2023-2024 SOCRA Annual Report - Flipbook - Page 19
SOCRA 2021 ANNUAL REPORT
EDUCATIONAL OPPORTUNITIES
2020 - 2021
CLINICAL RESEARCH PROJECT / PROGRAM
MANAGEMENT CONFERENCE
This conference considers project
management and risk management
principles, budget development /
financial management and global
considerations for clinical
research programs. Clinical trial
project and program management
incorporate a broad range of skill
sets in order to plan, administer,
Nancy Wintering, LCSW,
track, evaluate and report activities
CRC, CCRP, Assistant
and budgets involved in the health
Director of Research,
care product development process.
Thomas Jefferson University The goal of this program is to
Program Chairperson
introduce, affirm and enhance the
participant’s understanding of the
project management endeavor.
Topics Include:
Developing an Infrastructure
Introduction to PMI (Project Management Institute)
Principles of Initiation, Planning, Execution, Monitoring,
Controlling, Mapping, Risk Management and Closing
Charts, Planning and Tracking Tools
Organizational Tools and Techniques
Organizational Dynamics in Project Management
Global Regulatory Considerations Affecting the Project
Plan
Creating a Study Budget and Managing Finances from
Start Up to Close Out
Contract Development for Good Outcomes
Managing Multisite Projects & Projects Related to INDs and
IDEs
This program will broaden the
participants’ knowledge of the
regulatory framework, project
management art and science,
planning and accounting, and
their attitude and aptitude for
achieving successful
clinical trials.
OFFERED
VIRTUALLY AND
IN-PERSON
'HOT TOPICS' AND PRACTICAL CONSIDERATIONS FOR
PROTECTING HUMAN RESEARCH PARTICIPANTS
CONFERENCE
This conference is designed to
aid the clinical research
professional’s understanding of
current ‘Hot Topics’ as well as the
practical considerations in
human subjects research.
Wendy Lloyd, BA, CCRP, LPN, CIP,
Senior Clinical Research
Quality Analyst,
Vanderbilt Medical Center
Program Chairperson
The attendee will understand
and be able to convey the
responsibilities of these very
important functions and the
complementary role of the
clinical researcher as a
fundamental contributor to
successful clinical research and
the protection of research
subjects.
The program will focus on the
relationships among clinical trial
staff, investigators, IRBs, the FDA,
CROs and sponsors. The
conference will highlight areas
that present challenges to
sponsors and investigational
sites: writing informed consent
documents, the informed
consent process, use of genomic
data, future use of stored biospecimens, communication,
education, and research fraud.
The program will explain and
discuss how ICH GCP and the Code
of Federal Regulations guide and
direct clinical investigator
responsibilities, IRB management
issues, audits and inspections, the
informed consent process, and
administrative activities.
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