Speakers

Bishoy Anastasi

Director - Clinical Research Finance
UCLA

The training is led by Bishoy Anastasi, Director of Clinical Research Finance at UCLA’s Dean’s Office of Clinical Research. Bishoy is highly regarded as a national clinical research subject matter expert, particularly in coverage analysis, research pricing, and clinical research billing & financials. In addition to co-authoring UCLA’s coverage analysis and research pricing policies and processes, Bishoy brings over 18 years of clinical research management, contracting, coverage analysis and trial coordination experience

Sessions

• Modernizing Clinical Research Staff Roles & Career Tracks

Kelly Anastasio, COC, CPC, CPCO, CPCI, CLSSGB

Associate Director of Clinical Trial Operations
Yale School of Medicine

Kelly Anastasio is the Associate Director of Clinical Trial Operations which includes the oversight of the Yale School of Medicine (YSM) Out-Patient Clinical Research Unit , coordinator pool, budgeting and financial management unit, Oncore-Epic integration unit, and the recruitment call center. Kelly’s experience provides the ability to oversee the OnCore-Epic 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 across all disciplines. In addition, Kelly is overseeing the Yale BioBank – Generations Health, one of the largest DNA sequencing projects of its kind in the United States. 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.

Sessions

• Optimization of Financial Management and the Trial Lifecycle

Julie Anthony

Business Analyst, OnCore CTMS
University of Michigan Health Information Technology & Services

Julie Anthony is a Business Systems Analyst for the University of Michigan Health Information Technology & Services. She began her career in clinical care and transitioned into information technology as an Epic trainer. In 2017 Julie joined the OnCore team as a trainer where she gained valuable knowledge of clinical trials as well as experience in implementation and maintenance of OnCore. In her current role, she is responsible for supporting multi-organizational teams throughout the University of Michigan by maintaining the interfaces between OnCore & Epic, providing end user support, and delivering training. Julie holds a Bachelor of Science in Health Fitness in Preventive and Rehabilitative Programs and has multiple certifications including OnCore Clinical Research Management, OnCore Financials, and EpicCare Inpatient Procedure Orders. Julie is passionate about engaging end users through innovative trainings and materials, specifically by offering alternative solutions to classroom learning & improving workflow efficiencies.

Sessions

• Ready, Set … Finance! Gamifying OnCore to Spark Understanding

Stacey Banks, MS, CCRC®

Director, Research Applications
Inova Health System

Stacey Banks is the Director of the Research Applications SquaD (RAD) in the Office of Research at Inova Health System. The RAD manages the implementation and use of OnCore, eReg, and Payments for Inova. Stacey began his research career 13 years ago and has served as a research coordinator and manager in both oncology and heart & vascular. His passion is in connecting people to technology in ways that allow them to improve and efficiency and quality of their work.

Sessions

• Lessons Learned from Implementing OnCore and eReg Simultaneously

Cheryl Byers

Director, PRMS and Regulatory Affairs
Moffitt Cancer Center

Cheryl oversees the Protocol Review and Monitoring System (PRMS) & Regulatory Affairs at Moffitt Cancer Center. Previously, Cheryl worked as a Project Consultant for Huron Consulting Group and served as Director and later, Assistant Vice President for Research Compliance at the University of South Florida. Cheryl worked at Wake Forest University School of Medicine and served as the Director of the Institutional Review Board (IRB). She is certified in Healthcare Research Compliance (CHRC) and Certified IRB Professional (CIP) and holds a Bachelor of Science and a Master of Health Administration. Ms. Byers also served as a site visitor for AAHRPP.

