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 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. These projects give
essential initial experience in the field. This is what potential
employers like about us; 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, an industry-recognized organization.
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
has also been invited to send a speaker for the Society’s
Fall Conference.
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, the Woolf Group, PPD
Inc., Princess
Margaret Hospital,
and the University
Health Network
to name a few. 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.
There are 50 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 live, on-line teachers
(active researchers in our company involved in real clinical trials
projects). Most of our teaching personnel have MSc - PhD level
experience 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 Quality Assurance Specialists for the 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
Clinical Research Associates (CRA’s), Clinical Data Managers (CDM’s),
Quality Assurance Specialists (QA) 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 Quality
Assurance Specialists ?
How valid is this certification?
At
present, there is no professional designation for the positions of Quality Assurance Specialist 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 Quality Assurance 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.
Why do we ask open
questions?
Because we wish to prepare
our students for job interviews with prospective employers most
of our open-ended questions are based on questions asked by employers
during interviews with our previous graduates. That is why it is so important that you answer each question in
as much detail as you can. In order to make a good impression with a
prospective employer you need to be competent in professional
terminology and related concepts. So, you are encouraged to use this
opportunity to prepare yourself for a real job interview by answering
our open questions as best as you can.
Clinical trials are about
medicine whether we want it or not. Even though pharmaceutical
companies and CRO's advertise that they want BSc. biologists,
microbiologists, mathematicians,
database specialists and statisticians for data management positions,
they do expect people to have a true interest in medicine, rather
than a formal medical background. We are here to help you. If there is anything that you don't
understand just ask. There is nothing that cannot be explained.
Training
Quality Assurance &
Regulatory Affaires, ICH GLP, GCP, GMP Guidelines Professional
Development Program is designed for Bachelor / Master (or PhD) Degree
in Engineering, Business Administration, Computer & Information
Technology, Bachelor of Science in Business / Management , Chemistry,
Biochemistry, Pharmacology and other BSc degrees.
This course is intended
to give both general and specific information and guidelines to help
establish, develop, and implement Quality Assurance in a
biopharmaceutical manufacturing environment. This program is designed
to provide a focused course of study for individuals seeking to
position themselves for pharmaceutical and biotechnological industry
as a quality assurance auditor, validation specialist or regulatory
affairs officer. It will also provide knowledge and skills of
excellence Good Laboratory, Clinical and Manufacturing Practices. This
course provides a comprehensive overview of the roles/responsibilities
of both the quality assurance auditor, validation specialist or
regulatory affairs officer in pharmaceutical industry. This program
was created to provide you with the key aspects, differences,
challenges, job criteria and demands, and industry expectations.
Course content will focus on key concepts and information essential to
effectively function in the pharmaceutical / biotechnological
industrial arena. This course can open doors to new and exciting
career opportunities in quality assurance as the demand for qualified
and trained specialists is still growing.
The development of the
biotechnology, or "biotech", industry for biopharmaceuticals
is exciting and rapid. Many new, small companies have been, or are
being, established. The main emphasis of these companies is the
development of the science associated with their particular products.
There is a tendency to develop the science and leave the quality
function in the background. For the ultimate success of the company,
it is important to start developing the QA function in parallel with
the science.
We would like to highlight
once again the benefits of your enrolment in this program:
1. You get the essential
knowledge of everything you need in order to apply for Quality
Assurance Positions. Along with in-class sessions you get free access
to Interactive Training Programs On-line. You have complete coverage
of all materials needed. Upon completion of this program you will pass
on-line final exams and receive by mail or in person Diploma stating
your new qualifications.
2. You receive a specially
designed Diploma stating the program objective: “The International
Conference on Harmonization (ICH): "Good Clinical, Laboratory,
Manufacturing Practice (GCP, GLP, GMP) Guidelines, Quality Assurance
& Regulatory Affaires in Pharmaceutical Industry”. This is
essential in requirements to any position of Quality Assurance. (Look
at the positions on our site or in our Newsletter - you will see that
all of them require this knowledge).
3. You participate and gain
unique experience in real Practical Projects.
4. You get reference letters
on your project participation adjusted to your needs and reflecting
all appropriate details of your active participation in full-scale
practical projects. Without proper reference letters it is completely
useless to approach any serious Pharmaceutical Company in order to get
a job.
5. You get perpetual
support of our research centre staff when you mention our institution
in your resume as a place where your potential employer could obtain
references. Almost always, prospective employer would make a call to
collect references in personal phone conversation.
6. When your prospective
employer will call us for reference, we would reflect all the details
of your research participation and appropriate qualifications. This
could drastically increase your chances to get a job .
7. You get active help in
your resume editing. Remember, your resume is the first step to get a
job. Now you would include into your resume as last entries, your
participation in GCP, GLP, GMP Guidelines, Quality Assurance &
Regulatory Affaires in Pharmaceutical Industry seminar and US /
Canadian Experience in Real Project at Kriger Research Center
Inc.
8. You will get return on
your investment in your education and training at KRC at
least at 40 times more then you have paid and this in very first year
of your work in Quality Assurance.
