Speakers

Rafie Abdul Khalid

Research Systems Administrator 2
Baptist Health South Florida

Rafie started his career in healthcare at a regional public hospital, where he was exposed to multiple facets of healthcare operations, primarily in the Ambulatory side of operations. Some areas he was involved with were finance, biosafety, patient/employee/provider satisfaction, project management, and clinical research. He then continued his career at Baptist Health South Florida, at the Library & Research Support Systems, helping the team manage Advarra’s products. His interests include reading in various disciplines, running, martial arts, badminton/soccer, and superhero/action films. He has 3 adopted children in addition to one biological daughter, with his spouse Caroline.

Sessions

• Advarra Managed Infrastructure: Security and Compliance Considerations

Bishoy Anastasi

Research Academy

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

Sessions

• Coverage Analysis Certification™
• Coverage Analysis Certification™

Molly Brock

Sr. Director Global Site Partnerships
PRA Health Sciences

Molly Brock joined PRA in 2018 as Director of Clinical Operations of Global TMF Services. Prior to joining PRA, Molly has over 14 years of experience as Director of Clinical Research Operations at University of Kansas Medical Center Research Institute and Saint Luke’s Health System. Molly is currently the Sr. Director of Global Site Partnerships.

Sessions

• Panel: Best Practices for Building Strategic, Sustainable Partnerships Between Sites and CROs

Carlee Brueser

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

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

Sessions

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

Marc Buehler

Clinical Research Systems Manager
UW Carbone Cancer Center

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

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Suzanne Calzada, MPA

Senior Contract Officer, Clinical Trials Administration Office
Cedars-Sinai Medical Center

Suzanne has been working in the research administration field for 19 years and has been with Cedars-Sinai Medical Center (CSMC) for a little over 7 years. Her roles in the past have included managing research compliance including the Institutional Review Board and Institutional Animal Care and Use Committee at California State University, Northridge and currently serving as a Senior Contract Officer at CSMC analyzing research budgets for compliance, training new Contract Officers, and acting as the point person for Oncore Financials at CSMC. Suzanne prides herself on constantly seeking to improve processes to maintain efficiency and training staff to provide thorough detailed analysis of budgets/payment terms. In her free time she enjoys cooking, hiking, trying new restaurants, and hanging out with her family including her husband and 3 furry children.

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Stuart Cotter

Director, Product Management
Advarra

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

Sessions

• Panel: Onsemble Community Experiences with Advarra eReg

Kasha Donahue, CCRP

Regulatory Manager, CTO
Barbara Ann Karmanos Cancer Institute

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

Sessions

• Panel: Onsemble Community Experiences with Advarra eReg

Chloe Fournier

Associate Director, Compliance and Training
Duke Cancer Institute

Chloe Fournier, MBA is the Associate Director of Compliance and Training within the Duke Cancer Institute. She has a strong background in oncology clinical research, having held patient-facing, data, regulatory and financial roles in both the community and academic settings over the last 15 years. Chloe was involved in the implementation of clinical trials management systems at two previous institutions, as well as the Advarra eReg implementation at Duke University; she has demonstrated a keen eye for process improvement and implementing change for increased operational efficiency and transparency.

Sessions

• Panel: Onsemble Community Experiences with Advarra eReg

Mercedes Franco

OnCore Administrator
Cedars-Sinai

Mercedes is the Administrator for OnCore Enterprise at Cedars-Sinai. She has a Bachelor's Degree in Cell Biology from the University of Utah and an MD degree from Far Eastern University in the Philippines. She has over 20 years experience working in Cancer clinical trials and 7 years experience as OnCore Administrator.

