2014 AnnuAl RepoRt

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2014
Annual Report
Quality Education
Peer Recognition
Clinical Research
Certification
Society of Clinical Research Associates
Table of Contents
Welcome from the Board
of Directors
3
Mission and Introduction
4
History and the Future
5
Certification for Clinical Research
Professionals “CCRP®”
6
Annual Conference
8
Education Overview
10
Online Education
10
Clinical Investigator GCP and
Trials Management Conference 11
2
Quality Improvement Through
Standard Operating Procedures 15
Harnessing Social Media to
Advance Clinical Research
15
Clinical Trial Management
Systems (CTMS) Conference
15
FDA Clinical Trial Requirements
and GCP Conference
16
Conducting Clinical Trials
in Canada
16
Clinical Research Project / Program
Management Conference
17
11
Protecting Human Research
Participants: Legal, Ethical and
Practical Considerations 17
12
Device Research and
Regulatory Conference
18
Advanced Site Management:
Finance and Productivity
12
Pediatric Clinical
Trials Conference
18
Clinical Science Course
13
Chapter Development
19
Certification Preparation and
Review Course
13
Board of Directors Directory
20
Member Resources
14
Management Directory
22
Executive Director’s Report
23
2014-2015 Calendar of Events
24
Clinical Research Monitoring
and GCP Workshop
Clinical Site Coordinator /
Manager Workshop
SOC R A A NNUA L REP ORT 2014
I thank our hundreds of speakers, exhibitors,
advertisers, and chapter and Board member
volunteers who contribute to the improvement of
health for people around our world.
Wendy Lloyd, BA, LPN, CIP, CCRP
President 2013-2014
Dear Colleagues in
Clinical Research:
I am pleased to advise you that
and other researchers by allowing
committee members and the
credentials. See page 10 for details.
The examination is scheduled at
them to maintain their licenses and
the Society of Clinical Research
Included in this annual report are
membership of over 15,000 clinical
programs (conferences, workshops
Associates (SOCRA) has achieved a
research professionals. With 70%
of our members certified, and
all members striving to improve
clinical research protections and
research outcomes, we are assured
that SOCRA is benefitting the
research community, the millions of
research subjects who support the
overviews of the SOCRA education
and training programs) available
implemented its first conference
dedicated to pediatric research in
2014. Additional program are in
development at this time. We are
sincerely proud of our conferences
and education programs.
and Japan.
variety of content, as well as a poster
exchange of information, peer to
peer conversation, and personal
connection with industry experts.
researchers may apply for SOCRA
the research professional. SOCRA
as well as Saudi Arabia, Singapore,
for networking, discussion,
science and research.
education programs to support
2014 throughout the US and Canada,
Our annual conference offers eight
These programs offer opportunities
development of medical care, and all
We continue to develop new
94 different venues in the year
to the clinical research community.
As a result of their experience
patients worldwide who benefit from
staff who support the program.
and education, qualified clinical
certification as certified clinical
research professionals. Our
tracks (100+ speakers) with a large
and exhibit program. If you have
attended as a participant in the past,
please consider becoming more
involved by submitting a poster or
presenting at the annual conference.
The conference will be held in
Denver, CO in 2015; Montreal, QC in
2016; and Orlando, FL in 2017.
certification program recognizes
We continue to encourage excellence
and ability to apply clinical research
our new logo and on our new web
an individual’s understanding of,
regulations and guidance within
the realm of medical research.
Certification recognizes the
candidate’s dedication to quality
research and to the protection of
research subjects. They understand
SOCRA education is accredited by
the clinical research policies,
medical education for physicians, and
pertaining to best practices,
of continuing nurse education by the
safety. We hold this program in
nurses, physicians, pharmacists
volunteer certification program
the ACCME to provide continuing
procedures, rules, and regulations
SOCRA is an accredited as a provider
operating procedures, and subject
ANCC. These accreditations benefit
high esteem and are proud of our
in clinical research, as displayed in
site, in addition to our education and
certification programs. I encourage
your participation and greater
involvement in SOCRA activities,
including chapter activities and
speaking opportunities.
Sincerely,
Wendy Lloyd, BA, LPN, CIP, CCRP
President, SOCRA Board of Directors
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3
INTRODUCTION and HISTORY
MISSION
In order to promote quality clinical research, protect the welfare of research participants, and
improve global health, SOCRA’s mission is:
To establish educational
To establish an internationally
To foster the professional
continuing education for
program for clinical research
recognition of clinical
programming and provide
clinical research professionals.
recognized certification
professionals (CCRP®).
development and peer
research professionals
Introduction
The Society of Clinical Research Associates (SOCRA) is
The most important factors in our success over the
organization committed to providing education,
educational programming and our certification program.
a non-profit, charitable and educational membership
certification, and networking opportunities to all persons
involved in clinical research activities. SOCRA began as
the premier educational organization for oncology site
coordinators and has emerged as a leading educational
organization for clinical researchers in all therapeutic
areas, supporting industry, government and academia.
Since incorporation in 1991, SOCRA has been through
many changes, all of which were important contributors
to our growth. The lack of available educational
opportunities for site based coordinators and the thirst
for information resulted in an organization founded
by creative and forward thinking leaders. Today, the
organization has realized membership growth and
past years have been our membership support, our
Innovation and investment of skill and knowledge have
resulted in an exceptional organization with expertise
and understanding in providing educational programming
and member services. The quality of our programs and
educators is unparalleled.
Our educational programming has been wonderfully
successful as has our certification program and our
noteworthy Annual Conference. We are committed to
devoting a tremendous effort to developing and providing
new and innovative approaches to learning. We intend to
explore new educational opportunities and to maximize
those opportunities for future success.
program expansion exceeding its expectations.
Membership Demographics
5% IRB /
Ethics Boards
30% Industry
5% Other
Areas of
Research
60%
Investigational
Sites
15,165 members as of August 15, 2014
Our worldwide membership includes members from the U.S.A.,
Canada, Australia, Austria, Bangladesh, Belgium, Bolivia,
Brazil, Bulgaria, Cayman Islands, Chile, China-SAR, Colombia,
Costa Rica, Denmark, Egypt, France, Germany, Greece, India,
Ireland, Jamaica, Japan, Lebanon, Malaysia, Mexico, Netherlands,
Nigeria, Philippines, Portugal, Puerto Rico, Qatar, Russia,
Saudi Arabia, Scotland, Singapore, South Africa, South Korea,
Switzerland, Thailand, UAE, Uganda, and United Kingdom.
4
SOC R A A NNUA L REP ORT 2014
A BRIEF HISTORY OF SOCRA
As you review this list of accomplishments you will see that our mission to develop meaningful
education for our members continues to be in the forefront of our activities. SOCRA has again made
important strides in offering educational opportunities.
