Speakers

Chad Adams

UACC Assistant Director, Cancer Clinical Research
University of Arizona Cancer Center

Chad Adams works as the Assistant Director for Cancer Clinical Research at the University of Arizona Cancer Center (UACC), an NCI comprehensive cancer center. His responsibilities include overseeing the administrative, operational and financial management of clinical research. Mr. Adams has 20+ years working in operational management of which 17 years have been in the Healthcare Industry. Mr. Adams is the administrative chair of the UACC Clinical Research Oversight Council, Scientific Review Committee, DSMB, and is a member of the UA Research Operations Advisory Board. Prior to joining UACC, Mr. Adams has worked in leadership roles with several other research organizations.

Sessions

• Real-Time Custom Reports Supporting Research Operational Management

Bishoy Anastasi

Director of Clinical Research Finance
UCLA Dean’s Office

The training is led by Bishoy Anastasi, Director of Clinical Research Finance at UCLA’s Dean’s Office of Clinical Research. Bishoy is highly regarded as a national clinical research subject matter expert, particularly in coverage analysis, research pricing, and clinical research billing & financials. In addition to co-authoring UCLA’s coverage analysis and research pricing policies and processes, Bishoy brings over 18 years of clinical research management, contracting, coverage analysis and trial coordination experience.

Sessions

• Coverage Analysis Certification™ (Mon 9-5 & Tues 9-5)
• Coverage Analysis Certification™ (Mon 9-5 & Tues 9-5)
• Leveraging OnCore to Integrate and Streamline Financial Study Activation

Rhoda Arzoomanian

Associate Director of YCCI and Yale Cancer Center
Yale

Rhoda Z. Arzoomanian, MSM, BSN, RN, joined Yale in 2014 as Associate Director of YCCI and Yale Cancer Center. A nationally recognized expert in cancer clinical research, clinical trials databases, and the management of an NCI-designated cancer center with 30 years of clinical research experience, her current role at Yale encompasses clinical research across the medical campus. She oversees clinical research operational and regulatory units, developing results-oriented strategies for these areas, as well as testing and verifying technology solutions, compliance and good clinical practices. Her background is an asset to investigators across the spectrum of translational and clinical research.

Sessions

• Visualizing Study Activation Tasklists for Transparent Operations

Kristy Astin

Training and Education Coordinator
Duke University

Kristy Astin is a Training and Education Coordinator at the Duke Office of Clinical Research (DOCR). Kristy began her career as a healthcare professional in the field of Radiology where she excelled in patient interactions, communication, and customer service. She transitioned to clinical research in 2000 and has been working for Duke School of Medicine for the past eight years. In her current role, Kristy serves as the OnCore and Epic training lead, content developer, and course instructor. Her vast experience in managing clinical research projects and clinical research management systems has contributed to Kristy’s ability to succeed in a variety of functional roles within the research community. Kristy appreciates the big picture of clinical research management and this allows her to connect easily with members within the clinical research community.

Sessions

• Designing Effective and Innovative Role Based Training in OnCore

Dr. Howard Bailey

Director and Professor of Medicine
University of Wisconsin Carbone Cancer Center

Howard H Bailey, MD is the Andy and Susan North Professor of Cancer Research, Professor of Medicine and Obstetrics & Gynecology and Director of the University of Wisconsin Carbone Cancer Center (UWCCC). The UWCCC was one of the original National Cancer Institute-designated comprehensive cancer centers and is currently one of approximately 40 comprehensive cancer centers in the U.S. Dr. Bailey, a medical oncologist who has specialized in the development of new anti-cancer agents for prevention or therapy, currently lead a group of NCI-designated cancer centers in the development of novel cancer prevention agents. He recently was the Chair of the Cancer Prevention Committee of the American Society of Clinical Oncology which is the largest professional society in the world focused on cancer care and research. In that role he authored an international position paper on the need for increased HPV vaccination rates in the U.S. and around the globe.

Sessions

• General Session: Sponsor-funded IITs Panel: Lessons Learned, Challenges and Opportunities

Franco Basarabescu

OnCore Support Team Lead
Washington University in St. Louis

Franco Basarabescu is an OnCore Support Supervisor at Washington University School of Medicine in St. Louis, Missouri. Franco works with end users throughout the University by training new employees, collaborating with Forte to streamline institutional standards, and providing application support. Before his current position, Franco worked as an end user himself as a Clinical Trial Coordinator for two years. The knowledge he gained from his previous position has been beneficial to his support role in helping others. Though originally from Texas, Franco received a Bachelor of Arts from Saint Louis University in Chemistry and started his career at Washington University shortly thereafter.

