Speakers

Chad Adams

UACC Associate Director, Cancer Clinical Research
University Of Arizona

Sessions

• Top 10 Review in Clinical Research

Bishoy Anastasi

Director - Clinical Research Finance
UCLA Dean’s Office

Sessions

• Leveraging OnCore for Clinical Research Billing Compliance

Kelly Anastasio, COC, CPC, CPCO, CPC-I, CLSSGB

Associate Director of Clinical Trial Resources
Yale School of Medicine, Yale Center for Clinical Investigation

Kelly Anastasio is the Associate Director of Clinical Trial Resources, the out-patient research unit, coordinator pool, and recruitment and development. Ms. Anastasio’s experience provides the ability to oversee the OnCore project which includes many aspects of Yale’s institutional clinical research program, including determining the feasibility of research projects, allocating resources, budgeting for resource needs, financial management for all industry activity, and communicating and providing support to research teams. Her organizational and managerial skills have been an asset to YCCI as it seeks to broaden its ability to provide these critical services to investigators across the health campus.

Sessions

• Leveraging OnCore for Clinical Research Billing Compliance

Ashley Anderson, MBA, ACRP-CP

Assistant Director Clinical Research Administration and Compliance
University of Florida Health Cancer Center

Ashley Anderson, MBA, ACRP-CP, Assistant Director Clinical Research Administration and Compliance at the University of Florida Health Cancer Center (UFHCC). Ashley works with the UFHCC assisting with oversight of Data Integrity & Safety, Monitoring and Auditing team, as well as supporting the Scientific Review & Monitoring Committee. Previously, Ashley worked within the clinical trials regulatory department and also worked at the local IRB for several years.

Sessions

• Data Safety and Monitoring Committees: A Best Practices Discussion

Rhoda Arzoomanian

Associate Director
Yale University

Rhoda Z. Arzoomanian, MSM, BSN, RN, joined Yale in 2014 as Associate Director of YCCI and Yale Cancer Center, in March 2019 she began focusing all her time across the medical campus. With 30 years of clinical research experience, she is a nationally recognized expert in cancer clinical research, clinical trials databases, and management of NCI-designated cancer center. Her current role encompasses clinical research across the medical campus. Her background is an asset to investigators across the spectrum of translational and clinical research.

Sessions

• How Can OnCore Facilitate the Upcoming PRMS Changes?
• Top 10 Review in Clinical Research

Cheryl Byers

Director, Protocol Review & Monitoring Systems and Regulatory Affairs
Moffitt Cancer Center

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

Sessions

• Leveraging Commercial IRB and IBCs for Study Activation: A Case Study

Jason Cline

Contracting Officer III
University of Florida, Office of Clinical Research

Jason Cline is a graduate of the University of Florida and spent the first 10 years of his professional career as a pre-award research administrator at the University of Florida. In his current role, he supervises a team of five contract negotiators in the University of Florida’s Office of Clinical Research. His group is responsible for the negotiation and execution of all clinical research related agreements for the institution. Outside of his appointment at the university, he enjoys disc golf and spending time with his family.

Sessions

• Leveraging OnCore in Contracting at an Academic Medical Center

Stuart Cotter

Director, Product Success
Forte

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

Sessions

• Regulatory Personnel and Organizational Document Management
• Implementation, Validation and Best Practices Using Forte eReg
• How to Make Sure Your Site is Prepared for an FDA Inspection

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 16 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

• Project Management, Ticketing System, and Upgrade Tracking
• eReg Implementation and Considerations for Going Enterprise-wide

Kevin Dudley

Programmer/Analyst IV
UCLA

With over 15 years of experience in clinical and research data systems, Kevin has been working to support researchers and their data needs from OnCore since 2010. Kevin had been part of the OnCore implementation team at Cedars-Sinai before joining UCLA in 2014 for their OnCore implementation. He has developed a custom IRB integration using the OnCore API and works with in the Clinical Research Informations Systems group to further leverage OnCore data for custom reports, notifications and workflow management on demand. Kevin previously gave a talk at Onsemble in 2016 focusing on the UCLA IRB integration via the OnCore API.