Sessions

• Streamlining your Budget, Contract and Regulatory Processes for Study Activation: Myths and Legends

Amanda Childs

OnCore Program Manager
University of Colorado, Denver | Anschutz Medical Campus

Amanda currently serves are the OnCore Program Manager for the University of Colorado, Anschutz Medical Campus, joining the OnCore team in 2017 as the OnCore Trainer. Since then, I have worked in various capacities, including assisting with the OnCore/UCHealth Epic Integration, development of new institutional centralized processes for amendments, and start up of studies, updating the in-person training, assisting with on-boarding new departments and institutions, and aiding in the roll out of Insights to the Anschutz campus. Previously, I have worked extensively in non-profit program management, successfully managing several programs for oncology patients in the greater Denver area. Making a difference is where my passion lies and what ultimately lead me to the University of Colorado research program. With this in mind, my goal is to improve and optimize the experiences of our end users.

Sessions

• (Double Session) You're in OnCore, Now What? Leveraging Your Integrations for Accountability
• (Double Session Cont'd) You're in OnCore, Now What? Leveraging Your Integrations for Accountability

Stuart Cotter

Director, Product Success
Advarra/Forte

Stuart Cotter is Director, Product Success at Forte. In this role, he collaborates with our current customers to understand their challenges, and translates those challenges into solution-based enhancements to our product offerings. Prior to joining our Product Management team, Stuart worked as a Product Support Specialist at Forte on Allegro CTMS, where he worked alongside dozens of small- to mid-sized research sites to help them overcome their operational hurdles.

Sessions

• Regulatory Fine Points: A Panel Discussion

Kasha Donahue, CCRP

Regulatory Manager
Karmanos Cancer Institute

Kasha Donahue is a Regulatory Manager in the Clinical Trials Office at Karmanos Cancer Institute. She joined KCI in 2012 and has held several positions at the institution. In 2017, she transitioned into her current role managing the Regulatory Coordination group. For the past three years, she has worked with the small team responsible for implementing eREG™ at the Cancer Center in Detroit and the Network locations across the state. Kasha holds a B.S. in Biochemistry from the University of Michigan and retains her CCRP certification.

Kate Fiorito

Staff Augmentation
Advarra/Forte

Kate Fiorito is a member of the Staff Augmentation team at Forte. As part of the Staff Aug team, she is able to assist organizations in a multitude of areas related to clinical research technology and has worked in numerous roles for Forte customers for over five years. She specializes in on site data quality and analysis, application administration, training, documentation, workflow design, and project management. Kate is passionate about optimizing research operations.

Sessions

• Creating and Maintaining an OnCore QC Program

Patricia Fontaine

Manager, Clinical Research Budgeting and Billing
Yale University

Sessions

• Optimization of Financial Management and the Trial Lifecycle

Erwin Go

OnCore Coordinator
Inova Health System

Erwin Go serves as the OnCore Coordinator in the Research Applications SquaD (RAD), a part of the Office of Research at Inova Health System. His primarily role is overseeing the implementation of OnCore at Inova. Erwin’s has served in both Clinical Research Coordinator and Business Analyst roles in the academic medical center, consulting, and health system settings.

Sessions

• Lessons Learned from Implementing OnCore and eReg Simultaneously

Anna Grant, RRT

Manager, PRMS and OnCore Oncology
University of Nebraska Medical Center

Anna Grant is the Manager of the PRMS office and OnCore Oncology at the University of Nebraska Medical Center (UNMC). With a background of over 13 years in critical care Respiratory Therapy, Anna began her career in research as the Auditor for the PRMS office at UNMC and has since taken on an Operational Leadership role with Oncology for the Fred & Pamela Buffett Cancer Center at UNMC. After transitioning briefly to Nebraska Medicine to assist in the development, training and implementation of OnCore, Anna’s role with Nebraska Medicine and UNMC has continued to evolve to lead both the operations of the PRMS office and operations for OnCore Oncology.

Sessions

• Leveraging OnCore to Separate IRB and Institutional Requirements

Natalie Hellmer

Senior Project Manager
Advarra/Forte

Natalie has twenty years project management experience as well as instructional design and teaching experience; the majority of this experience is from working in the health care and research space. Her specialties and passions are understanding and managing software integration areas, facilitating process mapping and validation, developing effective presentations and course curriculum, and directing organizational goals setting, planning and execution.

