Speakers

The nation’s leading clinical research professionals are presenting at Onsemble.
Learn more about our speakers.

Bishoy Anastasi

Bishoy Anastasi

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

Bishoy Anastasi

Bishoy Anastasi

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

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

Sessions

Candida  Barlow, MSN, CTN, RN

Candida Barlow, MSN, CTN, RN

Clinical Research Strategist , Advarra

Nick Fisher, MBA

Nick Fisher, MBA

Executive Director of Research & Business Administration, Siteman Cancer CenterWashington University & Barnes Jewish Hospital

Nick Fisher, MBA

Nick Fisher, MBA

Executive Director of Research & Business Administration
Siteman Cancer CenterWashington University & Barnes Jewish Hospital

Nick Fisher is the Executive Director of Research & Business Administration at the Siteman Cancer Center. Mr. Fisher has nearly 20 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 across the center. In 2015, Fisher became the Director of Operations, taking on responsibility for all of the center’s research administration operations. Finally, he accepted the Executive Director role in 2017, assuming oversight of all research and business operations for Siteman and representing the center’s research interests throughout the university. Fisher received his Masters of Business Administration from Washington University in St. Louis in 2011.

Sessions

Aidan  Gannon

Aidan Gannon

Director, Client Services, Advarra

Aidan  Gannon

Aidan Gannon

Director, Client Services
Advarra

Aidan has over 20 years’ experience in clinical research, having managed global studies from both the sponsor and CRO perspective. Aidan’s particular passion is to make conducting and participating in clinical trials a less burdensome experience for site staff, and patients, their families and caregivers. As Director of Client Services at Advarra, Aidan guides development and adoption of the Longboat Platform, providing study portals, tools, and apps to support and empower trial participants, site staff, study monitors, and the extended study team.

Sessions

Anuja  Gutal

Anuja Gutal

Research Information Systems Administrator, Intermountain Healthcare

Anuja  Gutal

Anuja Gutal

Research Information Systems Administrator
Intermountain Healthcare

Anuja Gutal is a Research Information Systems Administrator at Intermountain Healthcare. She has a Master’s of Science in Information Systems from the University of Utah and Bachelors of Engineering in Information Technology from the Mumbai University, India. She is one of the CTMS administrator who manages all the CTMS specific responsibilities for Intermountain Healthcare’s Office of Research. In addition to CTMS, she also manages other research applications like REDCap, Progeny (Laboratory Information Management System) and Publication Library. She also holds interest in SQL, R programming, business intelligence report creation, and data related topics.

Sessions

Yasmeen Hafeez

Yasmeen Hafeez

Clinical Research Informatics Specialist, Henry Ford Health System

Yasmeen Hafeez

Yasmeen Hafeez

Clinical Research Informatics Specialist
Henry Ford Health System

Yasmeen takes immense pride in being part of Henry Ford Health System and is interested in creating innovative approaches to the management of healthcare information. She works on various research studies, focusing on improving efficiency of workflows to optimize standards and outcomes.Yasmeen started her career as a certified Oracle Database Administrator and has over 15 years of experience in Clinical data management systems. She leverages her knowledge of multiple electronic data capture systems to create novel solutions for researchers in their projects. She enjoys cooking, gardening, and spending time with her husband and two children.

Sessions

Helen He

Helen He

Product Manager, Advarra

Helen He

Helen He

Product Manager
Advarra

Helen He joined the EVAL team in 2021 as the EVAL Product Manager. She is passionate about product and user experience. Before Advarra, she worked at Epic, focusing on quality assurance and user research for several billing products. She is a graduate of the University of Michigan-Ann Arbor, where she studied political science and sociology and discovered her love of squirrel-feeding.

Sessions

Dave Henderson

Dave Henderson

Business Analyst, Karmanos Cancer Institute

Dave Henderson

Dave Henderson

Business Analyst
Karmanos Cancer Institute

Dave has an MBA from Baker Graduate School and is a Six Sigma Black Belt. He joined Karmanos Cancer Institute in 2018, focusing on Clinical Trials / Financial process improvement.