Sessions

• Developing Custom Notifications: Bridging the Gap

John Eckmann

CTMS Administrator
East Carolina University

John Eckmann, MPH, CPHIMS, is the CTMS Administrator for the Office of Clinical Trials at East Carolina University. John is an accomplished health information technology professional with vision and proven success leading complex initiatives from feasibility to reality. His experiences as a HIT practitioner include numerous care settings - clinical, acute, post-acute, etc. – where he has demonstrated his ability to leverage best practices for delivering innovative solutions. His interests are in information assurance, privacy, and data security to safeguarding the interests of study participants while assuring the integrity and credibility of the clinical research.

Sessions

• Data Safety and Monitoring Committees: A Best Practices Discussion

Katherine Eddleton

Associate Director
University of Florida

Katie Eddleton, MPH is an Associate Director at the University of Florida (UF) Office of Clinical Research (OCR). She is responsible for redesigning the management process for health-related human subjects research under the direction of Brian Sevier, PhD, Director. Currently, Ms. Eddleton is focused on creating an efficient and streamlined process to reduce study start-up time and improve financial performance. Next, she will be focused on optimizing UF’s agility in responding to multi-site study opportunities. Ms. Eddleton has been with UF for 11 years and previously served as the co-director for UF’s PCORI-funded Clinical Data Research Network, OneFlorida.

Sessions

• Strategic Approaches to Identify Recruitment Issues and Interventions

Edye Edens

Senior Research Compliance Consultant
First Class Solutions, Inc.

Edye T. Edens, JD, MA, CIP, CCRP, serves as the Senior Research Compliance Consultant for First Class Solutions, Inc., focusing on research compliance and life sciences. Edye is a licensed attorney with an international human rights, ethics, and health law background, who was in-house for a decade with a major academic medical center where she focused on human subjects, contracts, clinical research compliance, research misconduct, and oncology. Additionally, she teaches at IU’s McKinney School of Law and Fairbanks School of Public Health in Indianapolis and oversees the Hall Center for Law and Health’s Externship Program.

Sessions

• Data Safety and Monitoring Committees: A Best Practices Discussion

Abby Ehringer

Director, Training
Forte

Abby Ehringer is the Director of Training at Forte. An enthusiastic and innovative software trainer with more than 12 years of experience, Abby works hard to make technical content engaging and relevant for adult learners. She has expertise in the areas of instructional design, training environment build, eLearning development, blended learning, and developing role-based and workflow-based training strategies for enterprise software products.

Sessions

• Lessons Learned Roundtable (Double Session)

Becca Ennis

Senior Support Engineer
Forte

Becca Ennis is a support engineer at Forte Research. Working closely with the Product Support team and other Forte engineers, she helps discover and create solutions for customers of Forte products.

Sessions

• Financials Reporting - OnCore Reports and Insights

AnnMarie Eve

IRB Operations Manager
Medical College of Wisconsin

AnnMarie completed her undergraduate education at Alverno College and earned her BA in Psychology with a minor in Business Management. AnnMarie’s professional background is in regulatory compliance as a former Quality Assurance Supervisor for a biologics company and clinical and social behavioral research. AnnMarie Eve has worked for the Medical College of Wisconsin in the Human Research Protection Program (HRPP) for the past twelve years. During this time, she has held several different positions including Institutional Review Board (IRB) Coordinator and IRB Manager. AnnMarie is an appointed IRB Committee member serving on two of the six IRB Committees at the Medical College of Wisconsin. AnnMarie is currently serving as the Manager of IRB Operations responsible for the daily operations of the HRPP. Working closely with the IRB Coordinators, IRB Chairs and Committee members to ensure compliance with Federal Regulations, Institutional Policy and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards. Responsible for development of operations, growth strategy, strategic planning, and solutions that strengthen the protection of human subject research conducted at the Medical College of Wisconsin, Froedtert Hospital and Health Systems and the BloodCenter of Wisconsin.

