Speakers

Marlon Abrazado

Lead Outpatient Principal Trainer
UCLA Health

Marlon Abrazado is the Lead Outpatient Principal Trainer at UCLA Health IT. Marlon manages the research training portfolio for UCLA’s research community. He has nearly 20 years of experience in clinical trials and academic research and joined the Informatics Training team in 2015 to train new research staff and faculty on the use of research applications at UCLA. He is passionate about eLearning development to enhance and supplement learning.

Sessions

• Simulation-Based Proficiency Tests for Training

Chad Adams, MPH

Associate Vice President, Research & Chief Operational Officer
HonorHealth Research Institute

Chad Adams has more than 25 years working in healthcare operational management of which 20 years have been in research. His experience, combined with a broad background in operational management in healthcare administration, with specific training and experience in integrating technology in addressing gaps that act as barriers to successful portfolio performance of clinical trials. Mr. Adams actively participates in advisory boards for multiple industry organizations and actively helps build research organizations. Mr. Adams brings a high level of analytical skills, combined with novel approaches, to his current role as AVP within HonorHealth and COO of the HonorHealth Research Institute.

Sessions

• Retaining Staff through Structured Environmental Change

Jonathan Aguilar

Sr. Research Quality Coordinator
The University of Texas MD Anderson Cancer Center

Jonathan Aguilar is a Sr. Research Quality Coordinator for the Office of Clinical Research at the University of Texas MD Anderson Cancer Center. He joined MD Anderson in 2014 and currently serves as an educator training research personnel on various responsibilities regarding managing participants in clinical trials. He has experience in oncology research, HIV research, cardiovascular research, and basic science research. He has worked in academia and government settings for the City of Houston Department of Health and Human Services, UT Southwestern, and Baylor College of Medicine. Privately: Husband and father to a one-year-old daughter. He loves hiking, food, and traveling.

Sessions

• A Blended Approach: Instructor-Led Training & Custom eLearnings for Large Scale Implementations

Bishoy Anastasi

Director, Clinical Research Finance, UCLA Dean’s Office of Clinical Research / CTSI
Research Academy

Bishoy Anastasi, Director of Clinical Research Finance at UCLA’s Dean’s Office of Clinical Research and CTSI. Bishoy is regarded as a national clinical research subject matter expert, particularly related to research operations, coverage analysis, research pricing & financials, as well as clinical research billing compliance. In addition to co-authoring UCLA’s coverage analysis and research pricing policies, Bishoy brings over 20 years of clinical research operations and management experience.

Sessions

• Coverage Analysis Certification™

John R. Baumann, PhD

Associate Vice President for Research Compliance
Indiana University

John R. Baumann, Ph.D. is the Associate Vice President for Research Compliance at Indiana University, including all 7 campuses and affiliated hospitals. He earned his Ph.D. in Sociology from the Graduate Center of the City University of New York. He is a site visitor – and former member of Council of Accreditation -- for AAHRPP and chairs the social-behavioral IRBs of National Development and Research Institutes and American Academy of Family Physicians. Previously, Dr. Baumann was Vice Provost for Research at University of Missouri – Kansas City and Deputy Executive Director of NDRI, a research institute in New York City with a primary focus on substance abuse, HIV/AIDS, and related social problems.

Sessions

• Supporting DEI Recruitment Efforts in Clinical Trials

Tia Bly

Manager of Study Architecture
CCT Research

Tia Bly is the Manager of Study Architecture at CCT Research. Tia has worked in clinical research for 8 years, specializing in source document creation for both paper and electronic source. She joined CCT Research 2 years ago where she originated the Study Architect role, eventually developing the Study Architecture department, which builds the electronic source and study builds for all studies performed at CCT. Tia lives in Arizona with her husband and dog, Amelia, and loves board games and drawing.

Sessions

• A CTMS and Beyond: Implementation Strategies Across Applications

Sharmila Bristol

CTO
Javara

Sessions

• What’s workflow got to do with it?

Susie Brown

OnCore Coordinator
University of Arizona

After over 20 years as a special education teacher, Susie returned to school in 2015 to obtain her degree in Clinical Research Coordination. In 2018, Susie started as the Sarcoma and Lung Cancer CRC at the University of Arizona Cancer Center. During her time at UACC, she worked closely with OnCore Coordinator, Wendy Chmara, and discovered an affinity for OnCore. With Wendy’s encouragement, Susie moved to University of Arizona Health Sciences Research Administration as an OnCore Coordinator in February 2020. Susie loves being part of the OnCore Team and the greater Research Administration Team as the OnCore Subject Management SME.

Sessions

• Best Practices for Calendars and Financials

Cheryl L. Byers, MHA, CIP, CHRC

VP & Principal Institutional Research COE
Advarra

With over 20 years’ research compliance experience, Cheryl Byers is an expert in human subject research. She has provided oversight to research compliance programs such as pre-clinical testing, conflict of interest, HIPAA Privacy, research misconduct, institutional biosafety, radiation safety, export control, and facility security. Byers is a former AAHRPP site visitor and step 1 reviewer; is certified in healthcare research compliance; and is a certified IRB professional.

