Speakers

Chad Adams, MPH

AVP | Chief Operations 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 of operational management in healthcare administration, with specific training and experience in integrating technology that address gaps for 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 of Research within HonorHealth and as COO of the HonorHealth Research Institute.

Sessions

• Panel: Best Practices for Using Clinical Conductor CTMS

Jonathan Aguilar

Clinical Research Training Specialist
The University of Texas MD Anderson Cancer Center

Jonathan Aguilar is a Clinical Research Training Specialist 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 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. Husband and father to a two-year-old daughter. He loves hiking, food, and traveling.

Sessions

• A Blended Approach: ILT & Custom eLearning for Large Scale Implementations

Sandra Ahrendsen

Senior Business Analyst
University of Iowa

I joined the University of Iowa in 2022 where my primary responsibilities include coordination and administration of the Clinical Trails Management Systems supporting all non-oncology research studies. During the last 12 months we have completed an enterprise-wide expansion of the OnCore solution. This expansion included many priorities along with the development, scheduling, delivery and sustainment of our CTMS training program.

Sessions

• Examining University of Iowa's CTMS Custom Training Model

Kari Allen, MBA, CRA

Director, CTMS Operations
UC Davis Clinical and Translational Science Center

Kari is a South Florida native and holds a master's degree in healthcare administration. With over three decades of experience in research administration and clinical trials, she is a Certified Research Administrator. During much of her professional journey, she contributed her expertise to a leading academic institution, where she spearheaded the establishment of a collaborative Shared Service team. This team seamlessly integrated Sponsored Programs Research Administration (both pre- and post-award) and Clinical Trial Administration, providing invaluable support to the School of Medicine. In her current role, Kari continues to further expand her contributions in the field of healthcare administration.

Sessions

• The Art of Centralization: How to Wrangle Cats and Catch Smoke

Amie Anderson

Business Analyst, OnCore and eReg CTMS
University of Michigan

Amie Anderson is a Business Systems Analyst for the University of Michigan Health Information Technology & Services. She came to this role with over a decade of study coordinator experience encompassing the regulatory, data, and clinical coordinator roles. In her current role, Amie supports multi-organizational teams throughout the University of Michigan with OnCore and eReg.Amie received a Bachelor of Science degree from Eastern Michigan University.

Sessions

• Embracing the Cloud: Strategies for Seamless Upgrades and External Monitor Access
• Connecting the Spokes to the Hub:  Creative Solutions for Support Services

Josiah Argo

Clinical Trials Management Systems Analyst
University of Iowa

I grew up in Cedar Rapids Iowa, then went to college at the University of Iowa. I graduated with a BBA in Business Analytics and Information Systems and am currently in the Master of Business Analytics program at the University of Iowa. I started working for the University of Iowa June 2022 to work on the OnCore implementation as part of a team of three, which included among other things, designing a training course for new OnCore users.

Sessions

• Examining University of Iowa's CTMS Custom Training Model

Emma Barkman, MHA, CCRP

Director, Regulatory Quality Improvement & Compliance
University of Maryland - Greenebaum Comprehensive Cancer Center

Emma Barkman is the Director of Regulatory Affairs at the University of Maryland Greenebaum Comprehensive Cancer Center, with an extensive background in healthcare operations and clinical research. In her role, Emma oversees critical procedures for various clinical research projects and provides direction for Regulatory Affairs across Solid Tumor, Hematology, Blood, and Marrow Transplant Oncology protocols. With certifications as a Clinical Research Professional and Lean Six Sigma Green Belt, alongside a Master’s degree in Health Administration, Emma brings a strategic approach to navigating regulatory complexities. Her dedication ensures unwavering adherence to the highest standards of patient care and ethical guidelines, driving forward the center's mission of excellence in oncology research and treatment.

Sessions

• General Session: Advarra Customer Highlight

Mindy Blake, MBA, CRCR, CTBC

Manager, Research Business Operations
HonorHealth Research Institue

Mindy Blake has worked in healthcare for over 20 years, working throughout different parts of the hospital system, and joining the billing team in 2015. She began working for HonorHealth Research Institute (HRI) in 2021, and became the manager of the Finance Team in 2022. In the time that she has worked with HRI, she has encountered and persevered through multiple issues surrounding the CTMS. Mindy has extensive experience in Commercial Insurance, Medicare, and Medicaid billing. When Mindy is not working she can be found practicing martial arts, and adventuring with her husband and dogs throughout Arizona and surrounding states.