1991
SOCRA Founded (June) and Incorporated
(October)
1992 First Annual Conference
First Certification Examination (CCRP)
1995 1996 Clinical Science Course offered
Chapter Program begun
Annual Conference workshop on
Statistics in Clinical Research
2009 Annual Conference workshop on
Device Research
Clinical Investigator Training
Course offered
2010 Awarded Accreditation with
Commendation as a provider of
physician CME by ACCME
2000 Clinical Research Monitoring
Workshop developed
2001 Certification Preparation & Review
Course offered
Chapter Chairperson Recognition
Award first presented
2002 Awarded ANA/ANCC providership for
Nurse CNE
Project / Program Management
Conference offered
2003 Japanese Language Certification
examination offered
2011 Online training courses offered
Annual Conference workshop on
Project Management
Site Symposium for Coordinators,
Associates, Nurses offered
Clinical Trial Management System
(CTMS) Conference offered
FDA Clinical Trial Regulations
Conference series begun
2012 Completed / published Task Analysis
survey of clinical research activities
French Language Certification
exam offered
Instituted option for Peer Review of
SOCRA SOURCE journal articles
French Language Prep Course offered
2005
SOP for Senior Site Managers
workshop offered
2013 Conducting Clinical Trials in Canada
Conference offered
Salary Survey for Clinical
Researchers Published
2006 First annual Device Clinical
Research Conference
Advanced Site Management/ Finance
Workshop offered
First on line basic GCP course
(through CITI program)
1999 Human Research Protections
Program begun
2004
2008 Approved as a provider of physician
CME by ACCME
Social Media in Clinical Research
Conference offered
2007 Annual Conference workshops added on
Research Law, Protocol Development,
and Grant Writing
2014
Pediatric Clinical Research
Conference offered
THE FUTURE
SOCRA promises to provide continued educational programming that will offer the most current information available to
the clinical researcher. Clinical research professionals and other experts working in the clinical research arena will deliver
courses. Our education programs offer high levels of participation and great overall satisfaction. Our certification program
offers many testing dates and locations, with 94 testing opportunities scheduled in 2014.
For all our enthusiasm, we remain realistic about the changing work environment and current economic conditions. We will
continue to work towards innovative programming and technologies to benefit our members in cost effective ways.
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5
CERTIFIED CLINICAL RESEARCH PROFESSIONAL
CERTIFICATION “CCRP®” PROGRAM
Why Certification?
Exam Description
Program for
Currently more
than 10,000
certified!
Professionals in
94 exam sites hosted in
practice. The case studies are
an internationally
Singapore and Saudi Arabia
SOCRA established
the Certification
Clinical Research
order to create
Donna Headlee, RN,
BSN, CCRP
Program Chairperson,
Certification
accepted standard
the USA, Canada, Japan,
of knowledge,
in 2014
experience by
2,166 candidates tested*
education, and
which clinical research professionals
will be recognized by the clinical
83% passed exam*
individuals so approved may use
2,170 CCRPs recertified*
research community. Those
the title “Certified Clinical Research
Professional” or “CCRP®”
* based on May 2013- May 2014 data
The Certified Clinical Research
CCRP Examination
Content
is intended to evaluate a CRP’s
examination is organized into
Scope
multiple choice questions. The
examination contains case studies
that relate to clinical research
intended to evaluate a candidate’s
ability to abstract data and do
not require clinical experience.
The questions are formulated to
be straight-forward and easily
understood. Each question is
weighted equally. The certification
examination is offered in the
English language.
Exam Scoring
The 135 question exam consists of
130 scored questions and five (5)
unscored questions. SOCRA collects
data on unscored test items to assure
that the questions are clear, concise
Professional Certification program
The CCRP® certification
knowledge, understanding, and
five major subject areas.
in future exams as scored items.
Five Subject Areas and
Percent of Test Items in
Each Area
102 out of 130 scored items in
application of the conduct of clinical
investigations involving humans in
accordance with the International
Conference on Harmonisation
Guideline for Good Clinical Practice
(E6) (ICH/GCP), ICH Clinical Safety
• Ethical Principles / Informed
Standards for Expedited Reporting
• Institutional Review Board /
Data Management: Definitions and
(E2A), the United States Code of
Federal Regulations (CFR) Parts 11,
50, 56, 312, 812 and the ethical
principles that guide clinical research
consistent with the principles of the
Nuremberg Code, the Belmont Report
and the Declaration of Helsinki.
Consent / Safety = 20% - 25%
and understandable before appearing
Examinees must correctly answer
order to achieve a passing score.
The passing score is determined
by a panel of experts and
validated using a psychometric
and statistical analysis.
Institutional Ethics Committee
Exam Validation
Responsibilities = 7% - 11%
psychometrically validated by
(IRB/IEC) Roles and
• Clinical Trial Protocol and Protocol
Amendments = 4% - 8%
• Investigator Roles and
Responsibilities = 28% - 32%
• Sponsor Roles and
Responsibilities = 31% - 35%
6
The examination is made up of
SOC R A A NNUA L REP ORT 2014
The exam is statistically and
an independent consultant. The
Certification Committee evaluates
the results from the statistical/
psychometric evaluations and updates
the exam, as needed.
Candidate Eligibility
Maintaining your Certification
In order to be considered for SOCRA certification, the
The CCRP credential is awarded in three year increments.
EC/REB approved (or specifically exempted) protocols
SOCRA is based on a continuing process of professional
applicant must be working with GCP guidelines under IRB/
SOCRA will not be able to consider candidates who
Certification of Clinical Research Professionals by
experience and education. This program is intended
are unable to provide the supporting documentation
requested regarding their clinical research experience.
to provide recognition and validation of the continued
professional growth of the individual CCRP®.
Minimum Experience
Maintenance of Membership
Continuous membership in SOCRA is required to maintain
1 year of full-time experience* as a Clinical
2 years of
Research Professional within the past two
full-time
experience* as a OR years
Clinical Research
*equal to 1750 part-time hours
Professional
and
and
within the past
five years
Undergraduate
Degree in
*equal to 3500
or Graduate
“Clinical
part-time hours
OR Certificate
Research” from
in “Clinical
an Associate,
Research”
Undergraduate or
Graduate Degree
and
Program*
*Degree and Certificate Programs must meet
requirements. Visit www.socra.org/certification
for more details
the CCRP credential.
Continuing Education (CE) Requirement
Certificants must complete 45 hours of CE during their
three-year certification period. The breakdown of CE that
may be claimed within each CE category follows:
Minimum of
Operations /
claimed (no
Research
Regulatory
Associate or
Bachelor Degree
in a science,
health science,
pharmacy or
related field
+
Therapeutic /
Professional
Area
+
Recertification
Quiz
Application Portfolio
22 CE must be
maximum)
Total of 45
CE per 3-year
NO minimum
= certification
period
1 CE may be
claimed
Only educational hours may be claimed for CE; you may
The applicant must submit the following:
not claim CE credit for your work hours.
• Certification Application
Recertification / Certification Renewal
• Membership Application (or include member ID #)
• Resume / CV
To maintain active certification status, certificants must
• Verification of Employment Letter
apply for renewal of certification every three years.
