research administration, responsible conduct of research, conflicts of interest, and human subjects protections. Through his career, Dr. Byrdsong has served in several roles in academic medicine and research administration at Virginia Commonwealth University, Meharry Medical College, and Vanderbilt University Medical Center.

Quincy received his bachelor and master’s degrees in biology from Middle Tennessee State University where he became part of the institution’s first cohort of Patricia Roberts Harris Fellows in Biology. He received his Doctor of Education in Curriculum and Instruction at Tennessee State University. He is the Treasurer and a Member of the Board of Directors for the Society of Clinical Research Associates as well as a Member of the Board of Trustees at Monmouth University.


Candy Campbell, DNP, RN, CNL, CEP, FNAP
International Speaker, Award-Winning Actor, Filmmaker, and Author

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Candy Campbell, DNP, RN, CNL, CEP, FNAP, international speaker, award winning actor, filmmaker, and author, works with individuals and corporations to improve interprofessional communication, leadership, and team development.  She is also an assistant professor in the graduate School of Nursing and Health Professions at the University of San Francisco.

Her third solo show and book of the same name, Channeling Florence Nightingale: Integrity, Insight, Innovation, is a character portrayal of that Victorian thought leader. Evidently, Miss Nightingale likes to travel, now that she has a new, “borrowed” body.
So far, she has delighted audiences in several countries.

Campbell co-founded an improv troupe in the San Francisco area and has taught improv to all ages and stages since 1995. Her latest book is, Improv to Improve Healthcare: A System for Creative Problem-Solving. For more information, visit https://candycampbell.com


Kate Cohen, J.D., CHRC, CIP
Research Compliance Director, Office of Corporate Business Integrity, MEDSTAR HEALTH

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Kate Cohen, JD, CHRC, CIP is the Research Compliance Director for MedStar Health. She leads the Research Compliance Program, administered by the MedStar Health Office of Corporate Business Integrity, which supports and promotes ethical research practices throughout the MedStar Health system.

Kate is an attorney licensed to practice law in both Florida and Missouri. She obtained her law degree, cum laude, from Florida International University College of Law in Miami, Florida and her Bachelor of Arts in Latin American Studies from Colgate University. Kate is a native of Kansas City but has lived in a number of different places, including Santiago, Chile. Kate most recently served as the Research Compliance Officer for Saint Luke’s Health System in Kansas City, Missouri. In that role, Kate oversaw the research compliance program and directed the Institutional Review Board, managing the day to day operations of the IRB office, the staff and review of research. Prior to entering the research compliance role, Kate served as the Ethics, Compliance and Privacy Officer for multiple entities within the Saint Luke’s Health System. As the Ethics, Compliance and Privacy Officer, Kate provided general compliance guidance and education and investigated compliance and privacy complaints from staff and patients. Before becoming compliance professional, Kate was the Director of the Medical Legal Partnership within Saint Luke’s Health System, representing indigent patients with the goal of removing legal obstacles to healthcare access. In that role, she represented patients in varied legal areas including access to public benefits, Medicaid denials, Social Security disability benefit denials, domestic violence, divorce and custody, housing issues, and guardianships.


Gina Cravey, BSN, RN, CHRC, CCRC
Clinical Research Manager, HARRINGTON CANCER CENTER

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Gina is the Clinical Research Manager of Harrington Cancer Center in Amarillo, Texas where she oversees clinical trial operations and research compliance. Her responsibilities include study selection and implementation, budgeting, Medicare Coverage Analysis; regulatory, research billing, and good clinical practice compliance. She has over 22 years of experience in healthcare as a Registered Nurse, spending the majority of her career in cardiology and oncology with a dedicated focus in research since 2007. She graduated from Amarillo College with an Associate’s Degree in Nursing, later completing her BSN from West Texas A&M University. Gina’s research experience began in 2002 when she helped coordinate a cardiac-resynchronization trial for patients with advanced chronic heart failure. She loved the rapid changing world of research, and witnessing yesterday’s research translated into tomorrow’s practice, and began working full-time as a research coordinator in cardiology device and drug trials from 2007 to 2010. Since 2010, her role in research has been as a Clinical Research Manager, transitioning from Cardiology to Oncology in 2012.

She maintains certifications in Healthcare Research Compliance (CHRC), and as a Certified Clinical Research Coordinator (CCRC) through Association of Clinical Research Professionals. She currently serves as the 2018 President of the Texas Panhandle Chapter of the Oncology Nursing Society.


