Speakers

Sheri Alexander

ICTR OnCore Administrator
University of Wisconsin – Madison Institute for Clinical and Translational Research (ICTR)

Sheri has over 20 years’ experience working in clinical trials. She has worked as a project manager coordinating multi-center studies including both federally funded and industry sponsored trials and as a validation specialist performing software validations. She has brought her experience with upgrades, testing, and clinical trial management to the UW-Madison Institute for Clinical and Translational Research (ICTR). She is currently serving as manager of UW ICTR’s Enterprise implementation of OnCore.

Sessions

• From In-Person to Online Training: One Site's Experiences Converting

Bishoy Anastasi

Director of Clinical Research Finance
UCLA Dean’s Office

Sessions

• Coverage Analysis Workshop™

Julie Anthony

Business Systems Analyst
University of Michigan

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

• The Keys to Successful Transition to Remote Work: Process, Procedures, and People

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

• Implementing OnCore & eReg Simultaneously

Mollie Bodin, M.A.

Business Intelligence Analyst Senior
Clinical Trials Support Office, University of Michigan Medical School Office of Research

Mollie works closely with University of Michigan Medical School leadership to implement, analyze, and provide continuous quality improvement to the Clinical Trials Support Office (CTSO). Specifically, she bridges the business & technical teams for harmonious communication and service excellence. Mollie developed, implemented, and continues to lead the CTSO Quality Program. Prior to joining the CTSO, Mollie provided project management expertise in various fields, centered around the themes of innovation and cutting-edge research. She coordinated large grants at the Vanderbilt Institute for Clinical & Translational Research, served as an assistant to the MacArthur Foundation Research Network on Law & Neuroscience, and as an analyst at a major economic consulting firm. Mollie received a B.A. from Lawrence University (English & History) and a M.A. from University of Wisconsin Milwaukee (History - gender, 18th century pirateology).

Sessions

• Institutional Perspectives on Stabilizing Clinical Research & Managing Communication during COVID-19

Cyndi Bower, M.S.

Director
Clinical Trials Support Office, University of Michigan Medical School Office of Research

After completing her MS at the University of Rochester in Rochester, N. Y. Cyndi began her career with the University of Michigan in 1982. She has held positions in the School of Nursing, Ambulatory Nursing Administration, and as an Advanced Practice Nurse with the Pediatric Bone Marrow Transplant team. She has spent the last 20 years in clinical research administration with MICHR (the University of Michigan’s CTSA funded Institute) and most recently with the Medical School Office of Research Clinical Trials Support Office as the Director of Clinical Trials Support Office. In addition, she has also worked with the Senior Associate Dean for Research in the School of Dentistry as an administrative consultant for their Clinical Research Program. As the business and administrative lead for the research mission, Ms. Bower is responsible for the strategic oversight of the infrastructure, implementation, and operational and fiscal management of the CTSUs, the research clinical support unit and strategic partnerships. She assists with devising and deploying the associated strategic research initiatives; managing projects; and advising on policy, procedural, and operational issues for the clinical trial enterprise and work with partners and affiliates within and external to the university. She has directed her own research in the areas of participant experience in research and the variables affecting retention, satisfaction and regret. She has published on a business model using mobile research support teams to enhance investigators being able to include vulnerable populations in research. Ms. Bower is an active member of committees at both the local and national level.

Sessions

• Institutional Perspectives on Stabilizing Clinical Research & Managing Communication during COVID-19

Kerri Briesmiester, MBA, CCRC

OnCore Coordinator & Clinical Trials Application Manager
University of Michigan

Kerri Briesmiester, MBA, CCRC, is the Clinical Trials Application Manager and OnCore Coordinator for the University of Michigan Clinical Trials Support Office and Health Information Technology & Services. She began her career in research as a Research Nuclear Medicine Technologist and quickly moved into a Study Coordinator role supporting a variety of cardiology trials. Over the course of 25 years, she gained broad experience in the lifecycle of clinical trials and has held a variety of management and leadership roles including her most recent role as the Research Administrator for the Frankel Cardiovascular Center. In this role she facilitated both clinical and basic science research and in 2015 was awarded the Frankel Cardiovascular Center Award of Excellence for Research. She holds an MBA and BBA from Cleary University and is a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals.

Sessions

• The Keys to Successful Transition to Remote Work: Process, Procedures, and People

Suzanne Calzada

Senior Contract Officer, Clinical Trials Administration Office
Cedars-Sinai Medical Center

Suzanne has been working in the research administration field for 19 years and has been with Cedars-Sinai Medical Center (CSMC) for a little over 7 years. Her roles in the past have included managing research compliance including the Institutional Review Board and Institutional Animal Care and Use Committee at California State University, Northridge and currently serving as a Senior Contract Officer at CSMC analyzing research budgets for compliance, training new Contract Officers, and acting as the point person for Oncore Financials at CSMC. Suzanne prides herself on constantly seeking to improve processes to maintain efficiency and training staff to provide thorough detailed analysis of budgets/payment terms. In her free time she enjoys cooking, hiking, trying new restaurants, and hanging out with her family including her husband and 3 furry children.