Sessions

• Real-time IRB review process: A Smoother Pathway Toward Initial Approval

April Firstencel

Protocol Review and Monitoring Committee (PRMC) Manager, OnCore Administrator
Case Comprehensive Cancer Center

April Firstencel joined the Case CCC in January 2010 as a research coordinator for clinical trials whose main responsibility was trial registration and results reporting in ClinicalTrials.gov and registration of trials in NCI/CTRP. In February 2013 she was promoted to Protocol Review and Monitoring Committee (PRMC) manager. Additionally, she is an OnCore administrator dealing with all areas of OnCore life. April is also involved with all the reporting requirements for the CCSG. April has an associate’s degree in medical technology (Hudson Valley Community College) and a bachelor’s degree in biology (University of Pennsylvania). In her previous life she worked in basic science research and taught science and art in the public schools and the Cleveland Museum of Natural History.

Sessions

• How Can OnCore Facilitate the Upcoming PRMS Changes?
• What's on Your Website?

Neva Garner

Research Facilitator/Trainer
University of Colorado Anschutz Medical Campus

Neva Garner is a Research Facilitator/Trainer at CU Anschutz, where she manages the Human Subjects Research Protocol Submission Portal and serves as an OnCore trainer for the Office of Regulatory Compliance. Neva has worked in research administration for 12+ years, serving as a project coordinator, program administrator, clinical data specialist, instructor, and protocol facilitator for multiple departments and institutions. Neva helps research teams navigate the study start-up process and become successful in OnCore utilization. Neva enjoys hiking, traveling, and teaching ESL and believes no day is complete without chocolate. Please feel free to contact Neva at neva.garner@cuanschutz.edu.

Sessions

• Recruitment Support Strategies from an Institutional Perspective

Alyssa Gateman, MPH, CCRP

Associate Director of Quality Assurance
Yale Center for Clinical Investigation

Alyssa K. Gateman has more than 15 years of experience in Quality Assurance. She began her career at the Dana-Farber/Harvard Cancer Center, where during her 14-year tenure, she served as Director of the Quality Assurance Office for Clinical Trials. Alyssa joined Yale University in July 2014 and is currently the Associate Director of QA at the Yale Center for Clinical Investigation (YCCI). At YCCI, she oversees the Office of Quality Assurance and Training, which is a centralized shared resource that provides data and safety monitoring, auditing, monitoring, consultations with investigators and research staff regarding compliance with Good Clinical Practices, and training and educational instruction to improve the quality of clinical research at Yale. At Yale, Alyssa also has administrative oversight of multiple research oversight committees, including the Yale Cancer Center Protocol Review Committee. Alyssa received her Masters of Public Health from Boston University and is a Certified Clinical Research Professional (CCRP). She has served on national committees including a three-year term on the American Association of Cancer Institutes: Clinical Research Initiative’s Steering Committee. She was the the President of the Boston Chapter of the Society of Clinical Research Associates (SoCRA) from 2010-2014 and is currently the President of the SoCRA Greater New Haven Chapter.

Beau Grignon

Senior Vice President, Engineering & Infrastructure
Forte

Beau oversees software engineering activities across the entire Forte product family. He balances a steady stream of strategic priorities, product enhancement opportunities and technical support responsibilities, and also leads engineering team activities for the production and support of Forte’s industry-leading products. Beau has over 15 years of experience in software engineering and integration solutions.

Sessions

• Discussion Groups: Epic and Cerner Users

Robert Haskins

Systems Coordinator
Fox Chase Cancer Center

Robert has nearly a decade of clinical research experience working in academia, industry, and national groups. In his current role, he is primarily responsible for the training of all OnCore CTMS users at Fox Chase Cancer Center. Additionally, he serves on the local clinical research policy committee as a policy writer and reviewer.

