SOCRA 2023 Annual Conference Brochure - Flipbook - Page 8
THURSDAY, SEPTEMBER 28, 2023
PRECONFERENCE SEMINARS
Legal Issues Involving Researchers,
Including Fraud and Misconduct
Traditionally research has been the one area in
medicine where, other than the regulatory process,
there has been little interaction with the legal
system. However, in recent years this has changed.
Within the U.S. and internationally there has been
an increase in civil and criminal actions against
researchers. This session will provide an overview of
recent problem areas, as well as insight on how to
avoid them.
Presenter: Melissa Markley, JD, CISSP, Attorney /
Shareholder, Hall, Render, Killian, Heath & Lyman,
LLP
Clinical Research Administration,
Budgeting, Contract Negotiation and
Finance: A Site’s Perspective
GCP 101: A Workshop for the New Study
Coordinator
In an effort to enhance quality assurance at
academic institutions, private practices or
government-supported sites, SOCRA is offering a
workshop for research personnel who are new to
the field, or for those coordinators who want to
refresh their understanding of GCP in the ever
changing world of clinical research. This four-hour
interactive workshop will include presentations,
group discussion, and Q&A. The workshop will
provide essential tools for coordinating and
managing a research project. The material will
range from understanding terminology to tackling a
new project.
Presenter: Tammy Neseth, MA, CIP, CCRP, Monitor
This session will discuss the elements of a clinical
trial protocol, budgeting and contracting, and the
impact of these elements on the conduct of a trial.
The administrative and financial aspects of the trial
will be covered with special emphasis on the study
administration, effective budget development and
management and contract negotiations. This session
will be interactive with participation from
attendees to include developing and negotiating
the study budget.
Presenters: Bryan Soronson, MPA, FACMPE, Retired
Senior Administrator, University of Maryland
Department of Neurology
Lisa Benson, BS, CRCP, President, Pediatric Clinical
Research Consulting, LLC
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