Sessions

Leah Henley

Leah Henley

Clinical Systems Manager, AES: Accelerated Enrollment Solutions

Leah Henley

Leah Henley

Clinical Systems Manager
AES: Accelerated Enrollment Solutions

Leah is the Clinical Systems Manager at AES within a team of five members from the US and Europe. She has spent 5 years in the pharmaceutical research industry and has a comprehensive background with Budgets and Contracts and the Study Build processes within CTMS. Leah understands the effort and work put in by clinical staff users and wants to ensure the system runs at full efficiency and is effective for site use. Leah primary goal is for her team to be of value to the organization by providing technical solutions within the CTMS to operational challenges.

Sessions

Laura Hilty

Laura Hilty

VP, Strategy, Advarra

Laura Hilty

Laura Hilty

VP, Strategy
Advarra

As Vice President of Strategy, Laura leads efforts to create efficiencies for all stakeholders in the clinical research landscape through Advarra solutions and external partnerships. In her eleven years with Advarra, Laura has worked with customers and community members to grow the company’s range of services that address inefficiencies within the clinical research industry, as well as launching several products. Given the many years working with research sites in depth and seeing the challenges they face on industry studies in particular, she is passionate about bringing together multiple stakeholders to collaborate in industry-wide efficiencies across sites, sponsors, CROs, the IRB and participants.

Sessions

Jessica Houlihan

Jessica Houlihan

ClinicalTrials.gov Manager, Duke Office of Clinical Research (DOCR)

Jessica Houlihan

Jessica Houlihan

ClinicalTrials.gov Manager
Duke Office of Clinical Research (DOCR)

Jessica Houlihan is a QA and Regulatory Associate in the Duke Office of Clinical Research (DOCR) within the Duke University School of Medicine. In her 10+ years working for Duke she has gained experience in study and regulatory coordination, calendar building, and study start-up. She currently helps support the Duke research community with their use of ClincialTrials.gov and Advarra’s OnCore and eReg systems.

Sessions

Rachel Jarrard

Rachel Jarrard

Manager, Pre-Award Contracting, Karmanos Cancer Institute

Rachel Jarrard

Rachel Jarrard

Manager, Pre-Award Contracting
Karmanos Cancer Institute

Rachel Jarrard, PhD has been with KCI since 2014.  She is responsible for managing the Pre-Award budget and contract negotiations and the research billing compliance for clinical trials supported by industry sponsors, grants, and foundations. Rachel received her Doctorate in Medicinal Chemistry/Molecular Pharmacology from Purdue University and her Bachelor of Science in Biology-Chemistry from Saint Joseph’s College in Rensselaer, Indiana.

Sessions

Miranda Kolb, PhD

Miranda Kolb, PhD

Manager, Technology Training, Advarra

Miranda Kolb, PhD

Miranda Kolb, PhD

Manager, Technology Training
Advarra

Miranda Kolb, PhD is a Manager of Technology Training at Advarra. She has worked in training and higher education for over 10 years, including 6 years of teaching and research at the University of Wisconsin – Madison where she earned her doctorate in Organizational Communication. Her current focus is on utilizing technology to create effective and engaging content for both instructor-led and self-guided courses. She believes in finding unique solutions so that distance learning does not mean diminished learning. When not leading or creating training, she enjoys spending time with her partner and their dog, going hiking, and trying new recipes.

Sessions

Ann Kreeger

Ann Kreeger

Program Manager, Advarra

Ann Kreeger

Ann Kreeger

Program Manager
Advarra

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

Sessions

Rudy Latta

Rudy Latta

Manager, Product Support, Advarra

Rudy Latta

Rudy Latta

Manager, Product Support
Advarra

Rudy has been working in the Clinical Research world since 2011. His career started working at a Clinical Trial Global Lab for 7 years running 4 support teams globally. He later transitioned to work with Clinical Trial Management Systems and eSource systems, where he worked closely with customers to train and deploy Clinical Conductor and eSource throughout their organizations.