Sessions

• Supporting DEI Recruitment Efforts in Clinical Trials

Tiffany Danielle Chisholm Pineda

Assistant Director, Clinical Research IDEA Chair, Diversity and Cultural Competence Council
University of Florida

Tiffany Danielle Chisholm Pineda was born in Philadelphia, Pennsylvania. She is a poet, comedian, author, orator, radio personality, educator, and writer. Walking on fire thirteen times prepared her to the mother of three amazing children Gregory II, Courtney, and Noah. Tiffany Danielle graduated from the University of Florida in Gainesville where she still resides with her family. She holds certifications in Minority Mentorship from the University of Florida; Cultural Competence from Albany State; and Diversity, Equity, and Inclusivity in the Workplace from University of South Florida. Tiffany Danielle has created a certification for Obtaining Consent for Research Participation with an emphasis on cultural competence and many other trainings related to diversity, equity, and inclusivity. She is the Chair and co-founder of the University of Florida’s Clinical and Translational Science Institute’s Diversity and Cultural Competence Council known as DC3. Tiffany Danielle is an Assistant Director for Inclusivity, Diversity, Equity, and Access at the University of Florida where she has been blessed to work in various positions for over 25 years including having been an Institutional Board Member for almost a decade. She has been a Board Member of Kids n Capes a non-profit dedicated to protecting children for over five years.

Sessions

• Co-Mentoring: The Circle of Success

Wendy Chmara

OnCore Coordinator
University of Arizona

Wendy Chmara received her BS degree from Brigham Young University Hawaii in 1993. She started working for the University of Arizona Cancer Center in October 2015 as a Budget Analyst. This role transformed from Budget Analyst to OnCore Coordinator, a role which included building calendars, entering in financials, creating eCRFs, and training CRCs. As OnCore went Enterprise-wide at the university in 2020, Wendy transitioned to University of Arizona Health Sciences Research Administration to support the institutional implementation of OnCore. Wendy's strong skill set continues to shape and mold the direction of OnCore at a higher level.

Sessions

• Best Practices for Calendars and Financials

Kathy Cole

Sr. Director, eClinical Solutions
Javara

Sessions

• What’s workflow got to do with it?

Briannna Cooney

Solutions Consultant
Advarra

Brianna Cooney is a Solutions Consultant, working predominately with prospective clients, helping them better understand our technology solutions and how it can best benefit their organization. Having been with the company for a year and a half, she specializes in products such as Clinical Conductor CTMS, Advarra eReg, and Advarra eConsent. She comes to Advarra with a background in Sales, Implementation, Exercise Science, and Theatre. In her spare time, she enjoys road biking, running, sculling, and cross-country skiing.

Sessions

• Advarra Solutions Overview for Clinical Conductor Customers: Getting the Most out of Onsemble

Stuart Cotter

Director, Product Management
Advarra

Stuart Cotter is the Vice President of Product Management at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Cotter also leads the Advarra Site-Sponsor Consortium, helping to seamlessly connect site and sponsor technology by addressing key data and process inefficiencies across the clinical research ecosystem.

Sessions

• Advarra Site-Sponsor Consortium Meeting (Invite Only)

Jana Dock

Director of Business Operations
Mercy Research

Jana holds a Bachelor’s Degree in Accounting and is a Certified Public Accountant. Her career with Mercy Health began in 2002 in Springfield, MO, serving in Finance in various positions over the course of over 15 years before transitioning to Mercy Research. Since January 2018, Jana has served as the Director of Business Operations for Mercy Research, overseeing CTMS management and reporting, study start-up, physician compensation, financial management for clinical trials, grant management, and business & financial metrics.

Sessions

• Ensuring Congruency Between Clinical Study Documents
• Using Feasibility to Select the Best Studies for your Organization

Tonya K. Edvalson, MHA, CCRP, CHRC

Operations Manager
University of Utah

Tonya Edvalson has worked in research operations for over 20 years, most recently as the Operations Manager in the Clinical Research Support Office (CRSO) at the University of Utah. She coordinated the OnCore CTMS implementation from the cancer center to enterprise-wide that went live in April 2022. She has experience in human subjects protection, protocol and billing compliance, and research study management. Tonya has completed certifications in clinical research, compliance, and recently completed her master’s degree in healthcare administration.

Sessions

• One Year Later: What Just Happened with OnCore and Epic Research?
• Adaption through Adoption: Modifying Teaching Tactics to Build an Effective Virtual Training Program
• Staffing: Who, What, When, How?

Becca Ennis

Manager, Analytics & Reporting
Advarra

Becca Ennis is currently the Manager of Analytics and Reporting at Advarra. She has previously held various roles across the support and engineering teams that have given her a depth of insight into the reporting needs of Advarra’s site customers. She is excited to share what is being built in the new Advarra Data and Analytics platform and demo how it will take Advarra reporting to the next level.

Sessions

• Reporting and Data Analytics using the Advarra BI Tool

Angelena Fiorito

Solutions Consultant
Advarra

Angelena Fiorito is a Solutions Consultant at Advarra who specializes in providing product demonstrations of Advarra technology solutions. After graduating from Georgia Tech with a degree in Biology, she joined the physician contracting team for a major hospital in Atlanta. She most recently worked as an analyst at a healthcare non-profit, whose mission was to improve the safety, quality, and cost-effectiveness of care. Her experience across multiple realms of the healthcare industry has helped her to better serve her clients in understanding their unique needs and the nuances of the healthcare in the US.