Sessions

• Filling the Gaps: Developing Role-Based OnCore Training

Natalie Hellmer

Senior Project Manager
Forte

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

Sessions

• OnCore Charge Master Implementation Guidance
• Financials Reporting - OnCore Reports and Insights
• Executing Process Improvements

David Henderson

Business Analyst
Karmanos Cancer Institute

David Henderson is a Business Analyst from Karmanos Cancer Institute, with a BS in Computer Science and an MBA. He is a certified Six Sigma Black Belt and has specialized in Process Improvement for over 15 years.

Sessions

• Executing Process Improvements

Ajay Indrajit

Senior Manager
Forte

Ajay Indrajit is a Senior Manager at Forte’s Business Operations Services Office in Bangalore, India. He pioneered the OnCore calendar services and is currently involved in the development and finalization of institutional specific guidelines for customers utilizing OnCore calendar services. He holds a master’s degree in Biochemistry along with a Post Graduate Diploma in Clinical Research. He has an overall clinical research experience of more than 10 years and has had the opportunity to work with contract research organizations, hospitals and not for profit organizations.

Sessions

• How Forte Creates Customer Calendar Build Standards

Jason Jaszewski

Principal Administrator, Managed Infrastructure
Forte

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

Sessions

• Transitioning to Forte Managed Infrastructure

Sandi Johnson

Enterprise Research System Administrator
Medical College of Wisconsin

Sandi Johnson is the OnCore Enterprise Research System Administrator at the Medical College of Wisconsin (MCW) located in Milwaukee, WI within the Office of Research. She joined MCW Cancer Center CTO in 2012 with the goal of implementing OnCore enterprise wide. Working closely with MCW IS, the CCCTO and project managers, OnCore has been launched in all adult cancer divisions, Children’s Oncology, the Departments of Cardiology and Pulmonary, BSM for the MCW Tissue Bank and Children’s Research Institute. MCW is onboarding MCW’s remaining departments and Children’s Hospital of WI, as well as implementing EDC and RPE, within the coming year.

Sessions

• What's on Your Website?

MaryAnn Kempker

Computer Software Validation Project Manager
Forte

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

Sessions

• Workshop: Change Control in Validated and Non-Validated Products
• How to Make Sure Your Site is Prepared for an FDA Inspection

Courtney Kennedy

Manager, Clinical Trial Applications
UNMC/Nebraska Medicine

Sessions

• What's on Your Website?
• Optimizing Recruitment and Best Practices

Beth Kettenring

Director, Office of Sponsored Programs
Ochsner Health System

Beth Kettenring is the Director of the Office of Sponsored Programs and Research Finance (OSP) at Ochsner Health System in New Orleans, LA. Ochsner is the largest private not-for-profit healthcare system in the region. OSP oversees study budget development, coverage analysis and contract negotiations along with research billing and financial management of industry and federal research funding. In addition to her OSP responsibilities, Beth manages the Research Division financials and prepares the annual Division budget. She also recently completed an MS degree in Research Administration from Johns Hopkins University.

Sessions

• Financial Impact of Non-Enrolling Industry-Sponsored Clinical Trials

Ann Kreeger

Program Manager
Forte

Ann has twenty years project management experience with information technology and software implementation. She has been with the Forte Project Management Office for over 8 years, working with dozens of customers and several of the customer collaboration teams. Her “forte” focuses on implementation planning, integrations, and research financials. She is often heard saying, “Just because you can, doesn’t mean you should.”

Sessions

• Marketing 101: Driving Adoption of New Systems

Stephanie Lee

Solutions Consultant
Forte

Stephanie Lee is a Solutions Consultant at Forte and previously served as a Product Support Specialist and subject matter expert for Forte Insights. Stephanie has over 12 years of combined experience in organizational leadership, education, health policy, public and private sector management, and program development and improvement. She is passionate about improving operational efficiencies and leveraging software as a tool for collaboration and organizational improvement. Outside of work, Stephanie enjoys practicing or teaching yoga, listening to music and going to concerts, playing tennis, reading, and cooking.

