Speakers

Bishoy Anastasi

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

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™ (Virtual)

Stacey Banks, MS, CCRC

Director of the Research Applications SquaD (RAD)
Inova Health System

Stacey Banks, MS, CCRC, 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, along with several other research software applications . Stacey began his research career 15 years ago and has served as a research coordinator and manager in both oncology, cardiology, and hospice/palliative care. His passion is in connecting people to technology in ways that allow them to improve and efficiency and quality of their work.

Sessions

• General Session: Advarra Customer Highlight

Natalie Barton

St. Jude Children's Research Hospital

Sessions

• General Session: Advarra Customer Highlight

Michael Bonavilla

Senior Account Executive
Advarra

Michael is a Senior Account Executive at Advarra. His work is focused on matching research organizations with technology solutions, such as CTMS, eSource, eRegulatory and eConsent systems. His passion is to provide helpful and meaningful tools to clinical research professionals, that streamline their clinical research organizations and improve research as a whole. Michael has worked with eClinical solutions for 15 years helping grow solutions with the evolving ecosystem and connect research organizations to tools that enhance their operations.

Sessions

• Getting the Most Out of Onsemble - OnCore & Clinical Conductor Together
• Advarra Solutions Overview for Clinical Conductor Customers: Getting the Most out of Onsemble

Sharmila Bristol

Chief Technology Officer
Javara

Sharmila R. Bristol is the Chief Technology Officer at Javara, a leading Integrated Research Organization. In this position she drives strategy and enables the technology platform to deliver clinical research as a care option to millions of patients, with healthcare partners nationwide. Sharmila has over 20 years of experience leading organizations through technology enabled business transformation and creating trusted partnerships. Prior to joining Javara, Sharmila was a Customer Success Executive at Microsoft, leading value-based technology enablement at higher education institutions across the country. Prior to that, she was Head of Digital Technologies at IQVIA, where she led the cloud transformation of the organization to bring advanced collaboration capabilities to clinical staff for improved patient outcomes. Her diverse industry experience includes working at Nortel Networks and McKesson, where she held leadership positions in business operations, solutions delivery, and cyber security. Sharmila received her M.S. in Computer Science from Rensselaer Polytechnic Institute in New York.

Sessions

• The Integrated Research Organization (IRO)

Matt Brown

Business Systems Analyst
The Ohio State University James Comprehensive Cancer Center

Matt Brown is a Business Systems Analyst in the Clinical Research Operations department at the James Comprehensive Cancer Center at the Ohio State University. Matt has over a decade of research experience, including study design, database design and management, CTMS management, laboratory operation and liaising, and clinical research regulatory compliance. While working in regulatory, Matt participated in the implementation of and training of staff for eReg and continues to serve as a subject matter expert for regulatory and eReg in his role with the Research Operations team, while also participating in the implementation of EDC and AMI during this time.

Sessions

• Keys to Success: Tips for Implementing Advarra EDC

Cheryl Byers, MHA, CIP, CHRC

VP & Principal Institutional Research COE
Advarra

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

Sessions

• Setting Yourself Up for Success During Investigator Initiated Trials (IITs)
• Leveraging Advarra Technologies to Define and Monitor Study Activation Performance Indicators
• Building and Maintaining a Compliant Regulatory Binder

Matt Cavallo, MPH

Speaker | Author | Podcaster

Matt Cavallo is the co-founder of the non-profit, Situation Positive, where he hosts a popular patient experience podcast. Matt’s personal patient story can be read in his memoir, The Dog Story: A Journey into a New Life with Multiple Sclerosis. Matt is a moving motivational speaker who shares his story all over the globe. He has been featured in major publications including the Boston Globe, US News and World Report and WebMD. Matt obtained his Master of Public Health Administration from Grand Canyon University. Matt is the proud father of two sons and the loving husband to his wife, Jocelyn.

Sessions

• General Session: Guest Keynote - Matt Cavallo

Kathy Cole

Director of eClinical Solutions
Javara

Kathy started her research journey in 1997 as a clinical research coordinator and has extensive clinical, operational, and strategic expertise. She spent the last 15 years in data driven site feasibility where she focused on predictability accuracy and most recently led a global team of feasibility specialists at a CRO owned site network. Additionally, she supported the business with advancing and leveraging technology platforms to support meaningful growth and scale. Kathy has served for the past two years as an executive steering committee member and Teams Competition Chair for the Clinical Researcher of the Year competition, and currently an ACRP RTP Chapter co-chair.

