Kriger
Research Center Inc. is an organization with broad expertise in
the planning, execution and interpretation of research projects.
As our clients know, KRC Inc. serves as a partner in clinical
research with extensive experience in different phases of
clinical trials. KRC Inc. provides focused, comprehensive
planning, which leads to a successful trial. Beyond the trial, we
remain involved and committed to a development process that is
custom-designed to our clients' needs. We are committed to
investing in ongoing training for our employees to ensure they are
kept on the leading edge of new technologies. These training
initiatives include interactions with academia, attendance at
scientific conferences and meetings, training courses from experts
in various fields, etc.
We have
good working relationships with most reputable clinical research
recruiters such as Kelly Scientific Resources, clinical research
organizations (CRO),
and pharmaceutical companies that recognize us as a reputable
institution. Some of them are posting their openings for clinical
research positions on our site . We have also an affiliated
recruitment agency Biorole Scientific Solutions Inc. All our
graduates are eligible to post their resumes on it's web. based
database www.biorole.com . The
famous recruiter for biopharmaceutical industry Woolf Group is
routinely recommending KRC Inc. training in their e-mails to
unqualified candidates.
Our
Diplomas state that the student has passed a program on
Data Management in clinical Trials, ICH
Good Clinical practice (GCP)
which is a standard requirement in this industry.
The most important benefit of our program is student enrollment
in a volunteer position in real projects that give
essential initial experience in the field. This is what potential
employers like about us because our graduates know exactly what they
are going to do in the industry, and that's what every employer
actually needs.
Most
of KRC Inc. graduates become members of the Association of Clinical
Research Professionals and Society for clinical Data Managers
the industry most recognized organizations.
The
KRC Inc. Programs are recognized by the
Society
for Clinical Data Management
and
KRC is currently in negotiations to become a certification-training
provider for this organization. KRC
invited to send a speaker for the Society’s
Fall Conference. A request was also made at that time for KRC to
provide certification training for the Society for Clinical Data
Management’s Certification Exams.
KRC is listed on the most respected and trusted website for the
Clinical Trials Industry: http://www.centerwatch.com/professional/prv392.html
as a CRO and as a Training
Institution .
KRC
Inc. graduates have been hired by many other industry providers. (AAI
Development Services Clinical Trials Division, Woolf Group , Princess
Margaret Hospital,
University
Health Network )
. Over
half of KRC’s current or previous employees are KRC Inc.
graduates.
All
graduates are involved as volunteers in research activities, are
evaluated by KRC Inc. Practical Projects Coordinators and are
entitled to receive references for their participation. Other
industry providers recognize and accept these references.
Why
would you need this program?
This truly interactive program can
help you gain appropriate knowledge and practical skills in order to
apply for the position of Clinical Research Data Manager . Upon
completion of this program and after passing on-line final
exams you will receive, by mail, a diploma stating your new
qualifications. You will be approved as a clinical research
associate to participate in clinical research projects
at our center. You will be appointed to one of the on-line research
groups working on a specific drug. You will receive individual
clinical research tasks that will give you sufficient
experience to get started on your first job in this field. Modern
clinical research activities are almost entirely based on networking
and internet on-line communications. Your experience in this area
will be most valuable for your future employment. All your tasks you
will be received on-line and will be conducted by you as a
home-based Clinical Research Associate.
You would actively participate in the development
of clinical research data bases, data entry, data analysis,
development of some parts of the protocol, preparing CRF-s (Case
Report Forms), reviewing informed consent forms, networking with
potential investigators, initiating clinical research sites,
monitoring, creating databases, performing data entry and analysis
and many other tasks. You will utilize your knowledge of ICH GCP
(Good Clinical Practice) in each phase of the clinical research. You
will submit your work for approval by e-mail. At the end of your
work you will receive a reference letter stating your new
qualifications and experience with our contract research center. At
this stage you could work with our company as a volunteer. The most
successful participants could be offered employment with our company
upon completion of this program.