Sessions

• OnCore Financial Implementation: Our Struggles and Successes

Sue Blackburn

Project/Portfolio Manager
University of Michigan

Sue Blackburn RN,BSN, MBA is a Project/Portfolio Manager for the University of Michigan, Clinical Trials Support Unit-Heart, Vessel, Blood. Her interest in research began while she was a Director of Nursing and Special Projects at Anderson Area Medical Center in Anderson, SC. In this role she implemented and managed some of the first clinical trials within the Medical Center. In 2003 she joined the University of Michigan, Section of Vascular Surgery as a Research Coordinator/Project Manager where she worked on a variety of sponsored and investigator initiated drug and device trials. With over 25 years of research and management experience she is well versed in all aspects of clinical research. Sue holds a BSN from the University of Connecticut and a MBA with a concentration in Health Care Administration from Rensselaer Polytechnic Institute.

Sessions

• Study Coordinators; Value for Successful OnCore Implementation

Cyndi Bower

Director Clinical Trials Operations
University of Michigan

After completing her MS at the University of Rochester in Rochester, N. Y. Cyndi began her career with the University of Michigan in 1982. She has held positions in the School of Nursing, Ambulatory Nursing Administration, and as an Advanced Practice Nurse with the Pediatric Bone Marrow Transplant team. She has spent the last 18 years in clinical research administration with MICHR (the University of Michigan’s CTSA funded Institute) and most recently with the Medical School Office of Research Clinical Trials Support Office as the Director of Clinical Trial Operations. In addition, she has also worked with the Senior Associate Dean for Research in the School of Dentistry as an administrative consultant for their Clinical Research Program. As the business and administrative lead for the research mission, Ms. Bower is responsible for the infrastructure, implementation, and operational and fiscal management of the CTSUs. She assists with devising and deploying the associated strategic research initiatives; managing projects; and advising on policy, procedural, and operational issues for the clinical trial enterprise. She has directed her own research in the areas of participant experience in research and the variables affecting retention, satisfaction and regret. She has published on a business model using mobile research support teams to enhance investigators being able to include vulnerable populations in research. Ms. Bower is an active member of committees at both the local and national level.

Sessions

• Study Coordinators; Value for Successful OnCore Implementation

Barbara Bradley

OnCore Coordinator
Augusta University

Barbara Bradley is the OnCore Coordinator for Augusta University and is responsible for product management, overseeing project implementation, developing standard operating procedures, creating help documents, conducting training, and providing technical support to users. Barbara has been involved in research administration for more than 40 years. During Barbara’s employment with a biotech company, she played an important role in developing a clinical research management system for profit. This experience triggered an ongoing interest in clinical database management, which continues today. Barbara has a Bachelor’s in Business Administration, an MBA in International Business, and is now pursuing certification in cyber security.

Sessions

• Cerner RPE/CRPC in Action

Kerri Briesmiester

OnCore Coordinator and Clinical Trials Application Manager
University of Michigan

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

Sessions

• Change Management for CRPC Enterprise Rollout

Stephanie Brogan

Assistant Director of Quality Assurance and Training
Yale Center for Clinical Investigation

Stephanie Brogan, CCRP is an Assistant Director of Quality Assurance and Training for the Yale Center for Clinical Investigation. Stephanie has nine years of clinical research experience in an academic research setting. She is responsible for oversight and management of teams which provide and administratively support scientific review, data and safety monitoring, multi-center monitoring, and educational instruction to improve the quality of clinical research conducted at Yale.

Sessions

• Visualizing Study Activation Tasklists for Transparent Operations

Cyndi Burkhardt

Executive Director
Hoosier Cancer Research Network

Cyndi is the executive director of the Hoosier Cancer Research Network. She is a registered nurse with more than 20 years of health care experience in hospital, clinic, and research settings. While in research, she was a clinical coordinator at a large community oncology practice before coming to Hoosier Cancer Research Network.

Sessions

• General Session: Sponsor-funded IITs Panel: Lessons Learned, Challenges and Opportunities

Diane Clemens

OnCore System Specialist
Siteman Cancer Center - Washington University in St. Louis

Diane Clemens, DC is an OnCore System Specialist at the Siteman Cancer Center, Washington University & Barnes-Jewish Hospital. Dr. Clemens has 5 years of clinical practice experience and 15 years of research administration experience. She has managed several compliance teams within both the IRB and Clinical Trials offices. An interest in data management, validation, and reporting led to her involvement with implementation of the OnCore system at Siteman. Diane received her doctorate from Logan University and her bachelor of science from The University of Tulsa.