Sessions

Kristen Matta

Lead Business Systems Analyst, University of Michigan

Kristen Matta

Lead Business Systems Analyst
University of Michigan

Sessions

Jill McKinley

Jill McKinley

Staff Augmentation, Advarra

Jill McKinley

Jill McKinley

Staff Augmentation
Advarra

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

Sessions

Jen Mead

Jen Mead

Director, Customer Success, Advarra

Jen Mead

Jen Mead

Director, Customer Success
Advarra

Crystal Mendenhall

Crystal Mendenhall

Sr. Application Specialist, Advarra

Crystal Mendenhall

Crystal Mendenhall

Sr. Application Specialist
Advarra

Crystal has been working in the Clinical Research world since 2012. Her career started in Business Development, but she later transitioned to work with Clinical Trial Management Systems, where she worked closely with customers to train and deploy Clinical Conductor throughout their organization.

Sessions

Orla Mester

Orla Mester

SVP, Professional Services, Advarra

Orla Mester

Orla Mester

SVP, Professional Services
Advarra

Sessions

Jake Meyer

Jake Meyer

Senior Manager, Business Operations Services, Advarra

Jake Meyer

Jake Meyer

Senior Manager, Business Operations Services
Advarra

Jake Meyer is the senior manager at Advarra and oversees the coverage analysis, budget negotiation, and CTMS study build services. He has assisted research sites across the nation in their CTMS, billing, and budgeting efforts associated with clinical trials. Prior to joining Advarra, Jake worked on behalf of a service provider and academic medical center. With 5+ years of experience supporting research operations, Jake takes price in his work and helping the industry grow.

Sessions

Marcus Miers

Marcus Miers

Director of Client Training, Advarra

Marcus Miers

Marcus Miers

Director of Client Training
Advarra

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

Sessions

Chris  Mulhern

Chris Mulhern

Solutions Consultant, Advarra

Chris  Mulhern

Chris Mulhern

Solutions Consultant
Advarra

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

Sami Naber

Sami Naber

Program Manager, Clinical Trial Billing, Cedars-Sinai Medical Center

Sami Naber

Sami Naber

Program Manager, Clinical Trial Billing
Cedars-Sinai Medical Center

Sami has been part of the Post Award team in Office of Research Administration at Cedars-Sinai for seven years, and is the primary OnCore Biller at the hospital. He was a key stakeholder in the organization’s Accounts Receivable integration of OnCore with Peoplesoft.  Prior to joining the central office, Sami began his career as a research administrator in the Kidney Transplant department at Cedars-Sinai. In his free time, he chases around his surprisingly fast 2 year old son.  He has been at Cedars-Sinai for 11 years.

Sessions

Erin Nelson, MPH, CCRP

Erin Nelson, MPH, CCRP

Regulatory Manager, The Ohio State University

Erin Nelson, MPH, CCRP

Erin Nelson, MPH, CCRP

Regulatory Manager
The Ohio State University

Erin Nelson is the Regulatory Manager for The Ohio State University Comprehensive Cancer Center – Clinical Trials Office. She has been working in regulatory compliance for over 3 years and clinical research for 5.5 years. She currently supports her institution by providing regulatory guidance to investigators and clinical staff as well as external sponsors. She trains her team of 25 staff members on how to promote regulatory compliance in clinical research through the use of tools like Advarra OnCore and eReg.

