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INTRODUCTION
Welcome to KRC Inc. On-line training!
Who are we?
Kriger Research Center (KRC) 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 meet 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 may include interactions with academia, attendance at scientific conferences and meetings, and training courses from experts in various fields, to name just a few of the opportunities available.
We have good working relationships with respected clinical research recruiters such as Kelly Scientific Resources, clinical research organizations (CRO), and pharmaceutical companies that recognize and respect our training programs in the industry. Some of these organizations publicize and post their openings for clinical research positions on our website.
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 Training Institution. The Woolf Group, a well-known and highly respected recruiter in the biopharmaceutical industry, routinely recommends KRC Inc. training in their correspondence with unqualified candidates.
We also have an affiliated recruitment agency - Biorole Scientific Solutions Inc. All our graduates are eligible to post their resumes on Biorole’s web based database www.biorole.com.
Upon successful completion of a KRC
Inc. training program, a student receives a diploma indicating that
he/she has passed a program on
ICH Good Clinical practice (GCP),
which is a standard requirement for the industry.
The most important benefit of our program is that each student
participates as a volunteer on clinical research projects. These
projects provide a valuable and essential initial experience into the
field. 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. Industry
providers recognize and accept these references.
This training feature of the KRC Inc. program 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 graduates of our program become members of the Association of Clinical Research Professionals, an industry-recognized organization.
The Society for Clinical Data Management also recognizes KRC Inc. training programs, 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.
Many other industry providers have hired KRC Inc. graduates. For example, AAI Development Services Clinical Trials Division, the Woolf Group, PPD Inc., Princess Margaret Hospital, and the University Health Network are just some of the organizations that employ our graduates. Over half of our current or previous employees are graduates from the KRC Inc. training program.
Why would you need this program?
Our truly interactive program can help you gain appropriate knowledge and practical skills in order to apply for the position of Clinical Research Associate/Coordinator. Upon completion of this course, and after passing on-line final exams, you will receive, by mail, a diploma outlining your new qualifications. You will be approved as a clinical research associate to participate in clinical research projects at our center. You will also 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 will be received on-line and will be conducted by you as a home-based Clinical Research Associate.
You will actively participate in the development of some parts of the protocol, preparing CRFs (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 50 sessions with many open-ended questions to answer throughout the 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 extensive clinical research experience. Each and every answer you submit to the open-ended questions will be reviewed and receive comments from our on-line teachers. They will send you additional related articles; you will submit your feedback on these articles and receive comments if necessary. You will also receive comments on every practical task you submit. That usually adds up to at least 200-250 communications throughout the program.
Students are encouraged to ask many questions and they always receive 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 you 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 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-ended questions. If you have answered enough of them satisfactorily - 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, only those students who have demonstrated their knowledge of the subject by answering most of our questions correctly are eligible to receive a Diploma.
Why are there not enough Clinical Research Associates (CRA) on the market and why is it important to train new specialists out of other professions with the right educational background?
The market for clinical research associates is currently expanding faster than the introduction of newly qualified professionals that inevitably creates work force demand. Recent market studies show that the global market for biopharmaceuticals has been growing at a compound annual growth rate of almost 20% the last five years. 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 as multiple disciplines are brought together 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 CRAs, Clinical Data Managers (CDMs), Quality Assurance Specialists (QAs) 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 Clinical Research Associates or Data Manager, Quality Assurance 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 as well. For example, bioinformatics requires a background in genetics, statistics, and software development, but most graduates lack such multi-disciplinary training.
Who can train Clinical Research Associates? How valid is this certification?
The ideal training environment would be in a research company itself
(like ours) where the trainees can gain access to practical experience.
Most, if not all, companies are very reluctant to hire individuals
without any experience, so even 6 months as a volunteer (you get 6
months equivalent experience participating in our research projects)
could be enough to secure 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. "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, reputation is very important and goes a long way – professional references are usually the determining factor when a person is considered for a position.
Why do we ask open questions?
KRC Inc. training programs use open-ended 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. For this reason, it is very 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 demonstrate competence 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. Even though pharmaceutical companies and CRO’s advertise that they want individuals with a university-level science degree, (e.g. 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.
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 Clinical Research Associate / Coordinator Positions. You have complete coverage of all materials needed and interactive practical open-ended questions. Upon completion of this program you will pass on-line final exams and receive (by mail or in person) a Diploma stating your new qualifications.
2. You receive a specially designed Diploma stating the program objective: Clinical Research Associate, ICH GCP Guidelines, Clinical Trial Monitoring and Research Site Coordination. These are essential requirements for any position of Clinical Research Associate / Coordinator.
3. You participate and gain unique experience in Clinical Trial Projects: EGF03/CT PRODUCT: Recombinant Human Epidermal Growth Factor, ISTA project, Prolipostat Project and PUCR project, preparing CRF (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.
You will submit your work for approval on-line. Upon completion of your work, you will receive a reference letter stating your new experience and qualifications with our contract research center.
4. You get reference letters on your project participation adjusted to your needs and reflecting all appropriate details of your active participation in a full-scale research project. Without proper reference letters it is difficult to approach any serious Clinical Research Organization or Sponsor in order to get a job as Clinical Research Associate / Coordinator.
5. You get constant support of our research centre staff when you mention our institution in your resume as a place where your potential employer could obtain references. Prospective employers are highly likely to make a call to collect references in a personal phone conversation. When your prospective employer calls us for a reference, we will refer to the details of your research participation and appropriate qualifications. This could drastically increase your chances to get a job as Clinical Research Associate / Coordinator.
6. You get active help in your resume editing. Remember, your resume is the first step to get a job. You would include in your resume your knowledge of ICH GCP Guidelines, Clinical Trial Monitoring and Research Site Coordination and Canadian experience in a full-scale research project at Kriger Research Center Inc.
7. You get a letter from us approximately every two weeks of employment opportunities, including Clinical Research Associate / Coordinator positions, that you can apply for right away.
8. You will get a return on your investment in your education and training at KRC.