Sessions

• (Double Session) Leverage OnCore for Vendor Payables
• (Double Session Cont'd) Leverage OnCore for Vendor Payables

Kirk Hohsfield, BA

BSM Administrator and OnCore Calendar Builder Team Lead
University of Colorado Anschutz Medical Campus

Kirk currently works as a BSM Administrator, Calendar Builder Team Lead, OnCore Finance Instructor, and Report Writer for the University of Colorado – Anschutz Medical Campus. In this role, he serves as a technical resource for OnCore Support colleagues, organizational leaders, and end-users in the realms of business intelligence, system functionality, application testing, and bio-specimen configurations. Before his latest appointment within the Clinical Research Administration Office in 2016, he served as a Calendar Builder, starting in 2014, under the Research Informatics Shared Resource – a component of the University of Colorado Cancer Center. While there, he provided assistance in the development and implementation of standard operating procedures, institutional guidelines, staff training, application support, and configuration testing as part of the initial data migration, application launch, and subsequent enterprise rollout. In May of this year, he will obtain a Master’s degree in Public Health from the Colorado School of Public Health with dual concentrations in Environmental/Occupational Health and Epidemiology.

Sessions

• Optimizing Financial Builds for All Funding Sources

Jason Jaszewski

Director, IT
Advarra/Forte

Jason focuses on the technical details and operations of Forte Managed Infrastructure. Through collaboration with Forte technical teams, he helps design and implement robust infrastructure designed for managing Forte product environments for customers. Jason has over 17 years of technical experience through various roles spanning network operations, systems administration and information technology management.

Sessions

• (Double Session Cont'd) Managed Infrastructure: Info Session and Office Hours
• (Double session) Managed Infrastructure: Info Session and Office Hours

Diana Jin

OnCore Trainer and Support
University of Minnesota

Diana currently serves as training and support for the Clinical Trials Management System (CTMS) at the University of Minnesota as well as for the Minnesota Cancer Center Trials Network (MNCCTN).

Sessions

• OnCore All Access! An All-Access Discussion about Access

MaryAnn Kempker

Computer Software Validation Project Manager
Advarra/Forte

MaryAnn Kempker is the project manager for computer systems validation at Forte. She is dedicated to ensuring the customer’s needs are met when validating their Forte product for compliance with FDA 21 CFR Part 11. She comes to Forte with over 17 years of experience in computer system validation in both the medical device and pharmaceutical industries and has a master’s degree in Quality Assurance.

Sessions

• Annual Review and Audit Preparedness for Clinical Research Systems - Part 1
• Regulatory Fine Points: A Panel Discussion
• Annual Review and Audit Preparedness for Clinical Research Systems - Part 2

Melissa Lingis, PhD, CCRP

Clinical Trials Lead, Pediatric Research Hub
University of Florida, Pediatric Research Hub

Melissa Lingis is a SOCRA-Certified Clinical Research Coordinator and Clinical Trials Lead for the Pediatrics Research Hub (PoRCH) in the Department of Pediatrics at the University of Florida. Melissa has 6.5 years of experience in clinical trials and over 15 years in scientific research. She earned her PhD in Pharmacodynamics from the UF College of Pharmacy in 2009 and completed her postdoctoral training within the UF College of Medicine in 2013.

Sessions

• Change Agent: Using OnCore to Build Trust

Richard Lush

Director, Clinical Trials Office
George Washington Cancer Center

Dr. Richard Lush has a Ph.D. in Clinical Pharmaceutical Sciences from the University of Pittsburgh School of Pharmacy. He completed a post-doctoral fellowship at the Intramural Program at the NCI where he worked within the Clinical Pharmacology Laboratory, Medicine Branch. After completing his fellowship he worked for 20 years at the H. Lee Moffitt Cancer Center in various positions within the Clinical Research Unit and the Clinical Research Administration. He is currently the Director of the Clinical Trials Office at the GW Cancer Center in Washington DC.