Sessions

• Using Clinical Conductor to Run Research as a Business

Suzan Bruce, CPC

Associate Director, CTMS Operations
UC Davis Clinical and Translational Science Center

Suzan is the Associate Director at the CTMS Ops Office, UC Davis. Suzie has over 25 years of experience in the medical field and extensive knowledge in Coverage Analysis, clinical trial startup, budgeting, negotiating, and medical billing experience. She has assisted many physician specialties in developing department processes for clinical trials. She is certified in Coding with the American Academy of Professional Coders (CPC)

Sessions

• The Art of Centralization: How to Wrangle Cats and Catch Smoke

Elisa Cascade, MBA

Chief Product Officer
Advarra

Elisa Cascade, Chief Product Officer, is responsible for driving Advarra’s technology product vision and management. She brings more than 30 years of experience in the clinical research industry with a focus on using technology to transform clinical research for all stakeholders.Prior to joining Advarra, Cascade held the position of Chief Product Officer for Science 37 where she was responsible for setting the company’s product vision and roadmap and leading product management, business analysis, design, and strategic customer support. Previously, she held several key leadership positions including Executive Vice President and Product Line Executive for eCOA at Clario, Chief Product Officer at DrugDev, an IQVIA Company, and Vice President of the Digital Patient Unit at Quintiles (now IQVIA).Cascade currently serves as the Vice Chair for the Association for Clinical Research Professionals Board of Trustees.Cascade earned a Bachelor of Science degree in Economics from the University of Michigan and a Master of Business Administration degree from The Wharton School of the University of Pennsylvania.

Sessions

• General Session: Advarra Technology Deep Dive

Ryan Childers

Associate Director, eClinical Solutions
Javara Research

Ryan Childers has nearly 20 years of experience in the clinical research industry. With 15 years in site operations, Ryan has conducted hundreds of trials in Phases I-IV encompassing a broad range of therapeutic areas and indications. During his stint in operations, Ryan developed a knack for CTMS administrative responsibilities, including system configuration, study and financial configuration, and execution. Since moving into a technology role, Ryan has used his clinical experience and project management as the business lead in global CTMS implementations. Currently, Ryan acts as the CTMS product owner and Director of Enterprise Solutions for Javara Research.

Sessions

• Panel: Best Practices for Using Clinical Conductor CTMS

Sonam Choden, MPH

Clinical Research Management Analyst
University of California, San Francisco (UCSF)

Sonam Choden is an experienced research professional. She received her BS from University of California Davis and MPH from University of California Berkeley. She has been with UCSF for 8 years in different roles. Prior to joining the UCSF OnCore team, she worked with the Non-Malignant Hematology team at UCSF on all aspects of study start-up and maintenance. In her current role as a Clinical Research Management Analyst, she leverages her extensive experience in research study management while setting up OnCore Calendar builds and financials builds. She is committed to continuous learning and values the importance of quality improvement initiatives.

Sessions

• Transitioning to OnCore Financials for Post-Award Management

Adam Civils, MSHA, CCRP

Regulatory Affairs Team Lead
VCU Massey Comprehensive Cancer Center

My name is Adam Civils, I’m a Regulatory Affairs Team Lead with VCU Massey Comprehensive Cancer Center. I’ve been with Massey for a little under 7 years. I have a Bachelors in Exercise Science from Virginia Commonwealth University, a Master's in Healthcare Administration from Virginia Commonwealth University and I have my CCRP through SOCRA. I’ve lived in Richmond VA my entire life but enjoy traveling whenever I get the opportunity.

Sessions

• Task Lists: More Than A Checklist
• Clinical Trials Office Environmental Assessment

Courtney Clark

Keynote Speaker

Courtney Clark is the luckiest unlucky person in the world. After witnessing the terrorist attacks of September 11th from her office just 18 blocks north, she thought she had escaped unscathed. Little did she know the events of 9/11 would cause her to develop cancer just a few years later. Her experiences caused her to become a researcher and author on resilience and adaptability, to help people achieve their goals even when everything changes. Courtney has built two successful businesses and is the author of three books, including her most recent book ReVisionary Thinking. She works with people who want to adapt faster and achieve more, and has spoken worldwide to organizations like Nike, Dell, Google, and Amazon. Courtney’s resilience work has been called “practical," “powerful,” and “empowering” by industry leaders, and she’s been featured on CNN, CBS, ABC, Forbes, and USA Today. If she wasn’t writing and speaking about resilience, Courtney would have wanted to be a tap dancer. Thankfully for her audiences, she wasn't very good at it.

Sessions

• General Session: Guest Keynote

Kate Connelly

Lead Calendar and Financial Analyst
Fred Hutch Cancer Center & University of Washington

Kate Connelly, MS has been with the Fred Hutchinson Cancer Center and University of Washington for two years and currently serves in the role of Lead Calendar and Financial Analyst. She has over 4 years of OnCore experience and is passionate about streamlining clinical research workflows. Prior to joining the team at Fred Hutch, Kate worked as a CTMS Project Analyst at the University of Colorado. Outside of work, Kate enjoys running, coffee, and ice cream – because life is all about balance.

Sessions

• The 2-step Amendment Dance

Amy Drake

Senior Business Systems Analyst
The Ohio State University Wexner Medical Center

Amy Drake is a Senior Business Systems Analyst who works as the Enterprise Administrator for OnCore, EDC and EReg at The Ohio State University College of Medicine. Amy has a love for research and has worked in the field for over 20 years. Her expertise spans from patient care to database management and Amy’s vast experience has helped to develop her divergent thinking. She has a passion for helping others which carries over to her work and ability to aid faculty in executing successful research projects.