• Job Description(s)
• Payment for the examination fee - $195 (US Funds)
Clinical
Those wishing to renew their CCRP certification must
If applying using a degree or certificate program for eligibility
purposes, appropriate forms and documentation (including transcripts)
must be included (see website for details)
successfully complete a re-certification quiz and provide
documentation of 45 hours of validated CE credit. The fee
for re-certification is currently $100.
To A p p l y V i s i t w w w . s o c r a . o r g / c e r t i f i c a t i o n
Applicants should thoroughly review all of the information provided in
the Certification section of the website. Before submitting an application
packet, applicants must review the eligibility requirements, application
procedures and deadlines, and certification program policies and procedures.
Candidates application and documentation must support the minimum work
experience required.
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7
Annual Conference
The Annual Conference, held in
Orlando, FL in 2014, features 100+
speakers presenting in 8 scholarly
tracks - covering 21 different sessions/
Jody L. Green,
PhD, CCRP
Chair, 2014 Annual
Conference
topics. The conference also includes
a robust exhibit and poster program.
It offers a great way for clinical
research professionals to meet their
educational goals.
2 0 1 5 D enver , C O
Sheraton Denver Downtown
The year 2015 Annual Conference
is scheduled for Denver, CO and
The SOCRA Annual Conference has been enhanced and
now includes eleven pre-conference workshops, plenary
includes twelve pre-conference
workshops and more than 110
sessions, break out sessions, an exhibit program,
regulatory, technical and scientific
and CME (Continuing Medical Education) Credit,
sessions, exhibits, social events,
posters sessions, and CNE (Continuing Nurse Education)
all contributing to attendance growth and positive
evaluations and testimonials.
presentations, as well as poster
a welcome reception, and an
opportunity to participate in
committee and planning meetings.
Exhibit Program
The Annual Conference exhibit program offers
opportunities for attendees to stay up-to-date on
current products and services offered to support clinical
research programs in enhancing their effectiveness and
productivity. The exhibit program is held on Friday and
The 2016 Annual Conference
will be held in Montréal, Québec
Canada at the Palais des congrès
de Montréal.
Saturday, from 10am - 4pm.
Poster
Program
The poster
program offers an
opportunity for
members to share
their research
with interested colleagues. Posters offer information
for viewers to understand the methods, results, and
significance of the research, and to promote conversations
and networking among conference participants.
8
SOC R A A NNUA L REP ORT 2014
2 0 1 6 M ontr é a l ,
Q u é bec
Pa l a i s d e s c o n g rè s
de Montréal
2013 Annual
Conference In- Review
The 22nd Annual Conference, titled Faces of Global Research:
Compliance, Quality, Integrity, and Human Subjects Protection,
was attended by more than 1,000 clinical research professionals.
The conference featured scholarly presentations on topics such as Site Management, Ethics,
Project Management, IRB, Academic Research, Oncology Research and more!
2013 President’s
Award
SOCRA presents a
special recognition
2013 Chapter
Chairperson
Recognition
award annually
who has given
President’s Award for outstanding
service was Linda Higgins, CCRP.
Ms. Higgins is the Manager,
Regulatory and Clinical Research
Affairs in the Scott Department
of Urology at Baylor College of
Medicine in Houston, TX. She served
as a member of the SOCRA Board of
Directors from 2002 to 2005 and
was chapter chair of the Greater
Houston SOCRA chapter from 2004
to 2010. She has presented for
our SOP workshop since 2005. A
current member of the certification
committee, Ms. Higgins has
served as the lead auditor for the
re-certification program since 2004
and has proctored over 50 exams.
We thank Ms. Higgins for her
continued support of SOCRA.
research in the two categories of
granting the
society.
of the 2013
the chapter
from the chapter
service to the
The recipient
This program recognizes excellence
chairperson
exceptional
Linda Higgins
accepts the President’s
Award at the 2013
Annual Conference in
New Orleans
SOCRA annually
recognizes
to an individual
Dan Redline
presents the Chapter
Chairperson Award to
Lyndsey Avery, BS,
CCRP of the Arkansas
Chapter
2013 Poster
Program Special
Recognition Award
greatest amount
of learning
opportunity
(SOCRA approved
Continuing
Education hours)
to clinical research professionals.
Lyndsey Avery, BS, CCRP of the
SOCRA Arkansas Chapter, was
in activities involved in clinical
Clinical Trials and Clinical Research
Management. The posters are
evaluated by a group of experts
in clinical research. The recipients
demonstrate ability to present their
work during the Annual Conference
poster program.
The special recognition awards for
2013 were presented to:
Research Management Category
Development of the
Study Coordinator
Apprenticeship and
Mentoring Program
(SCAMP)
honored as the 2013 recipient of
the Chapter Chairperson Award for
awarding 29 CE hours to clinical
research professionals between
June 1, 2012 and May 31, 2013.
Author: Stephanie Swords, MA, CCRP
Johns Hopkins Institute for Clinical &
Translational Research
Clinical Trials Category
Prevalence and
Reproducibility of
Masked Hypertension
Among Primary
Care Patients
Author: Laura Tuttle, MA, CCRP
University of North Carolina,
Chapel Hill School of Medicine
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9
SOCRA Education and Training
The Importance of Training in the
Conduct of Clinical Trials
FDA Center for Drug Evaluation and Research (CDER) audit inspection findings
from fiscal year 2006 through 2013 show trends in clinical investigator
deficiencies in areas such as following protocol, record keeping and informed
consent. SOCRA recognizes these trends and issues and offers education to
clinical research professionals
on Good Clinical Practice (GCP)
and more. Our hope is that
by participating in SOCRA
programming, our members will
be leaders in the clinical research
profession and inspection
findings will improve.
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SOCRA is presently holding educational programs in
the U.S.A., Canada, Mexico, Brazil, and Singapore.
E ducation
B rou g ht
to you at
the S ite
In addition to our numerous
offerings throughout the
US and Canada, SOCRA
will schedule the Certification
Preparation and Review
Course at your site for a
minimum of 20 guaranteed
participants.
SOCRA can also customize our
SOCRA OFFERS CME and CNE
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.
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.
educational offerings to meet
the needs of your research
site/ institution.
ONLINE Training Programs
SOCRA offers online learning in
addition to the already robust array
of live educational opportunities.
The programs are offered as selfpaced on-demand presentations.
A quiz following the presentation
summarizes the topic and evaluates
the participant’s understanding of
the material.
10
SOCRA’s online courses
provide any-time
access to training and
education for on-the-go
clinical research
professionals.
SOC R A A NNUA L REP ORT 2014
Current offerings include:
• GMP for Investigational New Drugs
(IND) in Phase I Clinical Trials
• What You Should Know Before
the FDA Arrives
• IND / IDE Assistance in an
Academic Health Center -
Why Provide IND/IDE Assistance?
2013 - 2014 Education
Opportunities
Clinical Investigator GCP
& Trials Management
Conference
Clinical Research Monitoring
and GCP Workshop
For Monitors, Site Coordinators,
and Auditors
For Clinical Investigators and
Key Research Staff
This interactive workshop, for site
monitors, managers or auditors with
This course, for clinical investigators
0-5 years of experience, will review
and key research staff, will review GCP,
GCP and clinical research monitoring
research finance and budgeting, and
best practices.
legal responsibilities of the clinical
investigative site.