Sessions

• OnCore Implementation Within a Developing Cancer Center

Marissa Macri

Senior Project Manager
UCHealth

Marissa Macri is the Business Systems Analyst for UCHealth Research Administration. In this role, her primary function is as the OnCore Epic integration project manager, supporting the implementation of RPE and CRPC across the UCHealth region. She collaborate closely with the University of Colorado, Denver OnCore Team on integration requirements, training and ongoing study activation and amendment processes. Marissa holds a B.S. in Biochemistry from the University of Tampa, CPC and CGSC certifications, Epic Revenue Cycle Certifications, and is currently completing a Data Science Specialization from Johns Hopkins.

Sessions

• (Double Session) You're in OnCore, Now What? Leveraging Your Integrations for Accountability
• (Double Session Cont'd) You're in OnCore, Now What? Leveraging Your Integrations for Accountability

Kristen Matta

Business Systems Analyst
University of Michigan

Sessions

• Ready, Set … Finance! Gamifying OnCore to Spark Understanding

Rebeccah Mercado

Clinical Research Manager
University of Florida, Pediatric Research Hub

Rebeccah Mercado, MS is the Clinical Research Manager and co-Founder of the Pediatric Research Hub (PoRCH) within the Department of Pediatrics at the University of Florida. The primary purpose of the PoRCH is to provide research staff and support to the growing research portfolio within the department of Pediatrics. Rebeccah has 10 years of research experience at an academic institution and 10+ years of business, event planning and contracting experience in private industry and banking. She strives to create a culture that is creative, engaging and fun. When she is not working she is either training for a half marathon, spending time with her husband and two sons or going to the beach.

Sessions

• Change Agent: Using OnCore to Build Trust

John Musser

Director of the Clinical Trials Business Office
Moffitt Cancer Center

John Musser is the Director of the Clinical Trials Business Office (CTBO) where he oversees budgeting and contracting for clinical trials. He moved to Tampa after completing his undergraduate degree at the University of Alabama. He then obtained his MS in Molecular Medicine from the University of South Florida. After graduation, he started working in the CTBO and has worked within the department for over eight years; the last three in his current role. In his free time, he enjoys being outside with his family, running, golfing and watching Alabama football.

Sessions

• Streamlining your Budget, Contract and Regulatory Processes for Study Activation: Myths and Legends

Jeff Parks

Product Manager
Advarra/Forte

Jeff Parks is a Product Manager at Forte on the OnCore team, where he collaborates with customers to understand their unique needs and works to translate those needs into effective software solutions.

Sessions

• OnCore Upgrades and What’s the Value of Being an Early Adopter?

Katie Penas

Clinical Research Manager
Nebraska Medicine

Katie Penas joined the Clinical Research Center at Nebraska Medicine in 2012. She began her career in research as a clinical trials analyst performing coverage analysis and negotiating budgets. In 2017 she transitioned to a managerial role and currently oversees a team of clinical trials analysts and regulatory coordinators. Katie acts as the business analyst for OnCore and has assisted with workflow development.

Sessions

• Leveraging OnCore to Separate IRB and Institutional Requirements

Makenzie Pick

Solutions Consultant
Advarra/Forte

Makenzie Pick is a Solutions Consultant at Forte who specializes in providing demonstrations of Forte’s portfolio of software. She previously worked on healthcare software implementations for three years where she focused on project management for major academic institutions across the country. Makenzie is passionate about helping organizations understand how software can be used to create efficiencies for staff throughout the healthcare and research realms.

