November 2024 SOCRA Source Journal - Journal - Page 96
SOCRA Clinical Research Project /
Program Management Virtual Conference
VIRTUAL
FEBRUARY 25 - 28, 2025 | VIRTUAL
Workshop registration fee: $430 (Non-member $505 - includes one year’s membership)
Goal: Clinical trial project and program management incorporate a broad range of skill sets in order to
plan, administer, track, evaluate and report activities and budgets involved in the health care product
development process. The goal of this program is to introduce, af昀椀rm or enhance the participant’s
understanding of the project management endeavor.
Objective: Through discussion, presentation, and interaction, 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.
Learning Objectives - The attendee should be able to:
• Describe project management and basic risk management principles following PMI (Project Management
Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing)
• Discuss the processes and procedures that are necessary to develop an infrastructure that will support the
various tasks associated with Project Management in Clinical Research
• Discuss how to incorporate IRB interaction activities into a project plan, focusing on issues involved in
managing multiple investigational sites. Disaster recovery and contingency planning will be discussed
• Discuss Organizational Dynamics and psychological issues in project management to promote effective
team building. Describe con昀氀ict resolution strategies; discuss approaches to work effectively with different
leadership and personality styles
• Describe general start up issues including; budget development, cash 昀氀ow issues and solutions, billing to
CMS (Centers for Medicare & Medicaid Services), and contract management
• Describe contract development topic issues including: intellectual property (IP) rights, publication,
indemni昀椀cation, payment schedule management, clinical trial sponsor interactions and negotiations
• Describe various international regulatory bodies and their submission processes using the US Code of
Federal Regulations (FDA/OHRP) as a baseline
• Describe Project Management of the IND and IDE, review guidance documents, forms and accountability
measures designated for use by industry and academic research sponsors and sponsor investigators
• Discuss pharmacy issues related to risk management, safety, drug accountability, drug purity,
randomization, blinding and unblinding, inventory control drug & device administration, dose calibration
and dose escalation schedules
SOCRA designates this educational activity for a maximum of 15.0 Continuing Education Credits
for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 15.0 AMA PRA Category 1 Credit(s)™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education
by the American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series 250
96
SOCRA SOURCE © November 2024