Sessions

• Developing a QA Program for NCI Submission Data

Mario Contreraz

Administrator
Indiana University

Mario Contreraz, MBA, MSN, RN, is the Administrator of the IU Simon Cancer Center Clinical Trials Office (IUSCC CTO) in Indianapolis, Indiana. He worked as a Clinical Research Nurse Manager for the Indiana CTSI, School of Medicine, from November 2008 through May of 2016. In May of 2016, he was hired in the IUSCC CTO as the Research Nurse Associate Administrator and promoted to Administrator in January 2017.

Sessions

• Study Feasibility Using Predictive Modeling

Tess Cummings

Administrator of Clinical Research Operations
University of Maryland Greenebaum Comprehensive Cancer Center

Theresa (Tess) Cummings is the Administrator of Clinical Research Operations at the University of Maryland Greenebaum Comprehensive Cancer Center, with responsibility for day to day oversight of operational aspects of all (200+) oncology clinical trials. Prior to joining UMGCCC in 2015, she worked for over a decade as Director of Clinical Research Operations at several companies, with a focus on oversight of Phase 1 Healthy Normal Volunteer clinical research units. Ms. Cummings holds a bachelors degree in Nursing from Georgetown University and an MS in Nursing Education from University of Maryland School of Nursing.

Sessions

• Strategies Used to Accommodate NCI CCSG eData Reporting Requirements Using OnCore and CTRP/STRAP

Julie DeJager Glavic

Manager, Research Administrative Operations
Case Western Reserve University

Julie DeJager Glavic is the Research Administration Operations Manager for the Case Comprehensive Cancer Center at Case Western Reserve University (CWRU). Prior to moving to Cleveland, Julie worked in research administration at Northwestern University and Seattle Pacific University. With an academic background in religious history and sacred texts, Julie is enthusiastic about translating complicated grant requirements ordained by higher powers into straightforward checklists and visualizations for PIs and administrators. She enjoys meeting with the growing group of other EVAL users at Onsemble. Other interests include eliminating data redundancies, incrementally improving reports from central university data systems, and handbuilding ceramic stoneware.

Sessions

• EVAL: Beyond the (CCSG) Basics
• Research Program Analysis with EVAL Member Scenarios

Abby Ehringer

Training Manager
Forte

Abby Ehringer is the Training Manager at Forte. An enthusiastic and innovative software trainer with more than 10 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, software training environment build, eLearning development, blended learning, engaging learners during web-based training, and developing role-based and workflow-based training strategies for enterprise software products.

Sessions

• Learn How the 80+ Resources in Forte Academy Can Help You Train Your Staff

Becca Ennis

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

• Workshop: Jaspersoft Reporting in Forte Products

Katie Fick

Clinical Trial Business Office
Moffitt Cancer Center

Katie Fick is a Clinical Trial Budget/Contract Specialist. She began working in clinical research for the VA after obtaining a master’s degree in Audiology from USF in 2008. She’s served many roles at the Medical College of Wisconsin and Moffitt including CTC, regulatory specialist, and budget analyst. Her unique perspective has challenged her to initiate the breakdown of organizational communication silos. Most recently, she was nominated for CTO Professional of The Year and currently works remotely from Nashville. In her free time she enjoys hiking, reading, and fielding a million questions per day requiring all the coffee (aka parenting).

Sessions

• Trials and Tribulations of OnCore Financials Implementation

Nick Fisher

Executive Director of Research & Business Administration
Siteman Cancer Center

Nick Fisher is the Executive Director of Research & Business Administration at the Siteman Cancer Center. Mr. Fisher has over 15 years of experience managing Siteman’s administrative operations and oncology clinical trials program. He was named Director of Clinical Research in 2013 where he was responsible for all clinical research operations and represented Siteman’s interests throughout the medical center. In 2015, Fisher became the Director of Operations at Siteman, taking on responsibility for all research administration operations at the center. Finally, he accepted the Executive Director role in 2017, assuming oversight of all research and business operations at the center. Fisher received his Masters of Business Administration from Washington University in St. Louis in 2011.

Sessions

• General Session: DIRECT Consortia Panel: The Opportunity

Allie Frear

Clinical Research Coordinator
Duke University

Allie began her career in clinical research in 2012 at Copernicus Group IRB in Durham, North Carolina after graduating from the University of South Carolina with a Bachelor of Science degree in Public Health. She developed a passion for the safety and well-being of clinical research participants during her time at CGIRB. For the past 5 years, Allie has worked at Duke University as a Clinical Research Coordinator and through her contributions to numerous research studies has had the privilege to facilitate improvement of quality of life for individuals with pulmonary disease. Allie currently serves as Senior Clinical Research Coordinator on the Lung Transplant Research team in the Pulmonary Division at Duke, where she leads the day-to-day operations of multiple federal, foundation, and industry-sponsored clinical and translational research studies, including training and oversight of the team’s clinical research staff. Allie receives the most joy and satisfaction in her role when she has the opportunity to share her passion for clinical research through training, teaching, and mentoring others in guidelines, best practices, and regulations for the conduct of clinical research.