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Rhodora Garcia, MMCi

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

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

Sessions

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

Annie Geo-Thomas

Business Systems Analyst Senior
University of Michigan

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

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Beau Grignon

Security Officer and SVP of Technology
Advarra

Sessions

• Advarra Managed Infrastructure: Security and Compliance Considerations

Molly Grosse

Senior Manager, Study Start-Up Delivery – Americas
PRA Health Sciences

Molly has been in the Clinical Research Industry for over 14 years and has held a variety of roles with a focus specifically on Study Start-Up. Her previous experience includes Study Start-Up Delivery and Project Management, Resource Management and Line Management. She joined PRA in 2009 and has been a Manager in the Clinical Delivery team for over 5 years, with a specific focus in SSU Delivery since 2017. She has experience in a variety of indications and during her time at PRA, she has held several positions including IHCRA, Start-Up Lead, Resourcing Specialist and Manager of Clinical Operations & SSU Delivery. She has a passion for clinical research and in particular getting potentially life-saving drugs to patients faster, hence her love for the fast paced timeline driven environment that is Study Start-Up. She currently manages the Duke Site Relationship with PRA and oversees a team of Site Activation Specialists in North America. She is responsible for the management of staff including performance feedback, training and mentoring, supporting growth and career development as well as maintaining oversight of performance across projects. As part of the Global SSU team, she is also responsible for driving high priority initiatives focused on Change Management and Process Improvement resulting in more streamlined processes, greater efficiencies, quality improvements and decreased cycle times.

Sessions

• Panel: Best Practices for Building Strategic, Sustainable Partnerships Between Sites and CROs

Kristina Harr, J.D.

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

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

Sessions

• Developing a Successful Enterprise Expansion Strategy

Tesheia Harris, MBA, MHS

Deputy Director and Chief Operating Officer / Director of Clinical Research
Yale Center for Clinical Investigation / Yale School of Medicine

Tesheia Harris, MBA, MHS, is Deputy Director and Chief Operations Officer of YCCI and the Director of Clinical Research for Yale School of Medicine, where she provides leadership and direction in the area of clinical research. Her career has focused on the development of clinical research programs and support infrastructure. Prior to assuming her current position, she held positions as Assistant Dean for Clinical Research at the University of Vermont College of Medicine and Director of Clinical Trials at the University of Wisconsin-Madison. She has served as a consultant for several academic centers interested in establishing clinical research programs and as a grant reviewer for the National Institutes of Health. Ms. Harris is nationally recognized for her expertise in the design and setup of clinical research programs and as such has been an invited speaker at many national and international conferences. She has served as Chair and co-Chair for several National Clinical and Translational Science Award (CTSA) Consortium Groups/Committees. She sits on the external scientific advisory boards for the CTSAs at New York, Washington, and Rockefeller Universities, the Universities of Buffalo, Colorado, Florida, Rochester, and Washington and at University College London Hospitals’ Biomedical Research Centre.

Sessions

• Panel: Improving Access to Research for Diverse and Underserved Populations

Lauren A.J. Hartsmith, JD

Director, Regulatory Affairs
Advarra

Lauren Hartsmith is Director of Regulatory Affairs at Advarra. She previously served as Policy Analyst for the Department of Health and Human Services’ Office for Human Research Protections (OHRP). In that position, she led scientific, regulatory, and legal experts to develop and revise policies and regulations. Lauren was a key analyst involved in all aspects of the revised Common Rule rulemaking process, where she developed reports analyzing and summarizing over 2,000 public comments submitted in response to proposed Common Rule revisions. Lauren has also conducted analyses and provided advice for the FDA’s human subjects protection regulation. She holds a Juris Doctorate degree from Wake Forest University School of Law, where she was a recipient of the Kilpatrick Stockton and Wake Forest University Law Scholarships. She holds a bachelor’s degree from Vassar College, where she majored in Geography.