Marie Falvo, CCRP
Bausch & Lomb
Co-Chairperson
George D’Addamio,
PhD
PharmConsult, Inc.
Program Committee
and Faculty
The purpose of this
workshop is to assist
has been a huge success
in 2000.
improving their skills and
The program is offered two to three
their understanding of
times annually and is designed with
the responsibilities of the
ALL research professionals in mind.
clinical research site.
This program creates opportunity for
dialogue among clinical investigators,
Monitoring workshop
since its implementation
Clinical Investigators and
key research staff in
Carole SampsonLanders, MD
Bayer HealthCare
Pharmaceuticals
Co-Chairperson
The Clinical Research
key research staff and program faculty.
Jacqueline
Busheikin,
RN, CCRP
Jana Research Corp.
Program Committee
and Faculty
This workshop addresses the roles and
responsibilities of a Clinical Research
Associate / Monitor/ Auditor, and is
also a great course for Research Study
Coordinators who want to improve their
understanding of the responsibilities
The intent of which is to enhance the participants’ ability
and interactions with Clinical Research Monitors.
regulations and guidelines. This program is designed to
The goal is accomplished through lecture and practical
to perform quality clinical research according to existing
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 the Minimum Criteria for ICH
GCP Investigator Site Personnel Training identified by
application facilitated by clinical research professionals
with a combined industry experience of more than 50
years. Information is presented and discussed regarding
monitoring of clinical trials according to FDA Regulations
and International Conference on Harmonisation (ICH)
guidelines, as well as practical procedures and issues
related to site / sponsor / CRO relationships.
TransCelerate BioPharma as necessary to enable mutual
recognition of GCP training among trial sponsors.
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11
2 0 1 3 - 2 0 1 4 E ducation O pportunities
Clinical Site Coordinator/
Manager Workshop
Advanced Site Management:
Finance and Productivity
This workshop, for site coordinators, research associates,
This workshop, for site managers and research associates,
GCP for Site Coordinators, Research
Associates, Study Nurses & Site Managers
and study nurses with 0-5 years experience, reviews the
responsibilities at the clinical research site.
Enhanced Business Practices for Clinical
Research Programs
reviews billing, budgeting, profitability, and business best
practices for clinical research programs.
The purpose of this workshop is to
SOCRA is pleased to
assist Site Managers, Site Coordinators
offer this workshop to
and Research Associates in improving
their skills and their understanding
assist Site Coordinators,
of the practical financial and business
Research Associates,
and Study Nurses in
Helen Darwin,
BSc, CCRP
Darwin Site
Management Services
Program Committee
and Faculty
improving their skill and
their understanding of
the responsibilities of the
tasks related to clinical research.
Jim Simmer,
MBA, RN
Performance Research
Ponte Vedra, FL
Program
Co-chairperson
clinical research site.
clinical trials according to Good Clinical
issued by the International Conference
on Harmonisation (ICH Guidelines), as
well as practical procedures and site /
sponsor / CRO relationships.
The goal is accomplished through lecture and practical
to benefit their clinical research
programs. This program is offered
three times per year.
processes continues
site related to the administration of
Federal Regulations and the guidelines
participants can immediately utilize
practices and business
all of the functions of the research
Jacqueline
Busheikin, RN, CCRP
Jana Research Corp.
Program Committee
and Faculty
tools and techniques that the
The topic of financial
This program is designed to address
Practices as defined by the U.S. Code of
This workshop focuses on providing
to be a challenge for
Andrew Snyder,
MBA, FACMPE, PMP
HealthEast
HeartCare Clinic
St. Paul, MN
Program
Co-chairperson
clinical research sites.
The goal is accomplished through
lecture, case study, practical application
and hands-on experimentation
facilitated by experienced clinical
research professionals. Information
application facilitated by clinical research professionals
and practical application recommendations are discussed
30 years.
related to finance, productivity, budgeting, billing,
with a combined industry experience of more than
TransCelerate BioPharma: This ICH E6 GCP Investigator
regarding all of the functions of the research site
and executive reporting.
Site Training meets the Minimum Criteria for ICH
GCP Investigator Site Personnel Training identified by
TransCelerate BioPharma as necessary to enable mutual
recognition of GCP training among trial sponsors.
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SOC R A A NNUA L REP ORT 2014
2 0 1 3 - 2 0 1 4 E ducation O pportunities
Clinical Science Course
For Clinical Research Professionals
The Clinical Science Course was first offered in 1995, as
SOCRA’s flagship educational program. Since its inception,
it has been revised and enhanced to meet the continually
Clinical Research
Professional Certification
Preparation and
GCP Review Course
changing needs of our members. This program is divided
The purpose of this workshop is to
medical/scientific module, to maximize its value to course
the SOCRA certification examination
assist the participant in preparing for
into 2 modules; a regulatory/procedural module and a
and to review GCP regulations, policies,
attendees. Attendees may elect to attend one (either) or
and procedures appropriate to the
both modules.
clinical research environment.
This course contains TWO modules.
George D’Addamio,
PhD
PharmConsult, Inc.
Program Committee
and Faculty
The attendee may elect to attend
one (either) or both modules.
Module 1 is the regulatory/procedural
and ICH Good Clinical
Practice (GCP) guidelines.
Module I is the Regulatory / Procedural Module consisting
Budgeting, Good Clinical Practice, ICH Guidelines,
Informed Consent, Preparing for a GCP Audit, Regulatory
Kathi Durdon,
MA, CCRP
Welch Allyn, Inc.
Faculty
Affairs and IRBs, IND/NDA, Research Ethics, and Source
venues in 2013. Faculty review basic
of clinical trials; regulatory guidelines
pertaining to: Ethical Issues in Clinical Trials, Anatomy
regarding IRB oversight and human
and Physiology, Cell Biology, Genetics, Clinical Laboratory
research protections; ethical issues in
Analysis, Epidemiology, and Research Statistics.
System IRB, University of Texas Health Science Center,
to your institution, was offered at 12
and device development; the conduct
Medical / Scientific Module consisting of sessions
Children’s Research Hospital, Duke University Health
The program, which can be brought
concepts of GCP compliance; drug
Documentation and Administration. Module 2 is the
Faculty from esteemed institutions such as St. Jude
preparing for the CCRP®
review of FDA regulations
scientific module.
Clinical Pharmacology, Adverse Event Reporting,
will aid participants in
certification exam through
module. Module 2 is the medical/
of sessions pertaining to: Drug Development Process,
This one-day course
Susan Devine, CCRP
Hospital for Sick
Children
Faculty
University of Maryland, and the Memorial Sloan Kettering
clinical research; Good Clinical Practice
and audits, misconduct and fraud.
Attendees participate in a case study
that stresses abstracting information
and completing case report forms and
other records.
Cancer Center lead this program.