Sessions

• Study Coordinators; Value for Successful OnCore Implementation

Anne Gerke

Senior Training Specialist
Forte

Anne Gerke is the Senior Training Specialist at Forte. An enthusiastic and innovative software trainer with more than 15 years of experience, Anne works hard to make technical training content relevant to adult learners’ day-to-day life. She has expertise in the areas of instructional design, eLearning development, software training, blended learning, web-based training, and developing role-based and workflow-based training strategies for enterprise software products.

Sessions

• What is Virtual Training and Can it be Effective?

Kathleen Granlund

Manager, Multi-Site Project Management Team
University of Michigan

Kathleen Granlund is the Manager for the Multi-site Project Management Team for the University of Michigan Rogel Cancer Center Oncology Clinical Trial Support Unit. Kathleen has 20 years of clinical research coordinating experience including pharmaceutical, contract research organization, non-for-profit sponsor, and academia. She is responsible for management of the team that performs coordinating center activities such study initiation, regulatory submissions, project management, central enrollment, site and stakeholder management, data quality management, and monitoring for multi-site investigator initiated studies.

Sessions

• Collaborating on Multi-site Investigator-Initiated Trials

Anna Grant

Manager of PRMS and OnCore Oncology
UNMC / Nebraska Medicine

Anna Grant joined the OnCore team at Nebraska Medicine/University of Nebraska Medical Center (UNMC) as the Applications Sr Analyst in 2017. With a background of over 13 years in critical care Respiratory Therapy, Anna began her career in research as the Administrator for the PRMS office at UNMC where she was responsible for development and maintenance of the homegrown reporting database. After transitioning to her new role, Anna assisted in development, training and implementation of OnCore in Oncology, and continues to assist in the coordination, assessment and implementation of OnCore enterprise wide at Nebraska Medicine and UNMC.

Sessions

• Implementation of Forte EDC
• Centralizing an Intake Process to Support Operations

Nick Griffiths

CTMS Protocol Analyst Sr / Task Manager Administrator
Moffitt Cancer Center

I started my career as a medical laboratory technologist for a major tertiary healthcare facility in Winnipeg, Manitoba, Canada. After 21 years of service, I decided to make a career change and in 2002 moved to an oncology software company as a clinical research calendar builder. During this period I worked on a pilot project for Moffitt Cancer Center and in 2004 I accepted a position at the facility as a CTMS Protocol Analyst. In 2006 we started using OnCore for our regulatory process’s including study specific calendar builds and eCRFs. Since then I have accepted the role as Task Manager Administrator and during the past year I worked closely with our Pre and Post Award financial teams with the implementation of the OnCore Financial Console.

Sessions

• Trials and Tribulations of OnCore Financials Implementation

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

• Focus on Managed Infrastructure

Curt Hampton

Sr. Business Systems Manager
Huntsman Cancer Institute’s Clinical Trials Office at the University of Utah

Curt Hampton has worked in the healthcare industry on both the vendor and provider sides. After supporting EMR and CTMS systems for large healthcare organizations nation-wide, he has been the Senior Business Systems Manager at the Huntsman Cancer Institute for the past four years where he enjoys collaborating with his peers from other institutions. Curt has an MBA from the University of Wisconsin – Madison, a Master’s degree in Chemical Engineering from the University of Colorado at Boulder, and is a SOCRA Certified Clinical Research Professional (CCRP). In his free time, he enjoys doing ultramarathons, watching his daughter’s horse shows, coaching his son’s lacrosse team, and trying to take over the world. After we cure cancer, Curt wants to build houses and shingle roofs for a living. Other spectacular things: - Was charged by a 2000-lb bison on a trail in the middle of the night - Won a car in a radio contest - Has been skydiving - Has been bungie jumping - Participated in the first World’s Toughest Mudder competition - Survived a confrontation with a black widow spider - Drinks expired milk - Leaves unrefrigerated left-over fish on his desk and eats it for lunch - SCUBA dives with sharks - Was a beekeeper - Has raised chickens - Can fit a whole Suzy-Q in his mouth - Applied to the astronaut training program. Twice - Has taken a picture with a tarantula

Sessions

• Real-Time Custom Reports Supporting Research Operational Management
• OnCore Use for Clinic Flow

Beth Harper

Workforce Innovation Officer
Association of Clinical Research Professionals

Beth is the President of Clinical Performance Partners, Inc. a consulting firm specializing in enrollment and site performance optimization. Beth serves as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth is also an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment and sponsor-site relationship management and clinical research professional competency. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas. (She can be reached at 817-946-4728 bharper@clinicalperformancepartners.com or beth.harper@acrpnet.org)