Sessions

• Advarra eSource + EDC: Tracking, Documentation and Onboarding for Protocols and Staff
• Exploring a Mechanism for Application Access Audits

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

• Visualizing OnCore Data Using Advarra Analytics

Stephen Gately

Research Information Systems Specialist/Administrator
University of Texas Medical Branch (UTMB)

Areas of Expertise: - Clinical Trials Management System (CTMS) Implementation: Assisted in building and implementing the CTMS, ensuring it meets organizational needs and standards. - System Integration and Monitoring: Oversee and manage system integrations, ensuring seamless operations and immediate remediation of any issues. - Upgrade Management: Coordinate, test, and ensure the successful implementation of system upgrades in collaboration with stakeholders, guaranteeing system efficiency and reliability. - Vendor Collaboration: Work closely with vendors to identify, report, and resolve system bugs and to discuss and implement system enhancements, ensuring the system's continuous improvement and optimization.

Sessions

• The Phases of the UTMB IRB / eReg Integration

Michael Gill

IS Project Manager Senior
Medical College of Wisconsin

Mr. Gill is an IT professional of 40-year working the last 15 as a Project Manager / Business Analyst assigned to the Office of Research at the Medical College of Wisconsin (MCW). In this role he has Managed the creation of their Institutional Biospecimen Repository and the Cancer Center Clinical Trials Office including the use of OnCore BSM and CRM. Recent efforts included the rollout of OnCore Financials and now the CRPC and Receivables interfaces. He is a process mapping evangelist who doesn’t tolerate sloppy mapping.

Sessions

• It Takes Two: Instituting a Shared Process for Coverage Analysis Between Two Separate Legal Entities

Erwin Go

Research Applications Specialist
Inova Health System

Erwin Go is a Research Applications Specialist at Inova Health System with 10 years of experience helping clinical research professionals with the complexities of clinical research. Specializing in research software applications such as OnCore, eReg, and Payments, Erwin utilizes these tools to advance the technological capabilities of Inova’s Research Organization. Over the years, Erwin’s strengths at Inova have garnered him some recognition for implementing and maintaining Advarra products such as OnCore and eReg. When he’s not at Inova, Erwin is an avid, below average golfer and loves spending time going on food adventures.

Sessions

• General Session: Advarra Customer Highlight

Rama Gundabhat

Sr. Applications Systems Analyst
The University of Texas MD Anderson Cancer Center

Rama Gundabhat works for Office of Clinical Research at University of Texas MD Anderson Cancer Center since 2018. He joined MD Anderson as Sr Application Systems Analyst and started working on designing applications which support multicenter clinical trials workflows. Currently he works with Clinical Trial Management System team which supports OnCore, eREG and EDC applications. In the past he worked with Harris County Department of Education building and supporting education applications. He likes to visit state parks, hiking and gardening.

Sessions

• A Blended Approach: ILT & Custom eLearning for Large Scale Implementations

Laura Heldt, CPC

Program Manager
Medical College of Wisconsin

Laura Heldt, CPC is a Program Manager for Clinical Practice Services at The Medical College of Wisconsin (MCW). Her background spans Physician Practice Billing, Auditing and Process Improvement. She has a BSBA in Health Care Management and is a Certified Professional Coder with extensive experience in charge capture for professional services. Froedtert and MCW Health Network includes over 2000 physicians, residents and medical professionals. Implementing OnCore Financials and CRPC interface with Epic, our Electronic Health Record will improve consistency and allow for accurate capture of Research processes for our organization. Excited to be part of this Team!

Sessions

• It Takes Two: Instituting a Shared Process for Coverage Analysis Between Two Separate Legal Entities

Cassie Hemmann

Sr 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

• CCS Recruitment Training Session
• Training Isn’t Duct Tape…It Can’t Fix Everything
• OnCore 101

Liz Hennessy MSN, RN, CCRP

Research Nurse Manager of Research Coordinator Support Services
University of Texas Medical Branch (UTMB)

Sessions

• The Phases of the UTMB IRB / eReg Integration

Kate Huffman

Director of Operations, Michigan Clinical Trial Support Unit
University of Michigan

Kate Huffman is the Director of Operations at the University of Michigan Clinical Trials Support Office. She has over 15 years of clinical research experience in both academic and industry settings. During her career she has held a variety of roles including CRA, Research Coordinator and Regulatory Manager, giving her a unique perspective of what it takes to run a successful clinical trial. Kate received her Bachelor of Science in Nursing from the University of Detroit Mercy and Bachelor of Science in Dietetics from Michigan State University.