Sessions

• Advarra Solutions Overview for OnCore Customers: Getting the Most out of Onsemble

Jill Frank, MS

OnCore Administrator
University of North Carolina

Jill Frank, MS, is the OnCore Administrator for Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill. Jill is responsible for application administration of OnCore for oncology studies providing user support, system training, report writing, and system integration development. Additionally, she provides user support to help optimize operational procedures. In previous roles, Jill developed and maintained research databases, wrote reports leveraging SAS and SQL, managed research projects, provided system troubleshooting, and developed application training for end users. In addition to her day job, Jill lives on a farm, enjoys baking, antiquing, designing houses, and supporting her kids.

Sessions

• Leveraging Advarra University Training

Ariel Gaede

Clinical Systems Administrator
CCT Research

Ariel Gaede is a Clinical Systems Administrator at CCT Research.  She has been working for the last 10 months on implementing Clinical Conductor CTMS, eSource, and eReg at this company and draws from her 6 years of experience in Clinical Conductor CTMS, 5 of those years as a study builder in CCE.  In her spare time, Ariel is an avid reader and lives in Arizona with her Border Collie mix and German Shepherd, Jax and Jesse.

Sessions

• A CTMS and Beyond: Implementation Strategies Across Applications

Marlyn Galindo

Associate Director of Accounting and Finance
University of Utah

Marlyn has been in clinical research for the past eight years, where she has gained an extensive knowledge of research finance in both the pre and post award areas while working at Huntsman Cancer Institute.  She used both the OnCore and Epic systems and understands the impact these have on clinical research patient billing.  Marlyn joined the Clinical Research Support Office team in 2021 where she has been able to use her knowledge to support the OnCore Enterprise rollout that has been live since April 2022. Marlyn is a native to Florida and now resides in Utah.

Sessions

• One Year Later: What Just Happened with OnCore and Epic Research?

Aidan Gannon

Senior Director, Client Services
Advarra

Aidan has over 20 years’ experience in clinical research, having managed global studies from both the sponsor and CRO perspective. Aidan’s particular passion is to make conducting and participating in clinical trials a less burdensome experience for site staff, and patients, their families and caregivers. As Senior Director of Client Services and Innovation at Advarra, Aidan guides development and adoption of the Longboat Platform, providing study resources and centralized integrations to support and empower trial participants, site staff, study monitors, and the extended study team. Aidan also is an active member in Advarra's Site-Sponsor Consortium, a group consisting of research site, sponsor, CRO, and data standards leaders, aiming to make clinical trials smarter and more efficient by integrating clinical research site and sponsor technology.

Sessions

• What Makes a “Sponsor of Choice?” - Critical Criteria to Consider
• Realities of Sponsor-Mandated Technology: Subtraction through Addition
• Site-Sponsor Panel: Patient Recruitment Strategies That Work (Invite Only)

Bridget Graves, PhD

Higher Ed Consulting Manager
Huron Consulting Group

Bridget has over 26 years of leadership and technical experience in clinical trials management systems, life science automation, and software design. She focuses on assisting higher education and academic medical centers with clinical research system implementations and integrations, system selection and design, program evaluations, and process improvement. Prior to joining Huron, Bridget was the System Architect for the University of Virginia (UVA) Cancer Center and an Assistant Professor in the UVA Department of Public Health Science. Prior to UVA, she was the VP of Technology and Chief Operating Officer of Biophile Inc., a manufacturer of robotic equipment for drug discovery and genomics research. She holds four patents for robotic laboratory equipment.

Sessions

• Integrating Oncore and Advarra eReg with Huron’s IRB

Gina Green-Harris, MBA

Director
UWSMPH Center for Community Engagement and Health Partnerships in Milwaukee (CCE)

Ms. Green-Harris is the inaugural Director of The UWSMPH Center for Community Engagement and Health Partnerships in Milwaukee (CCE). CCE is a newly created center to advance research in the African American community in a culturally inclusive manner. Ms. Green Harris is also the director for Life Course Initiative for Healthy Families (LIHF) and the Wisconsin Alzheimer’s Institute Regional Milwaukee office UW for the Wisconsin Alzheimer’s Institute’s (WAI) Regional Milwaukee Office. In these roles, she provides leadership and governance to design to develop and implement new and innovative research and community engagement programs using Asset Based Community Engagement (ABCE) to increase research, education, outreach services, programs, and resources that involve African Americans using culturally appropriate methods.

Sessions

• General Session: Guest Keynote

Natalie Hellmer

Program Manager
Advarra

Sessions

• Successfully Navigating Change Management at Your Site

Cassie Hemmann,CPTD

Training Specialist
Advarra

Cassie has worked in learning and development for 15 years, earning her Certified Professional in Talent Development (CPTD) from the Association for Talent Development (ATD) in 2009. Prior to working for Advarra, Cassie spent almost 20 years at The Walt Disney World Resort® in Orlando, Florida working with training and documentation for various Lines of Business spanning Merchandise to Animals, Science, and Environment. Cassie believes building a learning culture will create a solid foundation for all training and key change management events at institutions of any size.

Sessions

• OnCore 101
• Advanced OnCore CTMS Topics

Laura Hilty

VP, Strategy
Advarra

As Vice President of Strategy, Laura leads efforts to create efficiencies for all stakeholders in the clinical research landscape through Advarra solutions and external partnerships. In her eleven years with Advarra, Laura has worked with customers and community members to grow the company’s range of services that address inefficiencies within the clinical research industry, as well as launching several products. Given the many years working with research sites in depth and seeing the challenges they face on industry studies in particular, she is passionate about bringing together multiple stakeholders to collaborate in industry-wide efficiencies across sites, sponsors, CROs, the IRB and participants.

