Speakers

Rafie Abdul Khalid

Enterprise Systems Administrator
Baptist Health South Florida

Sessions

• Advarra Managed Infrastructure: Security and Compliance Considerations

Bishoy Anastasi

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

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

Sessions

• Coverage Analysis Certification™
• Coverage Analysis Certification™

Carlee Brueser

Clinical Research Analyst
Duke Office of Clinical Research (DOCR), Duke University School of Medicine

Carlee joined the OnCore Team in January 2020 as a Clinical Research Analyst within the Duke Office of Clinical Research. She primarily supports OnCore end users with an emphasis on training and compliance. She has helped initiate the development of a number of reports, processes and guidance materials to promote OnCore data entry accuracy. Carlee’s previous clinical research experience includes study start-up project management, regulatory submissions and compliance oversight, process optimization, change management and pharmacovigilance reporting.

Sessions

• Building a Successful Foundation for OnCore Reporting Throughout the Research Enterprise

Marc Buehler

Clinical Research Systems Manager
UW Carbone Cancer Center

Marc has been working as a physicist in the areas of particle and medical physics. In 2018, he joined the UW Carbone Cancer Center, where he’s been managing the oncology instance of OnCore.

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Suzanne Calzada, MPA

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

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Stuart Cotter

Director, Product Management
Advarra

Stuart Cotter is Director, Product Management at Advarra. 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 on Allegro CTMS, where he worked alongside dozens of small- to mid-sized research sites to help them overcome their operational hurdles.

Sessions

• Panel Session: Onsemble Community Experiences with Advarra eReg

Kasha Donahue, CCRP

Regulatory Manager, CTO
Barbara Ann Karmanos Cancer Institute

Kasha Donahue is the Regulatory Manager in the Clinical Trials Office at Karmanos Cancer Institute, a NCI designated Comprehensive Cancer Center in Detroit, Michigan. She and her team are responsible for the regulatory oversight of 750+ oncology trials at the cancer center. Since 2017, Kasha has acted as a project lead for the rollout, validation, and management of the Advarra eREG™ system at her institution. Karmanos went live with eREG™ in June of 2018. Kasha received her Bachelors of Science in Biochemistry from the University of Michigan and has held her SoCRA certification since 2014.

Sessions

• Panel Session: Onsemble Community Experiences with Advarra eReg

Chloe Fournier

Associate Director, Compliance and Training
Duke Cancer Institute

Sessions

• Panel Session: Onsemble Community Experiences with Advarra eReg

Mercedes Franco

Cedars-Sinai Medical Center

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Rhodora Garcia, MMCi

Team Lead, Application Data
Duke School of Medicine – Office of Academic Solutions and Information Systems (OASIS)

Rhodora Garcia is the team lead of the Application Data team for the Duke School of Medicine – Office of Academic Solutions and Information Systems (OASIS) and has been at Duke since 2014. She is involved in reporting, data governance, and ETL development across a variety of systems and platforms for research operations (administration, clinical, and basic). Prior to Duke, Rhodora worked in account management, data engineering, and analyst roles focusing on using data to improve marketing segmentation and customer retention for Fortune 500 companies.

Sessions

• Building a Successful Foundation for OnCore Reporting Throughout the Research Enterprise

Annie Geo-Thomas

Business Systems Analyst Senior
University of Michigan

Annie Geo-Thomas is the Technical Lead for the Clinical Trials Management System (CTMS) at the University of Michigan (UM). Annie has a M.S. in Information Systems and a B.B.A. Annie led the OnCore Biospecimen implementation in 2019. Annie is currently responsible for managing all technical aspects of OnCore including working with technical partners to perform application, database and OS upgrades, copy downs, security patching, and other system and application changes. The UM CTMS Team has deployed three successful OnCore upgrades since May 2020. Annie has also developed incident and change management processes to support OnCore operations.

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Beau Grignon

Security Officer and SVP of Technology
Advarra

Sessions

• Advarra Managed Infrastructure: Security and Compliance Considerations

Kristina Harr, J.D.

Director, Clinical Trial Support
Children’s Hospital of Philadelphia (CHOP)

Kristina Harr, J.D. is Director, Clinical Trial Support at the Children’s Hospital of Philadelphia (CHOP). She oversees the teams supporting OnCore, REDCap, and Epic Research, along with the IND/IDE Support Program, the Recruitment Enhancement Core, and Research Family Partners. Kristina led CHOP’s enterprise-wide OnCore expansion followed by CHOP’s recent OnCore Financials implementation.

Sessions

• Developing a Successful Enterprise Expansion Strategy

Mike Lee, MPH, CCRP

Business Systems Analyst Senior
University of Michigan

Michael Lee, MPH, CCRP is a Business Systems Analyst Senior for the University of Michigan Health Information Technology & Services. He began his career as a Data Clinic Research Coordinator and later as the OnCore Support Supervisor at Washington University in St. Louis where he gained valuable knowledge of clinical trials. In his current role, he is responsible for supporting multi-organizational teams throughout the University of Michigan, by providing OnCore training, support, and project management. Mike received a Bachelor of Science degree at Michigan State University and a Master’s degree in Public Health from Saint Louis University.