Jeannie Cunningham
Clinical Study Manager, W.L. GORE & ASSOCIATES

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Jeannie is a Clinical Study Manager with W.L Gore and Associates and has been in this position for 2 years. Previous to that Jeannie was the Interim Clinical Trials Director who started the Clinical Trials Management office at Greenville Health System. Prior to that Jeannie was the Clinical Research Manager for the Department of Surgery at Greenville Health System. Outside of work Jeannie enjoys traveling and spending time at the ocean and the lake. Reading is also a favorite.


Jessica Derr
CCRC, CRCP, CLINICAL RESEARCH CONSULTING


Lynne Franklin
Persuasive Communication Expert, Speaker, Author, WWW.LYNNEFRANKLIN.COM

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After a boy threatened to kill her with a machete, Lynne Franklin started learning everything she could about persuasion. Now she works with leaders and teams to use persuasive communication to create more connection, confidence and cash flow. Lynne wrote the book Getting Others To Do What You Want, is a TEDx speaker and president of the National Speakers Association Illinois Chapter.


Nancy Howard
Consultant, KELLY WILLENBERG & ASSOCIATES

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Nancy Howard is a clinical research compliance consultant, registered nurse and certified auditor. She provides consulting expertise in areas such as GCP compliance reviews, regulatory auditing, process development, coverage analysis and clinical trial staff training and coordination. She has more than 30 years of health care industry experience. She has acquired clinical research skills in several therapeutic areas as well as regulatory operations, compliance and research finance during her employment at Baylor College of Medicine and Houston Methodist Research Institute while working with internationally known medical and surgical physicians. She has a bachelor’s degree in nursing from Texas Woman’s University located in Houston’s Texas Medical Center. She is certified in both clinical research auditing and clinical research coordinating. She lives in Houston, Texas with her husband and has two adult sons.


Marie Jackson, Ph.D., MBA
Director, Clinical Research Billing, UNIVERSITY OF CALIFORNIA, SAN DIEGO

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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.


Elisha Jastram
Research Manager, SANFORD RESEARCH

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Elisha Jastram is the Clinical Research Manager of Contracts and Budgets at Sanford Health.  Her teams’ primary objective is to successfully complete processes related to coverage analysis completion, clinical trial billing and study budgets.  She has over 10 years of Research Experience including Financial Analyst and Financial Supervisor as well as Director of Research Finance roles, which included tasks from study budget analysis and negotiations to research claims review to the overall department financial status.  She has experience working across multiple therapeutic areas and types of trials including commercially-funded and Investigator-Initiated.    Elisha has a Bachelor’s of Science in Professional Accountancy and maintains an active CPA license through the State of SD.  She lives in SD with her husband and son.   


Heather Kemp
Consultant, Trial Capabilities, ELI LILLY AND COMPANY

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Heather Kemp has over fifteen years’ experience in clinical research; she is currently employed as a Consultant in Global Budgeting, supporting Eli Lilly and Company’s clinical trials portfolio. Prior to this, Heather held positions in research compliance, site operations and budget & contract negotiations; this includes experience conducting research at a public hospital, university and in a private, non-profit health system.


Joanne Krasnoff
Administrative Director, Clinical Translational Research Unit, Charles E. Schmidt College of Medicine, FLORIDA ATLANTIC UNIVERSITY

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Joanne B. Krasnoff, Ph.D. received her M.S. and Ph.D. from Indiana University in Clinical Exercise Physiology.  Dr. Krasnoff has over twenty years of clinical research experience spanning the many roles from Graduate Research Assistant, Clinical Research Coordinator, and Project Director to Program Manager and Operations Manager.  Dr. Krasnoff currently serves as the Administrative Director of the Clinical and Translational Research Unit (CTRU) at the Charles E. Schmidt College of Medicine, Florida Atlantic University.  In this role, Dr. Krasnoff ensures the CTRU provides an efficient and effective environment for the conduct of high quality clinical research and has begun developing a clinical research billing compliance program.


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.