Sessions

• The Integrated Research Organization (IRO)

Katherine Connors, MPH, CCRP

Program Manager, Research Participation Services
Stanford Medicine

Katherine Connors, MPH, CCRP is Program Manager for Research Participation Services at Stanford Medicine. She has 12 years of clinical research experience at Stanford and a background in public health. Katherine is passionate about increasing awareness of the importance of research participation and leveraging shared expertise to engage diverse patient populations and communities in research. The Research Participation team provides resources and tools to help researchers meet their participant recruitment and retention goals, with a focus on engaging participants as partners in research. The team has established a Participant Engagement Platform (PEP), integrated with OnCore, consisting of Epic MyChart study invitations, and other honest broker services, including direct email and postal mail. These services are available for engaging both healthy volunteers and patients with different conditions, from all ages and backgrounds.

Sessions

• Stanford’s Participant Engagement Platform (PEP) and OIS: Supporting Honest Broker Recruitment

Stuart Cotter

Director, Product Management
Advarra

Stuart Cotter is Director, Product Management at Advarra, focusing on technology solutions for sponsors, CROs, and research sites. In this role, he collaborates with Advarra customers and industry stakeholders to understand their challenges, and translates those challenges into solution-based enhancements to our product offerings. Prior to joining our Product Management team, Stuart worked as a Product Support Specialist at Advarra, where he worked alongside dozens of small- to mid-sized research sites to help them overcome their operational hurdles.

Sessions

• Building and Maintaining a Compliant Regulatory Binder
• General Session: Product & Service Deep Dive

Maria Del Pino Castillo MS, CVRN-BC, CCRP

Cardiac Eletrophysiology Clinical Research Nurse
Houston Methodist Academic Institute

Maria Del Pino is a Clinical Research Nurse at Houston Methodist Academic Institute since 2018. She earned a Bachelor of Science in Nursing from University of Barcelona in 2006. Three years later, she obtained a Master of Science from the same University. She also holds a Cardiovascular Research Nurse and a Clinical Research Professional Certifications. At her current position, in addition of coordinating clinical trials, Maria is interested in process development to expedite and improve the management of clinical research studies.

Sessions

• ESA Utilization to Improve Patient Safety Monitoring, Time Management, and Research Compliance

Gissela Delgado, BS, CCRC

Director of Operations
CTMD Research

Clinical Research Professional with 8 years of experience managing site teams. Proficiency in high enrollment studies in multiple medical indications reaching and exceeding patient enrollment goals. Expertise in all aspects of study execution at the site level from start-up to completion. Competitive and self-motivated, always looking for ways to increase productivity and efficiency.

Amy Drake

Senior Business Systems Analyst
The Ohio State University

Amy Drake is a Senior Business Systems Analyst who works as the Enterprise OnCore Administrator at The Ohio State University College of Medicine. Amy has a love for research and has worked in the field for over 18 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

• Optimizing Protocol Workflow by Harmonizing OnCore and REDCap
• Keys to Success: Tips for Implementing Advarra EDC

Kelly Dunsky, MS, CCRC

Clinical Research Manager
The Ohio State University

Kelly Dunsky, MS, CCRC is a Clinical Research Manager for the Center for Clinical Research Management at The Ohio State University, working with non-oncology clinical researchers in the College of Medicine. She has more than 10 years of experience in clinical research, with previous roles as a Clinical Research Coordinator and Float Clinical Research Coordinator.

Sessions

• Optimizing Protocol Workflow by Harmonizing OnCore and REDCap

Katie Eddleton, MPH

Associate Director, Operations
University of Florida

Katie Eddleton is Associate Director of the University of Florida Office of Clinical Research. She has been with OCR for over 5 years and brought with her experience in both quantitative and qualitative research, program evaluation, data management and visualization and program design. She offers a unique perspective having worked across all levels of clinical research from research coordinator up to acting director of the clinical trials office at a large. She is currently redesigning workflows around clinical research management for the entire University, regardless of college. Specific projects include enterprise-wide adoption of OnCore and redesigning workflows around contracting, budgeting, compliance and sponsor invoicing. Specific aims for the Office of Clinical Research are to create an efficient and compliance research process to reduce administrative burden; reduce overall study start-up time; and improve financial performance. She recognizes that success is dependent on overall culture changes that put patients and families at the center and ensure that core offices and research communities operate as a team. Armed with this knowledge, she has chosen to focus on transparency, communication and research advocacy.