Sessions

• Rolling Out Financials and CRPC

Amanda Childs

OnCore Program Manager
University of Colorado, Anschutz Medical Center

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

• You’re in OnCore, Now What? Leveraging Your Integrations for Accountability

Ilsa Gaulke

ICTR OnCore Training and Support Specialist
University of Wisconsin – Madison Institute for Clinical and Translational Research (ICTR)

Ilsa Gaulke discovered throughout her experiences as a clinical research coordinator and long-term case manager for adults with developmental disabilities that her strengths include navigating technology and helping others understand complex systems. This has translated to her becoming an effective OnCore Training and Support Specialist for non-oncology studies at the University of Wisconsin – Madison Institute for Clinical and Translational Research (ICTR). She is driven by the desire for clinical research to be a positive and productive experience for everyone involved.

Sessions

• From In-Person to Online Training: One Site's Experiences Converting

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

• Implementing OnCore & eReg Simultaneously

Tesheia Harris, MBA, MHS

Deputy Director, Chief Operating Officer
Yale School of Medicine

Tesheia Harris, MBA, MHS, is Deputy Director and Chief Operating Officer of YCCI and the Associate Director for Clinical Research for Yale School of Medicine, where she provides leadership and direction in clinical research. Her career has focused on the development of clinical research programs and support infrastructure. Prior to assuming her current position, she held positions as Assistant Dean for Clinical Research at the University of Vermont College of Medicine and Director of Clinical Trials at the University of Wisconsin-Madison. She has served as a consultant for several academic centers interested in establishing clinical research programs and as a grant reviewer for the National Institutes of Health.Ms. Harris is nationally recognized for her expertise in the design and setup of clinical research programs. She has been an invited speaker at many national and international conferences on topics such as developing funding for central support for clinical research, staffing models for clinical and translational research, training programs for research professionals, clinical research regulation, and contracting and budget negotiation. She has served as Chair and co-Chair for several National Clinical and Translational Science Award (CTSA) Consortium Group/Committees. She sits on the external scientific advisory boards for the CTSAs at NYU, Washington University, Rockefeller, and the Universities of Washington, Florida, and Buffalo.

Sessions

• Managing Research Operations During COVID

Kira Hulse, BSc, CCRP

CTMS Analyst
Clinical Trials Office, Research Quality and Education Moffitt Cancer Center

Kira received her BSc in Biology from Stonehill College in Easton, MA and desired to pursue her passion for research and healthcare in a warmer climate. The city of Tampa became her new home and she has lived there and worked within the departments of clinical research at Moffitt Cancer Center for over 10 years, which include Cutaneous Oncology, Research Quality and Education, and now the Protocol Support Office. Her current role as CTMS Analyst is known more colloquially as the OnCore Administrator and she strives to be the institution’s CTMS key subject matter expert and CTMS team lead. She provides application administrative support for all users within the institution and affiliate study sites. She acts as project manager and helps provide expertise and training for OnCore application users, technical support personnel, clinical research administration, and vendors during all system upgrades, issues, interfaces, and enhancements. Kira enjoys collaborating with the diversified teams that use OnCore including the study teams from all oncology programs, research leadership, regulatory, pre- and post-award finance, statisticians, and research IT to innovate new centralized workflows and boost clinical research process efficiencies. Though COVID-19 has put a temporary halt to participation in the sport, Kira is an avid paddler in the sport of Dragon Boat racing and hopes to rejoin her fellow teammates back on the water once it’s deemed safe.

Sessions

• Institutional Perspectives on Stabilizing Clinical Research & Managing Communication during COVID-19

Marissa Macri, PMP, CSSGB

Senior Project Manager
UCHealth

Marissa Macri is currently the Senior Project Manager for UCHealth Research Administration. After leading the OnCore Epic integration for the organization, she now looks for ways to improve the existing infrastructure and leverage all systems used by the health system for research. She collaborates closely with the University of Colorado, Denver OnCore Team on integration requirements and enhancements, training and ongoing study activation and amendment processes. The past year was spent revamping and streamlining the Research Invoice process and improving electronic source documentation. She holds a B.S. in Biochemistry from the University of Tampa, CPC and CGSC certifications, Epic Revenue Cycle Certifications, and obtained PMP and LSSGB certifications.

Sessions

• You’re in OnCore, Now What? Leveraging Your Integrations for Accountability

Jill McKinley

Staff Aug
Advarra

Jill has been working in the technology support and training for 25 years and has been with Advarra for 13 years. Her roles have included Product Support, Training, Implementation Support and Optimization. Her current role is with the Staff Augmentation team to help customers directly with their goals and projects. She prides herself in providing adoptable solutions and helps customers with OnCore coordination, project planning, workflow discussions, documentation, training, and adoption sessions. In her free time, she enjoys reading, hiking, and podcasting.