Sessions

• Regulatory and Ethical Considerations for Review of eConsent in Research

Peyton Howell

President, Commercial and Consulting and Chief Commercial & Strategy Officer
Parexel

Peyton Howell joined Parexel in May 2018 and leads the company’s Commercial and Consulting businesses along with its Corporate Business Development, Corporate Strategy, Marketing and Corporate Communications functions. In 2020, she led the company’s Biotech and Enterprise Commercial teams to record new business growth.   Peyton has more than 25 years of leadership experience in the healthcare industry and prior to joining Parexel held several leadership positions with AmerisourceBergen, a Fortune 20 company, most recently as President for Health Systems and Specialty Care Solutions, a $50B business unit. She also was President, Global Sourcing and Manufacturer Relations, responsible for leadership of $150B in manufacturer sourcing relationships. In this role, she led the creation of a new sourcing entity in Bern, Switzerland to support global manufacturer relations and a joint venture with Walgreens. Peyton also previously served as President, Consulting Services for the company, managing a portfolio of industry-leading pharma services (including acquisitions) focused on market access, reimbursement, patient programs, specialty pharmacy, specialty logistics and product commercialization.   Peyton also was a founder of Lash Group, growing the company from an early innovator of patient access services to nearly 5,000 employees and serving as President for nearly 10 years following its acquisition by AmerisourceBergen.   Peyton holds a Masters in Healthcare Administration (MHA) from The Ohio State University and a Bachelor of Arts in Speech Communication from The University of Illinois at Urbana-Champaign. In 2020 she was named a Luminary by the Healthcare Businesswomen’s Association (HBA). Peyton serves on the Board of Directors of Tandem Diabetes Care, Inc., as well as the Cancer Equity Initiative for Family Reach, a national 501(c)(3) organization dedicated to eradicating the financial barriers that accompany a cancer diagnosis.

Sessions

• Panel: Improving Access to Research for Diverse and Underserved Populations

Mike Lee, MPH, CCRP

Business Systems Analyst Senior
University of Michigan

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

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Alise Lombardo, BS, CCRP

Regulatory & Quality Manager
Lifespan Cancer Institute

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

Sessions

• Panel: Onsemble Community Experiences with Advarra eReg

Allison Massari

Allison Massari knows that you have the power to transform lives. As an advocate for both patient and provider, Massari has an intimate understanding of the demands and challenges of the medical profession. She experienced firsthand the critical value of receiving personalized health care from committed, empathetic healthcare professionals after surviving two life-threatening car accidents, one where she suffered second and third degree burns on over 50% of her body. In addition, raised by her father, a surgeon, and her mother, a nurse, Allison was mentored in the world of medicine from an early age. Captivated by her father’s compassionate work, she shadowed him in his practice, and also worked in hospitals and medical office settings. Allison’s riveting and courageous journey from absolute loss to a triumphant and hope-filled life, addresses sensitive topics, shining light on the provider’s immense value to a patient who is suffering, and helping to reinvigorate employees and heal burnout in the workplace.

Sessions

• Guest Keynote - Transforming Lives: The Art of Person-Centered Care℠

Yvette Moreira, MBA

Program Administrator
Cedars-Sinai Medical Center

Yvette Moreira has been with the Clinical Trials Administration Office as a Program Administrator for a year and half. She has over five years of research administration experience, in particular with the implementation of OnCore. She's responsible for the planning, implementing, and administering operations for a large portfolio of the research community at Cedars.

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Allie Moses

Research Systems and Recruitment Center Manager
MedStar Health Research Institute

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

Sessions

• Optimizing the Research Revenue Cycle From Protocol Initiation to Completion

Catee Mullen

Director of Research Operations
Duke Office Of Clinical Research

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

Sessions

• Building a Successful Foundation for OnCore Reporting Throughout the Research Enterprise
• Panel: Best Practices for Building Strategic, Sustainable Partnerships Between Sites and CROs

Sami Naber, MBA, CRA

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

Sami has been part of the Post Award team in Office of Research Administration at Cedars-Sinai for seven years, and is the primary OnCore Biller at the hospital. He was a key stakeholder in the organization’s Accounts Receivable integration of OnCore with Peoplesoft. Prior to joining the central office, Sami began his career as a research administrator in the Kidney Transplant department at Cedars-Sinai. In his free time, he chases around his surprisingly fast 18 month old son. He has been at Cedars-Sinai for 11 years.