Sessions

• Bright IDEA: Defining Culture and Action Planning for Change

Tonya K. Edvalson, MHA, CCRP, CHRC

Operations Manager
University of Utah Health

Tonya Edvalson is the Operations Manager for the Central Research Support Office (CRSO) at the University of Utah Health. She is primarily responsible for the oversight of the OnCore implementation from Huntsman Cancer Institute to the University enterprise. She has been involved in research for over 20 years including IRB, clinical research management and administration, and compliance. She graduated from the University of Utah with her bachelor’s degrees in Behavioral Science and Health and Sociology while recently completing her Masters in Healthcare Administration (MHA). She is a Certified Clinical Research Professional (CCRP) and holds a Certification in Healthcare Research Compliance (CHRC).

Sessions

• Learning and Succeeding Throughout an Enterprise Implementation

Josh Fehrmann

CTMS Director and IT Director
University of Minnesota, Clinical and Translational Science Institute (CTSI)

Josh Fehrmann’s expertise is at the intersection of health research and information technology. 20 years ago he was introduced to what is now called OnCore and has held various roles directly related with the CTMS space for over 14 years. Josh oversees the direction of the UMN OnCore CTMS and associated clinical research applications and services. Additionally, he is responsible for setting IT strategy and advancing the UMN CTSI’s IT project portfolio. Josh has a master’s of science in the Management of Technology from the UMN, which has expanded his passion for digital transformation.

Sessions

• Continued Innovation After 20 Years with OnCore

Karen Finch

Clinical Research Finance Associate
Duke Office of Clinical Research (DOCR)

Karen has been with the Duke Office of Clinical Research (DOCR) within the Duke University School of Medicine since 2020, bringing 10 years of experience in Clinical Research Administration, including both pre- and post-award support. In her current role, Karen’s responsibilities include pre-award budget implementation and post-award financials support for Industry Sponsored studies in OnCore. She is also part of a Process-Improvement team, where she is able to leverage lean six-sigma skills to help identify areas for improvement, propose solutions for streamlining current processes and develop “best practices” for both budget implementation and post-award financials.

Sessions

• Using OnCore Financials for Industry Sponsored Studies: Are we there yet?

Laura Fowler, RN, BSN, CCRC

Clinical Research Coordinator
Shriners Children's

Laura has been an employee of Shriners Children’s-Ohio for 35 years. Following a student nurse experience at Shriners Children’s, she decided that this was the only place she wanted to work. Laura started as a floor nurse, moved into an ICU nurse/charge relief role and did a stint on the burn air-transport team, but she always had a desire to work in research. In 1993, she joined the Research Department as a clinical research nurse, and then transitioned into a Clinical Research Coordinator position in 2013. Laura lives in Cincinnati, Ohio with her husband Cris, has three children, and one grandson.

Sessions

• Operationalizing a Multi-Site Genomics Research Initiative

Rob Gray

Director, Clinical Research Financial Management
Duke School of Medicine Finance Office

Rob has served as Director, Clinical Research Financial Management within the Duke University School of Medicine since 2020. Earlier in his 18 year career at Duke, Rob worked in cardiopulmonary diagnostic testing as well as cardiac and pulmonary rehabilitation. Upon completing his MBA, Rob worked as a financial analyst supporting site based clinical research studies, acquiring 15 years clinical research financial management experience within both academic and clinical research organizations.

Sessions

• Using OnCore Financials for Industry Sponsored Studies: Are we there yet?

Megan Guevarra

Clinical Research Billing Specialist
Cedars-Sinai Medical Center

Megan has dedicated her career to healthcare for 11 years and has been with Cedars-Sinai Medical Center for 5 years. During her tenure, she found herself drawn to research while working with the Kidney Transplant department. Megan has recently joined the Post Award Team in the Office of Research Administration with a primary role in OnCore’s full cycle billing. In her free time, she enjoys working out, cooking vegan recipes, and trying new restaurants.