There are 65 sessions with many open
ended questions in this program. You move through sessions at your
own pace and submit your answers to the open questions to life
on-line teachers (active researchers of our company involved in real
clinical trials projects). Most of our teaching personnel has a
MSc - PhD level in clinical trials-related areas and have intensive
clinical research experience. Each and every answer to open
questions that you submit receives comments from our on-line
teachers. They will send you additional related articles, you will
submit your feedback on the articles and receive comments if needed.
You will also receive comments on every practical task you submit.
That usually adds up to at least 200-250 communications throughout
the program. Also students ask many questions and they always get a
reply. We review everything that comes to us on-line: answers to
training questions, questions about practical tasks, resumes and we
even give advice to help with your future interviews. We also
prepare reference letters for successful participants in research
projects. The assessment of your performance works like this: We
save all your answers and your comments regarding the additional
articles in special folders under your name. When you finish the
course and pass your on-line final exam we receive notification from
the final page of the course along with your request to issue a
Diploma. We then check your participation in answering the open
questions. If you have answered enough of them - you get your
diploma by mail. If not, we ask you to answer some more questions,
and after you have completed them, you get your Diploma by mail.
It is recommended to save a copy of all your answers in one or
two text files in order to be able to re-submit them if necessary.
Our responsibility is to make sure that a Diploma is issued only to
those who qualify, in other words, have demonstrated his/her
knowledge by answering most of our questions.
Why
are there not enough Clinical Research Data Management Specialists on
the market and why is it important to train the new specialists out of
other professions with the right educational background?
In
fact, the market is currently expanding faster than the production of
new qualified professionals which inevitably creates a demand.
Most people are under the impression that the barriers to enter
this industry are extremely difficult to overcome, but the truth is
that everybody working in this industry had to start somewhere and as
the industry grows positions need to be filled.
Now the question is: how will this be accomplished?
One way of filling the vacuum is to take specialists from other
professions and turn them into professionals for this industry.
This has several added benefits of its own.
For instance bringing specialists from other professions or
industries actually diversifies the workforce and brings new
perspectives to the biopharmaceutical industry.
This in turn is a source of innovation where multiple
disciplines are being united and new perspectives are made more
apparent.
Of course, the need for training is obvious for specialists
that are re-aligning their careers as well as for individuals that are entering the industry as new
graduates. Most of the
skills and knowledge required in positions such as CRA’s, CDM’s,
QA’s and Marketing Managers are not covered in university courses.
Even where an individual has been through a specially
designed training program for the position through an academic
institution, the training may not involve a practical component in
which case the individual still lacks certain skills.
This should re-emphasize the importance of practical training
programs for the biopharmaceutical industry.
The
educational system does not appear to produce enough graduates to meet
the demand for entry level positions like CRA, Data Manager Specialists,
Quality Assurance Specialists and Marketing and Management
specialists. Skill shortages also affect the ability of
regulatory agencies to keep abreast of scientific advances and to
efficiently review the increasing number of new products. The diverse
range of skills required along with the dramatic pace of change is not
reflected in current university courses. The shortage of specialists
could be felt in other areas too. For example, bioinformatics requires
a background in genetics, statistics, and software development, but
most graduates lack such multi-disciplinary training. Also, there are
no Canadian undergraduate degree programs in bioengineering;
specialization options are normally offered within more traditional
programs.
Who
can train Clinical
Research Data Management Specialists ?
How valid is this certification?
At
present, there is no professional designation for the positions
of Clinical Data Manager although these are valid and mid
– high ranking positions in the corporate structure.
The ideal training environment would be in a research company itself
where the trainees can gain access to real practical experience.
Most if not all companies are very reluctant to hire
individuals without any experience, so even 6 months as a volunteer is
usually enough to get oneself into an entry level position.
Certification
is a process by which a non-governmental agency validates, based upon
predetermined standards, an individual's qualifications and knowledge
in a defined functional or clinical area. The issue of being
"certified" is confusing for many people who begin looking
at Clinical Research as a career, for example: "CRA" and
“CRC” are job titles not credentials. They neither imply nor
require "certification". The job function of CRA is not one
that requires any special certification in order to perform it
unlike, say, a CPA (Certified Public Accountant) or CMT (Certified
Massage Therapist). Those are regulated job functions where people
cannot call themselves "CPA" or "CMT" unless they
have gone through specific procedures regulated by a governing body.
