The Association of Clinical Research Professionals

ACRP Southeast Regional Conference

In conjunction with the ACRP Research Triangle Park Chapter

Stay up to date on key issues impacting clinical trials, connect with your community, and earn 12 ACRP Contact Hours at ACRP’s first-ever regional conference.

October 3-4, 2019
Sheraton Imperial at Raleigh-Durham Airport*
Research Triangle Park, North Carolina (Map >>)

*This hotel is sold out for all but one-night reservations for October 3. For all other types of reservations, please book at the nearby SpringHill Suites.

Limited hotel rooms for both the Sheraton Imperial and the SpringHill Suites are available for $115 per night through September 6 or while supplies last.

Program Details Below!

Program—Thursday, October 3

7:45-8:30am
Welcome 

Moderator: Craig Lipset, former Head of Clinical Innovation, Pfizer Inc.

8:30-9:30am
Keynote: A Non-Technical Discussion of Emerging Technologies in Clinical Research
This session is brought to you by a generous educational grant, courtesy of VirTrial.

There is much myth and hype about several emerging technologies (e.g. blockchains, smart contracts, artificial intelligence, FHIR, telemedicine, etc.) which undoubtedly have a role in the clinical research industry. Join our industry experts for this informal “fireside chat” that explores some of these technologies, and hear their insight into what the impact may be on the clinical research industry.

Speakers: Craig Lipset, former Head of Clinical Innovation, Pfizer Inc.; David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare

9:30-10:30am
The Impact of Disruptive Change in the Clinical Trials Industry on Research Sites

As we head towards the end of the second decade of the 21st century a great deal has changed about the way research is done at the site level, particularly as it relates to the many disruptive technology-driven changes that have evolved. Or has it? After 13 years managing sites and taking the investigator view followed by 13 years in the CRO industry taking the sponsor view, the presenter will look at what has changed in over a quarter of a century and what the future holds for clinical research sites. In particular, he will look at the site landscape through the lens of four, supposedly major, disruptive changes.

Speaker: Paul Evans, PhD, President & CEO, Velocity Clinical Research

10:30-11:00am
Coffee Break

11:00am-12:00pm
Leading Clinical Research Workforce Transformation

Research affects care. Without clinical research, we have standard of care. However, the clinical research landscape is complicated and increasingly burdensome to clinician scientists. To better handle the evolution of the research landscape, the role of the clinical research professional has become even more important; employing a top-notch clinical research workforce is critical. Our AMC prioritized the role of the workforce by using a competency-based framework, developed by the Joint Taskforce for Clinical Trial Competency (JTF), for many related initiatives: to 1) overhaul job classifications, 2) create advancement through a tiering process, 3) establish a professionals network, 4) align competencies with on-boarding and training, 5) create pipelines for clinical research positions, 6) centralize a hiring service, – all an institution-wide workforce strategic initiative called Workforce Engagement & Resilience (WE-R).

Speakers: Stephanie Freel, Interim Director, Office of Physician-Scientist Development, Duke University School of Medicine; Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University Medical Center

12:00-1:00pm
Lunch Break

1:00-2:00pm
Clinical Trial Navigators; Ensuring Continuity of Care to the Whole Person

As the industry shifts to a more patient-centered focus, it is imperative that the roles of professionals transition too. As a growing Integrated Research Organization (IRO), Javara is revolutionizing how clinical trials are conducted, beginning with the people. They have developed a role that is unique and helps better serve the patient: the Clinical Trial Navigator (CTN). The Clinical Trial Navigator role moves beyond what has previously been done in the patient’s care experience to help fully advance their care. Join Javara CEO, Jennifer Byrne, for a conversation on why and how the CTN role was created.

Speaker: Jennifer Byrne, CEO, Javara Inc.

2:00-2:30pm
techXpo Session: eRegulatory One Year Later: Just Smoke and Mirrors? Or Real Improvement?, presented by Florence Healthcare

It’s easy to talk about the benefits of eRegulatory, and all vendors will promise you headache-free transitions, but what really matters is the reality of how eRegulatory will impact your research site. In this session hear stories – both the good and the bad – of leading research sites who have made the switch to eRegulatory. What worked as promised? What didn’t? What was harder than expected? How has it actually impacted the day-to-day life of coordinators, PIs, and staff? What has been the Sponsor response? What improvements actually happened? What benefits did we see we didn’t expect? Was anything just “Smoke and Mirrors”?

Please Note: This session does NOT offer ACRP Contact Hours or CEUs of any kind.

Speaker: Jeff Pool, VP of Business Development, Florence Healthcare

2:30-3:00pm
Coffee Break

3:00-3:45pm
Regulatory Update

Enjoy a high-level overview of the recent changes to laws, regulations, policies, and trends that affect our industry. Many of these are from FRDA and OHRP buy many are intended mostly for healthcare operations that are unintentionally (or intentionally) bleeding over into research operations.