Sessions

• A/R Management: From Budget Building to Invoicing Using an Integrated Financial System

Jim Havens

Senior Manager, Application Implementation Specialist
Advarra

Jim is the Senior Manager for the Application Implementation Specialists. He and his team work with customers to make sure that they are utilizing the software to meet their needs. Jim has been with the company for over three years and has specialized in the CTMS and eReg products. Prior to coming to Advarra Jim spent over 10 years as a regulatory and compliance specialist for a global central laboratory.

Sessions

• Clinical Conductor Site 101
• A Deep Dive into Clinical Conductor Site Financial and Invoice Workflows

Louisa Khalil

Director of Business Operations
Rochester Clinical Research

Louisa Khalil is the Director of Business Operations at Rochester Clinical Research. In her role, she oversees all marketing communication, recruitment efforts, budgets and contracts and provides strategic vision related to the growth of RCR's brand and study volunteer community.

Sessions

• Building the Plane and Flying It Too: Successful Scaling of a Research Site

Ann Kreeger

Program Manager
Advarra

Ann has over twenty years project management experience with information technology and software implementation. She has been with the Advarra Implementation Project Management Office for over 11 years, working with dozens of customers and many of our potential customers. Her “forte” focuses on implementation planning, as well as integrations and research financials. If you haven’t heard it yet, just ask her about the “ends of the roast” or any of her other stories.

Sessions

• Using the OnCore Study Information Portal to Showcase Your Trials
• How Can You (and Why Should You) Plan for a Plan?

Adam Larrabee

President
Rochester Clinical Research

Adam Larrabee joined Rochester Clinical Research in 2008. Adam is responsible for operations, growth, marketing and business development, and the corporate strategic plan.

Sessions

• Building the Plane and Flying It Too: Successful Scaling of a Research Site

Kirsten Linsenmeyer, MACPR

OnCore Administrator and Manager
The Ohio State University James Comprehensive Cancer Center

Kirsten Linsenmeyer is a Senior Systems Consultant working within the Clinical Research Operations Department at The Ohio State University, James Comprehensive Cancer Center as the OnCore Administrator and Manager. In nearly a decade in research, her experience spans across data collection, reporting, query resolution, and coordinating the Clinical Scientific Review and Data Safety Monitoring committees. With her team, she has led the Caner Center’s implementation of eReg, EDC, AMI, RPE, CRPC, and an OnCore/Vestigo interface for Investigational Pharmacy. Kirsten received her BS in Molecular Genetics and Masters in Applied Clinical and Preclinical Research from The Ohio State University.

Sessions

• Keys to Success: Tips for Implementing Advarra EDC

Dan Lodes

Senior Director
Huron

Sessions

• How Can You (and Why Should You) Plan for a Plan?

Marmee Lutz

Product Manager
Advarra

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

Sessions

• Customer Collaboration Session: Advarra eReg

Marissa Macri

Research System Operations Manager
UCHealth

Marissa Macri is currently the Research System Operations Manager for UCHealth Research Administration. In this role, she leads a team that oversees the research revenue cycle, protocol activation, research functions in the EHR, and integrations with the CTMS. Marissa is experienced in utilization of the EHR for research, optimizing the research revenue cycle, and streamlining system processes while maintaining billing compliance.

Sessions

• General Session: Advarra Customer Highlight

Jen Mead

Senior Director, Customer Success
Advarra

Sessions

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

Orla Mester

SVP, Professional Services
Advarra

Sessions

• General Session: Product & Service Deep Dive

Marcus Miers, MBA, MFA

Director, Training
Advarra

Marcus Miers serves as the Director of Client Training for Advarra’s Technology Solutions division. Since 2012, he has worked in training and eLearning in both public and private sector organizations. Marcus has expertise in consulting on learning approaches, eLearning content development, and scaling learning programs. He’s passionate about finding the most impactful solution for training, whether it’s through optimizing training delivery methods or creating new learning services.

Sessions

• Models to Scale Your Training Program

Rossmeri Montaivo, MBA

President
CTMD Research

Clinical Research Professional with 15 years of expertise in site operations, participant recruitment and business development. Have overseen hundreds of high enrollment studies in varied medical indications from start-up to completion. A striving for continued excellence, passionate mentor, and motivator of fellow team members.

Lindsey Mooney

Director of PRMS and Regulatory Affairs
Moffitt Cancer Center

Lindsey has over 17 years of clinical research experience with the last 12 years specifically in cancer research. Throughout her career she has grown into research administration with her most recent positions as the Research Administrator of the Taussig Cancer Center at the Cleveland Clinic and now currently as the Director of PRMS and Regulatory Affairs at Moffitt Cancer Center. In both positions, Lindsey has worked extensively with her colleagues to drastically reduce the time to study activation by streamlining processes and defining key metrics to track and report performance indicators.