Sessions

• Workshop: Forte Solutions Overview: Getting the Most out of Onsemble

Erica Reece

Director, Sales Enablement
Advarra/Forte

As the Director of Sales Enablement, Erica serves as a liaison between the Product Management, Marketing and Customer Relationships teams in order to ensure all teams have the tools and materials to effectively engage with customers. Erica’s team members possess a thorough understanding of industry challenges and work to provide customers with demonstrations of Forte solutions that align with their organizational goals. Having served in numerous customer-facing roles, Erica has experience in all stages of the Forte customer journey, from software selection through successful implementation and continued adoption of Forte solutions.

Sessions

• Workshop: Forte Solutions Overview: Getting the Most out of Onsemble

Christine Ricklefs, MPH

OnCore Calendar Builder Program Manager
University of Colorado, Anschutz Medical Campus

Christine is the OnCore Calendar Builder Program Manager for the University of Colorado, Anschutz Medical Campus, starting her journey with OnCore in 2014 as one of the first Calendar Builders for the institution. She has contributed in various projects including building specifications, training new builders, aiding in development of centralized process for amendments, creating guidance documents, troubleshooting system issues, and preparing for the Epic integration. Her proudest achievement has been developing a comprehensive Calendar Builder Manual for the team that has defined the institution’s operating procedures for OnCore specifications. Christine has a Master of Public Health from the Colorado School of Public Health in Community and Behavioral Health.

Sessions

• Optimizing Financial Builds for All Funding Sources

James Riddle, MCSE, CIP, CPIA, CRQM

Vice President, Institutional Services
Advarra

James Riddle is the Vice President Institutional Services for Advarra where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra worldwide. Mr. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the CTTI Steering Committee; and leader of the ACRES SASI technology domain accreditation team. 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 served on the board of the Northwest Association for Biomedical Research (NWABR), was an AAHRPP site visitor, and was the Vice President of Operations and Director of Technology at another large central IRB. His expertise includes reengineering operational processes, systems evaluations, development and implementation of technology solutions, integration of technology solutions with operations, and management of large IRB and IACUC 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

• Regulatory Fine Points: A Panel Discussion
• (Double Session) How to Survive an Acquisition and Keep Your Research Program Running
• Demystifying FDA Part 11 Regulations and Preparing Institutions for Compliance
• (Double Session Cont'd) How to Survive an Acquisition and Keep Your Research Program Running

Rob Romanchuk

IRB Chair
Advarra

Rob Romanchuk is a seasoned clinical research professional with over 2 decades of experience including building and managing a central research office for a large multihospital community health system and leadership in human research protections as IRB member and Chair on both the local and central IRB settings. He has presented widely on topics ranging from the protection of vulnerable subjects in research to building institutional clinical trial billing processes. His credential include CIP, CCRC and CRCP (Clinical Research Contract Professional). He holds a BSHS in Clinical Research Administration.

Sessions

• Meeting the Challenges of Clinical Research in the Community Health System Setting
• Navigating Institutional Risk in CTA/Budget Negotiations
• How to Prepare for and Respond to an FDA Inspection

Shannon Roznoski

Director of Product Management
Advarra/Forte

As Director of Product Management, Shannon guides the strategic planning and management of Clinical Data Management solutions. She acts as a strong advocate for 21 CFR Part 11 awareness and the adoption of industry standards to ensure Advarra Forte solutions meet the needs of its customer community. Shannon has 20 years of clinical data management and IT experience, and is a CCDM through SCDM.

Sessions

• SCDM eSource Implementation Consortium Information Session
• Annual Review and Audit Preparedness for Clinical Research Systems - Part 1
• Annual Review and Audit Preparedness for Clinical Research Systems - Part 2