Sessions

• Intro to Advarra API Partnerships

Julie Holub, MBA, CCRP

Assistant Director, Clinical Trials Project Management
Yale University

Julie Holub has worked in the field of clinical research 2008 when she joined Yale as a research assistant. In these early positions Julie's interest in research administration grew and she obtained an MBA in 2021. In her current position at the Yale Center for Clinical Investigation as the Assistant Director of Clinical Trials Project Management, she works on a wide variety of studies helping PIs navigate the regulatory requirements of investigator-initiated research and multi-center trials. Julie has expertise in FDA regulated, investigator- initiated, multicenter clinical trials, including regulatory document maintenance for Sponsor-Investigator’s at Academic Medical Centers.

Sessions

• eTMF: Leveraging workflows in eReg for electronic Trial Master File maintenance

Ange-Lisa Jalovec

Sr. Director Clinical Systems
CCT Research

Ange-Lisa Jalovec is the Sr. Director Clinical Systems at CCT Research where she is currently leading implementation efforts of Clinical Conductor CTMS and other Advarra applications such as eReg and eSource across the organization. Ange is an RN and has over 20 years of experience in the clinical research site organization industry with 16+ of those years using, managing, and implementing Clinical Conductor CTMS. Ange lives in Arizona and in her spare time she loves watching ice hockey and creating flowers from crepe paper.

Sessions

• A CTMS and Beyond: Implementation Strategies Across Applications

Kathryn Kartalis

Executive Director, Clinical Research Data and Technology
Roswell Park Comprehensive Cancer Center

Kathryn Kartalis is an IT professional with almost 20 years of overall technical experience. She began her career as a software developer and has continued to grow by integrating multiple business operations using creative technical solutions. Kathryn has been involved with clinical research for 5 years and has assisted with the implementation of several software solutions including Advarra’s OnCore, EDC, and eReg. She has led the Roswell Park Clinical Research Services department through a digital transformation using data analytics, data transparency, and integration between various applications (including Advarra applications and Huron’s Click IRB application).

Sessions

• Integrating Oncore and Advarra eReg with Huron’s IRB

Marmee Lutz

Product Manager
Advarra

Marmee Lutz is the Advarra eReg Product Manager. She works with our Advarra eReg customers and internal development team to find solutions that help our customers streamline their workflows and processes. Marmee has been part of the Advarra team for more than 6 years, and has been instrumental in the ongoing evolution of the eReg system, facilitating the development of capabilities such as Review Sessions, Multi-Site Protocols, and email integration.

Sessions

• Customer Collaboration Session: Advarra eReg

Mariette Marsh, MPA, CIP, CHPC, CHRC

Assistant Vice President, Regulatory Affairs & Safety
University of Arizona

Mariette Marsh is the Assistant Vice President, Regulatory Affairs & Safety, at the University of Arizona. She has oversight of the Human Subjects Protection Program (IRB), Institutional Animal Care & Use Program (IACUC), HIPAA Privacy Program, Quality Program, Embryonic Stem Cell Research Oversight (ESCRO) Committee, Radiation Laboratory Safety Services and Occupational Health. Mariette has over 20 years of experience in higher education administration. She has extensive experience with all compliance offices. Mariette holds a master’s degree in public administration from University of Missouri-Columbia and has certifications in IRB regulations (CIP), HIPAA Privacy (CHPC), and hospital research compliance (CHRC). She serves as a site reviewer for the Association of Accreditation of Human Research Protection Programs (AAHRPP) and as a consultant helping minority-serving institutions build research capacity.

Sessions

• Supporting DEI Recruitment Efforts in Clinical Trials

Nicole Mason

Director, Office of Clinical Research (OCR)Clinical & Translational Science Institute (CTSI)
University of Rochester

Nicole Mason, MS, CIP, is the Director of the Office of Clinical Research at the University of Rochester Clinical and Translational Science Institute with an extensive professional background in clinical care, research and regulations. She is a Certified Internal Review Board (IRB) Professional with over 17 years of research experience and is skilled in clinical research compliance, management, design, and administration. She holds a master's degree in Management and Leadership as well as a certificate focused in Workshop Leadership from UR Simon School of Business at the University of Rochester.

Sessions

• Using Feasibility to Select the Best Studies for your Organization

Jen Mead

Senior Director, Customer Success
Advarra

Sessions

• Getting the Most Out of Onsemble - eClinical Solutions Overview
• Advarra Solutions Overview for OnCore Customers: Getting the Most out of Onsemble

Amy Mirabella, PhD, RN, CHPN

Director, Clinical Research Operations
HonorHealth Research Institute

Dr. Amy Mirabella has been a nurse for 30 years and is currently the Director, Clinical Research Operations at HonorHealth Research Institute in Arizona. Prior to taking on the role of Director, Amy spent 6 years as an oncology research nurse and educator within the research institute. Amy has also served as PI on 3 supportive care studies and currently co-leads the Health Literacy Committee within the Research Institute. Amy has a passion for education, and you can find her in classrooms teaching colleagues about health literacy, precepting, mentoring, and end of life care.

Sessions

• Retaining Staff through Structured Environmental Change

Chris Mulhern

Solutions Consultant
Advarra

As a Solutions Consultant Chris works with current and prospective Advarra customers to understand their organizational needs and identify pain points in their current workflows that could be alleviated by Advarra’s technology solutions. He specializes in providing in depth demonstrations of Advarra OnCore, EDC and eReg solutions.