Sessions

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

Kirsten Linsenmeyer

OnCore Administrator and Team Lead
The Ohio State University James Comprehensive Cancer Center

Kirsten Linsenmeyer is a Business Systems Consultant working within the Department of Clinical and Research Informatics at The Ohio State University, James Comprehensive Cancer Center as the OnCore Administrator and Team Lead. In nearly a decade in research, her experience spans across data collection, reporting, query resolution, coordinating the Clinical Scientific Review and Data Safety Monitoring committees. She has lead the implementation of eReg, support of an OnCore/Vestigo interface for Investigational Pharmacy, and work towards OnCore interfaces with Epic. Kirsten received her BS in Molecular Genetics and Masters in Applied Clinical and Preclinical Research from The Ohio State University.

Sessions

• eReg Implementation and Considerations for Going Enterprise-wide
• OnCore and Vestigo Integration – Improving Investigational Pharmacy Operations

Marmee Lutz

Senior Business Analyst
Forte

Marmee Lutz is a Senior Business Analyst at Forte. She is focused on our eRegulatory product and collaborates with our customers to gather information and better understand their regulatory and compliance needs.

Sessions

• Regulatory Personnel and Organizational Document Management

Chanel Mansfield, MPH, CCRP

Special Projects Manager, Office of Regulatory Compliance
University of Colorado Denver | Anschutz Medical Campus

In her current role as a Special Projects Manager, Chanel is primarily focused on advancing research recruitment efforts for campus and streamlining university-sponsored cell therapy research projects. Having earned a Master’s in Public Health she has worked as a Project Administrator at a CRO, an Application Analyst at an IRB, and as a Research Manager providing her with extensive experience in financial and regulatory oversight. Chanel has earned her certification as a Clinical Research Professional and has published several articles in the field of Obstetrics and Gynecology. In her spare time she enjoys Colorado life – camping, hiking, kayaking, and practicing yoga.

Sessions

• Recruitment Support Strategies from an Institutional Perspective

Mariette Marsh

Director, Human Subjects Protection & Privacy Program
University Of Arizona

Mariette Marsh is the Director of the Human Subects Protection & Privacy Programs at the University of Arizona. She has over 20 years of experience working in human subject protections, across multiple institutions and disciplines. Her focus for the past few years has been on how to achieve efficiencies for both the researcher and program staff within the framework of the federal rules, institutional culture, and a changing regulatory landscape.

Sessions

• Ask the IRB Director
• Leveraging Commercial IRB and IBCs for Study Activation: A Case Study
• Maximizing Your Relationship with Your IRB(s)

Brittany Matson

Project Manager
Forte

Brittany has over seven years of project management experience in the healthcare and research sectors. Her focus at Forte is on eRegulatory and Forte EDC implementations with 21 CFR Part 11 validation. She is passionate about process improvement, and developing strong customer relationships throughout her various Forte implementations.

Sessions

• Implementation, Validation and Best Practices Using Forte eReg

Deb McCollister

PRMS Program Director
University of Colorado Cancer Center

Deborah McCollister is the PRMS Program Director at University of Colorado Cancer Center. She moved to Denver after finishing nursing school at Johns Hopkins. Her first job as a new grad was on the inpatient oncology unit at University of Colorado Hospital, where she gained a great appreciation for clinical research. Deb has held several different positions in the clinical research realm over the past 20 years. She has published articles and editorials and given lectures on the topic of clinical trials. In her spare time, she enjoys running, hiking, swimming and spending time with her husband and two kids in the Colorado outdoors.

Sessions

• How Can OnCore Facilitate the Upcoming PRMS Changes?

