2023-2024 SOCRA Annual Report - Flipbook - Page 14
SOCRA 2021 ANNUAL REPORT
EDUCATIONAL OPPORTUNITIES
2020 - 2021
ADVANCED CONCEPTS FOR CLINICAL
INVESTIGATORS AND KEY RESEARCH STAFF
CLINICAL RESEARCH MONITORING AND GCP
WORKSHOP
GCP & Clinical Trials Management Conference
For Monitors, Site Coordinators and Auditors
This course, for clinical
investigators and key research
staff, will review GCP, research
finance and budgeting, and legal
responsibilities of the clinical
investigative site. This program
creates opportunity for dialogue
among clinical investigators, key
Marie Falvo, BA, CCRP
research staff and program faculty.
Senior Manager, Clinical
The intent of which is to enhance
Quality Assurance,
the participants’ ability to perform
Boston Scientific
quality clinical research according
Program Co-Chairperson
to existing regulations and
guidelines. This program is
designed to address all of the
functions of the research site
related to the Good Clinical
Practices as delineated by the U.S.
Code of Federal Regulations and
the guidelines supported by the
ICH Guidelines. TransCelerate
BioPharma: This ICH E6 GCP
Investigator Site Training meets
Carole Sampson-Landers,
the Minimum Criteria for ICH GCP
MD, Retired Former
Investigator Site Personnel
Director, Global Clinical
Training identified by
Development, Bayer
TransCelerate BioPharma as
HealhCare Pharmaceuticals necessary to enable mutual
Program Co-Chairperson
recognition of GCP training among
trial sponsors.
The purpose of this workshop is to
assist Clinical Investigators and key
research staff in improving their
skills and their understanding of
the responsibilities of the clinical
research site.
OFFERED
VIRTUALLY AND
IN-PERSON
Clinical Research Monitoring is an
evolving practice. This interactive
workshop, for site monitors,
managers or auditors with 0-5
years of experience, will review
GCP and clinical research
monitoring best practices.
James Simmer, BSN, MBA
President, Research Answers
Program Co-Chairperson
Gretchen Gall
Clinical Operations
Manager and Clinical
Operations Bidder,
IQVIA Biotech
Program Co-Chairperson
Lecture and practical application
are facilitated by clinical research
professionals with a combined
industry experience of more than
40 years. Information is presented
and discussed regarding
monitoring of clinical trials
according to FDA Regulations and
International Conference on
Harmonisation (ICH) guidelines.
Presenters share practical
procedures and issues related to
site / sponsor / CRO relationships.
This program is offered three times
annually and is designed with all
research professionals in mind.
OFFERED
VIRTUALLY AND
IN-PERSON
This workshop addresses the roles and
responsibilities of a Clinical Research
Associate / Monitor / Auditor. This is also a
great course for Research Study
Coordinators who want to improve their
understanding of the responsibilities and
interactions with Clinical Research
Monitors.
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