Sessions

• Leveraging Advarra Technologies to Define and Monitor Study Activation Performance Indicators

Tristin Morse, BA, CCRP

Clinical Research Manager
Shriners Children's

Tristin has been a part of the Shriners Children’s family since 2013, with 14 years of overall experience in clinical research including protocol and form development, regulatory oversight, CTMS system administration, data monitoring and auditing, and multi-site study operations. Tristin started in research at an academic university with involvement in cooperative group studies and has transitioned into her current role to help support the Shriners Children’s healthcare research mission. Tristin enjoys living in sunny Tampa, Florida with her husband, James, and their two energetic children.

Sessions

• Operationalizing a Multi-Site Genomics Research Initiative

Chris Mulhern

Solutions Consultant
Advarra

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

Sessions

• Getting the Most Out of Onsemble - OnCore & Clinical Conductor Together
• Advarra Solutions Overview for Clinical Conductor Customers: Getting the Most out of Onsemble

Sami Naber

Program Manager, Clinical Trial Billing
Cedars-Sinai Medical Center

Sami has been part of the Post Award team in Office of Research Administration at Cedars-Sinai for eight years, and is one of the primary OnCore Billers 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 finds himself chasing his 2 year old son around parks, restaurants, and Costco. He has been at Cedars-Sinai for 12 years.

Sessions

• A/R Management: From Budget Building to Invoicing Using an Integrated Financial System

Carrie Nemke

SVP, Customer Success
Advarra

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

Sessions

• General Session: Welcome & CEO Keynote

Melanie Nobello

Director of Clinical Research Initiation Services
Sutter Health

Melanie Nobello is the Director of Clinical Research Initiation Services (CRIS) for Sutter Health. She currently oversees a talented team of individuals responsible for coverage analysis, budget development and negotiation, regulatory, charge segregation, CTMS administration, and Epic research billing. Her career began in 2001 at Alta Bates Summit Medical Center (ABSMC), a Sutter affiliate in Oakland/Berkeley, California, where she held roles in the Patient Financial Services and Patient Access offices before moving to the ABSMC Research and Education Institute (REDI). She also spent time as a Budget and Coverage Analyst at UC San Francisco’s Clinical Trials Business Support Center just before taking on her current systemwide role for Sutter Research in 2015. She holds a bachelor’s degree in Business Management from Holy Names University. Melanie enjoys hiking, hot sunny days, and loves new adventures with family especially her niece and nephew.

Sessions

• How Effective Change Management Can Drive Successful Training and Adoption of a New CTMS

Makenzie Pick

Manager, Solutions Consultants
Advarra

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

Sessions

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

Tiffany Danielle Pineda

Research Navigator and Chair, DC3 (Diversity and Cultural Competence Council)
UF Clinical and Translational Science Institute

Tiffany Danielle Chisholm Pineda was born in Philadelphia, Pennsylvania. She is a poet, comedian, author, orator, radio personality, educator, and writer. She is the mother of three amazing children Gregory II, Courtney, and Noah. Tiffany Danielle graduated from the University of Florida in Gainesville where she still resides with her family. She holds certifications in Minority Mentorship from the University of Florida; Cultural Competence from Albany State; and Diversity, Equity, and Inclusivity in the Workplace from University of South Florida. Tiffany Danielle has created a certification for Obtaining Consent for Research Participation with an emphasis on cultural competence and many other trainings related to diversity, equity, and inclusivity. She is the Chair and co-founder of the University of Florida’s Clinical and Translational Science Institute’s Diversity and Cultural Competence Council known as DC3. Tiffany Danielle is a Regulatory Specialist at the University of Florida where she has been blessed to work in various positions for over 24 years including having been an Institutional Board Member for almost a decade. She has been a Board Member of Kids n Capes a non-profit dedicated to protecting children for over three years.

Sessions

• Bright IDEA: Defining Culture and Action Planning for Change

Tiffany Reinson

Training Manager
Advarra

Tiffany's training career began in 2004 working with the American Red Cross teaching infant, child and adult CPR across various Florida State Parks. From 2009 to 2019, she contract trained Veeva CRM and Veeva Vault MedComms to major pharmaceutical companies across the industry. She transitioned to the research side training Clinical Conductor's CTMS and eConsent products with new and existing customers. Over her career she has presented to more than 2000 participants using mirrored instruction, demo and train the trainer techniques in her field of work.