Sessions

• Getting the Most Out of Onsemble - eClinical Solutions Overview

Catee Mullen, MS, PA-C

Director of Research Operations
Duke University School of Medicine

Catee began her career in clinical research as a Physician Assistant acting as a Sub Investigator for clinical trials in Viral hepatitis at Metropolitan Liver Disease/Gastroenterology Center in Fairfax, VA. She joined Duke in 2006 and has held several positions including Clinical Trials Manager, Lead CRA, Research Practice Manager, and the Director of Clinical Research Financial Management. Catee’s current role is the Director of Clinical Research Operations focusing on Study Start up, Conduct and Closeout. In this role, Catee oversees the teams responsible for OnCore, OnCore Financials budgeting, Coverage Analysis, Charge Review and the Epic Analysts for Research.

Sessions

• Now Hiring: Good Humans

Carrie Nemke

SVP, Customer Relationships
Advarra

Carrie Nemke brings nearly 20 years of experience in healthcare, clinical research, and sales to her role as Senior Vice President of Customer Success at Advarra. In this role, she oversees the customer success activities for Advarra Technology Solutions.With a background in healthcare and clinical research, Nemke brings an understanding of research operations to the customer journey and relationship development process. The customer success team focuses on a consultative approach to understand customer priorities, working across our internal teams to ensure customers’ commitments are fulfilled.Prior to Advarra, Nemke worked in clinical research at a small medical device company and was a physical therapist specializing in neurological rehabilitation in the Madison, WI area. Nemke holds her MPT of Physical Therapy and BS in Kinesiology from the University of Wisconsin-Madison.

Carissa Pelstring

CTMS Business Analyst
Seattle Children's Research Institute

Carissa is an experienced operations and process improvement specialist with a diverse background. She has been at Seattle Children's Research Institute for 2 years and is currently the Business Systems Analyst part of the Clinical research Support Office, where she is primarily responsible for driving the implementation OnCore and integration with Epic and Click IRB existing data. She enjoys making complex processes simple and accessible for all stakeholders. Previously, she served as a US Peace Corps Volunteer on a remote island in Fiji working as a youth development and climate resiliency resource for rural communities. When not writing process docs, she enjoys walking her dog, Bananas, on local trails, traveling internationally, and practicing aerial acrobatics.

Sessions

• Integrating Oncore and Advarra eReg with Huron’s IRB

Erin Pennington

Higher Ed Consulting Director
Huron Consulting Group

Erin has more than 25 years of experience as a clinical research professional with experience managing large-scale clinical trial offices at both NCI-designated Cancer Centers and across an Academic Medical Center. Her expertise includes Research Billing Compliance, Clinical Trial Management System and eRegulatory Implementations and integrations, and Clinical Research Infrastructure Development. Prior to joining Huron, Erin originated the Clinical Trials Office for the University of Texas Medical Branch at Galveston, served as the Director of Clinical Trials for the Nevada Cancer Institute, and was the CTO Manager and Oncore Administrator for IU Simon Cancer Center.

Sessions

• Integrating Oncore and Advarra eReg with Huron’s IRB

Tamas Peterson

Product Manager
Advarra

Tamas is the Product Manager for OnCore at Advarra. A part of the OnCore team for more than 4 years, he is passionate about furthering clinical research through modernized technology and a collaborative approach to software design.

Sessions

• Customer Collaboration Session: OnCore

Leah Potts, MBA, CCRP

Director, Research Budget & Coverage
Norton Healthcare

Leah Potts is the Director, Research Budget & Coverage at Norton Healthcare in Louisville, KY. She joined Norton in 2011 and currently leads coverage analysis development and maintenance; research budget development and negotiations, research financial project work, and most recently the implementation of Clinical Conductor. She’s passionate about being a visionary leader and creating leaders and teams that share her love for research. She’s a lifelong learner that loves to read and spend time with her husband and three boys!

Sessions

• Clinical Conductor Enterprise Study and Budget Builds: Ensuring Financial and Data Integrity

Ken Quinn

Director, IT Research Applications
Roswell Park Comprehensive Cancer Center

Ken Quinn is an IT professional with over 25 years of healthcare application support experience. In his current role, he is the Director of Research Applications at Roswell Park Comprehensive Cancer Center. He and his team are responsible for supporting the technology and data management needs of the research community. This includes supporting many research disciplines - clinical research, basic science, laboratory animal, biospecimen, and data. Ken has experience successfully implementing and integrating Huron and Advarra software tools (Click-IRB, OnCore, EDC, eReg, EVAL) in support of the clinical trials lifecycle.

Sessions

• Integrating Oncore and Advarra eReg with Huron’s IRB

Jeetendra “JV” Rao

Vice President, Data Sciences
Advarra

With over 20 years of experience spanning drug development and technology, JV Rao currently leads data sciences at Advarra, which is responsible for generating insights that make clinical trials safer, smarter, and faster. His past experience working for a major CRO and one of the world’s largest technology organizations gives JV a unique perspective on clinical research processes. He is passionate about helping customers improve clinical trial performance by leveraging data insights and analytics.