Sessions

• Task Lists: More Than A Checklist
• Connecting the Spokes to the Hub:  Creative Solutions for Support Services

Ange-Lisa Jalovec, BSN, RN

Sr. Director, Clinical Systems
CCT Research / Avacare Clinical Research Network

Ange-Lisa Jalovec is the Sr. Director, Clinical Systems at CCT Research / Avacare Clinical Research Network where she leads a team to oversee the administration, study setup, design workflow, and implementation efforts for Advarra applications across a growing site network of 45+ locations. Ange is an RN with more than 22 years diverse experience in the clinical research site organization industry, including over 17 years using, managing, and implementing Advarra’s Clinical Conductor CTMS and more recently Advarra’s eSource+EDC, and eReg applications.

Sessions

• Panel: Best Practices for Using Clinical Conductor CTMS

Cena Jones-Bitterman, MPP, CIP, CCRP

Assistant Director, Compliance and Informatics
University of Iowa

Cena Jones-Bitterman is the Assistant Director for Compliance and Informatics at Holden Comprehensive Cancer Center (HCCC), University of Iowa. In this role, she leads the administration of PRMS, DSMC, and the clinical trials management system at the cancer center. She is a member of the leadership team within HCCC’s Clinical Research Services office and has collaborated with Iowa’s general research team in the expansion of OnCore and Advarra eReg across the enterprise.

Sessions

• Case Study: Applying CTME Maturity for Organizational Improvement

Maria Liwai

Senior Applications Analyst and Trainer
University of Nebraska Medical Center

Maria received her bachelor's degree from Brigham Young University – Hawaii in Hawaiian Studies and her master’s degree from the College of Saint Mary in Teaching, so naturally she is now working for Nebraska Medicine on the Clinical Trial Management System support team as a Senior Applications Analyst and Trainer. Since just prior to the beginning of the pandemic, Maria has been doing some of her most favorite things there: learning, growing, and teaching. Aside from converting in-person trainings to virtual classes and e-learnings, Maria also jumped on the eReg train way back at its implementation at her organization and has gotten the opportunity to watch it grow from infancy to the lovable little rascal the folks at UNMC know today. Maria’s favorite parts of her job are troubleshooting with end users and having the privilege of witnessing “light bulb” moments.

Sessions

• eReg Delegation of Authority: Best Practices and Use Cases

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

• Advarra eReg and eConsent Overview

Nichole Mahaffey, PhD, CCRP

Assistant Director, Protocol Review & Monitoring System
University of California Davis

Nichole Mahaffey leads the Protocol Review and Monitoring System (PRMS) in the University of California Davis Comprehensive Cancer Center’s Office of Clinical Research (OCR). Nichole holds UC Davis close to her heart, with a PhD. in genetics from UC Davis, and a deep background in the Office of Clinical Research as a Data Coordinator, Data Supervisor, Auditor, and member of many committees. Currently she serves as a research expert on UC Davis’s Data Sharing Committee and has been uniquely qualified to provide leadership and expertise to the Advarra EDC implementation.

Sessions

• The Journey from a Legacy EDC Platform to Advarra EDC

Ehsen Malik

IT Business Process Analyst
Fred Hutch Cancer Center & University of Washington

Ehsen Malik has been with the Fred Hutch/UW CTMS Program Office for over 4 years, starting on the Implementation Project Team before transitioning to the Program Office Training Team in July 2021. Ehsen’s contributions to the Training Team include developing eLearning modules, leading training sessions, presenting at monthly webinars, and managing the LMS. Prior to starting at Fred Hutch/UW, he assisted in the implementation of a CTMS across several oncology and non-oncology departments in the Adventist Health Systems, a multi-hospital system across several Southern and Midwestern states. He holds a B.S. in Speech-Language Pathology and Audiology from Brooklyn College CUNY.

Sessions

• No Train, No Gain: Key Elements of a Successful CTMS Training Program

Brenden Martenson

Director, Enterprise Research Solutions
Advarra

Brenden has a decade of experience leading healthcare technology implementations, teams, and change management initiatives. He and his team strive to continually define best practice and methodology to drive successful change management. He sees technology as a vessel to achieve optimal operational state and continually redefines methodology to help healthcare organizations leverage technology to it's full potential.

Sessions

• Planning for Complex Change at Your Organization

Susan Mauermann, RN, CCRC

Clinical Trial Budget Negotiation & Start-up Specialist
Medical College of Wisconsin

Sue Mauermann has a 35 year background in Nursing, with 28 years in clinical trials. Clinical Trial experience includes 25 years in Cardiology, with the last 3 years in adult and pediatric research administration. Focus areas of administration are study feasibility and start-up activities, budget development and negotiation, research billing disambiguation guidance and issue resolution. Since 2020, key enterprise system rollouts Sue has assisted with and continues to support include the research module for the electronic medical record system, the e-regulatory platform, the financial functions of the clinical trial management system. Support involves both training and day-to-day operations.