Sessions

Carrie  Nemke

Carrie Nemke

SVP, Customer Relationships, Advarra

Carrie  Nemke

Carrie Nemke

SVP, Customer Relationships
Advarra

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

Sessions

Kim Nothnagel

Kim Nothnagel

Research Contract & Budget Specialist, Karmanos Cancer Institute

Kim Nothnagel

Kim Nothnagel

Research Contract & Budget Specialist
Karmanos Cancer Institute

Kim Nothnagel joined KCI in 2017 as a Research Informatics Specialist and moved to KCI’s Pre-Award team in March 2020 to learn clinical trial budget negotiation and help train team members to build calendars and budgets in OnCore.  Before joining KCI, Kim worked in the legal field for 22 years, and in higher education administration for 7 years.  She received her B.A. Degree in Liberal Studies from the University of Michigan-Dearborn, and M.A. Degree in Human Resource Management from Marygrove College. 

Sessions

Casey O'Hara

Casey O'Hara

Application System Technical Analyst – Consultant, Intermountain Healthcare

Casey O'Hara

Casey O'Hara

Application System Technical Analyst – Consultant
Intermountain Healthcare

Casey O’Hara is an Application System Technical Analyst with Intermountain Healthcare. She has worked as a software QA engineer, change manager, event manager, and system analyst in both the financial and healthcare industries. She is a 15-year cancer survivor and joined Intermountain Healthcare 9.5 years ago, eager to give back to the healthcare community that enabled her survival. She was heavily involved in the Cerner EHR implementation starting in 2014 and recently moved to the Research Informatics/Precision Medicine team. She is excited to learn and make a difference with the research team.

Sessions

Mary Jo O'Loughlin

Mary Jo O'Loughlin

Director Pre-Award Contracting, Karmanos Cancer Institute

Mary Jo O'Loughlin

Mary Jo O'Loughlin

Director Pre-Award Contracting
Karmanos Cancer Institute

Mary Jo O’Loughlin is the Director Pre-Award Contracting at the Karmanos Cancer Institute.  She has more than 20 years of experience in research.  Mary Jo and the Pre-Award team manage the negotiation and execution of the CDAs, MTAs, and budget and contracts for the clinical trials.  She facilitates the review of budgets for investigator-initiated studies funded by grants, foundations or pharmaceutical or device companies.  The Pre-Award team is responsible for the Coverage Analysis and billing compliance processes for the clinical trials. 

Sessions

Jeff Parks

Jeff Parks

Director, Product Management, Advarra

Jeff Parks

Jeff Parks

Director, Product Management
Advarra

As the Director of Product Management, Jeff is responsible for Clinical Research Operations products at Advarra. This includes leading product management activities for OnCore and Clinical Conductors CTMS solutions. Jeff has been part of the product management team at Advarra for the last 4 years.

Sessions

Makenzie Pick

Makenzie Pick

Manager, Solutions Consultants, Advarra

Makenzie Pick

Makenzie Pick

Manager, Solutions Consultants
Advarra

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

Tiffany Danielle Pineda

Tiffany Danielle Pineda

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

Tiffany Danielle Pineda

Tiffany Danielle Pineda

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

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

Sessions

Dawn N. Pittinger, MBA, CHRC, CRCP

Dawn N. Pittinger, MBA, CHRC, CRCP

Corporate Compliance – Research Billing Compliance Manager, Moffitt Cancer Center

Dawn N. Pittinger, MBA, CHRC, CRCP

Dawn N. Pittinger, MBA, CHRC, CRCP

Corporate Compliance – Research Billing Compliance Manager
Moffitt Cancer Center

Sessions

Michael Rauwerdink

Michael Rauwerdink

Product Manager, Interfaces, Advarra

Michael Rauwerdink

Michael Rauwerdink

Product Manager, Interfaces
Advarra

With a passion for connecting workflows across enterprise systems, Michael guides development of interfaces that empower collaboration across research, clinical, and finance teams.  Michael brings a strong technical background from nearly 20 years in software engineering and a strong industry background in enterprise integration focused on healthcare interoperability standards to inform his work setting the interface product roadmap for Advarra’s OnCore Enterprise CTMS.