Sessions

• Reporting and Data Analytics using the Advarra BI Tool
• Maximizing Site Study Performance
• Advarra Trend Report & Product Deep Dive (Sponsor-CRO Only)

James Riddle

VP Research Services & Strategic Consulting
Advarra

James Riddle is the Vice President Research Services & Strategic Consulting for Advarra where he employs his extensive experiences managing large research operations, technology, and research compliance teams to support our client’s research programs and grow Advarra worldwide. In addition to leading Advarra’s Biosafety Service, Biostatistical Service, GPStm Service, and strategic consulting teams; Mr. Riddle also serves on the Board of the Northwest Association for Biomedical Research (NWABR); as Chair of the Site Accreditation and Standards Initiative (SASI) Accreditation Council; as member of the CTTI and MRCT Steering Committees; as editorial board member for IRB Advisor; as well as a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R).Prior to joining Advarra, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. In addition, he has previously served as an AAHRPP site visitor and was the Vice President of Operations and Director of Technology at another large central IRB. His expertise includes multi-national research operations and compliance, implementation of research technology solutions, computer software validation, and management of large IRB, IACUC, and IBC systems. Mr. Riddle has a bachelor’s degree in accounting with an emphasis in computer science from Western Washington University, College of Business and Economics.

Sessions

• Understanding the Role of DMCs and EACs in Research Oversight

Erica Rocco, BS, CCRP

Regulatory Project Manager
Yale University

Erica Rocco joined Yale University in 2015 as a Research Assistant in Regulatory Affairs at the Yale Cancer Center and is currently a Regulatory Project Manager at the Yale Center for Clinical Investigation (YCCI). She provides regulatory support for a number of research projects across many disciplines at Yale University. Erica has strong knowledge of regulatory requirements and GCP standards, and she works closely with faculty investigators and collaborating departments to initiate and conduct compliant clinical trials. Erica is both a user and an internal trainer for the Advarra eRegulatory system and provides regulatory guidance to the Yale research community.

Sessions

• eTMF: Leveraging workflows in eReg for electronic Trial Master File maintenance

Kimberly Rose

Training Specialist
Advarra

Kim has over 25 years of training and technical experience on a variety of platforms. Before joining Advarra she spent two years working as a Regulatory Coordinator for the Clinical Trials for Hematology and Oncology department at the University of Missouri-School of Medicine. She joined Advarra as a Training Specialist, and her current focus is on helping clients utilize Advarra solutions to streamline managing their clinical trials.

Sessions

• Clinical Conductor Site 101

Gadi Saarony, MBA

Chief Executive Officer
Advarra

Gadi Saarony, Chief Executive Officer at Advarra, has over 25 years of leadership experience, including strategic, commercial, and operational clinical research roles. Prior to joining Advarra, Saarony served as Executive Vice President and Chief Clinical Research Services Officer at Parexel and was a member the company’s executive leadership team. Saarony was responsible for the operational delivery of Parexel’s global clinical research services, including site strategy and selection, patient recruitment, data management, biostatistics and programming, clinical operations, project management, resourcing, clinical trial supplies and logistics, and Phase I units. Prior to that, Saarony held several other senior-level positions at Parexel and was instrumental in achieving rapid growth in Parexel’s regulatory consulting and medical communications businesses. Saarony initially joined Parexel in 2003 in the area of strategy development. Saarony also previously served as Director of Consulting Services for Habama, Inc., and as Associate Director, Strategy, with Ernst & Young, LLP, Inc. He graduated from Rider University with a bachelor’s degree in economics and holds a master’s degree in international business from The American Graduate School of International Business (now Thunderbird School of Global Management).

Miranda Schramm, PhD, CPTM

Director, Training
Advarra

Miranda has worked in training and higher education for over 12 years, including 6 years of teaching and research at the University of Wisconsin – Madison where she earned her doctorate in Organizational Communication. As Director, her focus is partnering with institutions to address training challenges through effective and engaging content. She believes in finding unique solutions so that distance learning does not mean diminished learning.

Sessions

• Advanced OnCore CTMS Topics
• Using the Portfolio Rationalization Model to Implement and Optimize Your Training Program
• Clinical Conductor Site 101

Brian Sevier, PhD

Sr. Associate Director of Research Operations
Yale University

Brian Sevier is the Sr. Associate Director for Research Operations for the Yale Center for Clinical Investigation (YCCI). He has been involved in academic research administration for over 20-years and has previously led clinical research operations at the University of Florida Office of Clinical Research, UF Health Cancer Center, and the UF Clinical and Translational Science Institute. As part of the YCCI, Brian actively supports translational workforce development, marketing and communications, OnCore, eREG, EDC, and Epic EHR integrations, and other CTSA-related research administration support activities.

Sessions

• Retaining Staff through Structured Environmental Change

Jeff Sidell, PhD

Chief Technology Officer
Advarra

Jeff Sidell is Chief Technology Officer at Advarra. He is responsible for progressing and executing Advarra’s overall technology vision, strategy, and roadmap. Sidell has over 25 years of technology experience in enterprise software development, data science, product and technical management. Prior to joining Advarra, he was CTO at RDC (now part of Moody’s Analytics) where he was responsible for product management, software engineering, data science, and technical operations. Previously, he was Vice President Data Analytics at the Federal Reserve Bank of New York where he led the data science consultancy. Sidell also has extensive technology startup experience including Strevus as founder and CTO and Siperian as Chief Scientist. Sidell holds an undergraduate degree in computer science from Dartmouth College, a master’s degree in computer science from the University of Illinois, and a doctorate in computer science from the University of California at Berkeley.