Sessions

• Workshop: Competency-Based Approaches to Staff Hiring, Management and Advancement

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

• Introduction to OnCore Financial Interfaces
• Hot Topics from Onsemble Groups

Jeanne Hunter

Principal Account Executive
Forte

Sessions

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

Mathew Innes, MBA, CCRP

Administrative Director of Clinical Research
University of Michigan Rogel Cancer Center

Mathew Innes, MBA, CCRP, is the lead administrator for the Oncology Clinical Trials Support Unit and Administrative Director for Clinical Research for the University of Michigan Rogel Cancer Center. His responsibilities include administrative, operational and financial management related to the center’s portfolio of 500+ clinical trials and research studies. Prior to being named director in 2013, he was IT manager for the Clinical Trials Office for 11 years, which included leading two CTMS transitions (now on No. 3). Mr. Innes has co-authored two articles in the Journal of the National Comprehensive Cancer Network (JNCCN) focused on improving workload management and complexity modeling of cancer clinical trials. Before coming to the University of Michigan, he worked for Pfizer and a software startup. He holds a BSE in Computer Engineering and a Master’s in Business Administration from the University of Michigan.

Sessions

• General Session: DIRECT Consortia Panel: The Opportunity

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

• Focus on Managed Infrastructure

Robin Johnson

Lead Clinical Data Management Associate
UNC Lineberger Comprehensive Cancer Center

Robin Johnson is the Lead Clinical Data Management Associate for the Lineberger Comprehensive Cancer Center Clinical Protocol Office at the University of North Carolina at Chapel Hill. Over the last 5 years at LCCC CPO, Robin has been involved in all aspects of data management including eCRF development, clinical data review, process documentation, OnCore administration and training. Prior to moving down Tobacco Road, Robin worked for 15 years at the CALGB Data Management Center at Duke University as both a Data Manager and Statistician. Robin has a Master’s Degree in Medical Sciences (Epidemiology) from the University of Newcastle, Australia. She shares her home in Chapel Hill with her husband and is owned by 3 cats.

Sessions

• Ensuring Data Quality with Clinical Data Management Associates

Ian Jones

Support Engineer
Forte

Ian Jones is a Support Engineer at Forte. He primarily works with Engineers, Product Support, and Forte customers to understand and solve reporting challenges using Forte products.

Sessions

• Workshop: Jaspersoft Reporting in Forte Products

Shree Kalluri

Founder, President, CEO & Chief Customer Officer
Forte

Inspired to create a company that makes a huge difference, Shree Kalluri founded Forte Research Systems, Inc. in 2000. Today, Shree continues to drive the company’s strategic direction and shape the culture that makes Forte a company that people and organizations seek out and stay with. Shree takes pride in the contribution that the company’s products make to the discovery of new cures through the work done at research organizations across the United States and beyond.

Sessions

• General Session: Keynote

Sam Karahukayo

IT Applications Analyst
University of Maryland Baltimore (UMGCCC)

Sam is an IT Applications Analyst at University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center. His main responsibilities are providing OnCore support administration, Training OnCore Users, report writing for CRO administration, calendar/eCRF build and overseeing any third party integrations with OnCore. Prior to joining UMB, Sam worked for Huawei Technologies as a Senior Functional Consultant where he oversaw customer requirement gathering, implementation and maintenance of Enterprise Convergent Billing Solution Software in some of the leading Telecom companies in Middle East and Africa. Sam has over 10 years of experience in implementing and supporting systems in large Organisations.

Sessions

• Strategies Used to Accommodate NCI CCSG eData Reporting Requirements Using OnCore and CTRP/STRAP

Courtney Kennedy

Clinical Trial Application Manager
UNMC / Nebraska Medicine

Courtney Kennedy joined UNMC/Nebraska Medicine 10 years ago and is currently the Clinical Trial Application Manager. She evaluates and develops workflows associated with clinical research including; research recruitment, CMS required documentation, billing workflows, and Medicare Coverage analysis. Her previous role was as a Research Informatics lead on the UNMC/Nebraska Medicine, Epic team for 5 years. She has facilitated the integration of Epic and OnCore with research operational workflows in order to improve the safety of research patients, the ease with which data is documented and retrieved, and the efficiency of recruitment. Her priority is focusing on enhancing technology to improve clinical research workflows and improve patient access to trials.

Sessions

• Implementation of Forte EDC

Harshita Koranne

OnCore Application Developer
University of Florida

Harshita currently serves as a software developer at the University of Florida Office of Clinical Research. Harshita is an innovative and forward-thinking developer that has released multiple applications and web projects. Known for the constant desire to learn the newest emerging technologies Harshita is currently pursuing her masters degree in Information Systems with an ambition to revolutionize clinical research industry with Big Data Analytics, Machine Learning and Artificial Intelligence.