Jill McKinley

Staff Augmentation
Forte

Jill has worked in software and IT support for 26 years since graduating from the University of Wisconsin-Madison with a psychology degree. As a Product Support Manager at Forte, she enjoys making technology more easy and relatable for real people and their priorities. Jill helps customers implement OnCore and conducts optimization site visits. When she’s not working, Jill loves to hike, bike and read.

Sessions

• Lessons Learned Roundtable (Double Session)
• Executing Process Improvements
• Marketing 101: Driving Adoption of New Systems

Wayne Millet

OnCore System Administrator
Lifespan Health System

Wayne Millet is an OnCore Administrator located in Rhode Island. Wayne has led the OnCore implementation and operations at the hospital since early 2017 - first in the cancer center and now for Lifespan's research enterprise expansion.

Sessions

• Transitioning to Forte Managed Infrastructure

Yvette Moreira

Application Analyst
UCLA

Yvette has been with UCLA for nearly 5 years. She served as liaison for the OnCore implementation to prepare end-users for the go-live. She supports the research community with various workflow and technical issues. She tests and troubleshoots various system setups, reports, and other functional areas of the software system and configuration tools.

Sessions

• Developing Custom Notifications: Bridging the Gap

Catee Mullen

Director, Clinical Research Operations
Duke School of Medicine

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

• The Road to a Successful OnCore Financials Interface and the Aftermath
• Begin with the End in Mind: Putting Data Planning into Practice

Mike Neuenfeldt

Services Manager
Forte

Mike is Forte’s Services Manager, focusing on the continuous improvement and sustained excellence of both Forte’s Business Operations Services (BOS) and Madison, WI-based services. In addition, Mike cultivates new service offerings to meet the growing and changing needs of Forte customers, ensuring optimal research performance.

Sessions

• How Forte Creates Customer Calendar Build Standards

Dan Paduchowski

Business Analyst and Developer
Wayne State University

New to Wayne State University as of October 2018, Dan Paduchowski has been working in the Healthcare Information Technology Field for 12 years. With an educational background in Computer Science, Dan has proven a valuable asset to the Wayne State Team. Formally serving as the OnCore Application Administrator for Karmanos Cancer Institute prior to on-boarding at Wayne State, Dan has displayed a wealth of experience and knowledge into the coordination efforts of clinical trials, development of data collection processes and project management.

Sessions

• EDC Implementation and Validation: The B side

Jeff Parks

Product Manager
Forte

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

Sessions

• Financials Reporting - OnCore Reports and Insights
• What Does Forte's Agile Transformation Mean for You?

Makenzie Pick

Solutions Consultant
Forte

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

Sessions

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

Michael Rauwerdink

Director, Software Engineering
Forte

As Director of Software Engineering, Michael directs the development of Forte integration solutions. With his passion for connecting critical workflows across systems, Michael guides the development of innovative technical solutions that empower collaboration across research, clinical, and financial systems. Michael has nearly 20 years of experience in software engineering with a strong background in enterprise integration.

Sessions

• Discussion Groups: Epic and Cerner Users

Shannon Roznoski

Director, Product Management
Forte

As Director of Product Management, Shannon guides the strategic planning and management of OnCore and Forte EDC. In her role, she acts as a strong advocate for 21 CFR Part 11 awareness and the adoption of industry standards to ensure Forte solutions meet the needs of its customer community. Shannon has extensive clinical data management and IT experience, and is a Certified Clinical Data Manager (CCDM) through the Society for Clinical Data Management (SCDM).