 


Amber Leach, CCRP, B.S., B.A.
Enterprise Director Research Compliance, SANFORD RESEARCH

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Amber Leach is the Clinical Research Enterprise Director of Research Compliance at Sanford Health.    Her teams’ primary objective is to oversee the process for clinical trial billing, budget, study startup, tracking, regulatory affairs and education.  She has 12 years of Research Experience which includes NCI Community Oncology Research Program (NCORP) Administrator, Director of Regulatory Affairs, study tracking and startup, study coordination and Clinical trial billing and budgets.  She has experience working across multiple  therapeutic areas and types of trials including NCORP, Industry sponsored and Investigator Initiated.    Amber has Bachelor degrees in Criminal Justice and Health Services Administration and is a Certified Clinical Research Professional through SOCRA.  She lives in Minnesota with her husband, son and daughter.


Tameika T.F. Lewis, MD, FACOG
Contractor Medical Director Medicare, WPS GOVERNMENT HEALTH ADMINISTRATORS

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Dr. Lewis is a board-certified obstetrician and gynecologist, author, and publisher
(www.thechristianmanifestobook.com). In July of 2010 she relocated to Orlando from
Greenville, South Carolina, where she was an active member of the South Carolina Medical
Association. She is also a member of several other professional societies, including the
Florida Obstetric and Gynecologic Society, the American College of Obstetrics and
Gynecology, the Society of Laparoendoscopic Surgeons, and the American Association of
Gynecologic Laparoscopists.

She received her training at some of the top universities in America, including her
undergraduate degree from Duke University and her medical degree from the Medical
University of South Carolina in Charleston. Subsequently, she completed her residency in
obstetrics and gynecology at Greenville Hospital System University Medical Center where she
won several awards, including the Society of Laparoendoscopic Surgeons Resident
Achievement Award for excellence in endoscopic surgery, two years in a row.

Because public health and giving back are important to her, Dr. Lewis has devoted much of
her time to speaking at engagements such as the State Farm Minority Health Summit
regarding topics such as sexually transmitted diseases, and volunteering as the Medical
Director for the First Baptist Pregnancy Center. She enjoys providing total care to the female
patient, and has particular interest in low risk obstetrics, family planning, treating abnormal
uterine bleeding, menopausal symptoms, aesthetics, and performing procedures in the office
such as tubals and ablations.

She and her husband Kevin Lewis, an Orlando native and retired NFL linebacker for the New
York Football Giants, returned to Florida to be close to family after the birth of their newborn
daughter, Kallie Lewis. Some of Dr. Lewis’s personal interests include travel, art, dance, fine
dining, physical fitness, reading, watching reality television shows, and spending time with
her family.

Dr. Lewis believes it is an honor to be your physician, and that that caring for patients is her
ministry. It is her goal to provide excellent patient care in a loving and compassionate way,
and to make sure that her patients understand their treatment plans. She works out of the
Lake Mary and Hunter’s Creek offices and holds hospital affiliations at Winnie Palmer Hospital
for Women & Babies.


Chris Longspaugh, Pharm.D.
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.


Pam Lowery
Director, Clinical Research Finance, PFS CLINICAL

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Pamela Lowery has over 24 years of accounting experience including 15 years of experience in clinical research, gained from previous employment with research sites and financial services organizations. Pamela joined PFS Clinical in 2010 and currently serves as Director of Clinical Research Finance. In this role, she manages a team that is responsible for tracking receivables, invoicing, reconciling grant payments, factoring and financial reporting for nearly 1,200 clinical research studies. Prior to joining PFS Clinical, Pamela headed the Site Services division of Clinical Financial Services. In this role, she was responsible for tracking and reconciling payments for research sites, as well as managing that organization’s clinical research receivables factoring activities. Prior to working for Clinical Financial Services, Pamela served as controller for Neeman Medical International, a contract research organization that supported clinical research activity. Pamela has presented at many research conferences and has moderated numerous webinars of the topic clinical trials revenue cycle management. 


Justin B. McGoldrick
VP of Research, BON SECOURS MERCY HEALTH


Ryan Meade, J.D.
Director, Center for Compliance Studies, LOYOLA UNIVERSITY OF 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.


Stacey Medeiros, CHRC
Research Support Services, PROVIDENCE ALASKA MEDICAL CENTER

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Stacey is the Manager of Research Support Services for Providence Health & Services Alaska and has been with the institution for the past 18 years.  She has over 20 years of work experience in Health Care Administration including Healthcare Research Compliance, Pharmacy Coordination, Quality Management, Medical Device Research and Development and Health Promotions Programs.  Stacey has developed a close working relationship with Noridian and other experts in the field of research billing compliance.  Stacey is certified as a Healthcare Research Compliance Professional.
 
She enjoys spending time with her family and being in the outdoors as well as crocheting and quilting.