TransCelerate BioPharma: This ICH
E6 GCP Investigator Site Training
meets the Minimum Criteria for ICH
GCP Investigator Site Personnel
Carolyn Rugloski,
MS, CCRP
Worldwide Clinical
Trials (WCT)
Faculty
Training identified by TransCelerate
BioPharma as necessary to enable
mutual recognition of GCP training
among trial sponsors.
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13
M E M B E R R E S O U R C E S and B E N E F I T S
SOCRA offers a variety of resources to aid members in reaching
their professional goals through education and networking.
Quarterly Journal
SOCRA’s quarterly publication, the SOCRA SOURCE,
Journal for Clinical Research Excellence, is a journal
offering scientific and technical information in
the form of academic and instructional articles of
interest to the clinical research professional. Articles
consist of items submitted by interested members
as well as specifically developed articles intended
to meet a need expressed by the membership.
A peer review process has been developed for
selected articles. The journal contains a section
advising the reader of planned educational
programming, and scheduled certification
examination sites, dates and times. The journal
contains a section devoted to products and services
available to the clinical research professional or
their organization as well as career opportunities for
clinical research professionals.
Website
SOCRA’s home page can be found at www.SOCRA.
org. The site offers a presentation of all of our
educational programming, locations, and links
to hotels and meeting facilities, as well as local
chapter information and meeting announcements.
The site keeps our members up-to-date regarding
the offerings of the society.
A current listing of all of our certification
examination sites may be found there.
NEWSLETTERS and EMAIL UPDATES
To aid members in staying current in changes
in the industry, SOCRA periodically sends updates
and alerts.
Linkedin, Twitter and Facebook
Stay connected with SOCRA by connecting with
us on LinkedIn, Twitter (@SOCRAnow) and
Facebook (socra.org).
MEMBERSHIP DIRECTORY
Our online Membership Directory may be found
under the Membership heading of the website.
The online directory was first launched in early
2007 and has provided quick access for member-tomember communication.
14
SOC R A A NNUA L REP ORT 2014
CAREER RESOURCES
Our Careers and Services section offers our
members a view of career opportunities in
clinical research available through employers and
recruiters associated with the pharmaceutical and
health care industries. It includes opportunities in
government, academia, and industry related to all
therapeutic areas.
Certification PROGRAM Reference Manual
This compilation of selected sections of the U.S.
Code of Federal Regulations (CFR) also includes
the ICH (International Conference on
Harmonisation) GCP Guidelines, the Declaration
of Helsinki, the Belmont Report, the Nuremberg
Code, and selected Health Canada documents.
The reference manual is included in the
certification application fee and is also available
for purchase through the SOCRA office.
CITI Program
SOCRA offers no-cost Basic GCP and Research
Protections online Education through the
Collaborative Institutional Training Program (CITI).
SoCRA has joined The Collaborative Institutional
Training Program (CITI) to offer SOCRA members
free entry-level basic courses in Human Subjects
Research, Good Clinical Practice (GCP), Health
Information Privacy and Security (HIPS), Animal
Care and Use (ACU), and Responsible Conduct of
Research (RCR).
REcognition by TransCelerate BioPharma
Clinical researchers who hold the SOCRA
“CCRP,” Certified Clinical Research Professional
designation, as well as those clinical researchers
who complete specific SOCRA GCP courses (noted
below), meet the minimum criteria for ICH GCP
investigator site personnel training as identified by
TransCelerate BioPharma member companies.
Certification
Preparation & GCP
Review Course
Clinical Site
Coordinator/ Manager
Workshop
Conducting Clinical
Trials in Canada
Clinical Investigator
GCP & Trials
Management
Conference
2 0 1 3 - 2 0 1 4 E ducation O pportunities
Quality Improvement
Through Standard Operating
Procedures (SOPs)
Harnessing Social Media to
Advance Clinical Research
SOCRA offers a program once per year on social media’s
This workshop will consider fundamental concepts for the
capabilities and benefits with regard to clinical research.
development and implementation of effective SOPs.
Featuring presenters on
This two-day workshop reviews
topics of social media
fundamental concepts and current
for recruitment, data
issues in the development and
implementation of effective SOPs for
the investigational site. The workshop,
Donna Headlee,
RN, BSN, CCRP
Program Chairperson
Jody Green,
PhD, CCRP
Rocky Mountain
Poison & Drug Center
Program Chairperson
offered once per year, is facilitated
by clinical research professionals
with experience and expertise in SOP
development and implementation.
collection, as well as
legal and ethical issues
encountered using social
media in clinical research
This program, intended for clinical research site
Standard Operating Procedures (SOPs)
administrators, managers, investigators, research nurses,
are effective tools to assist in the
other researchers and marketing personnel, considers the
conduct of high quality clinical trials.
impact of social media on healthcare and the regulatory
environment, including the IRB’s perspective on the use
of social media in clinical research as well as the clinical
Participants will discuss basic principles and current
research community’s ethical and legal responsibility to
challenges regarding development, writing, and
the clinical trial participant. The presenters share methods
implementation of SOPs. The importance of strategies
for using social media in various settings and review the
for addressing the approval process, development
newest concepts for the use of social media in clinical
of a training program, and tracking of training and
research. Topics also include social media as a method
implementation results will also be discussed.
for intervention and research collaboration, as well as
This workshop consists of lectures, discussions, and
applicable regulatory implications.
interactive group exercises.
Clinical Trial Management System (CTMS) Conference
The purpose of this program is to assist clinical research site
administrators, managers, system users, investigators, nurses,
other researchers and financial personnel in evaluating Clinical
Trial Management System (CTMS) capabilities and benefits.
Andrew Snyder,
MBA, FACMPE, PMP
HealthEast
HeartCare Clinic
St. Paul, MN
Program Chairperson
This two-day conference reviews
Participants will learn basic technical terms and concepts
management system evaluation,
to evaluate their organization in order to determine their
related to CTMS. The program will teach individuals how
strategies for clinical trial
selection, implementation and
management, as well as exhibits and
demonstrations from CTMS vendors.
CTMS requirements and to begin implementation. Revenue
management, financial reporting and budgeting will also
be discussed.
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15
2 0 1 3 - 2 0 1 4 E ducation O pportunities
FDA Clinical Trial
Requirements, Regulations,
Compliance and
GCP conference
SOCRA is pleased to offer this
conference, jointly sponsored in 2014
Conducting Clinical Trials
in Canada
A Uniquely Canadian Perspective for All
Clinical Research Professionals
Answering requests from Canadian members, SOCRA
offers a program on conducting clinical trials in Canada.
with the U.S. FDA Los Angeles, Detroit
This conference offers
the San Francisco, Cincinnati and New
perspective and will
and Florida Districts, and in 2015 with
a uniquely Canadian
England Districts.
assist all clinical
This two-day conference, jointly sponsored with the
U.S. FDA, shares information regarding clinical research
regulations and GCP guidelines and discuss methods
to aid the research professional in their practice.