Speaker: David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare

3:45-4:30pm
Panel Discussion: CRO/Site Relations Best Practices

Join ACRP Executive Director Jim Kremidas, for a discussion regarding the importance of a great CRO and site relationship. Learn about best practices from both the site and sponsor perspective, and explore opportunities to enhance communication from feasibility to study close-out.

Speakers: Melissa Holbrook, Vice President, Operations, Velocity Clinical Research; Christine Senn, PhD, FACRP, CSM, Chief Operations Officer, IACT Health; Moderator: Jim Kremidas, Executive Director, ACRP

4:30-6:00pm
PopUp Star LogoFinale Celebration

Enjoy networking, cocktails and hors d’oeuvres while celebrating the competing PopUp Star teams, judges and sponsors. See the 2019 PopUp Star winner crowned, and engage with thought leaders and innovators from the PopUp Star Program, which promotes grassroots efforts that cultivate a community rich in health literacy and clinical trial adoption.

 

Thank You to Our Sponsors

Southeast Regional Sponsors

Program—Friday, October 4

7:45-8:30am

Welcome 

Moderator: Jim Kremidas, Executive Director, ACRP

8:30-9:30am
Keynote: A Physician Leader’s Greatest Lesson from an Unexpected Place

Join Dr. David Zaas, President of Duke Raleigh Hospital, as he discusses his own unexpected journey and the lesson he learned along the way.

Speaker: Dr. David Zaas, MD, MBA, President, Duke Raleigh Hospital

9:30-10:30am
Leading Change Management Strategically within Research Operations through Adaptive Business Intelligence

This session will describe the steps and tools needed to use change management techniques utilizing concepts of design thinking and adaptive business intelligence within research operations. The session will include an overview of applications within areas such as research staffing, research finance, trial activation, research innovation implementation, research education/development, research information technology, and technology transfer.

Speaker: Leigh Burgess, MHA, MEd, MA, Vice President Research Operations, Dartmouth-Hitchcock Health

10:30-11:00am
Coffee Break

11:00am-12:00pm
Building the Best Inspection Team

We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection “game plan” brings confidence to any inspection team.

Speaker: Kara Harrison, MS, RAC, RQAP-GCP, Project Manager, FDA Quality and Regulatory Consultants

12:00-1:00pm
Lunch

1:00-2:00pm
ROI of a CTMS for Clinical Research Sites

This presentation will address the question for research organizations on how a CTMS will generate revenue and reduce costs. This content is helpful for both industry and site attendees as increasingly sites are engaging sponsors for reimbursement of their technology investments.

Speaker: Noelle Gaskill, MBA, ACRP-CP, Vice President, Research Operations, SignalPath, LLC

2:00-2:30pm
techXpo Session: How the Right eRegulatory Software Can Help You Take on More Trials, presented by Complion

As regulatory requirements continue to expand, it becomes more and more burdensome for research sites to manage regulatory documentation. At the same time, research coordinators, administrators, clinical staff and site managers face immense pressure to get more done with limited time and resources. This session will show you how the right eRegulatory software platform will remove the headaches of the regulatory documentation process, make you look like the superstar you are to your sponsors and ultimately give you the ability to take on more trials without adding resources.

Please Note: This session does NOT offer ACRP Contact Hours or CEUs of any kind.

Speaker: Rick Arlow, CEO, Complion

2:30-3:00pm
Coffee Break

3:00-3:45pm
Welcoming Technology into the World of Clinical Trials

100% virtual, or “site-less’, trials are entering the clinical research marketplace. Is the site community aware? Site sustainability hinges on sites’ awareness of this movement and their commitment to growing with the future of clinical research. This session will provide site staff with a high-level overview of what 100% virtual trials are, outline the difference between “site-less” trials and virtual or hybrid trials, and identify tools that sites can utilize when promoting their organization as the better, more desirable alternative. Attendees will be equipped with the knowledge and solutions needed to remain a strong, forward-thinking and sustainable site.

Speakers: Amanda Rangel, MS, CCRC, VP of Business Development, VirTrial; Kim Kundert, RN, BSN, VP of Operations, VirTrial

3:45-4:30pm
Workforce Gaps Post-RBM: It’s Time to ‘Dig’ In!

Training-up current resources and hiring qualified competent team members has been the biggest challenge for sponsors and CROs!  Using other functional areas results in the same challenge. Come to this presentation to discuss this global risk and the gaps, and more importantly discover where to dig to find the solutions and also how to supply the team the right skills set!

Speaker: Sandra “Sam” Sather, MS, BSN, CCRC, CCRA, Vice President, Clinical Pathways


Cancellation Policies: Please note ACRP applies a $40 fee per registration for all cancellations made through September 1, 2019. Refunds will not be provided for cancellations made after September 1, 2019, but paid fees can be transferred to any other ACRP training program through December 31, 2020. Walk-in registrations welcomed, though registrations made after October 1, 2019 will be assessed a Late Registration Fee of $25.

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