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Susan Natoli, MSW, CCRP

Senior Strategic Services Associate, OnCore and eReg Coordinator
Duke University

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

Sessions

• Panel: Onsemble Community Experiences with Advarra eReg

Melissa Palchak Opraseuth, PharmD

Chief Operating Officer
par8o, Inc.

Melissa Palchak Opraseuth, PharmD (COO at par8o). par8o optimizes health care operations through care coordination technology and services for >11MM patients across U.S. Its latest offering, par8o Research Network (PRN), improves health equity and access to research by connecting community health center patients with relevant trials. She led development and launch of two offerings outside par8o’s original patient referral management business that has brought over $50 million to US health centers. She also oversees corporate operations, and manages, mentors, recruits top talent. Melissa has diverse healthcare experience, starting as a PharmD at the University of Michigan then pursued a postdoc fellowship in biotech research and development helping to lead Medical Affairs launch at Cubist, then Merck. Melissa dedicates her career to fostering a culture of voracious curiosity aimed to deeply understand and ultimately improve our health.

Sessions

• Panel: Improving Access to Research for Diverse and Underserved Populations

James Riddle, MCSE, CIP, CPIA, CRQM

Vice President, Research Services & Strategic Consulting
Advarra

James Riddle is the Vice President Institutional Services for Advarra where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra worldwide. Mr. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the CTTI Steering Committee; and leader of the ACRES SASI technology domain accreditation team.Prior to joining Advarra, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. In addition, he has served on the board of the Northwest Association for Biomedical Research (NWABR), was an AAHRPP site visitor, and was the Vice President of Operations and Director of Technology at another large central IRB. His expertise includes reengineering operational processes, systems evaluations, development and implementation of technology solutions, integration of technology solutions with operations, and management of large IRB and IACUC systems. Mr. Riddle has a bachelor’s degree in accounting with an emphasis in computer science from Western Washington University, College of Business and Economics.

Sessions

• Mobile Medical Applications, New Technology and IRB Review

Ray Robles

Research Operations Manager
Cedars-Sinai Medical Center

Ray works with physicians, researchers, and other clinical and administrative research staff to successfully activate and manage basic, translational, clinical research, and other innovations. He is the Research Operations Manager overseeing all research from inception to closure for Cedars-Sinai's Departments of Surgery and Orthopaedics.

Sessions

• Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Carol Sadorra, Ph.D., CIP

Board Member, Board Lead for Minimal Risk Research
Advarra

Dr. Sadorra has over 20 years of experience in human subjects research protection, design and implementation. Dr. Sadorra joined Advarra (formerly Chesapeake IRB) as a Board Member in 2005, and currently serves as the Board Lead for Minimal Risk Review, with primary responsibility for coordination and review of expedited, minimal risk research protocols, as well as responsibility for review of protocol modifications, investigator/site submissions, subject and recruitment materials, and other research related materials. Dr. Sadorra received CIP certification in March 2019. Prior to joining Advarra, Dr. Sadorra’s educational and professional background included receiving a Bachelor of Science degree in Psychology from the University of Maryland in 1995, a PhD in Experimental Psychology from Brown University in 1999 (with a focus on research methodology and adolescent sleep research), and 5 years of experience designing and conducting healthcare survey research.

Sessions

• Regulatory and Ethical Considerations for Review of eConsent in Research

Brian J. Sevier, Ph.D.

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

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

Sessions

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

Denise Snyder, MS, RD, LDN

Associate Dean for Clinical Research
Duke Office Of Clinical Research

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 nearly 8 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

• Panel: Best Practices for Building Strategic, Sustainable Partnerships Between Sites and CROs

Jon Tack

Vice President, Product Management
Advarra

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

Sessions

• Strategies and Best Practices for Enterprise Technology Upgrades

Candice Vance

Director of Clinical Research Revenue Cycle
MedStar Health Research Institute

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

Sessions

• Optimizing the Research Revenue Cycle From Protocol Initiation to Completion