This conference is designed to enhance the participant’s
Helen Darwin,
BSc, CCRP
Darwin Site Mgmt
Services
Program
Co-Chairperson
understanding of the mission, responsibilities, and
FDA representatives.
highlights the following areas:
• FDA District Offices
Role, Structure and
Responsibilities
• Modernizing FDA’s
Clinical Trials / BIMO
Programs
• FDA’s Expectations
for a Pharmaceutical
Clinical Trial
• Medical Device Aspects
of Clinical Research
• FDA Center for Biologics
Regulation of Research
• Adverse Event Reporting
– Science, Regulation,
Error and Safety
• Ethical Issues in
Subject Enrollment
16
• Keeping Informed and
Working Together
• FDA Conduct of Clinical
Investigator Inspections
• Investigator Initiated
Research
• Meetings with the FDA Why, When and How
• Part 11 Compliance Electronic Signatures
• IRB Regulations and
FDA Inspections
• Informed Consent
Regulations
• The Inspection is
Over - What Happens
Next? Possible FDA
Compliance Actions
of the responsibilities
of conducting clinical
Health Canada’s regulations for
community to facilitate the understanding of regulations,
product development understanding. This conference
and their understanding
This program features sessions on
FDA representatives share information with the regulated
opportunities to enhance the research professional’s
in improving their skills
research in CANADA.
authority of the FDA and to encourage interaction with
guidelines and practices, and to suggest methods and
research professionals
pharmaceutical and medical device
Jacqueline
Busheikin,
RN, CCRP
Jana Research Corp.
Program
Co-Chairperson
clinical studies. Speakers also address
current trends in clinical research and
identify how these trends are influence
clinical development now and into
the future, as well as review ethical
challenges for research in the Canadian
regulatory environment; key elements in preparing for
a Health Canada inspection and potential corrective and
remedial actions for audit inspection findings . In addition,
the program reviews critical analysis and risk management
strategies to mitigate cultural challenges presented
by multinational trials , in addition to discussing the
objective, process, and final report of the ISCT (Initiative
to Streamline Clinical Trials).
TransCelerate BioPharma: This ICH E6 GCP Investigator
Site Training meets the Minimum Criteria for ICH
GCP Investigator Site Personnel Training identified by
TransCelerate BioPharma as necessary to enable mutual
recognition of GCP training among trial sponsors.
SOC R A A NNUA L REP ORT 2014
2 0 1 3 - 2 0 1 4 E ducation O pportunities
Clinical Research
Project/Program
Management Conference
Protecting Human
Research Participants
This conference considers project management and risk
Legal, Ethical, and
Practical Considerations
management and global considerations for clinical
Professionals reviews the activities and role of the FDA as
management principles, budget development / financial
This two-day conference for Clinical Research
research programs.
they affect record keeping, investigator responsibilities,
IRB management issues, audits,
the informed consent process, and
This program will
administrative activities falling under
broaden the participants’
FDA regulations. The presenters
discuss the responsibilities of
knowledge of the
these very important functions
regulatory framework,
Nancy Wintering,
LCSW, CRC, CCRP
Thomas Jefferson
University
Program Chairperson
project management art
Carolyn Rugloski,
MSc, CCRP
Worldwide Clinical
Trials (WCT)
Program
Co-Chairperson
and science, planning
and accounting, and their
attitude and aptitude for
budgets involved in the health care product development
Cheryl I. Jacobs,
CCRP
Translational Research
Management
Program
Co-Chairperson
process. The goal of this program is to introduce, affirm
and enhance the participant’s understanding of the
project management endeavor.
Topics include:
Principles of Initiation,
Planning, Execution,
Monitoring, Controlling,
and Closing
• Charts, Planning and
Tracking Tools
• Organizational Tools
and Techniques
• Organizational Dynamics
in Project Management
research subjects.
Professional’s
administer, track, evaluate and report activities and
Management Institute)
research and the protection of
Clinical Research
incorporate a broad range of skill sets in order to plan,
• Introduction to PMI (Project
contributor to successful clinical
designed to aid the
Clinical trial project and program management
Infrastructure
clinical researcher as a fundamental
This conference is
achieving successful clinical trials.
• Developing an
and the complementary role of the
• Global Regulatory
understanding of the
legal, ethical, and practical
considerations of human
subjects research.
The program focuses on the relationships among
Considerations Affecting
clinical trial staff, investigators, IRBs and the FDA. The
the Project Plan
conference highlights five areas that present challenges to
sponsors and investigational sites: safety reporting, data
• Creating a Study Budget
monitoring, communication, education, and the informed
and Managing Finances
from Start Up to Close Out
• Contract Development for
consent process. The program features a case study on
human safety protection considerations during clinical
research study recruitment and enrollment endeavors.
Good Outcomes
• Planning for
the Unexpected
• Managing Multisite
Projects & Projects Related
to INDs and IDEs
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17
2 0 1 3 - 2 0 1 4 E ducation O pportunities
Device Research &
Regulatory Conference
The Premier Conference for
Device Professionals
(Plus optional Pre-Conference 1/2 day
workshop DEVICE Basics)
Pediatric Clinical Trials
Conference
SOCRA’s newest program, highlights specific to pediatric
clinical trials.
SOCRA’s newest educational program
on pediatric clinical research was a
great success. Offered
This conference reviews fundamental concepts and
current issues relating to DEVICE
for the first time in
research compliance, research
February 2014, the
development, and clinical investigation
two day program
for Device Research in the current
regulatory environment. An optional
half-day program on Device Basics for
Kathi Durdon,
MA, CCRP
Welch Allyn, Inc.
Program Chairperson
participants new to device research
precedes the main conference.
Presenters discuss fundamental
Lisa Benson,
BS, CCRP, CRCP
Connecticut Children’s
Medical Center
Program Chairperson
concepts and current issues relating
reviews regulatory,
financial, and ethical
components of conducting
clinical trials in the
pediatric population.
to compliance, human subject protection, research
development and clinical investigation in the current
regulatory environment. Speakers from academia,
The conference featured information
and expertise.
administration of clinical trials
and discussion regarding the
government (FDA) and industry share their knowledge
according to FDA Regulations
Device Half Day Workshop:
DEVICE BASICS
(Optional Pre-Conference)
and International Conference on
Susan Devine, CCRP
Hospital for Sick
Children
Program Chairperson
The Pre-Conference Workshop, designed for those new to
research or for those who would like to have a refresher
on the device clinical research regulations and guidances,
offers a comprehensive overview for those interested in
device clinical research and serves as a building block for
the more advanced general session.
Device Research: General Session
This 2-day advanced conference includes experts involved
in the research and development of safe and effective
vulnerable populations.
This conference highlights the
following areas:
• Unique Challenges of
Conducting Clinical Trials
in a Pediatric Setting
• Regulatory
Considerations in the
Pediatric Population
• Challenges Faced in
Recruitment, Enrollment,
and Retention
medical devices. Topics include: 510(k) Program Update,
Device Total Product Life Cycle (TPLC) Case Study from
FDA experts, Conducting Device Trials in Ascending
Markets, IVD trials, IRB Roles and Responsibilities,
ISO 14155, as well as presentations from innovation,
communication and human factors experts.