Jaci Skidmore

Director, Clinical Research Support Office
University of Utah

Jaci has worked in clinical research at the University of Utah since 2008 and prior to that she spent 10 years at Intermountain Health Care. As the Director of the University’s first Clinical Research Support Office (CRSO), she has worked with an amazing team in the ongoing implementation and adoption of OnCore, the first University-wide clinical trial management system (CTMS), which includes eReg and participant payments. Jaci’s vision for the CRSO is to provide a centralized research support to study teams and investigators for Quality Assurance, CTMS, IND/IDE support, project management, and training and mentorship.

Sessions

• Staffing: Who, What, When, How?

Aubrey Smith

Manager of Business Operations
Mercy Research

Aubrey holds a Bachelor’s Degree in Psychology and has been part of the Mercy Health organization for 15 years, the last 14 with Research. Aubrey is currently the Manager of Business Operations with a focus in financial transactions at Mercy Research and is located in St. Louis, MO. Her early years with Research were spent specializing in recruitment and data. She looks forward to continued growth in business operations management as her oversight involves financial management for clinical trials, physician compensation, and EPIC® Research Billing module.

Sessions

• Ensuring Congruency Between Clinical Study Documents

Tiffani Smith

Application Implementation Specialist
Advarra

Tiffani has worked at Advarra for two years as an Application Implementation Specialist. During the past year she has successfully implemented multiple large organizations/clients. Prior to joining Advarra, Tiffani was the Business Officer Manager for a Hospital Research Site and responsible for all study start up and recruitment activities, as well as System Administrator for their Clinical Conductor CCE/CCS. Tiffani brings more than seven years of research experience, 13 years of hospital and clinic experience while holding a Bachelor’s degree in HealthCare Administration.

Sessions

• Clinical Conductor Enterprise New Finances and Invoice Payments
• Clinical Conductor Site 101
• Advanced Clinical Conductor Enterprise Topics

Denise Snyder, MS, RD, LDN

Associate Dean for Clinical Research
Duke University School of Medicine

After spending time in public health and clinical nutrition, Denise started work at Duke as a clinical research coordinator in 2000 for NIH funded trials in oncology. In 2009, her Research Management Team in the School of Nursing received support from Duke’s CTSA to leverage the group’s services and launch REDCap for the School of Medicine. For 10 years, Denise has been the Associate Dean for Clinical Research for Duke University School of Medicine. In this role, she leads the Duke Office of Clinical Research (DOCR) a central support office of expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation, and guidance for clinical research operations for Duke as a site.

Sessions

• Now Hiring: Good Humans

Erick Sperloen

Manager, Technology Training
Advarra

Erick has worked in education and software training for over 14 years, receiving his English degree from the University of Wisconsin-Madison and his education licensure from the University of Wisconsin-Whitewater. Erick has worked for a number of small technology companies where he created custom training content, curriculums, and training departments. As the training manager, his passion is on creating standardization across training solutions to help end-user training and adoption of clinical trial software.

Sessions

• Leveraging Advarra University Training
• OnCore 101
• A Blended Approach: Instructor-Led Training & Custom eLearnings for Large Scale Implementations

Chelsey Stephens

Senior Customer Success Manager
Advarra

Chelsey started her career in Clinical Research in 2008 as receptionist for a research site in Wichita KS. She quickly grew to become their Regulatory Specialist, Data Entry Specialist, and Patient Recruiter before taking on a Lead Coordinator role as a CCRC. From there she went on to work with large hospital networks helping to implement Clinical Conductor at their sites, and later joined the Bio-Optronics team in 2017 as a Senior Customer Success Manager for Tech Solutions. Chelsey holds over 13 years of Clinical Conductor experience both at Research Sites but working with Sponsors and CRO’s alike.

Sessions

• Advarra Solutions Overview for Clinical Conductor Customers: Getting the Most out of Onsemble

Lauren Stiller, MBA, CCRP, CPC-A

Manager, Research Finance Projects
Norton Healthcare, Inc.

Lauren began her healthcare career in 2012 by earning her medical coding certification. She then gained experience managing accounts receivable, claims auditing, revenue recovery, data analytics, and process improvement for a large network of healthcare providers. In 2017, Lauren found her way to Norton Healthcare’s Research Office, as a Financial Projects Coordinator. Throughout the height of the pandemic, she co-led the implementation of Clinical Conductor. As Projects Manager, she now leads a talented team of project coordinators whose responsibilities include study intake processing and Clinical Conductor administration. Lauren is from Louisville, KY, and received her MBA from Indiana University Southeast.

Sessions

• Clinical Conductor Enterprise Study and Budget Builds: Ensuring Financial and Data Integrity

Jon Tack

Vice President, Product Management
Advarra

As Vice President of Product Management, Jon leads the product planning function at Advarra. Jon’s team is focused on collaborating closely with the community, building out comprehensive roadmaps, and delivering value-add solutions that customers can easily adopt. Jon has 5+ years of experience in the clinical research industry and 15+ years of experience driving innovative software development initiatives.

Sessions

• Customer Collaboration Session: Advarra EDC/eSource
• Top 5 questions on Cloud

Christopher Thomas

Product Manager
Advarra

Christopher Thomas is a Product Manager at Advarra focusing on Clinical Conductor. Christopher has been with Advarra for 7 years, and he continues to be excited about contributing to the future of Clinical Conductor by improving the user experience, delivering high-quality features, expanding integration opportunities and ensuring customer confidence in all data outputs and reporting from Clinical Conductor.