Sessions

Tiffany Reinson

Tiffany Reinson

Application Specialist, Advarra

Tiffany Reinson

Tiffany Reinson

Application Specialist
Advarra

Sessions

Kacey Richards, MPH, CCRP, PMP

Kacey Richards, MPH, CCRP, PMP

Senior Business Systems Analyst, Yale Center for Clinical Investigation (YCCI)

Kacey Richards, MPH, CCRP, PMP

Kacey Richards, MPH, CCRP, PMP

Senior Business Systems Analyst
Yale Center for Clinical Investigation (YCCI)

With a Masters degree in Public Health from Yale University, I started working at the Yale Cancer Center in 2013. In 2015, I transitioned to YCCI as a Clinical Research Coordinator. Ahead of the pandemic in early 2020, I took on the role of Project Manager, focusing primarily on our OnCore system. Most recently, I have expanded my focus at YCCI to include our EDC and eReg systems in my current role as Senior Business Systems Analyst. With a combined 6 years working at YCCI in several diverse roles, I have been able to harness that unique experience to better serve our research community.  

Sessions

Lauren Rogers

Lauren Rogers

Director of Clinical Research, Prism Health North Texas

Lauren Rogers

Lauren Rogers

Director of Clinical Research
Prism Health North Texas

Lauren Rogers is the Director of Clinical Research at Prism Health North Texas (PHNTX) in Dallas Texas. She has worked at PHNTX since 2007 and assisted in the creation and development of its Clinical Research Department. The Clinical Research Department has participated in over 40 clinical trials (both NIH and industry sponsored), enrolled over 500 study participants, and its work has contributed to FDA approval of 16 medications for the treatment and prevention of HIV. Lauren manages the day-to-day operations of two clinical research sites and supervises the team of clinical research coordinators, data mangers, and laboratory technicians. She also oversees the administrative and financial management of the clinical research program and department.

Sessions

Shannon  Roznoski

Shannon Roznoski

Director, Product Management, Advarra

Shannon  Roznoski

Shannon Roznoski

Director, Product Management
Advarra

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

Sessions

Gadi Saarony, MBA

Gadi Saarony, MBA

Chief Executive Officer, Advarra

Gadi Saarony, MBA

Gadi Saarony, MBA

Chief Executive Officer
Advarra

Gadi Saarony, Chief Executive Officer at Advarra, has over 25 years of leadership experience, including strategic, commercial, and operational clinical research roles. Prior to joining Advarra, Saarony served as Executive Vice President and Chief Clinical Research Services Officer at Parexel and was a member the company’s executive leadership team. Saarony was responsible for the operational delivery of Parexel’s global clinical research services, including site strategy and selection, patient recruitment, data management, biostatistics and programming, clinical operations, project management, resourcing, clinical trial supplies and logistics, and Phase I units. Prior to that, Saarony held several other senior-level positions at Parexel and was instrumental in achieving rapid growth in Parexel’s regulatory consulting and medical communications businesses. Saarony initially joined Parexel in 2003 in the area of strategy development.Saarony also previously served as Director of Consulting Services for Habama, Inc., and as Associate Director, Strategy, with Ernst & Young, LLP, Inc. He graduated from Rider University with a bachelor’s degree in economics and holds a master’s degree in international business from The American Graduate School of International Business (now Thunderbird School of Global Management).

Sessions

Brian Sevier, PhD

Brian Sevier, PhD

COO, Clinical & Translational Science Institute, University of Florida

Brian Sevier, PhD

Brian Sevier, PhD

COO, Clinical & Translational Science Institute
University of Florida

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

Sessions

Stephen Shapiro

Stephen Shapiro

Senior Training Advisor, Advarra

Stephen Shapiro

Stephen Shapiro

Senior Training Advisor
Advarra

Stephen is a Senior Training Advisor at Advarra. He works mostly with OnCore and Advarra 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