Maureen Mieczkowski
Director, Office of Clinical Trials, GREENVILLE HEALTH SYSTEM

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Maureen Mieczkowski is the Director of Clinical Trials Research at the Greenville Health System in Greenville, South Carolina. Maureen has more than ten years of experience in research administration, including IRB management, clinical trial budgeting, contracting and operations. In her current role, Maureen has primary responsibility for research billing compliance and financial management. She is leading initiatives to expand research support infrastructure and streamline operations to support the efficient and compliant conduct of research at a growing academic health center. Primary areas of interest include leveraging and integrating technology solutions including EHR, clinical trial management systems and project management tools.


Diva Miliáns
Senior Manager, Clinical Trial Reimbursement, HE&R Department, ABBOTT

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Diva has a tremendous passion for her work, colleagues, sites, and most importantly, patients! Her patient- centric focus and dedication to her craft are the driving force for her role as her function directly impacts the ability for patients to participate in our clinical trials.

Diva has spent her professional career in the healthcare industry, starting in the VA Hospital System as a research assistant. From there, she worked at hospitals such as MD Anderson Cancer Center, Memorial Hermann and The Methodist Hospital. Fast forward to now, Diva serves as Senior Manager of Clinical Trial Reimbursement where she ensures appropriate coding, billing, and reimbursement for IDE clinical trials across all therapy areas. Diva has an Associate’s in Healthcare Administration and a Bachelor’s of Science in Accounting.

Diva lives in Texas on a quiet rural ranch, with her fives dogs, “Ruby, Daisy, William, Robert and Hazel”. She has a passion for cattle and raises registered Texas Longhorn. When not being a cowhand and caring for the herd, she enjoys traveling to Mayan archeological sites climbing ruins.


Christine Nelson
Director, Office of Clinical Trials, NORTH CAROLINA AT CHAPEL HILL

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Christine is a self-directed, results focused Senior-level Director of Clinical Trials with extensive experience and background in the executive oversight of clinical trial operations and compliance, including implementing systems and programs to support clinical trials. An effective leader with the ability to build teams across departments and divisions. Continuously exploring opportunities to improve processes and support standardization. As the Director for the Office of Clinical Trials at the University of North Carolina at Chapel Hill she works across the research community to facilitate and streamline the startup, conduct and administration of clinical trials.


Suzanne Nicholl 
Senior Account Manager, BIO-OPTRONICS, INC.

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Suzanne Nicholl is a Senior Account Manager with Bio-Optronics and has been working in the Clinical Research industry for almost 20 years specializing in clinical research management and helping large site networks and health systems streamline their overall research efficiencies. She has a PhD in Cardiovascular Pharmacology and is a certified CRA. Suzanne strives to help deliver best practices that utilize technology to research organizations around the world. More personally, Suzanne enjoys traveling to her home in Ireland, martial arts and spending time with her two children.


Al Peters
Managing Partner, GUIDESTAR RESEARCH

President, BTC NETWORK

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Al Peters is the Co-Founder of Clin-X, LLC, the parent company to ClinEdge, BTC Network, and GuideStar Research. Day to day, Al serves as the President of BTC Network, Vice President of ClinEdge, and Managing Partner of GuideStar Research. He is also an investor in RealTime.

Al is dedicated to creating a new site services category that would help streamline operations at the institutional level and provide increased trial access to patients. Al is not only known for his notable leadership achievements, he is also known for spotting inefficiencies in the currently fragmented site space, which has helped contribute to the business strategy and new service category that Clin-X represents.

Al has been involved in the clinical research industry since 2002. Prior to devoting his work full time to Clin-X, he founded three private research sites where he oversaw daily operations. In 2010, he co-founded ClinEdge and then later. BTC Network. Since their inception, the companies have grown to be a leader in the clinical trial services space, contributing to the disruption of the current network and site model. The companies provide site- and patient-centric services, such as pipeline development, patient recruitment, centralized financials services, a fully integrated network of research Intuitions, and more.

Looking forward, Al hopes to continue to contribute innovative ideas and improve efficiencies at the site level.

Al currently resides in Southeastern Massachusetts. His “stay positive” attitude has always proven helpful through his personal and professional career.