Sessions

• Managing Enterprise Clinical Trial listings with OnCore SIP

Maggie Lindenbaum

Director of Coordination Services and Education (CSE)
UCLA CTSI

Maggie Lindenbaum is the Director of Coordination Services and Education (CSE) in the UCLA CTSI, where she leads a dedicated team of clinical research professionals who manage study activation, on-study clinical research management, and clinical research education development for investigator initiated and industry-supported studies. She directly provides FDA submissions support, protocol development, and program oversight services. Prior to stepping into her role as Director, Maggie developed a broad perspective of the clinical research ecosystem in her roles as lab assistant while an undergrad at Stanford University, industry CRA, project manager for multi-institutional investigator initiated UCLA Hematology-Oncology trials, regulatory team manager, and UCLA coverage analysis administrator and trainer. Her recent achievements include leading the collaborative development of a well-received, novel Clinical Research Coordinator course and the continued development of rapid study activation tools aimed at leveraging existing software and application platforms in support of process transparency and lean operational practices. Maggie actively contributes to local and national working groups and committees as a subject matter expert in clinical research support services.

Sessions

• Study Coordinators; Value for Successful OnCore Implementation

Joe Martinelli

Director, QA
Forte

As the Director of Quality Assurance, Joe oversees the manual and automated testing efforts for all of Forte’s products. He is passionate about improving software quality and testing efficiency. He and his talented team work to make sure quality is at the core of Forte’s software development lifecycle.

Sessions

• How Forte Develops and Tests Software

Jill McKinley

Manager, Product Support
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

• Hot Topics from Onsemble Groups
• Geekonomics for OnCore

Meghan Mendick

Applications Sr. Analyst
UNMC / Nebraska Medicine

Meghan Mendick is an Applications Sr Analyst with the OnCore team at Nebraska Medicine (NM)/University of Nebraska Medical Center (UNMC). Her background in research began with the completion of her MS in Cancer Research at UNMC. Shortly after, she joined the Clinical Research Center as a Clinical Trials Analyst performing Medicare Coverage Analysis and negotiating budgets for 2 years. Meghan is currently responsible for the oversight of calendar builds and financial reporting in OnCore at NM/UNMC.

Sessions

• Centralizing an Intake Process to Support Operations

Allie Moses

OnCore Coordinator
MedStar Health Research Institute and Georgetown University

Allie Moses is the OnCore Coordinator for MedStar Health Research Institute and Georgetown University. Allie began working in research 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 the MHRI/ Georgetown implementation. At MHRI and Georgetown, Allie coordinates the OnCore enterprise rollout and leads the support and training for all users across both organizations.

Sessions

• Cerner RPE/CRPC in Action

Catee Mullen

Director, Clinical Research Financial Management
Duke University

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 Associate Director of Research Operations at the Duke Office of Clinical Research (DOCR)). For the past 3 years, Catee has been the Director of Clinical Research Financial Management in the Duke School of Medicine Finance Office. In this role, she leads a team that supports financial management of clinical research in the clinical departments. Some of their recent initiatives include the implementation of a reloadable debit card for participant payments, budgeting and payment terms education, research charge segregation and the enterprise-wide roll-out of OnCore Financials.

Sessions

• Take Charge of Your Charge Master

John Musser

Director, Clinical Trial Business Office
Moffitt Cancer Center

John Musser is the Director of the Clinical Trials Business Office (CTBO) where he oversees budgeting and contracting for clinical trials. He moved to Tampa after completing his undergraduate degree at the University of Alabama. He then obtained his MS in Molecular Medicine from the University of South Florida. After graduation, he started working in the CTBO and has worked within the department for over eight years; the last three in his current role. In his free time, he enjoys being outside with his family, running, golfing and watching Alabama football.

Sessions

• Trials and Tribulations of OnCore Financials Implementation

Katie Penas

Clinical Research Manager
UNMC / Nebraska Medicine

Katie Penas joined the Clinical Research Center at Nebraska Medicine in 2012. She began her career in research as a clinical trials analyst performing coverage analysis and negotiating budgets. In 2017 she transitioned to a managerial role and currently oversees a team of clinical trials analysts and regulatory coordinators. Katie acts as the business analyst for OnCore and has assisted with workflow development.