Sessions

• It Takes Two: Instituting a Shared Process for Coverage Analysis Between Two Separate Legal Entities

Megan Miller

CTMS Training Program Manager
Fred Hutch Cancer Center & University of Washington

Megan Miller joined the Fred Hutch/UW CTMS Program Office in November 2019 as the Training Program Manager. Previously, Megan gained extensive experience as a Research Coordinator at University of Washington, University of California, and University of Iowa before shifting her career focus to training and education. She earned a Master of Education and a Master of Public Heath while working on continuing education for healthcare teams. During her time with CTMS, Megan has overseen the implementation of a LMS, transition of onboarding training from recorded videos to interactive eLearning modules, the launch of monthly training sessions, and reference document development.

Sessions

• No Train, No Gain: Key Elements of a Successful CTMS Training Program

Barbara Moskalenko

National Director, Research Administration
Ascension

Mrs. Moskalenko joined Ascension in October 2021 and previously served as the Research Operations Director at Dartmouth-Hitchcock Medical Center. At Ascension, Barb's role is as National Director for Research Administration overseeing research operations across Ascension specifically looking at standardizing processes related to research billing compliance, Medicare Coverage Analysis, budget and contract negotiations and research bill review along with oversight of the Clinical Trials Management System, Clinical Conductor.

Sessions

• Using Clinical Conductor to Run Research as a Business

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 in Viral hepatitis clinical trials at Metropolitan Liver Disease/Gastroenterology Center in Fairfax, VA. Catee 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 a team of Epic Analysts for Research.

Sessions

• Enhancing Performance through Clinical Research Unit Scorecards: Driving Metrics for Excellence

Joyce Nancarrow Tull, MSN, RN

Executive Director, Office of Clinical Research
University of California Davis

Joyce Nancarrow Tull has spent 19 years working in clinical research, providing leadership in oncology clinical trials at The Ohio State University Comprehensive Cancer Center, City of Hope National Medical Center, University of Southern California Norris Comprehensive Cancer Center, Yale University Cancer Center, and currently, the University of California Davis Comprehensive Cancer Center. In her 47-year nursing career she has worked as a bedside nurse in all areas of Maternal Child Health, in Nursing Administration, Homecare, Hospice, Utilization Review and Discharge Planning, as well as in clinical research as an RN CRC. She obtained her BSN from Mercy College of Detroit and her Master’s from the University of Michigan.

Sessions

• The Journey from a Legacy EDC Platform to Advarra EDC

Susan Natoli

Sr. Strategic Services Associate
Duke University School of Medicine

Susan has over 20 years of experience in clinical research in Academic Medical Center and Industry settings, primarily in regulatory affairs and project management. Currently, Susan is a Senior Strategic Services Associate for the Duke Office of Clinical Research and is a key member of their OnCore and eReg operations teams. She has been with Duke’s OnCore team since their enterprise-wide implementation in 2018 and now focuses on developing and refining workflows and end user education and training.

Sessions

• Advanced Study Startup and Calendar Build Workflows in OnCore
• eReg Delegation of Authority: Best Practices and Use Cases

Cuong (Andy) Nguyen

Research Information Systems Specialist/Developer
University of Texas Medical Branch (UTMB)

Areas of expertise: CTMS Integration Specialist Development and Support of Application Systems

Sessions

• The Phases of the UTMB IRB / eReg Integration

Agnes Nika

Associate Director of Clinical Research Services
Stanford Clinical Trial Office

After graduating with a Bachelor of Science degree, Agnes Nika has held various leadership roles in her career. At Stanford, she started as a clinical research associate intern with the GI group and advanced into her current role as Associate Director of Clinical Research Services. She is passionate about collaboration with stakeholders, process improvement, and giving patients new opportunities to conquer cancer. When she’s not thinking up new tools and colorful dashboards for leadership, Agnes enjoys playing pickleball and trying to beat her fastest time of solving Wordle’s daily puzzle.

Sessions

• Workload Wizard: Paving the Path to Productivity, Balance, and Strategic Staffing

Andrew Nugent

Research Information Systems Manager
University of Texas Medical Branch (UTMB)

Areas of ExpertiseProject and Program Management

Sessions

• The Phases of the UTMB IRB / eReg Integration

Debra O’Connell-Moore, MBA

Clinical Trials Regulatory Core Manager
University of Iowa

Debra O’Connell-Moore is the Clinical Trials Regulatory Core Manager at the University of Iowa’s Institute for Clinical and Translational Science (ICTS). Ms. O’Connell-Moore, and her staff, provide oversight of regulatory submissions as well as interfacing with government and other external entities (e.g., FDA Investigational New Drug [IND], Investigational Device Exemption [IDE] and clinicaltrials.gov). She is the content expert on the ICTS NCATS QA/QC team assisting investigators with submission of pilot and KL2 human subject prior approvals. In addition to these roles, Ms. O’Connell-Moore also develops training for research staff throughout the University of Iowa and has served as a member of the general research implementation team for the enterprise-wide expansion of the Advarra CTMS system.