Roslyn Pierce
Manager, Oncology Research Program, INSTITUTE FOR RESEARCH AND INNOVATION, MULTICARE HEALTH SYSTEM

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Roslyn Pierce, BS is the Manager of Oncology Research for MultiCare’s Institute for Research & Innovation (MIRI). MultiCare is a nonprofit health care organization with more than 16,000 employees, and a family of brands that includes Mary Bridge Children’s, Immediate Clinic, MultiCare Indigo Urgent Care, Navos, Pulse Heart Institute and MultiCare Connected Care, our Accountable Care Organization. Roslyn is responsible for the daily operations management of the Oncology Research Program. Her primary responsibilities include ensuring quality performance for multiple and increasingly complex clinical projects across various research areas, clinics, and hospitals in the MultiCare Health System.   
 
Roslyn has spent the past 10 years working in various aspects of the research enterprise including NIH, DOD, Pharma-Sponsored, and privately funded projects administered in both the civilian and military sectors. She is currently attending Boise State University, enrolled in their Master of Business Administration program.


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, Office of Compliance and Privacy, 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. 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. Denise is a member of the American Academy of Professional Coders and the Health Care Compliance Association.


Anne Reedy
CRA Executive Director, MULTICARE INSTITUTE FOR RESEARCH AND INNOVATION

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Annie Reedy, MBA, CRA is the Executive Director for MultiCare’s Institute for Research & Innovation (MIRI). MultiCare is a nonprofit health care organization with more than 16,000 employees, 8 hospitals and a family of brands that includes Mary Bridge Children’s, Immediate Clinic, MultiCare Indigo Urgent Care, Navos, Pulse Heart Institute and MultiCare Connected Care, our Accountable Care Organization. Annie serves as the research operations executive for the research institute that promotes and supports research throughout the healthcare system and in community practices supported by MIRI. She is responsible for leading the research business enterprise, policy development, and operations related to research conduct and administration in both the Puget Sound and Inland Northwest regions. 
 
Annie is an experienced research administrator and non-profit leader with over 20 years’ experience in the industry specializing in medical research, drug and device clinical trials, grant writing, project and award management, and research operations. She is a member of the Society for Research Administrators International and Health Care Compliance Association.


Elizabeth Rodríguez, M.S., RHIA, CHP
Associate Director, Office of Clinical Research Billing Compliance, (Formerly CRB&QA), JOHNS HOPKINS MEDICINE

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Elizabeth “Liza” Rodriguez currently serves as the Associate Director for the Office of Clinical Research Billing Compliance for Johns Hopkins Medicine. She has a degree in Health Information Management from Boise State University and advanced degrees in Health Care Administration and Human Resources from Wilmington University; in addition, she completed a graduate certificate in Health Care Informatics from Johns Hopkins University. Liza has worked in the Health Care field for over 20 years in different capacities such as billing, medical records, coding and documentation audits, and heath care compliance. She holds the credentials of Registered Health Information Administrator (RHIA) and Certified in Heath Care Privacy (CHP) from the American Health Information Association (AHIMA.)

Liza has been involved in the development of processes related to clinical research billing compliance for Johns Hopkins since their inception in 2006.


Tana Smith, RN, BSN
Manager, Budgets and Contracts, VANDERBILT INGRAM CANCER CENTER

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Tana is the Manager of Budgets and Contracts for the Clinical Trials Shared Resources at Vanderbilt Ingram Canter Center. Her responsibilities include oversight of coverage analysis and study budget and contract negotiations. She started her career 19 years ago in the cancer center as a research nurse. After taking an extended leave to spend time with her family she returned to the cancer center in 2012 as part of the budgets and contracts team. Over the last few years, as manager of this team, Tana was tasked with developing improved billing grids, developing a process for charge reconciliation, and establishing a coverage analysis team. Tana has a Bachelor’s of Science degree in Nursing. She is also a mom to five active children.


Gerald Warren
Research Billing Specialist, MULTICARE INSTITUTE FOR RESEARCH AND INNOVATION

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Gerard Warren is MultiCare Health System’s Research Billing Specialist. After 10 years of medical billing experience, he joined MultiCare’s Institute for Research & Innovation.  In this role, Gerard has helped to establish a compliant research billing platform across the research enterprise. On a daily basis, Gerard is responsible for notifying payers of research enrollments, interfacing with pre-service center for pre-authorizations, research billing review and corrections, and research related denials. He also has established a platform for CED claim review and processing using Epic’s research module. Gerard serves as a liaison between the research institute, IS&T, and revenue cycle.


Kelly Willenberg, DBA, RN, CCRP, CHRC, 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.