Sessions

• Centralizing an Intake Process to Support Operations

Leslie Pettiford

Assistant Director
University of Florida

Leslie Pettiford, RN, MS, CCRC, Assistant Director, UF Health Cancer Center Clinical Trials Office. She earned her BSN from UF and worked as a staff nurse in Bone Marrow Transplant for 10 years. Leslie made the move into clinical research in 2007 and worked as a research nurse coordinator managing novel first in human trials. Leslie assumed the role of the Hematologic Malignancies Manager in the CTO in 2015 and then became the Assistant Director of Clinical Operations and Education in 2017. In her current role, she is responsible for general oversight of the clinical divisions within the CTO, managing the hiring process, daily assignments and the workload distribution of the clinical research teams. She earned her Master’s in Research Regulation and Ethics from UF in 2014 and has been a Certified Clinical Research Coordinator through ACRP since 2012.

Sessions

• OnCore Annotations for Workload Reporting and Planning

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

• Integrating the eIRB: The OnCore API in Action
• Introduction to OnCore Financial Interfaces
• Focus on Managed Infrastructure

Seth Richards

Supervisor of Research Finance
Moffitt Cancer Center

Seth Richards is the Supervisor of Research Finance – Clinical Trials. He started working at Moffitt 11 years ago as a patient transporter in the hospital while attending the University of South Florida. After graduation, he started working in the Research Finance department and has progressed through the department over the past 7 years focusing on grants, shared resources, and now, clinical trials. Most recently he received his MBA with a concentration in Healthcare Analytics from USF last December. In his free time, he enjoys playing soccer, golf, doing anything on the water, and brewery hopping with his wife & dog.

Sessions

• Trials and Tribulations of OnCore Financials Implementation

Natalie Roman

CCSG Coordinator / Research Administration Manager
University of Florida Health Cancer Center

Natalie Roman, Research Administration Manager, UF Health Cancer Center. In 2014, Natalie earned her BA in Analysis and Practice in Medical Administration from The Ohio State University School of Communication. In 2016, she relocated to Gainesville, FL from The Ohio State University Comprehensive Cancer Center, where she worked as NCI Core Grant (CCSG) Data Administrator for more than nine years. Natalie was recruited to join the UF Health Cancer Center (UFHCC) team to help lead the Cancer Center to their first CCSG designation. In her current role, she is co-leading the research administration and cancer informatics teams to build a cancer center reporting and data management infrastructure. The priority is to create a system that produces real-time cancer data metrics for all facets of research within the University of Florida as the cancer program continues to grow and expand university wide.

Sessions

• EVAL Implementation

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 14 years of clinical data management and IT experience, and is a CCDM through SCDM.

Sessions

• Optimizing EDC Form Design for Data Entry and Data Export

Ali Saren

Training and Education Coordinator
Duke University

Ali Saren is a Training and Education Coordinator at the Duke Office of Clinical Research. Beginning her career in Research Administration, Ali serves as the Instructional Design leader for training activities for the department. Her vast experience and talent have resulted in her keen insight in recognizing communication strategies and teachable moments within basic and clinical research. After transitioning into a career solely dedicated to education and training, Ali has successfully designed and implemented various training strategies for several programs at Duke University and has most recently focused on e-learning design and delivery. In her design strategies, Ali challenges both participants and organizations in adult learning approaches and methods, to ensure engagement and results. In a world of constant change in the demand of competencies and skills desired from employees, Ali’s approach to e-learning design is to provide learners with a sense of empowerment and confidence to better perform their roles.

Sessions

• Designing Effective and Innovative Role Based Training in OnCore

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

• To Centralize or Not to Centralize: A Panel Discussion
• OnCore Annotations for Workload Reporting and Planning
• CTSA Leadership Meet-Up
• Real-Time Custom Reports Supporting Research Operational Management

Jeremy Shapiro

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

• Research Program Analysis with EVAL Member Scenarios

Denise Snyder

Associate Dean for Clinical Research
Duke University School of Medicine

After completing her graduate degree in Nutrition at Penn State, Denise relocated to North Carolina in 1997. After spending time in public health and clinical nutrition, Denise resumed research work at Duke as a project manager in 2000 where she managed several NIH funded trials involving an array of diet and exercise interventions with breast, prostate and colorectal cancer survivors. She has co-authored more than 50 publications and presented at national conferences. In 2008, Denise created the Research Management Team (RMT) to support the School of Nursing’s research faculty. In 2009, RMT received support from Duke’s CTSA to leverage the group’s services for the School of Medicine and became the home for the REDCap EDC implementation. For the past 5 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

• To Centralize or Not to Centralize: A Panel Discussion
• General Session: DIRECT Consortia Panel: The Opportunity
• Moving Forward: Establishing Portfolio Management via Enterprise-Wide Implementation of OnCore

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 in Madison, WI with his band, Cats on Leashes.