Bhanu Sharma, PhD

Bhanu Sharma, PhD

Regulatory Compliance Leader, Stanford University

Bhanu Sharma, PhD

Bhanu Sharma, PhD

Regulatory Compliance Leader
Stanford University

Dr. Bhanu Sharma is a Regulatory Compliance Leader for the Stanford Center for Clinical Research. He has more than 15 years of experience working on drug and device trials in both industry and academia. He recently contributed to a significant project relating to Software as a Medical Device (SaMD). Over the years, he was instrumental in bringing out many clinical systems such as electronic data capture system, ePRO and medical devices. Dr. Sharma is a key opinion leader on 21 CFR Part 11 and has lectured around the globe. He holds a PhD in Biochemistry and bachelor’s in Information Technology.

Sessions

Kelly Smith

Kelly Smith

Senior Solutions Consultant, Advarra

Kelly Smith

Kelly Smith

Senior Solutions Consultant
Advarra

Kelly Smith,CCRP began in research in 2007. Kelly joined Advarra via legacy Bio-Optronics in October 2016. She brought with her a site perspective and an understanding of the problems facing the industry today as well as an extensive knowledge of Clinical Conductor CTMS and eClinical products. She currently supports the Account Executives with demonstrations, proposed configurations, and solutions. Before that Kelly worked as the CTMS Administrator for an Investigative Site Network. She started as a Regulatory Document Specialist and evolved into a Quality Assurance Coordinator for a dedicated research site. Kelly lives in San Diego and enjoys spending time with her family, hiking, traveling, cooking, and practicing Pilates.

Denise C.  Snyder, MS, RD, LDN

Denise C. Snyder, MS, RD, LDN

Associate Dean of Clinical Research, Duke School of Medicine

Denise C.  Snyder, MS, RD, LDN

Denise C. Snyder, MS, RD, LDN

Associate Dean of Clinical Research
Duke School of Medicine

After spending time in public health and clinical nutrition, Denise started work at Duke 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 and launch REDCap for the School of Medicine. For nearly 10 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

Samantha  Spell

Samantha Spell

Clinical Systems Application and Learning Specialist , AES: Accelerated Enrollment Solutions

Samantha  Spell

Samantha Spell

Clinical Systems Application and Learning Specialist
AES: Accelerated Enrollment Solutions

Samantha is a CTMS Application and Learning Specialist with AES. Samantha has spent almost 8 years in pharmaceutical research, with approximately 4 years of site experience. In this unique role, Samantha facilitates administrative duties within the application as well as leading CTMS training for users, using data reporting to isolate key training needs. Samantha fully supports cohesive workflows through training. A believer of teamwork, she thrives on training system users to understand the CTMS as well as comprehend the need for accurate and efficient data.

Sessions

Erick Sperloen

Erick Sperloen

Senior Training Specialist, Advarra

Erick Sperloen

Erick Sperloen

Senior Training Specialist
Advarra

Erick Sperloen is a Senior Training Specialist at Advarra with focuses on OnCore and EVAL. He has worked as a software trainer, educator, and coach across various fields for over 12 years. Erick has always been passionate about education having received his Bachelor’s in English at the University of Wisconsin – Madison and his Secondary Education Licensure from the University of Wisconsin – Whitewater. Focusing on developing efficient training strategies and workflows, Erick also works to prep and support customer trainers as well. When he isn’t training, he enjoys playing and coaching competitive baseball as well as taking long walks with his dog, Zeus.

Sessions

Tim Spinler

Tim Spinler

eLearning and LMS Manager , Advarra

Tim Spinler

Tim Spinler

eLearning and LMS Manager
Advarra

Tim Spinler is the eLearning and LMS Manager at Advarra.  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 drums in multiple punk rock bands.