Sessions

• Case Study: Applying CTME Maturity for Organizational Improvement

Angie Padget

Associate Director, Study Startup and Billing Compliance
Duke University School of Medicine

Angie has worked in clinical research operations at Duke for over a decade, primarily in research billing compliance. In her current role in the Duke Office of Clinical Research, she manages the central charge review team as well as the study startup team responsible for building calendars and performing coverage analysis in OnCore. She has extensive experience in the study startup process, particularly as it relates to calendar-building in OnCore and Epic.

Sessions

• Advanced Study Startup and Calendar Build Workflows in OnCore

Haley Parker

Research Analyst, OnCore Clinical Trials Management System
Mass General Brigham

Haley is an OnCore Research Analyst on the Clinical Trials Team at Mass General Brigham. She currently resides in Waterville, ME, and has been working for Mass General Brigham for five years and in her current role for two years. Haley helps with protocol/budget builds, manages OnCore upgrades, and has assisted with the MGB/Workday Implementation. In her spare time, Haley enjoys coaching basketball, CrossFit, and adventuring throughout Maine with her husband, Billy, and two dogs.

Sessions

• An Overview of the Implementation Process: From PeopleSoft to WorkDay

Julie ReBeau, BAA

Business Systems Analyst
University of Michigan

Julie ReBeau is a Business Systems Analyst for Health Information Technology & Services at Michigan Medicine. She began her career at UofM in medical education, supporting continuing education for practicing physicians. As the program manager and accreditation specialist there, she gained valuable knowledge of accreditation practices, regulatory requirements, continuing education principles and maintenance of certification. In that role, Julie supported the implementation of an enterprise-wide credit management system, which led to her current BSA role, and the implementation and support of the eReg system at Michigan Medicine. Julie received her BAA from Central Michigan University.

Sessions

• Embracing the Cloud: Strategies for Seamless Upgrades and External Monitor Access

Chris Redig

Team Lead Clinical Trials Management Systems
Mass General Brigham

Chris is the Team Lead at Mass General Brigham’s Clinical Trials Office, overseeing the technical support of OnCore CTMS and Advarra Payments applications and the analysts that support the applications. He currently resides in Houston, Texas and has more than 11 years of experience in healthcare. Chris previously worked for the University of Texas Medical Branch in Galveston, Texas supporting Research within the IT department. In his spare time, Chris enjoys surfing, camping, and watching The Office on repeat.

Sessions

• An Overview of the Implementation Process: From PeopleSoft to WorkDay

Nancy Reilly, RN, MS

Executive Director, Clincial Trials Office
Rutgers University

Nancy Reilly, RN, MS, works as the Executive Director for the Rutgers Health - Clinical Trials Office. In this capacity, she oversees contract and budget negotiation, as well as feasibility assessment and coverage analysis for non-oncology clinical trials and is responsible for the development of streamlined and efficient workflows for non-oncology clinical research across the Rutgers Health enterprise. Ms. Reilly held prior roles in clinical research administration and also as a research nurse and research manager in HIV/Infectious Disease.

Sessions

• Leveraging OnCore to Streamline Partner Hospital Processes

Albert Renteria

CTMS Administrator
University of Texas MD Anderson Cancer Center

Albert Renteria is the CTMS Administrator for the Office of Clinical Research at the University of Texas MD Anderson Cancer Center. He joined MD Anderson in 2008 providing support to the now retired legacy applications that once served as the CTMS. Albert now supports the Clinical Trial Management System that is now comprised of Advarra OnCore, eReg, and EDC applications. His experience spans multiple industries to include banking, software, and healthcare. He enjoys outdoor activities such as hiking, cycling, hunting, and fishing.”

Sessions

• General Session: Advarra Customer Highlight

Kacey Richards

Manager of Intake and Feasibility
Yale Center for Clinical Investigation (YCCI)

Kacey Richards is the Manager of Intake and Feasibility at Yale Center for Clinical Investigation (YCCI). She received her BA from Boston College and MPH from Yale University. She has worked at Yale for over 10 years (9 of those years at YCCI) in a variety of clinical research roles, spanning from regulatory and clinical research coordination to project management and system administration. Each of those roles has had a different vantage point into one or more of the Advarra systems, leading to extensive knowledge of OnCore, eReg and EDC+. This extensive breadth of experience and knowledge gives her a unique perspective which she leverages in her current role. Outside of work, you will find Kacey outside, rain or shine, running, hiking, and playing at the park with her baby girl.

Sessions

• eReg Delegation of Authority: Best Practices and Use Cases

Christine Ricklefs, MPH

CTMS Assistant Director
Fred Hutch Cancer Center & University of Washington

Christine Ricklefs, MPH has been the CTMS Assistant Director at Fred Hutchinson Cancer Center since fall 2020 overseeing the calendar & financial analyst team. Prior to joining the Fred Hutch team, Christine worked at the University of Colorado in various OnCore roles. Having 10 years of OnCore experience, Christine continues to be passionate about OnCore functionality and optimizing research administration workflows. Outside of work, you will find Christine hiking, cooking, listening to Audible, and playing Pokémon Go in a local park – gotta catch ‘em all!