18
Harmonisation (ICH) regarding
SOC R A A NNUA L REP ORT 2014
• Development of Pediatric
Research Studies
• Budgeting and
Contracting
• Project Planning and
Management
• Monitoring, Auditing
and Compliance
• Study Closeout
CHAPTER DEVELOPMENT
SOCRA’s chapter program was developed to help support
In 2013, SOCRA chapters held 165 meetings throughout
peer-to-peer education and foster a community for clinical
meetings offered 212 CE to over 3,600 attendees. SOCRA’s
continuing education at the local level. Local chapters support
research continuing education and networking. SOCRA’s
chapter model allows clinical research professionals to acquire
no-cost continuing education credit.
Interested members of SOCRA wishing
to administer educational programming
at the local level may organize a local
chapter and plan clinical research
education. Those interested may
contact the SOCRA office for
information and to discuss their
educational programming.
A SOCRA chapter’s membership
consists of current members of
SOCRA who are located within a
non-exclusive geographic area defined
by the local chapter. Therefore,
the chapter’s “active” membership
consists of those who are interested
in developing and participating in the
local chapter activities.
the U.S.A., Canada, Brazil, Japan, and Saudi Arabia. These
chapter program continues to grow, with over 50 chapters
actively engaging their local clinical research community.
SOCRA encourages the
Chapter Chairperson
Special Recognition
chapters to provide a cost
SOCRA recognizes that chapter
development of local
free forum under which
members can learn,
exchange information,
grow professionally in
clinical research, acquire
CE for SOCRA CCRP®
re-certification, and
build strong foundations
for successful clinical
research outcomes.
education programs, coupled with
SOCRA programming, help our
members to achieve personal and
professional growth through continuing
education. This award recognizes a
SOCRA volunteer chapter chairperson
for excellence in their commitment
to this goal through the coordination
of education to local clinical research
professionals. This award recognizes the
representative of the chapter granting
the greatest amount of learning
opportunities for the period between
June 1 and May 31 annually. See page 9
for details regarding the 2013 recipient.
CURRENT CHAPTERS INCLUDE:
BRAZIL
Sao Paulo
CANADA
British Columbia - Northern
Vancouver
Vancouver Island
Nova Scotia - Halifax
Ontario - Kingston Area
London
Ottawa Area
Toronto Area
Saudi Arabia
Riyadh
U.S.A.
Alabama
Arizona - P hoenix / Valley of the Sun
Arkansas
California - G
reater Los Angeles
Inland Empire
Northern California
Orange County
San Diego Area
Sylmar
Colorado - Rocky Mountain Area
Southern Colorado
Connecticut
District of Columbia - Nat’l Capital Area
(DC/VA/MD)
Florida - Central Florida
North Florida
South Florida
Suncoast
Georgia - Atlanta
Idaho - Treasure Valley
Illinois - Central Illinois
Indiana - C rossroads (IN/OH/KY/IL)
Southern Indiana
Maryland - Baltimore Area
Massachusetts - Boston Area
Western MA
Michigan - S aginaw Bay Area
Southeast
Minnesota - North Central Regional
Southeast (MN/IA/WI)
New Jersey - Northern (NJ/NY)
New Mexico
New York - Hudson Valley (NY/NJ)
New York State
Western NY
North Carolina - NC East / RTP Area
Ohio - Northeast Ohio
Oklahoma - Central Oklahoma
Oregon
Pennsylvania - Harrisburg/ Hershey
South Carolina - Palmetto
Upstate
South Dakota - Central Plains
(SD/NE/IA/ND)
Tennessee - Greater Nashville
Greater Smoky Mtn Regional
Mid-South
Texas - Central
Dallas / Ft. Worth
Greater Houston / Galveston
San Antonio
West Texas
Vermont
Virginia - C entral Virginia
Southeastern Virginia
Washington State
Wisconsin
VIS IT WWW.S OCRA.ORG
19
SOCRA BOARD
OF DIRECTORS
2013- 2014
SOCRA’s leadership is comprised
of an all volunteer, 15 Member
President
Wendy H. Lloyd, BA,
LPN, CCRP, CIP
Regulatory Affairs &
Compliance Specialist,
Vanderbilt Univ.
Medical Center, IRB
Nashville, TN USA
President Elect
Jody L. Green,
PhD, CCRP
Director of Research
Admin,
Denver Health Rocky
Mountain Poison &
Drug Center
Denver, CO USA
Secretary
Nancy A. Wintering,
MSW, LCSW, CCRP
Research Program
Manager,
Thomas Jefferson
University
Philadelphia, PA USA
Treasurer
Ann Marie Von Worley,
RN, BSHS, CCRP
Research Associate,
Health
Services Research
Division,
LCF Research
Albuquerque, NM USA
Board of Directors.
Our volunteer leaders are clinical research professionals
from all areas of clinical research, including academia,
government and industry and with experience in a wide
range of therapeutic areas.
20
SOC R A A NNUA L REP ORT 2014
Immediate Past
President
Daniel E. Redline,
BA, CCRP
Director, IRB
Administration,
University of
California, Davis
Sacramento, CA USA
Directors
Cheryl M. Chanaud,
PhD, CCRP
System Executive
Director, Research,
Memorial Hermann
Healthcare System
Houston, TX USA
Maribelle Guloy,
MSHS, CCRP
Clinical Trials Director
Clinical Trials and
Research Associates,
Inc.
Montebello, CA USA
John M. Furlong,
RN, CCRP
Director of Clinical
Research
Delaware Valley
Clinical Research
Cherry Hill, NJ USA
Tammy S. Neseth,
BS, CCRP
Manager - IRB
Regulatory Compliance
Mayo Clinic Cancer
Center CRO
Rochester, MN USA
Angela Rock, MBA,
CCRP
Manager, Clinical
Research Associate
Group
BIOTRONIK
Lake Oswego, OR USA
Ruben Q. Rodarte,
MBA, MS, CCRP
Clinical Projects
Director, Preventative
Medicine, Pennington
Biomedical Research
Center, LSU System
Baton Rouge, LA USA
Susanna K.
Sellmann, BSc, MRT,
CCRP
Quality Manager, Cancer
Clinical Research Unit,
Princess Margaret
Hospital / University
Health Network
Toronto, ON, Canada
Radhika
Sivaramakrishna,
PhD, PMP, CSSB,
CCRP
Senior Director, Project
Management, Covance
Princeton, NJ USA
Mariah Tackett,
MSPH, CCRP
Associate Director,
Clinical Operations
St. Jude Medical Inc Implantable Electronic
Systems Division
Sylmar, CA USA
Stephanie J.
Zafonte, MSN, RN,
RAC, CCRP
Nurse Consultant/
Clinical Project
Manager, NIH/NIAID
Rockville, MD USA
Jamie Harper, MHA,
CCRP
Director of Clinical
Research
Illinois CancerCare
Peoria, IL USA
Lenore JacksonPope, RN, BSN,
MSM, CCRP
Manager, Medical &
Research Ed
Massachusetts/
NH Chapter of The
Alzheimer’s Association
Watertown, MA USA
Directors Elect
Quincy J.