Michele Russell-Einhorn, JD

Chief Compliance Officer and Institutional Official
Advarra

Michele Russell-Einhorn, JD is the Chief Compliance Officer and Institutional Official for Advarra, an independent institutional review board. Her expertise is in the areas of protection of human subjects in research, scientific review of cancer research and research administration generally. Previously, she was the Vice President for Human Research Protections at Schulman IRB and prior to that she served for 11 years as the Senior Director, Office for Human Research Studies at the Dana-Farber Cancer Institute where she was responsible for the management and support of scientific review and institutional review board review, as well as other regulatory matters, involving all cancer relevant research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center. She has over 30 years of professional experience including service as the Conflicts of Interest Attorney for the National Institutes of Health; Director of Regulatory Affairs for the U.S.D.H.H.S Office for the Protection from Research Risks (OPRR) and its successor office, the Office for Human Research Subjects (OHRP); Director in the Global Pharmaceuticals Practice at PWC; as well as the Associate General Counsel for the J. Craig Venter Institute. She is a co-chair of the U.S.D.H.H.S. Secretary’s Advisory Committee on Human Research Protections, Subcommittee on Subpart A; as well as a founder of the IRB Directors Group of the National Comprehensive Cancer Center. She served as the Co-Chair for three years and a core planning committee member for five years of the annual Ethics in Research Conference sponsored by Public Responsibility in Medicine and Research. More recently, she helped to initiate and run the new AAHRPP collaborative network. She is a speaker at numerous conferences on various topics relating to research involving human subject protections, bio-repositories and FDA regulations.

Sessions

• Privacy Considerations in Research: the Changing Landscape

Benjamin Search

CTMS Analyst
Memorial Sloan Kettering Cancer Center

Benjamin Search is a CTMS Analyst at Memorial Sloan Kettering. He joined the MSK CTMS team in July of 2017, as the implementation of the subject tracking and financial modules in OnCore began. Benjamin’s focus is in a data-driven approach to ensure a successful implementation and adoption of OnCore at MSK. Prior to this, Benjamin held several positions working within MSK’s Department of Neurology and Integrative Medicine Service as both a study coordinator and supervisor since 2012. He holds an MPH in Epidemiology from NYU and a BA in Psychology from Clemson University.

Sessions

• Planned Visit Reconciliation with Tableau Dashboard

Michele Seliga

CTMS Study and Support Analyst
University of Minnesota

Michele’s experience in healthcare databases started in her work as a regulatory specialist at a local medical device company collecting and reporting post-market data. She currently works as lead support analyst on the Enterprise OnCore Administration Team led by Josh Fehrmann at the University of Minnesota. She works to support the needs of clinical researchers in their utilization of the OnCore CTMS at the U of MN.

Sessions

• OnCore All Access! An All-Access Discussion about Access

Stephen Shapiro

Sr. Training Specialist
Advarra/Forte

Stephen is a Senior Training Specialist at Forte. He works mostly with OnCore and Forte EDC. He has a vested interest in just-in-time training materials, how to make classroom training more engaging, and general public speaking. Outside of work, he enjoys cooking, taking long walks, making music, and playing with his cat Carlos and dog Bandit.

Sessions

• End-Users & U: Providing Quality End-User Documentation

Saheed Shittu

Project Manager
Inova Health System

Saheed Shittu serves as the Project Manager of the Research Applications SquaD (RAD) in the Office of Research at Inova Health System. The RAD manages the implementation and use of OnCore, eReg, and Payments for Inova. Saheed began his healthcare IT career 12 years ago and has experience with electronic prescribing, meaningful use, Epic and Project Management.

Sessions

• Lessons Learned from Implementing OnCore and eReg Simultaneously

Denise Snyder, MS, RD, LDN

Associate Dean for Clinical Research
Duke University

After spending time in public health and clinical nutrition, Denise started work as a research coordinator and project manager 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 for the School of Medicine. RMT became the home for the REDCap EDC implementation. For nearly 8 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 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

• Modernizing Clinical Research Staff Roles & Career Tracks

Tim Spinler

Sr. eLearning Developer
Advarra/Forte

Tim Spinler is a Sr. eLearning developer and LMS administrator at Forte. He has worked within adult education and training for almost 20 years, including work within the telecommunications, health care, and insurance industries. He has focused on eLearning development for the last 10 years, including earning a Masters in eLearning Education from the University of Illinois. Tim strives to create online learning that is effective, efficient and fun. When he’s not creating new training, he enjoys spending time with his wife and two kids and playing punk music with his bands Cats on Leashes and Mono In Stereo.