Sessions

• Rolling Out Financials and CRPC

Sami Naber, MBA, CRA

Senior Post Award Analyst, Post Award Reporting and Compliance
Cedars-Sinai Medical Center

As a member of the Post Award team, Sami oversees a portfolio of over 300 research studies from federal, non-federal, pharmaceutical, and institutional funding sources, and is responsible for all invoicing, financial reporting, and compliance of those studies. In addition, he is the primary OnCore Biller at the hospital and was a key stakeholder in the organization’s Accounts Receivable integration of OnCore with Peoplesoft. Prior to joining the Office of Research Administration, Sami began his career as a research administrator in the Kidney Transplant department at Cedars-Sinai. In his free time, he chases around his surprisingly fast one year old son. He has been at Cedars-Sinai for 10 years.

Sessions

• Rolling Out Financials and CRPC

Tricia Pearce, J.D.

Associate Director, Clinical Trials Administration Office
Cedars-Sinai Medical Center

Tricia is the Associate Director of the Clinical Trials Administration Office at Cedars-Sinai. She oversees the coverage analysis team, budget compliance review team and contract officer team, as well as the OnCore program administrator for General Research. She has been at Cedars-Sinai for 9 years.

Sessions

• Rolling Out Financials and CRPC

Lyle Portice

Senior Application Programmer/Analyst
University of Michigan

Lyle Portice is the lead report writer for the Michigan Medicine CTMS team and has a Bachelor of Science from Michigan Technological University. Lyle is responsible for development of complex financial reports tying together data from OnCore, Michigan Medicine Financial and Proposal Management systems. He has developed visualizations used to streamline the operations of the Clinical Trials Support Unit and the Clinical Trials Support Team. His interests include creating a collaborative work environment and helping find answers in data.

Sessions

• The Keys to Successful Transition to Remote Work: Process, Procedures, and People

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

• Managing Research Compliance in the “New Normal” (IBC, IRB regulations, SOPs, staffing)

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

• Implementing OnCore & eReg Simultaneously

Kim Smith, MS, RN, CCRP

Research Clinical Specialist
Clinical Trials Office, Research Quality and Education Moffitt Cancer Center

Kim is a Master’s prepared Registered Nurse with almost 30 years’ experience healthcare and clinical trials research, the last 10 spent with Moffitt Cancer Center. She has varied experience as a Registered Nurse and Gerontological Clinical Nurse Specialist, with clinical trial monitoring and auditing for major pharmaceutical companies, as well as study coordination and Investigator Initiated Trial monitoring. In her current role as Research Clinical Specialist, she helps develop and disseminate educational content for both clinical trial staff and ambulatory and inpatient clinical staff, assists in creation and updating of Standard Operating Procedures and work processes for the Clinical Trials Office, and works with both clinical trial and ambulatory and inpatient clinical staff to improve communications regarding their shared patients’ participation in clinical trials at Moffitt Cancer Center.

Sessions

• Institutional Perspectives on Stabilizing Clinical Research & Managing Communication during COVID-19

Devon Still

Guest Motivational Speaker

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

• Guest Keynote: Thriving in the Midst of Adversity

Ginnette Watkins-Keller RN, MSN, OCN

Associate Director of Clinical Trials Administration
Rutgers Cancer Institute of New Jersey

Ginnette Watkins-Keller RN, MSN, OCN, has been in oncology and clinical research for over 25 years. She holds a master’s and a bachelor’s degree in nursing from Drexel University (Summa cum Laude), a bachelor’s degree in fine art from Temple University. She is currently enrolled at Thomas Edison State University (with only four more classes to go) in the Doctorate of Nursing Practice program with a focus on Systems-Level leadership. Ms. Watkins-Keller has held a variety of different positions throughout the years. These positions include being one of the original research nurses at Rutgers Cancer Institute of New Jersey back in the mid-nineties, hospital-based education for the oncology and ambulatory care units, Performance Improvement Coordinator, Mercer County Cancer Coalition Coordinator, Palliative Care Coordinator, and currently the Associate Director of Clinical Trials Administration. Her responsibilities include overseeing Informatics, Quality, and Education for a National Cancer Institute Comprehensive Cancer Center Clinical Trials department. Ms. Watkins-Keller has presented presentations, abstracts, and posters on various performance improvement, oncology, and educational topics nationwide.

Sessions

• Beyond Remote Monitoring - Conducting a Clinical Trials Audit Remotely During a Pandemic

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, collecting and analyzing end-user feedback, and performing routine quality assurance with the goal of improving the experience through positive iterative changes.

Sessions

• Managing Multi-Site Studies