Sessions

• Workshop: Change Control in Validated and Non-Validated Products

Anne Schnatterly

Director, WVUCI CRU
West Virginia University

Anne is the Director of the West Virginia University Cancer Institute Clinical Research Unit as well as the Executive Director of West Virginia Cancer Clinical Trials Network. Anne has been involved in clinical research for over 20 years. While pursuing her nursing degree at Case Western Reserve University she was introduced to the world of research as a data coordinator for a public health study of infant pulmonary hemosiderosis and black mold. After a few years of floor nursing in the adult organ transplant program, she returned to pediatrics as a cystic fibrosis research nurse. Anne began her career in cancer research at University Hospitals of Cleveland Seidman Cancer Center in 2000, concentrating in lung cancer and HIV malignancies, including the opportunity to work with international sites in Africa. Eventually, Anne progressed into a management track and oversaw clinical and financial operations, including a regional network and Phase I developmental therapeutics program. Anne joined WVU in the summer of 2014 with the challenge to develop the cancer portfolio as well as bring the newly created West Virginia Cancer Clinical Trials Network from concept to a reality and has greatly enjoyed the collaboration and reciprocal growth with the cancer team in the state.

Sessions

• Practices Behind Being A Forte Benchmarks Process Leader

Brian Sevier

Director, Office of Clinical Research
University of Florida

Brian Sevier, PhD, Director, UF Office of Clinical Research. He has served as a research administrator at UF for over 15 years, including university-wide and college level leadership in contracts & grants administration. Most recently he lead the UF Health Cancer Center’s Clinical Trials Office. He has held leadership and committee membership at the National Council of University Research Administrators (NCURA) as an active member since 2005. He has managed complex grants and research agreements at the department, center, college, and university level. As the Director, he oversees the operations of the OCR, including institutional clinical research billing compliance, clinical research agreement negotiation and execution, and pre and post award financial management. OCR is also leading the enterprise-wide adoption of OnCore. He has also earned his bachelors, masters, and doctorate degrees, during his 20+ years at the University of Florida.

Sessions

• Leveraging OnCore in Contracting at an Academic Medical Center
• Data Safety and Monitoring Committees: A Best Practices Discussion
• Top 10 Review in Clinical Research

Nirav Shah, MD, MSHP

Assistant Professor of Medicine
Medical College of Wisconsin

Nirav Shah, MD, MSHP, is currently an Assistant Professor of Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology, specializing in lymphoma, stem cell transplant, and CAR-T therapy at Froedtert Hospital. He graduated with honors and Alpha Omega Alpha Honor Society membership from the University of Illinois at Chicago College of Medicine in 2008. He then completed his Internal Medicine residency at Harvard University and Massachusetts General Hospital in Boston, Massachusetts in 2011. Post-residency, he took a position at Northwestern Memorial Hospital in Hospitalist medicine before proceeding to the University of Pennsylvania where he completed both hematology/oncology fellowship and a Master’s degree in Health Policy research in 2015.

Sessions

• Real-time IRB review process: A Smoother Pathway Toward Initial Approval

Jeremy Shapiro

EVAL Product Manager
Forte

Jeremy Shapiro is the Forte Research Evaluation System (EVAL) Product Manager, responsible for the strategic product planning and management. EVAL has allowed him to continue pursuing his passion: bringing interconnected software solutions to new niches, and the tremendous, transformative impact they can have there. Prior to joining Forte, Jeremy worked in a similar conceptual space but a different niche, designing tax filing portal software for eGov Systems in Baton Rouge, Louisiana.

Sessions

• What Does Forte's Agile Transformation Mean for You?

Stephen Shapiro

Training Specialist
Forte

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

Sessions

• Workshop: OnCore 101

Becky Sharp

Training and Applications Senior Analyst
Nebraska Medicine/UNMC

Becky Sharp is a Trainer and Senior Applications Analyst at Nebraska Medicine/UNMC. She has worked within adult education and training for almost 15 years, including work within the head injury community, Epic Systems, and OnCore. Becky strives to create a fun and effective learning environment, allowing users to feel comfortable asking any question- big or small. When she’s not creating new training, she enjoys spending time with her husband, son, and three dogs and customizing dollhouse miniatures.

Sessions

• What's on Your Website?