Sessions

• Clinical Conductor Site 101
• A Deep Dive into Clinical Conductor Site Financial and Invoice Workflows

Shannon Roznoski

Director, Product Management
Advarra

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

Sessions

• Customer Collaboration Session: Advarra EDC
• Customer Collaboration Session: Advarra eSource

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

Katie Schmitz

Training Specialist
Advarra

Katie Schmitz is a Training Specialist at Advarra. She has worked in a training capacity for over 10 years; the majority of her career spent at Medtronic, a medical device manufacturer. Utilizing her degree in Communications, her time has been spent training others and also ensuring clear and concise instruction materials for her learners. Being a huge advocate for simulated training, she enjoys seeing trainees succeed and become confident within training environments. Outside of work, she enjoys reading, board games, and all the outdoorsy things she can do around the Puget Sound.

Sessions

• Keep Your Model in Mint Condition: How to Build and Maintain a Stellar Training Data Set

Miranda Schramm, PhD

Manager, Technology Training
Advarra

Miranda Schramm, PhD is a Manager of Technology Training at Advarra. She has worked in training and higher education for over 10 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. When not leading or creating training, she enjoys spending time with her husband and their dog, going hiking, and trying new recipes.

Sessions

• A Deep Dive into OnCore Calendars
• Keep Your Model in Mint Condition: How to Build and Maintain a Stellar Training Data Set
• OnCore 101

Brian Sevier, PhD

COO, Clinical & Translational Science Institute
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

• Bright IDEA: Defining Culture and Action Planning for Change

Jonathan E. Shough

President Technology Solutions
Advarra

Jonathan E. Shough is President, Technology Solutions, at Advarra. In this position, he drives technology product strategy and offerings, commercialization, and customer relationships.Jonathan has over 30 years of experience in information technology, including more than 20 years in the clinical research industry. He has deep expertise in both the development and commercialization of innovative, award-winning technology solutions.Before joining Advarra, Shough was Senior Vice President and CIO, LabCorp Drug Development and GM Software Platforms, where he managed a large data and technology team and worked on several successful mergers and acquisitions. Prior to that, he held the position of Senior Vice President and Chief Data Officer at Syneos Health where he was responsible for developing and executing the data and commercialization strategy. At IQVIA, Shough served as Executive Director, IT, where he developed the technology go-to-market strategy. Earlier in his career, he held numerous information technology leadership positions in the financial and telecommunications industries.Shough attended Guilford College and is a US Marine Corps veteran.

Sessions

• General Session: Welcome & CEO Keynote

Jeff Sidell, PhD

Chief Technology Officer
Advarra

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

Sessions

• General Session: Welcome & CEO Keynote

Jaci R. Skidmore

Director, Operations and Logistics
University of Utah Health

Jaci Skidmore is the Director of Operations and Logistics for the Central Research Support Office (CRSO) at the University of Utah. She has been leading the initial stages of the implementation of OnCore to enterprise. In addition to supporting the ongoing implementation of OnCore, she is leading the development of the University’s first CRSO. She has 14 years of research expertise including contracting, staff management, and business development. She graduated from the with her bachelor’s degrees in Behavioral Science and Health and Sociology.

Sessions

• Learning and Succeeding Throughout an Enterprise Implementation

Brian Stage, JD, CIP

Research Compliance Consultant
Indiana University

I graduated from Butler University with a B.A. in Psychology and International Studies, and from the University of Texas School of Law. In 2015, I returned to my hometown of Indianapolis to work in Human Research Protection. My passion is educating the research community and working directly with researchers to ensure safe and ethical practices. When I’m not talking about regulations and policies, I probably have my camera in my hands, looking for someone who wants their picture taken.

Sessions

• Reviewing the Revised Common Rule: 3 Years Out

David Staley

Associate Director, Institutional Research Center of Excellence
Advarra

David Staley serves as an Associate Director in Advarra’s Institutional Research Center of Excellence. He is an accomplished leader, writer, and public speaker with eighteen years of experience working in human research protection programs, research compliance, and research operations. In both realms of research compliance and operations, he has led and overseen system-wide programs in dynamic research enterprises, while advising and educating on complex ethical and compliance issues. He has authored and spoken about a variety of topics ranging from risk preparedness to the informed consent process. David has earned both a Master's degree in Spanish Literature and a Bachelor's degree in Spanish Translation.