Sessions

• eLearning on a Budget
• Train Your End Users in Forte's LMS

Trish Stamm, M.Ed.

OnCore Support Analyst
University of Florida

Trish Stamm is an OnCore Support Analyst and the primary OnCore Trainer for the University of Florida’s Office of Clinical Research. Trish received her Master of Education in 2010 from UF, and has over ten years of experience in Clinical Research Administration. Since early 2017, she has been an integral part of UF’s enterprise-wide OnCore implementation. When she isn’t teaching OnCore classes, you can find her consulting with users about all aspects of OnCore. Trish’s personal interests include eating/cooking/talking about gourmet cuisine, traveling, and anything related to the Marvel Universe.

Sessions

• From Caveman to Spaceman! A Successful Evolution and Integration of OnCore & Epic

Devon Still

Devon Still is an author and one of the world’s top resiliency experts. He is also a former NFL Professional Athlete, Big Ten Defensive Player of the Year, Penn State University All-American, and TED Speaker. Perhaps most importantly, Still is Leah’s dad, helping her publicly “beat up cancer” and embarking on a pediatric cancer-fighting journey. A snapshot of his accolades speaks volumes about his purpose, his heart, his life’s mission – the 2012 53rd overall pick of NFL Draft, the 2015 Jimmy V Espy Award for Perseverance, People Magazine’s 2016 Dad of the Year, the 2017 Penn State Alumni Achievement Award for most successful alumni under 30, and 2019 American Icon Award Recipient. He’s thrived amidst adversity and stayed in the game. As a presenter, Devon has the rare ability to capture the hearts and minds of an audience while delivering memorable speeches, filled with actionable insights, that lead to individuals becoming Playmakers in the game of life and business. Many of the most well-known organizations on the globe, ranging from the FBI, Proctor & Gamble, Chick Fil A, and Virgin, have chosen Devon Still for their most important events, when they're in need of a winning playbook to help their organization build resiliency and perform at the highest level possible. Devon's book, "Still In The Game; Finding The Faith To Tackle Life’s Biggest Challenges," his social media posts, his Podcast, and bi-weekly segment on Fox reach over one hundred million people a year, making him a true global phenomenon for helping people overcome adversity, thrive amid change and develop a championship mindset.

Sessions

• Keynote

Melissa Sykes

Epic Research Application Analyst
University of Florida Health

Melissa Sykes holds a B.S. degree in Public Relations from the University of Florida and is the sole Epic Research IT Analyst for UF Health. She has developed and implemented UF Health’s Epic Research Module from its infancy and continues to enhance and progress the Research IT infrastructure, including the implementation of the RPE and CRPC interfaces between OnCore and Epic. Melissa’s 22 years of healthcare experience includes: Physician Practice Operations and Financials, Training/Education of Physician Practice Operations and Financials, and Development/Delivery/Training of Epic IT infrastructures. Melissa represents UF Health’s research interests by providing continued IT development and support for an innovative and robust research environment.

Sessions

• From Caveman to Spaceman! A Successful Evolution and Integration of OnCore & Epic

Wendy Tate

Director, Research Operations
Advarra/Forte

Wendy Tate, PhD, GStat, is the Director of Research Operations at Forte. Wendy’s work is focused on the evaluation of clinical research administration, including the development and testing of quantitative methods to measure and assess protocol feasibility and workload. Her passion is to provide helpful and meaningful processes and tools to clinical research professionals that streamline clinical research practices and better the clinical research enterprise as a whole. Prior to Forte, Wendy spent 15 years at the University of Arizona in various roles within human laboratory, human subjects protection, and clinical research roles, including leadership roles with the IRB and Cancer Center clinical trials office. She received her MS in Applied Biosciences from the University of Arizona in 2005 and PhD in Pharmaceutical Sciences with an emphasis in Pharmaceutical Economics, Policy, and Outcomes and a minor in Epidemiology from the University of Arizona in 2016.