Byrdsong, EdD,
CIM, CIP, CCRP
Associate VP for Health
Sciences
Strategic Initiatives &
Engagement
Virginia
Commonwealth
University
Richmond, VA USA
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21
MANAGEMENT
The SOCRA management and
Erich Lukas, MBA
Executive Director
Rita Lukas
Administrative Director
Kristen McNeill
Associate
Administrative Director
Brent Williamson,
MBA, CPIM
Associate Executive
Director
Cindy Baker
Membership
Susan Benedetti,
MSOL
Program Management
Laura Brewster
Certification
Laura Engebreth
Data Management
Susan Ciotti
Events Management
Anne Howell
Continuing Education
Linda Seidel
Accounting
Janis Skarbowski
Recertification /
Advertising / Exhibits
administrative team has combined
experience of more than 75 years
in non-profit and association
management.
Our management team additionally has 25 years of
experience working in healthcare, clinical research
and the pharmaceutical industry. Our office
provides accounting and financial management,
membership records and dues management,
meeting management and development,
publications development and production, web site
management, educational programming assistance,
certification committee support and support for
marketing and promotion activities.
22
SOC R A A NNUA L REP ORT 2014
EXECUTIVE DIRECTOR’S REPORT
Thank you for your interest in clinical research
and in SOCRA. Our organization and its
stakeholders strive for excellence in all aspects
Erich Lukas, MBA
of clinical research.
Executive Director
raises the bar for quality research management and
SOCRA has developed a culture that encourages the
operations, and for subject care.
highest levels of integrity and care from all who are
involved in our leadership and from faculty and staff
involved in our education and certification programs.
We encourage our members to take advantage of “free
content is valid, professionally developed, and delivered
Chapter education programs, a totally volunteer effort,
Our members and stakeholders can trust that program
of cost” local education offered through our chapters.
with utmost care. We administer our programs to
were originally designed to allow our certified members to
exceed expectations and to impart the highest levels of
professionalism attainable. Our emphasis on Good Clinical
(Research) Practices, quality research outcomes, and
safety for the research subject, has surely contributed to a
more professional and productive research environment.
SOCRA’s Board of Directors and education committees
have succeeded in broadening the course offerings to
accrue required continuing education for re-certification
at no cost and are also open to visitors. Our chapter chairs
are open to your suggestions for speakers and topics.
More than sixty chapters now offer valuable education
opportunities throughout the year.
As a provider of continuing nurse education (CNE) and
include 16 programs offered at more than 35 venues
continuing education for physicians (CME), SOCRA holds
throughout the year.
to the highest standards for identifying participant
needs, determining educational objectives, selecting and
We are also quite proud of the rate of growth of our
presenting content, and ensuring that education delivery
membership. Despite the difficult economy, our
methods meet participant needs.
membership has doubled during the last seven years to
over 15,000 members.
We sincerely appreciate the faith and confidence of
The designation “Certified Clinical Research Professional
(CCRP®),” is available to researchers working under
to greater professionalism and expertise in clinical
our members. They have selected SOCRA as their avenue
research. As a result of our programming, the greater
Good Clinical Practice (GCP) regulations, who meet
reward granted to our Board of Directors, faculty, staff
certain eligibility requirements that are stipulated in the
and members, is their knowing that activities in research
certification section of this report.
The SOCRA Board of Directors, staff and faculty strive to
are addressed by competent and disciplined clinical
research professionals.
offer our members the very best environment for learning,
in order to promote the protection of research subjects
Thank you for your trust, confidence, and support.
and quality research outcomes. Our certification process
VIS IT WWW.S OCRA.ORG
23
SOCRA Education Calendar 2014/2015
2014
OCTOBER
9 and 10
16 and 17
20 to 24
Baltimore, MD
Clinical Research
Project / Program
Management
New Orleans, LA
Clinical Research
Monitoring and GCP
San Diego, CA
Clinical Science Course
NOVEMBER
5 and 6
13 and 14
17
L ake Buena Vista, FL
FDA Clinical Trial
Requirements
Nashville, TN
Clinical Site Coordinator
/ Manager - GCP
Tampa, FL
Certification
Preparation and
Review Course
DECEMBER
4
4 and 5
11 and 12
Kansas City, KS
Certification
Preparation and
Review Course
Las Vegas, NV
Clinical Investigator
and GCP Workshop
San Diego, CA
Advanced Site Finance
and Productivity
2015
JANUARY
29 and 30
FEBRUARY
5
5 and 6
12 and 13
26 and 27
27
MARCH
11 and 12
23 to 27
Las Vegas, NV
Clinical Site Coordinator / Manager - GCP
Los Angeles, CA
Certification Preparation and Review Course
San Diego, CA
Clinical Research Monitoring and GCP
San Diego, CA
Pediatric Regulatory Conference
New Orleans, LA
SOP Development and Implementation
New Orleans, LA
Certification Preparation and Review Course
S an Francisco, CA
FDA Clinical Trial Requirements
Lake Buena Vista, FL
Clinical Science Course
APRIL
13 and 14
T oronto, ON Canada
Clinical Site Coordinator / Manager - GCP
16 and 17
San Francisco, CA
Protecting Human Research Participants Legal, Ethical & Practical Considerations
23 and 24
Denver, CO
Advanced Site Finance and Productivity
30 and May 1 Toronto, ON
Conducting Clinical Trials in Canada
MAY
6 to 8
13 and 14
24
S an Diego, CA
Clinical Device Research (and Device Basics
Preconference)
Cincinnati, OH
FDA Clinical Trial Requirements
SOC R A A NN
JUNE
18 and 19
18 and 19
JULY
9 and 10
20 to 24
30 and 31
SEPTEMBER
16
17 to 20
OCTOBER
8 and 9
19 to 23
22 and 23
NOVEMBER
4 and 5
12 and 13
DECEMBER
3 and 4
10 and 11
Society of Clinical Research Associates
530 West Butler Avenue
USuite
A L109 R E P O R T 2 0
Chalfont, PA 18914 USA
14
Nashville, TN
Clinical Research Monitoring and GCP
Nashville, TN
Advanced Site Finance and Productivity
S an Francisco, CA
Harnessing Social Media to Advance Clinical
Research
Chicago, IL
Clinical Science Course
Chicago, IL
Clinical Site Coordinator / Manager - GCP
Denver, CO
Certification Preparation and Review Course
Denver, CO
Annual Conference (and preconference
workshops)
Philadelphia, PA
Clinical Research Monitoring and GCP
Scottsdale, AZ
Clinical Science Course
Scottsdale, AZ
Clinical Research Project / Program
Management
Boston, MA
FDA Clinical Trial Requirements
Lake Buena Vista, FL
Clinical Site Coordinator / Manager – GCP
Tampa, FL
Clinical Investigator and GCP Workshop
Las Vegas, NV
Advanced Site Finance and Productivity
Phone: (800) 762-7292 or (215) 822-8644
Fax: (215) 822-8633
E-mail: [email protected]
www.SOCRA.org
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