Sessions

• Setting Yourself Up for Success During Investigator Initiated Trials (IITs)
• Leveraging Advarra Technologies to Define and Monitor Study Activation Performance Indicators

Trish Stamm

Senior OnCore Support Analyst
University of Florida

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

Sessions

• Using the OnCore Study Information Portal to Showcase Your Trials

Jon Tack

Vice President, Product Management
Advarra

Sessions

• Customer Collaboration Session: Clinical Conductor CTMS

Wendy Tate, PhD, MS, GStat

Director, Advanced Analytics and Research Optimization
Advarra

Wendy Tate, PhD, is Senior Clinical Research Strategist with Advarra. Wendy’s work is focused on the evaluation of clinical research administration, operations, and workflows. Her passion is to provide helpful and meaningful processes and tools to clinical research professionals that streamline clinical research practices and better the clinical research enterprise as a whole. Prior to Advarra, Wendy spent 15 years at the University of Arizona in various roles within human laboratory, human subjects protection, and clinical research roles, including leadership roles with the IRB and Cancer Center clinical trials office. She holds a Master's degree in Applied Biosciences and a PhD in Pharmaceutical Economics, Policy, and Outcomes with a minor in Epidemiology.

Sessions

• Operationalizing Advarra Insights
• Enhancing Research Conduct Using eConsent

Blake Taylor

Group Product Manager
Advarra

Blake Taylor is a Group Product Manager at Advarra with a primary focus on the data analytics and reporting suite of products. With five year’s experience working at Advarra and twelve total in a product management role, Blake is passionate about creating products that delight end users, enable teams to be more efficient and deliver high value to institutions. Blake has collaborated with various customers to help them better understand their data and processes, maximize their use of Advarra technologies and contribute to the ongoing evolution of the product features and capabilities.

Sessions

• Operationalizing Advarra Insights

Christopher Thomas

Product Manager
Advarra

Christopher Thomas is a Product Manager at Advarra focusing on Clinical Conductor. Christopher has been with Advarra for almost six years, previously working in the realm of implementation and delivery of OnCore and supporting products and integrations, but is excited to now be contributing to the future of Clinical Conductor through in-depth customer collaborations. Christopher is passionate about improving the user experience, delivering high-quality features, and ensuring customer confidence in all data outputs and reporting from Clinical Conductor.

Sessions

• Customer Collaboration Session: Clinical Conductor CTMS

Doug Vosters

Sr. Product Support Specialist
Advarra

Doug Vosters is a Senior Product Support Specialist with over 4 years of experience working with Advarra technology. Doug works with current and implementing Advarra customers, specializing in OnCore, eReg, and Advarra Connect, providing technical support. With a degree in Secondary Education – Mathematics, Doug’s passion is to take a logical approach to problem solving and communication, enabling the customer to have a deeper understanding of the technology products they use. Prior to joining the Product Support team, Doug served as a Training Specialist for Advarra Technology Solutions. When Doug is not working, he spends his time with his spouse, Kelsey, children, Willow and Ezra (2 years old), and dog, Ruxin. If there is any time left in the day, Doug is playing the drums or building something in his wood shop.

Sessions

• A Deep Dive into OnCore Calendars
• OnCore 101

Dorothy Wullenwaber

Senior Research Project Manager
Sutter Health

Dorothy Wullenwaber’s career spans information technology and clinical research. For the last 16 years, she has helped Sutter Health develop research billing, privacy, and quality improvement initiatives and has served on committees to review and select multiple clinical trial management and conflict of interest systems. She collaborated across research operations, compliance, and revenue cycle to design and implement a comprehensive billing compliance assurance process. At present, she oversees Clinical Conductor project optimization while providing research billing compliance assurance across the Sutter enterprise. At LifeScan, a Johnson & Johnson device company, she was a systems analyst, supporting numerous quality assurance initiatives. She is certified as an Epic research billing analyst.

Sessions

• How Effective Change Management Can Drive Successful Training and Adoption of a New CTMS

James Wurdeman

Chief Product Officer
Advarra

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

Sessions

• General Session: Product & Service Deep Dive