Denise Snyder, MS, RD, LDN

Associate Dean for Clinical Research
Duke University School of Medicine

After spending time in public health and clinical nutrition, Denise started work as a research coordinator and project manager in 2000 for NIH funded trials in oncology. In 2009, her Research Management Team in the School of Nursing received support from Duke’s CTSA to leverage the group’s services for the School of Medicine. RMT became the home for the REDCap EDC implementation. For the past 7 years, Denise has been the Associate Dean for Clinical Research for Duke University School of Medicine. In this role, she leads the Duke Office of Clinical Research (DOCR) a support office of expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation and guidance for clinical research operations for Duke as a site.

Sessions

• Practices Behind Being A Forte Benchmarks Process Leader
• Begin with the End in Mind: Putting Data Planning into Practice

Lonnie Sorrells

CSRC Informatics Systems Analyst
Waynes State University

Sessions

• EDC Implementation and Validation: The B side

Ryan Spellecy, PhD

Ursula von der Ruhr Professor of Bioethics
Medical College of Wisconsin

Dr. Spellecy is The Ursula von der Ruhr Professor of Bioethics in the Center for Bioethics and Medical Humanities at the Medical College of Wisconsin, where he chairs one of the IRBs. His work focuses on research ethics, informed consent, ethical issues in psychiatry, and community involvement in research. Recently, he was the co-PI for an NIH funded national study evaluating a novel, easier to read consent form for blood and marrow transplant trials. Currently, he is the PI on a study evaluating the strengths and barriers regarding cancer clinical trial participation in Milwaukee’s African American population.

Sessions

• Real-time IRB review process: A Smoother Pathway Toward Initial Approval

Tim Spinler

eLearning Developer
Forte

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

Sessions

• Improve Your Classroom Training with eLearning

Sarah Stewart

Assistant Director of Clinical Research
University of Wisconsin Carbone Cancer Center

Sarah Stewart is the Assistant Director of Clinical Research at the University of Wisconsin Carbone Cancer Center. She is a native Madisonian and loyal employee of Carbone, where she began her career in clinical research as a study coordinator in gynecologic oncology 17 years ago. After believing for years that she needed an advanced degree, she came to the realization that a BS in Biology and Sociology from UW-Madison is serving her quite well. She loves data, challenges, her team, playing a small role in improving the lives of cancer patients, and eating pancakes at her family’s breakfast joint.

Sessions

• Perspectives on Cancer Community Activation Timelines

Joe Stokes

Associate Director, Office of Clinical Research
University of Florida

Joe Stokes is an Associate Director for the Office of Clinical Research at the University of Florida. His professional roles have included stem cell transplant nurse, clinical research coordinator, and research team manager. Joe has led the OnCore operations at the University of Florida since 2009 – first for the cancer center and now for UF’s larger research enterprise.

Sessions

• OnCore and Vestigo Integration – Improving Investigational Pharmacy Operations

Jon Tack

Vice President, Product Management
Forte

As Vice President of Product Management, Jon leads product strategy for Forte’s OnCore, EDC, Payments, Platform, and Integration products. He also oversees the Forte product documentation function. Jon’s team is focused on delivering value-add solutions that customers can easily understand and adopt. Jon has over 10 years of experience driving collaborative, complex software development initiatives.

Sessions

• What Does Forte's Agile Transformation Mean for You?

Wendy Tate

Director, Analytics
Forte

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

Sessions

• Practices Behind Being A Forte Benchmarks Process Leader
• Perspectives on Cancer Community Activation Timelines
• Accrual Prediction Through Machine Learning in Reviewing Protocol Feasibility

Doug Vosters

Training Specialist
Forte

Doug Vosters is a Training Specialist at Forte. He is dedicated to meet the learning needs of his adult learners, with over 7 years of experience of classroom teaching. Doug is passionate about assessments, with experience in developing state and national exams in mathematics. In addition to assessments, he has expertise in instructional design to make the learning experience inclusive for learners, creating and maintaining software training environments, and has experience creating custom reports for grading certification projects.

Sessions

• Workshop: OnCore Financials Certification
• OnCore Charge Master Implementation Guidance
• Marketing 101: Driving Adoption of New Systems