However,
many companies use Certificates of Training as a screening mechanism
for hiring or promoting employees. This results in multiple sources of
training for Clinical Research professionals, where the certifications
are tied to the completion of different courses offered by various
training providers.
A
certification offered by a pharmaceutical research company would be
recognized in the industry as a professional development course.
More important than this however, is the reference that backs
the certification. An
individual with a reference from a pharmaceutical company will be held
in a
higher regard than an individual with a reference from an academic
college. In this industry
especially, reputation is very important and goes a long way –
professional references are usually the deal maker or breaker when a
person is considered for a position.
We would like to highlight once again the benefits of your
enrolment in this program:
1. You get the essential
knowledge of all you need in order to apply for the following
positions: Data Manager/Associate, Clinical Data Coordinator (CDC),
Clinical Data specialist (CDS), Clinical Data Analyst, Data Base
Developer, and if you have the appropriate statistical or math background
- Bio Statistician and SAS Programmer. You will learn the most important
principles of Clinical Research Data Management like working with
logical, consistent and complete data. You will get all
necessary materials, interactive, practical, open-ended questions. Upon completion of this program you will
need to pass an on-line final exam and will then receive by mail your diploma stating your
new qualifications .
2. You will receive a specially
designed Diploma stating the program objective "Data Management
in clinical Trials , ICH
GCP
Guidelines, Clinical Trial Monitoring and Research Site
Coordination.". This is an essential requirement in any position
in Clinical Research Data Management .
3. You participate and gain
unique experience in real Clinical Trial Projects
| PROJECT
I |
Efficacy
of the lowering effect of PROLIPOSTAT®
on Blood concentrations of
low-density lipoprotein cholesterol (LDL-C) in patients with
normal and elevated blood concentrations of LDL-C
|
| PROJECT
II |
Phase
II Study the Efficacy of the healing effect of recombinant human
epidermal growth factor (rhEGF) on diabetic foot ulcers
|
| PROJECT
III |
Phase
I Study the safety and Dose determination of Immuno -
Stimulatory Therapy Agent for Bladder cancer, melanoma and colon
cancer. |
| PROJECT
IV |
Survey:
Proper Use and Cost Reduction strategies for prescription and
non-prescription drugs
|
You will be preparing CRF-s
(Case Report Forms), reviewing inform consents forms, networking with
potential investigators, clinical research site initiation ,
monitoring, performing data entry and analysis, and many other tasks.
You will implement your knowledge of ICH
GCP
(Good Clinical Practice)
in each phase of clinical research. Your partner will create a data
base of case report form CRF results using SAS program or simple
spread sheet program. Conduct the double data entry . Your
partner for double data entry would enter the data for the second time
and the data base would find mistakes by verifying validity of the
data entered. You will use real CRF forms . You will
submit your work for approval on-line. At the end of your work you
will receive a reference letter stating your new experience and
qualifications with our contract research center.
4 Any experience in
data management in the research area is crucial in order to get a job in
Clinical Research Data Management.
5. You get reference letters
based on your project participation adjusted to your needs that
reflect the details of your active participation in the full-scale
research projects. Without proper reference letters it is completely
useless to approach any serious Clinical Research Organization or
Sponsor in order to get a job as Clinical Data Manager.
6 . You get perpetual support
of our research center staff when you mention our institution in your
resume as a place where your potential employer could obtain
references. Almost always prospective employers make a call to
collect references through a personal phone conversation. When your
prospective employer calls us for a reference we would relate the details of your research participation and appropriate
qualifications. This could drastically increase your chances of getting a
job in Clinical Research Data Management.
7. You get active help in
your new resume preparation. Remember, your resume is the first step
towards getting a job. You can now include on your updated resume your participation in Clinical Research Data Management and
ICH
GCP
Guidelines Seminar and Canadian experience in Data Management
in a real full-scale research project at Kriger Research Center Inc.
8. You will get a return on
this investment in your education and training at KRC of at
least at 36 times more than you have paid, and this in very first year
of your work in Clinical Research Data Management!