Sessions

• (Double Session) How to Survive an Acquisition and Keep Your Research Program Running
• (Workshop/Triple Session): Getting the Most out of Forte Insights
• (Double Session Cont'd) How to Survive an Acquisition and Keep Your Research Program Running

Blake Taylor

Senior Product Manager
Advarra/Forte

Blake Taylor is a product manager at Forte, with a current focus as a product manager for the Forte Insights platform. With two years experience working at Forte and eight total in a product management role, Blake is passionate about creating products that delight end users, enable teams to be more efficient and deliver high value to institutions. Blake has collaborated with various Forte customers to help them better understand their data and processes, equip them to use the Forte technologies to effect positive change and ensure that their input translates into new product solutions fit their needs

Sessions

• (Workshop/Triple Session Cont'd): Getting the Most out of Forte Insights
• (Workshop/Triple Session Cont'd): Getting the Most out of Forte Insights
• (Workshop/Triple Session): Getting the Most out of Forte Insights

Molly Van Rheen, MS MBA

CTMS Program Director
Fred Hutch Cancer Research Center, University of Washington, and Seattle Cancer Care Alliance

Molly Van Rheen has over 10 years of research experience including lab, animal, and human subject research as a study coordinator. She worked previously at the University of Colorado managing the OnCore system. Starting in late summer 2019 she joined the Fred Hutch Cancer Research Center, University of Washington, and Seattle Cancer Care Alliance as the CTMS Program Director. She worked closely with Kate Fiorito from OnCore's staff augmentation team to develop the UWFHSCCA’s QC program.

Sessions

• Creating and Maintaining an OnCore QC Program

Brett Weaver

CTMS Trainer and Customer Experience Analyst
University of Minnesota

Brett Weaver currently serves as the CTMS Trainer and Customer Experience Analyst for the OnCore team at the University of Minnesota's Clinical and Translational Science Institute. His support focuses on providing cross-functional and multi-organizational OnCore training by aligning enterprise-wide goals and opportunities. In addition, he focuses on creating and maintaining learning content plus documentation, as well as collecting and analyzing end-user feedback with the goal of improving the experience through positive iterative changes.

Sessions

• Configuring Multi-Site Studies in OnCore

Kate Weber

Clinical Research Applications Administrator
George Washington University Cancer Center

Kate Weber is the Clinical Research Applications Administrator for the George Washington University Cancer Center. She makes up one half of the OnCore (and Forte EDC) implementation team. In addition to maintaining OnCore and Forte EDC, she also trains users on both systems, provides first-line troubleshooting for any and all OnCore/EDC issues, and serves as webmaster for the new Clinical Trials Office website. She holds a BA from New College of Florida and earned her Master of Science in Library Science (MSLS) degree from UNC-Chapel Hill. Before transitioning to a career in health information management, she was a public librarian.

Sessions

• OnCore Implementation Within a Developing Cancer Center

Brian Williams

Clinical Trials Management System (CTMS) Analyst
Memorial Sloan Kettering Cancer Center

Brian Williams is one of four analysts responsible for development, implementation, training, and maintenance of OnCore at MSK. He has been a part of the Clinical Trials Management System (CTMS) team since the spring of 2019. Brian previously held several positions working in MSK’s phase I Immunotherapy group as a clinical trials study coordinator and supervisor since 2013, where he gained extensive experience in clinical trials operations. He was one of the first end users initially trained for system rollout at MSK and brings that unique viewpoint to updating current trainings. He received a B.S in Biology from Fordham University.

Sessions

• End User Trainings: Lessons Learned Over Time

Matthew Wyatt

Director of Clinical Research Informatics
University of Alabama at Birmingham