Kickoff and Keynote

• Arti Shah, Director of  Education, ITHS (Welcome)
• Beth Harper, Workforce Innovation Officer, ACRP (Introduction of Dr. Kurilla)
• Mike Kurilla, MD, Director of Innovation, NCATS (Keynote Address)
• Arti Shah, Director of  Education, ITHS (Un-Meeting Introduction and Instructions)
• Carolynn T. Jones, DNP, MSPH, RN, FAAN, Co-Director of Workforce Development, The Ohio State University CCTS (Survey Results)
• Aric Lane, ITHS, and Karen Carter, The Ohio State University CCTS (Technology Orientation)

KEYNOTE SPEAKER

Michael G. Kurilla, MD, PhD
Director
Division of Clinical Innovation
National Center for Advancing Translational Sciences
National Institutes of Health

Michael Kurilla is the director of the Division of Clinical Innovation at NCATS. In this capacity, he oversees the Clinical and Translational Science Awards (CTSA) Program, which supports innovative solutions to advance the efficiency, quality and impact of translational science, with the ultimate goal of getting more treatments to more patients more quickly. Prior to joining NCATS, Kurilla served as the director of the Office of Biodefense Research Resources and Translational Research within the National Institute of Allergy and Infectious Diseases (NIAID), where he focused on translational efforts toward infectious disease product development, including vaccines, therapeutics and diagnostics, with emphasis on biodefense and emerging infectious disease threats. Prior to joining NIAID in 2003, Kurilla was an associate director for infectious diseases at Wyeth. He also worked in antimicrobials at DuPont and on clinical microbiology and molecular pathology at the University of Virginia Health Sciences Center.

Kurilla received his M.D. and his Ph.D. in microbiology and immunology from Duke University. He was a postdoctoral research fellow at Harvard Medical School and completed a residency in pathology at Brigham and Women’s Hospital. He received a B.S. in chemistry from the California Institute of Technology.

Competency-Based, Standardized Job Titles

4 x 4 Speaker

Denise Snyder, MS, RD
Associate Dean for Clinical Research
Duke University

Denise Snyder 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. Her team has transformed the workforce by developing and implementing competency-based job descriptions and progression pathways for clinical research professionals.  Earlier in her career, 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.

Issues in Onboarding Training

4 x 4 Speaker

Wendy Lloyd, BA, LPN, CCRP
Senior Clinical Research Quality Analyst
Vanderbilt University

Wendy received her Bachelor of Arts degree in Management in Human Relations from Trevecca Nazarene University in 2007. She has been a Licensed Practical Nurse since 1985. She has 19 years’ research experience at Vanderbilt.  In her role as a Senior Clinical Research Quality Analyst she is developing a competency program, New Employee Orientation as well as coordinates education/training for the Vanderbilt Coordinating Center. She has 13 years’ experience in human subject protection, regulatory affairs and compliance adherence conducting random compliance reviews /directed audits and providing educational session across the Institution.  She has also worked as a recruitment specialist on the Recruitment Innovation Center Grant, a research nurse for Pulmonary Hypertension protocols and as research coordinator for multiple sites including cooperative group studies. Wendy serves on numerous Vanderbilt Committees including the Evidence Based Nurse Committee, Editorial Board member for The Empowered Nurses peer reviewed journal and is the Chairperson for the Nurses Week research poster session.

Wendy obtained her Certified Clinical Research Professional (CCRP) certification in 2002, became a Society of Clinical Research Associates (SoCRA) Director, Board Member and eventually President. As president she was awarded the opportunity to speak in Tokyo, Japan providing physicians with information regarding newly implemented ASCO publishing guidelines.  Wendy continues her SoCRA involvement as a member of the CCRP Certification Committee and as the Chair for the SoCRA Human Research Protection Program.  She not only assists with content and speaker selection for Annual SoCRA Conferences she has been a conference speaker for many years and is a published author.  As co-founder and chapter Chairperson for the Middle TN SoCRA chapter Wendy plans monthly meetings at Vanderbilt and coordinates the CCRP exam offered annually in Nashville. The Greater Nashville Area Chapter received the recognition award for offering the most continuing education for clinical research professionals for the past two consecutive years, 2019 and 2020.  Wendy is passionate about educating others about research, her most recent project is establishing a SoCRA chapter and presenting a Good Clinical Practice course for Vanderbilt Global Health and research personnel in Abuja, Nigeria.

Issues in Competency-Based CRP Continuing Education

4 x 4 Speaker

Mary-Tara Roth, RN, MSN, MPH
Director, Clinical Research Resources Office
Assistant Director, Human Research Protection Program
Boston University Medical Campus/Boston Medical Center

As Director of the Clinical Research Resources Office, Mary-Tara is responsible for defining the office’s services and overseeing the implementation of those services to support clinical researchers at BMC/BU Medical Campus. In addition, she works at providing services to investigators and study teams, especially in the areas of regulatory consultation and training for all levels of the research team.  Mary-Tara also oversees the Quality Assurance program within the Human Research Protection Program.

Mary-Tara has been involved in clinical research for more than 20 years.  She has a BS in Psychology from Tufts, a BS in Nursing from Johns Hopkins, and a Master’s in Nursing and a Master’s in Public Health from Johns Hopkins.

Issues in Attrition, Retention, and Progression

4 x 4 Speaker

Gerri O’Riordan, RN, BSN, CNS, CCRN

Director of Clinical Research for Cardiovascular Medicine Division
Director of Stanford Clinical Research Preceptor Program
Stanford University

Gerri O’Riordan is Director of Clinical Research for the Cardiovascular medicine Division at Stanford University.  She also is Director of the Stanford Clinical Research Preceptor program. During her 25 plus year at Stanford, Gerri has worked as clinical research coordinator in anesthesia, study facilitator at Spectrum Child Health, Chief operating officer and senior director of regulatory compliance at the Sean N. Parker Allergy Center.

Enhancing the CRP Pipeline

4 x 4 Speaker

Clare Tyson, MA, CCRA
Research Coordination and Management Program Manager
Medical University of South Carolina

Clare Tyson, MA, CCRA is the Research Coordination and Management (RCM) Program Manager for the South Carolina Clinical & Translational Research (SCTR) Institute at MUSC, the academic home of the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) grant.  In this role she works with investigators and departments to identify research support needs and provides fee-based nurse and research coordination services within at MUSC.   Through RCM she has developed a research coordinator and nurse coordinator mentorship and career development program that offers internal and external training opportunities to student interns and entry-level employees interested in research in the academic setting.

She currently serves as a co-lead of MUSC’s Clinical Research Job Classification initiative.  This initiative has evolved through a collaboration between MUSC’s central Human Resources (HR) office and the MUSC research community and is focused on establishing a job classification track that enhances career and professional development opportunities for the clinical research workforce.

Clare has over 20 years of research experience and is a Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP).  Previously she served as the Project Manager of the South Carolina Node of the National Institutes on Drug Abuse (NIDA) Clinical Trials Network (CTN). She was responsible for implementing protocols in research-naïve community sites, providing quality assurance monitoring, regulatory support, training, and study management.