Sessions

• The 2-step Amendment Dance

Erica Rocco, BS, CCRP

Senior Regulatory Project Manager
Yale Center for Clinical Investigation (YCCI)

Erica Rocco joined Yale University in 2015 as a Research Assistant in Regulatory Affairs at the Yale Cancer Center and is currently a Senior 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, and she serves as the Team Lead for YCCI’s Regulatory Support Services team. 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

• eReg Delegation of Authority: Best Practices and Use Cases

Mariel Rojas, MS

Clinical Research Management Analyst
University of California, San Francisco (UCSF)

Mariel Rojas is a Clinical Research Management Analyst with UCSF's Office of Clinical Trial Activation. She has nearly 10 years of experience in clinical research coordination, operations, and management of oncology and non-oncology trials. In her current role, she is responsible for implementing Financials builds in OnCore for UCSF's industry-sponsored trials. Mariel is thankful to be a part of her team and to utilize her clinical research experience to support study teams in improving post-award management workflows in OnCore. In addition to her day job, Mariel enjoys reading, cooking, and spending time with her family.

Sessions

• Transitioning to OnCore Financials for Post-Award Management

Kimberly Rose

Training Specialist
Advarra

Kim has over 26 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

• CCS Recruitment Training Session
• Clinical Conductor Enterprise 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).

Sessions

• General Session: Welcome & CEO Keynote

Brian Scates, BRMP

Clinical Application Manager
University of California Davis

Brian H. Scates is a Clinical Application Manager responsible for clinical trial applications and their integrations at UC Davis Health IT. Brian received his Bachelor’s degree from CSU, Sacramento and holds several certifications in IT. Brian has over 20 years of Healthcare IT experience, particularly in software implementation and process improvement. Joining UC Davis Health 3 years ago, Brian led the implementation of the new OnCore clinical trial management system, Advarra EDC, as well as several other regulatory and compliance applications.

Sessions

• The Journey from a Legacy EDC Platform to Advarra EDC

Miranda Schramm, PhD, CPTM

Director, Training
Advarra

Miranda has worked in training and higher education for over 14 years, including 6 years of teaching and research at the University of Wisconsin – Madison where she earned her doctorate in Organizational Communication. Her current focus is on utilizing technology to create effective and engaging content for both instructor-led and self-guided courses. She believes in finding unique solutions so that distance learning does not mean diminished learning.

Sessions

• Clinical Conductor Enterprise 101
• Advanced OnCore Topics

Brian Sevier, PhD

Chief Operations Officer
Yale University

Brian J. Sevier, PhD., has worked in research administration for >25 years and clinical research for >10 years. As the Chief Operations Officer at the Yale Center for Clinical Investigation, Brian’s focus is on CTMS and eRA systems, integrations between regulatory software platforms, the CTMS and EHR, and specifically managing enterprise operations for efficient clinical research activation and management.

Sessions

• Developing a Data-Driven Financial Feasibility Process
• General Session: Customer Leadership Panel

Denise Snyder, MS, RD, LDN

Associate Dean for Clinical Research
Duke University School of Medicine

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 11 years, Denise has been the Associate Dean for Clinical Research. In this role, she leads the Duke Office of Clinical Research (DOCR), a central support office with expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation, clinical research systems at-elbow support, and guidance for clinical research operations for Duke as a site.

Sessions

• General Session: Customer Leadership Panel
• Enhancing Performance through Clinical Research Unit Scorecards: Driving Metrics for Excellence

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

• A Blended Approach: ILT & Custom eLearning for Large Scale Implementations
• Advanced OnCore Topics
• OnCore 101

Nick Spittal

Chief Operations Officer
Velocity Clinical Research

Nick Spittal is COO of Velocity Clinical Research, the largest global organization of fully-owned clinical research sites. With over two decades in a broad range of roles at global CROs, Nick brings innovative ideas and technology into site operations to fulfill Velocity’s vision of making clinical research accessible to all. Nick’s team is leading sites to deliver faster startup, predictable enrollment, and the highest quality data at scale for clinical Sponsors.

Sessions

• General Session: Customer Leadership Panel

Wendy Tate, PhD, MS

Director, Advanced Analytics and Research Optimization
Advarra

Wendy Tate, PhD, is a Product Strategy Director with Advarra. Wendy’s passion is to provide meaningful processes and tools that streamline clinical research. Wendy has over 20 years of experience in the clinical research industry, including 15 years in academia in laboratory, compliance, and clinical research roles. Within academia, Wendy has held leadership roles in the IRB and Cancer Clinical Trials Offices. She holds a Master's degree in Applied Biosciences and PhD in Pharmaceutical Economics, Policy, and Outcomes with a minor in Epidemiology.