Sessions

• Customer Collaboration Session: Clinical Conductor CTMS

Barry Treichel

Product Manager, EDC & eSource
Advarra

Barry has a wealth of experience designing and implementing products across various domains. He loves creating tools that make people's lives and work easier, and is especially excited to be working in the clininical trial space. Starting at Advarra right at the outset of the pandemic underscored the importance what we do, and drives his passion for buiding great products. He speaks 3 languages at varying degrees of proficiency, is a retired musician, and loves outdoor activities like camping, kayaking, and hiking.

Sessions

• Customer Collaboration Session: Advarra EDC/eSource

Mariessa Turner

Training and Development Coordinator
University of Utah

Mariessa Turner has worked in research operations for three years, most recently as a Training and Development Coordinator in the Clinical Research Support Office (CRSO) at the University of Utah. She was instrumental the OnCore CTMS implementation from the cancer center to enterprise-wide that went live in April 2022. Her experience training users on the Epic system provided valuable insight in the process. She has recently completed her PMP certification as well as completing the train-the-trainer course with Advarra.

Sessions

• Adaption through Adoption: Modifying Teaching Tactics to Build an Effective Virtual Training Program

Scott Uebele, MBA

Chief Operating Officer
Advarra

Scott Uebele is Chief Operating Officer of Advarra. In this role, he is responsible for strategy and operations for Review Services, including institutional review board (IRB), institutional biosafety committee (IBC), data monitoring, and endpoint adjudication, Global Services and Product Delivery, Consulting Services as well as the related business development and customer relationships teams. Uebele has over 20 years of global experience in strategic operations and financial leadership with 15 years in the pharma-services industry. Most recently, he was President and Chief Research Services Officer at Advarra, overseeing Review Services and Consulting. Previously, he served as Chief Financial Officer at Advarra where he directed the financial, legal, analytics, and contracts activities. Previously, Uebele held the position of Chief Financial Officer at Chesapeake IRB, which merged with Schulman IRB in 2017 to form Advarra. Earlier in his career, Uebele held multiple financial and operational roles, including Global Vice President of Finance for Research Pharmaceutical Services (RPS), a global clinical research organization now part of PRA Health Sciences. Uebele earned his bachelor’s degree in economics from Bucknell University and his MBA in finance from Seton Hall University where he was awarded the Robert Troccoli Business Policy Award.

Amanda Wigand, MS

CTMS Project Manager
Henry Ford Health System

Amanda Wigand is a graduate of Northern Michigan University where she earned her master’s degree in biology. Soon after graduation, she began working at Henry Ford Health, and was a research coordinator for both oncology and non-oncology trials for four years. In 2019, she began her role as the CTMS Project Manager. Since then, she has implemented Oncore with Henry Ford Cancer Institute and will soon be integrating non-oncology research groups into the OnCore community at HF.

Sessions

• Preparing for Implementation of OnCore Receivables and Go-Live

Kenneth G. Winters RN, BSN, OCN

CTMS Project Manager
Henry Ford Health System

Ken is a CTMS Project Manager at Henry Ford Health System in Detroit MI. He has a Baccalaureate degree in Nursing from University of Detroit Mercy and has been a practicing Registered Nurse since 2006. Ken has over 12 years of experience working in Oncology research as a clinical trial coordinator specializing in Neuro-oncology, Head and Neck cancer, GI cancer and Phase 1 Trials. He is a presenting and voting member of his institutions local IRB. In the past year he has recently joined the CTMS team at Henry Ford as part of a planned enterprise-wide roll out of the system beyond oncology clinical trials.

Sessions

• Preparing for Implementation of OnCore Receivables and Go-Live

James Wurdeman

Chief Product Officer
Advarra

James joined Advarra in 2005 and has led both the Customer Support and Product Management teams. As Chief Product Officer, James brings a deep understanding of customer needs to the product development roadmap. Collaborating with customers is the cornerstone of Advarra’s product strategy, and James works to ensure that all Advarra products contribute to the company’s over-arching mission of helping our customers succeed.

Sessions

• Advarra Trend Report & Product Deep Dive (Sponsor-CRO Only)

Kate Yawman

Director, Product Management
Advarra

Kate Yawman is a Director of Product Management who partners with customers conducting research to deliver software that streamlines regulatory compliance and ROI reporting. Kate believes that technology should play a vital role in facilitating how organizations from sites to sponsors collaborate to run research more efficiently. Kate has been with Advarra for 8 years. Before taking on her current role, she worked on CTMS and eSource products providing a broad view of the clinical research site technology market. Kate started her career in pre-clinical research at Johns Hopkins University and University at Buffalo. She holds a Bachelor’s degree in Biological Sciences from the University of Delaware and a MBA in Health Sciences Management and Competitive Strategy from the Simon School of Business at the University of Rochester.

Sessions

• Customer Collaboration Session: Advarra eReg

Jiwon Yeo

Director for the Clinical Research Support Office (CRSO)
Seattle Children's Research Institute

Jiwon Yeo is the Director for the Clinical Research Support Office (CRSO) at Seattle Children’s Research Institute where she is leading the implementation of the OnCore CTMS and Participant Payments. Her office is also responsible for budget development for industry-sponsored trials and Medicare coverage analysis. Prior to her current role, she oversaw pre-award and post-award activities for phase 1 oncology trials as the Clinical Research Finance Manager at an academic center.

Sessions

• Integrating Oncore and Advarra eReg with Huron’s IRB