Sessions

• Simplify eLearning Development with Storyboards

Christian Stephens

Project Manager - Office of Research Informatics
Duke University School of Medicine

Christian transplanted from Stony Brook, NY to North Carolina to attend the University of North Carolina – Chapel Hill. Christian began his project management career at a digital publishing startup in the early 2000’s, where he was responsible for managing the creation and implementation of a full dental curriculum on a custom DVD for SUNY-Buffalo, UMDNJ, NYU, BU, UNLV, and UTHSC-San Antonio. In 2006, Christian started work as an EDI PM for LabCorp responsible for creating electronic lab interfaces between LabCorp and their most complex EMR vendors (Epic, Cerner, Allscripts, Siemens, McKesson, Meditech) and consulting for new vendors who were creating EMR’s. In 2011, Christian transitioned to Rex Hospital/UNC to begin Health Care project management in the patient care/HIM areas, working on installing medical devices into patient care areas, and deploying patient registration and finance tools. He began his enterprise wide project management with the ICD-10 conversion effort where he was the lead PM on a task force working with all UNC Hospitals, with full responsibility for all work-streams at Johnston Health in Smithfield NC. In 2014, Christian joined Duke Health Technology Solutions where he was the primary project manager for a Paperless Solution program initiated to assist Duke University Health System meet HIMSS Stage 7 paperless requirements for both Inpatient and Outpatient facilities. After successfully leading the team in the design and deployment of the paperless program, which helped Duke receive both HIMSS Stage 7 certifications, Christian transferred to the School of Medicine to lead the OnCore enterprise wide deployment. On May 2018, Duke completed the enterprise wide deployment of OnCore which included EMR and IRB interfaces, 600+ calendars built; 1200 users trained, data migration of 15,635 protocols, 191,417 IRB review outcomes (i.e. initial, Continuing Reviews, etc.), 176,527 subjects, and 263,520 enrollments.

Sessions

• Moving Forward: Establishing Portfolio Management via Enterprise-Wide Implementation of OnCore

Joe Stokes

Associate Director
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

• Managing Enterprise Clinical Trial listings with OnCore SIP
• Take Charge of Your Charge Master

Jon Tack

Director of Product Management
Forte

As Director of Product Management, Jon leads product strategy and release planning activities in the Platform and Integrations space. Jon’s team builds reusable components that deliver a consistent experience for end users, reduce the administrative burden on research teams, and promote speed to market for Forte products. Jon has over 10 years of experience defining technical solutions that deliver business value.

Sessions

• How Forte Develops and Tests Software

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

• Study Feasibility Using Predictive Modeling

James Thomas, MD, PhD

Interim Director Associate Director, Translational Research Medical Director, Clinical Trials Office
Medical College Of Wisconsin

James Thomas, MD, PhD is the Interim Co-Director, the Medical Director of the cancer Clinical Trials Office and the Associate Director of Translational Research at the MCW Cancer Center. He is a professor in the Department of Medicine, Division of Hematology/Oncology Professor and the Solid Tumor Oncology Section Head. Dr. Thomas came to MCW in 2010 from Ohio State University. He is responsible for integration and translation of MCWCC basic science research into the clinic and of clinical research into the community. He oversees the review process, protocol review, monitoring system and data and safety monitoring committees for all cancer clinical research activity. In addition, Dr. Thomas ensures quality, efficiency and continual monitoring for needed growth and improvements in clinical research services. He identifies clinical oncology leaders with clinical research experience and interests, and assists with strategic recruitment plan development, interacting with the senior leadership. He also oversees investigator-initiated trial development, and as a result, IITs have increased from 16 to 41 over the past five years. Dr. Thomas works to promote clinical collaborations to bring preclinical work to the clinical trial setting

Sessions

• General Session: Sponsor-funded IITs Panel: Lessons Learned, Challenges and Opportunities

Terri Thommes

Clinical Research Financial Analyst
University of Minnesota

Terri Thommes, CPA, is a Clinical Research Financial Analyst at the University of Minnesota. She co-led a pilot project bringing together finance and other administrative professionals to provide a new model of pre- and post-award support. She is involved in several special projects to improve and streamline these processes. She was also the Financials lead for the OnCore Implementation team at the U of MN. Terri has more than twenty years of experience working with a variety of business sectors: public accounting, higher education, research, and various commercial industries.

Sessions

• Take Charge of Your Charge Master

Tom Wendt

Director, VPRED Information Systems
University at Buffalo

Experienced Director of Information Technology (IT) working in electronic research administration. Strong IT professional skilled in Data Analysis, systems integration, Business Analysis and Strategic Planning. Chaired several national, state and local committees dedicated to research IT as well as held several IT related certifications.

Sessions

• Integrating the eIRB: The OnCore API in Action

Daniel Wilson

Solution Consultant
Forte

Sessions

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