Sessions

• Developing a Data-Driven Financial Feasibility Process

Robert Till

Associate Director, Information Systems, Operation & Strategy
University of California, San Francisco (UCSF)

Robert works in the Office of Clinical Trial Activation at the UCSF, where he serves as Associate Director, Information Systems, Operation & Strategy. His work helps streamline clinical trial start-up, management and compliance. Robert began working in clinical research operations at a site/CRO in 2012. He joined UCSF's Office of Clinical Research in 2016. There he helped lead the enterprise-wide adoption of OnCore, integration with Epic, roll-out to Children's Hospital of Oakland, and most recently implementation of post-award sponsor invoicing with OnCore Financials. Robert is driven to increase trial management and visibility with OnCore and strengthen UCSF's billing compliance program.

Sessions

• Transitioning to OnCore Financials for Post-Award Management

Scott Uebele, MBA

Chief Operating Officer
Advarra

Sessions

• General Session: Welcome & CEO Keynote

Molly Van Rheen, MS, MBA

CTMS Program Director
Fred Hutch Cancer Center & University of Washington

Molly Van Rheen is a Sagittarius who enjoys long walks through a schedule of events. She currently serves in the role of CTMS Program Director but dreams of riding her bike through segments of Mallorca someday, stopping at milestones and interesting consoles. After 7 years of deep meditation and one-ness with OnCore her status update is super-super user. Prior to overlapping her segment with OnCore, Molly's protocol staff assignments included Research Coordinator for clinical, animal, and basic science Research protocols. When she logs out Molly enjoys spending time with her child (records), running (scripts) and downhill (NOT downtime) skiing.

Sessions

• The 2-step Amendment Dance

Jennifer Warmington

Director of Clinical Trial Management Systems
Mass General Brigham

Jennifer is the Director of Clinical Trial Management Systems at Mass General Brigham’s Clinical Trials Office, where she oversees the Clinical Trials Office CTMS and Clinical Trials Central Billing teams. She has over 20 years of experience in the healthcare industry. Joining Mass General Brigham in 2008, she has worked in various roles, including overseeing interface development teams and project management. Since 2018, Jennifer has focused on implementing and supporting clinical trial management systems (CTMS) and Clinical Trials central billing at Mass General Brigham.

Sessions

• An Overview of the Implementation Process: From PeopleSoft to WorkDay

Travis Wheeler, BA

CTMS Program Analyst
Henry Ford Health System

Travis is a CTMS Program Analyst at Henry Ford Health System in Detroit MI. He has a Bachelor of Arts degree from Oakland University. He has worked in Public Health and clinical research since 2006, with a particular focus on GU cancers and clinical trials regulations. In his current CTMS Analyst position, Travis is working as a liaison between the OnCore Support Team and individual departments during the system wide Oncore & eReg implementation at Henry Ford Health.

Sessions

• CTMS Program Analyst - Role Creation and Utilization

Amanda Wigand

Data Operations Manager- OnCore Support
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 Data Operations Manager of the OnCore Support team.

Sessions

• Health System Wide Implementation: Decisions Made and Lessons Learned

Ken 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. Ken is currently a project manager helping lead an enterprise-wide CTMS implementation at Henry Ford Health.

Sessions

• CTMS Program Analyst - Role Creation and Utilization
• Health System Wide Implementation: Decisions Made and Lessons Learned

Kathryn (Katie) Wong, MSCIS, PMP, CBAP, CSM

Senior Information Systems Analyst
UC Davis

Kathryn (Katie) Wong is the Lead Electronic Data Capture analyst for UC Davis Health’s Clinical Trials and Regulatory Applications team. Katie received her Master’s degree in Computer Information Systems with a sub-concentration in Health Informatics. Katie has over 10 years of experience serving as a lead information technology project manager and lead business systems analyst for software development, web development, and system implementations.

Sessions

• The Journey from a Legacy EDC Platform to Advarra EDC

Alex Young

Feasibility Navigator, Clinical Trials Office
Rutgers University

Alex Young works as the Feasibility Navigator for the Rutgers Health - Clinical Trials Office. In this role, Ms. Young is primarily responsible with evaluating the feasibility and operational needs of non-oncology clinical research studies, as well as steering and improving study startup processes throughout the Rutgers Health enterprise and its hospital & health system affiliates. Prior to her current role, Ms. Young served as clinical research manager and coordinator at NCI designated cancer centers.

Sessions

• Leveraging OnCore to Streamline Partner Hospital Processes

Xiyu (Sherry) Zheng, MS

OnCore Data Analyst
Stanford Clinical Trial Office

Since 2019, I have been a member of the Stanford Cancer Institute Clinical Trial Office, where my responsibilities include working with data, identifying and addressing problematic data, closing data gaps, and resolving root causes of data issues. I specialize in designing and customizing Tableau dashboards to enhance the transparency of our services. My enthusiasm for data analytics is evident in my approach to problem-solving, where I leverage both quantitative and qualitative methods. My goal is to translate data-driven insights into actionable decisions. The implementation of Tableau dashboards has proven instrumental in improving our operations, offering user-friendly interfaces that effectively convey the narrative behind the data in a visually engaging manner.

Sessions

• Workload Wizard: Paving the Path to Productivity, Balance, and Strategic Staffing