Sessions

Chelsey Stephens

Senior Customer Success Manager, Advarra

Chelsey Stephens

Senior Customer Success Manager
Advarra

Lauren Talley

Lauren Talley

Manager, Clinical Research Informatics, St. Jude Children’s Research Hospital

Lauren Talley

Lauren Talley

Manager, Clinical Research Informatics
St. Jude Children’s Research Hospital

Sessions

Tim Van Dijk

Tim Van Dijk

Business Systems Analyst, University of Michigan

Tim Van Dijk

Tim Van Dijk

Business Systems Analyst
University of Michigan

Tim van Dijk is a business systems analyst for the Calendar Review and Analysis Office in the University of Michigan Medical School Office of Research. He has been with CRAO since the adoption of OnCore at U of M, and has been building, maintaining, and optimizing calendars over the course of multiple migrations and procedural changes. In addition to calendaring, he is also involved in Medicare coverage analysis, supporting end-users both within CRAO and throughout the Office of Research, and collaborating with the Clinical Trials Support Unit (CTSU) to implement workflow efficiencies that meet the ever-changing needs of the research community. He holds a Bachelor’s degree in English from the University of Michigan.

Sessions

Katy Wile

Katy Wile

Higher Ed Consulting Director, Huron

Katy Wile

Katy Wile

Higher Ed Consulting Director
Huron

Katy is a Director in Huron’s Research Enterprise Solutions group and co-leads the Clinical Trials Management System (CTMS) team. Katy brings over fifteen years of experience in clinical research operations. She specializes in the design, implementation, and optimization of clinical research applications, including OnCore. Her work includes implementation planning, training strategy development, business process redesign, and system integration and optimization. Prior to joining Huron, Katy worked at the Vanderbilt-Ingram Cancer Center where she was a Phase I oncology research coordinator and an OnCore system administrator.

Sessions

Mary Elizabeth  Williams

Mary Elizabeth Williams

Keynote Speaker, Author

Mary Elizabeth  Williams

Mary Elizabeth Williams

Keynote Speaker
Author

Mary Elizabeth Williams is a metastatic melanoma survivor, clinical trial veteran, and the author of "A Series of Catastrophes and Miracles: A True Story of Love, Science, and Cancer." She has written for the LA Times, the Guardian, Health, and other publications. Her New York Times essay was recently adapted for the second season of Amazon Prime's "Modern Love." She has spoken for ASCO, PRIM&R, Bristol Meyers Squibb, and DIA, and is the winner of the 2020 AMWA Walter Alvarez Award. She is currently a doctoral student of Medical Humanities at Drew University.

Sessions

James Wurdeman

James Wurdeman

Chief Product Officer, Advarra

James Wurdeman

James Wurdeman

Chief Product Officer
Advarra

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

Sessions

Kate Yawman

Kate Yawman

Director, Product Management, Advarra

Kate Yawman

Kate Yawman

Director, Product Management
Advarra

Kate Yawman is a Director of Product Management who partners with customers conducting clinical trials to deliver software that streamlines regulatory compliance. Kate believes that technology should play a vital role in facilitating how organizations from sites to sponsors collaborate to run research more efficiently. Kate has been with Advarra (formerly part of Bio-Optronics) for 8 years. Before taking on her current role, she worked on CTMS and eSource products providing a broad view of the clinical research site technology market. Prior to joining Bio-Optronics Kate started her career in pre-clinical research at Johns Hopkins University and University at Buffalo. She holds a Bachelor’s degree in Biological Sciences from the University of Delaware and a MBA in Health Sciences Management and Competitive Strategy from the Simon School of Business at the University of Rochester.

Sessions

Omid Zia

Omid Zia

Grant and Contract Officer, Cedars-Sinai Medical Center

Omid Zia

Omid Zia

Grant and Contract Officer
Cedars-Sinai Medical Center

Omid Zia works in the Clinical Trial Administration Office at Cedars-Sinai Medical Center as a Grant and Contract Officer.  Omid assists study teams and Principal Investigators in budget negotiation, Pre-award setup, ICF Financial language, CDAs and Financial language within Clinical Agreements.  Omid was born and raised in Santa Monica, CA.  On Omid’s free time he enjoys going to the beach and hiking.

Sessions