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Alise Lombardo, BS, CCRP

Regulatory & Quality Manager
Lifespan Cancer Institute

Alise Lombardo, BS, CCRP, is the Regulatory & Quality Manager for the Lifespan Oncology Clinical Research Department at the Lifespan Cancer Institute and holds a professional certification in clinical research. In addition to managing the adult and pediatric department study portfolios and leading the department quality committee, she manages the regulatory coordinators, regulatory assistants and administrator coordinators across all sites.

Sessions

• Panel Session: Onsemble Community Experiences with Advarra eReg

Allie Moses

Research Systems and Recruitment Center Manager
MedStar Health Research Institute

Allie Moses is the Research Systems and Recruitment Center Manager for MedStar Health Research Institute. Allie began working in research in 2013 as an OnCore Support Specialist at Forte. After leaving Forte to move to Washington DC, she returned to the world of OnCore to work on MHRI and Georgetown’s OnCore implementation. In her current role, Allie oversees the use of OnCore at both MHRI and Georgetown University, and manages the centralization of subject recruitment efforts at MHRI.

Sessions

• Optimizing the Research Revenue Cycle From Protocol Initiation to Completion

Catee Mullen

Director of Research Operations
Duke Office Of Clinical Research

After completing her Masters in Healthcare Science and becoming a Physician Assistant, Catee completed a one-year fellowship in liver disease with Metropolitan Liver Disease and Gastroenterology Center and Metropolitan Research. Catee spent the next six years working as a sub-investigator on various viral Hepatology studies. In 2006, Catee joined Duke University as part of the Hepatitis C research group. During her time at Duke University, she has held several positions (Clinical Trials Manager, Lead CRA at the Duke Clinical Research Institute (DCRI), Research Practice Manager in the Duke Heart Center and Director of Research Financial Management in the Duke School of Medicine Finance Office. Catee is currently working as the Director of Research Operations at the Duke Office of Clinical Research (DOCR). In this role, she is the product manager for OnCore and OnCore Financials. Some of Catee’s team’s most recent initiatives include the implementation of a reloadable debit card for participant payments, implementation of a real time interface with SAP and OnCore and the roll-out of OnCore Financials across the Duke School of Medicine.

Sessions

• Building a Successful Foundation for OnCore Reporting Throughout the Research Enterprise

Sami Naber, MBA, CRA

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

Sami has been part of the Post Award team in Office of Research Administration at Cedars-Sinai for seven years, and is the primary OnCore Biller at the hospital. He was a key stakeholder in the organization’s Accounts Receivable integration of OnCore with Peoplesoft. Prior to joining the central office, 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 18 month old son. He has been at Cedars-Sinai for 11 years.

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Susan Natoli, MSW, CCRP

Senior Strategic Services Associate, OnCore and eReg Coordinator
Duke University

Susan Natoli, MSW, CCRP, has over 20 years of clinical research experience, having worked in both academic medical center and industry settings. She started her research career by developing data collection tools for a pharmaceutical company and later managed regulatory offices at the University of North Carolina and Duke University. Currently she serves as the OnCore and eReg Coordinator for the Duke Office of Clinical Research and was involved in the implementation of both systems. Susan continues to work on optimizing workflows and developing training materials for the research community.

Sessions

• Panel Session: Onsemble Community Experiences with Advarra eReg

James Riddle, MCSE, CIP, CPIA, CRQM

Vice President, Research Services & Strategic Consulting
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

• Mobile Medical Applications and IRB Review

Brian J. Sevier, Ph.D.

COO, Clinical & Translational Science Institute and Director, Office of Clinical Research
University of Florida

Brian Sevier, Ph.D., is the Chief Operating Officer of the UF Clinical & Translational Science Institute (CTSI) and the Director of the Office of Clinical Research (OCR). As the COO of the CTSI, Brian oversees the operational implementation of the UF-FSU CTSA Hub strategic initiatives, establishing new collaborations, and partnering with health system administrators to execute on the mission of the CTSI within the academic medical center. Additionally, this role oversees the administration of multiple research cores and auxiliary service centers, managing revenue recovery portfolios. As the Director of the OCR, Brian leads a multidisciplinary team of research administrators delivering high levels of customer service to internal stakeholders and extramural sponsors. The OCR is responsible for managing all UF|Research workflows related to clinical study protocol activation, contracting, pre- and post-award financial management, award setup and management, CTMS operations, and coverage analysis.

Sessions

• Response, Resource Expansion, and Recovery: Lessons Learned and Planning for Next Time

Jon Tack

Vice President, Product Management
Advarra

As Vice President of Product Management, Jon leads the product planning and documentation functions at Advarra. Jon’s team is focused on setting a clear direction for each product and delivering value-add solutions that customers can easily adopt. Jon has over 15 years of experience driving collaborative, complex software development initiatives.

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Candice Vance

Director of Clinical Research Revenue Cycle
MedStar Health Research Institute

Candice Vance is the Director of Clinical Research Revenue Cycle at MedStar Health Research Institute. She oversees clinical research billing compliance, coverage analysis, budget negotiation, and revenue recognition. Candice has a background in auditing health systems for billing and coding compliance and moved into the research realm twelve years ago. She has an MBA and is certified in healthcare research compliance

Sessions

• Optimizing the Research Revenue Cycle From Protocol Initiation to Completion