BioPharmArena.com

APPROVED
(International Biopharmaceutical Association Approved Trainer)

About Kriger
We are Kriger Research Group International (KRGI) and would like to offer our training services for various positions in the pharmaceutical industry to you, your staff and your prospective students seeking careers with Pharma. We are also a contract research organization, which means we provide services in clinical research on behalf of a sponsor company.

As we are all aware the previous century saw the emergence of computers and IT with a tremendous impact on human civilization in the form of a technological revolution; this new century heralding the new millennia will be known as the ‘Age of Biotechnology and Bioinformatics’ with amazing new cures and new therapeutic approaches aside from the all-important Human Genome Project. Our lives will see new breakthroughs and discoveries. With this spiraling growth of new accumulating data from diverse resources from the many specialized fields of interest within the health sector, it is reasonable to speculate that the need for specialists will become especially more acute and new positions will need to be filled by trained and dedicated personnel.

Contacts

Positions that We Train for:

1. Clinical Research Associate (CRA)

This individual is essentially the main link between the Sponsor/CRO (Contract Research Organization) and the investigative site(s). The CRA is responsible mainly for ensuring that the investigator (the physician conducting the trial) and his/her support staff are conducting the trial in accordance with the requirements of the sponsor as well as international and domestic regulations and GCP guidelines. The CRA will liaise with the Data Management department to ensure accuracy and completeness of the data collected. The CRA may also be responsible for recruiting and training investigators as well as recruiting patients for the study.

Background
A CRA should have a background in life sciences (Biology, Biochemistry, Pharmacology, etc.). According to ICH GCP guidelines, the minimum education requirement is a B.Sc. degree. Nurses, pharmacists and physicians (local or foreign-trained) make ideal candidates.

2. Clinical Data Manager (CDM)/ Clinical Data Analyst`(CDA) / Clinical Data Coordinator (CDC)

This individual works in the data management department and is mainly responsible for implementing patient data into the clinical database which includes data validation and verification as well as security of the database integrity, software and hardware among other specific duties and responsibilities.. The CDM should have a good understanding of GCP guidelines and regulatory requirements, as they do affect data management practices. The CDM would work with the CRA’s in data validation/verification, error-checking and with the biostatisticians in the data analysis. The position may or may not involve SAS programming.

Background:
IT professionals who are proficient in database software (i.e., Oracle). Sometimes individuals with a statistics background are considered for this position if they are comfortable managing databases.

3. Quality Assurance Officer (QA)

Quality assurance is a very important process at all stages of drug development. There is always a quality assurance/quality control specialist working at the manufacturing, laboratory and clinical levels. This position has a purpose of ensuring that the minimum standards set forth by the Sponsor are being met which would include at the very least, specifications set for the by GMP, GLP and GCP, respectively. Quality control procedures ensure that accurate results are met which are essential for the eventual approval process for the experimental drug (or medical device). The Sponsor may also hire an independent QA auditor to ensure that the work being done by the CRO is satisfactory.

Background:
The ideal background is chemical engineering, although other chemistry backgrounds are suitable as well as related sciences.

4. Management and Marketing Managers

Behind every successful business is an effective manager. The pharmaceutical industry is particularly intriguing because companies are dealing with budgets of hundreds of millions of dollars for a given clinical trial and the business people managing these trials must also be knowledgeable about clinical trials and pharmaceutical research in general. The effective manager in this industry will have a combination of business experience and/or education, a good sense of marketing, sales and negotiating skills, and a sound functional knowledge of the pharmaceutical industry.

Background
Individuals with a background in business (MBA) or several years of experience in the industry would do well.

5. SAS Programming

SAS is a very powerful software package used for statistical analysis in the pharmaceutical and financial industries (mostly). This training is usually offered to students in the DM and QA programs as an upgrade. There are few positions in the industry solely for SAS programmers; usually it is listed as a skill requirement for other positions.

6. Recruitment and Training Managers

Recruitment and training are two more important pieces of the puzzle. If a successful business is defined by it’s personnel, then a high degree of importance must be placed not only on finding the right people to fill the positions but also to make sure they are knowledgeable in every aspect of their duties and responsibilities. Effective recruiters are utilized to ensure the highest quality personnel are employed for the given budget, and suitable training programs are developed (either in-house or outsourced) to ensure the highest quality of work is produced.

7. Licensing for Physicians

Foreign trained doctors are required to pass a series of exams in order to practice in Canada as an MD. KRC provides a preparation course for the MCCEE and MCCQE1. (USMLE in USA)

8. Licensing for Nurses

Foreign trained nurses are required to pass an exam in order to work in Canada as an RN. KRC provides a preparation course for the CNAT. (CGFNS in USA)

Who are the instructors and what are their qualifications?

Bruce: senior online instructor for all programs has a PhD in medical education and has been working in the area of clinical trials for over 8 years.
Yuri: In-class instructor for CRA & DM; Medical doctor by profession, currently working in Data Management department and Medical Monitoring for a US Pharma in Toronto.
Mohammed: In-class and Online instructor for CRA & DM; currently working as a Clinical Data Coordinator for St. Margaret’s Hospital in Toronto.
Gilda: In-class instructor for QA has B.Sc. and QA diploma, working experience with GenPharm and GlaxoSmithKline.
Christopher: In-class instructor for QA.
Kamal: In-class instructor for QA, extensive experience in pharmaceutical industry.
Hugh: In-class and online instructor for MM, 14 years of experience with Health Canada in regulatory affairs.
Mudhar: In-class instructor for MCC, has been through the entire licensing process successfully.
Stella: In-class instructor for RN, has been through the licensing process and is currently working as RN in Toronto.

What does the Diploma say? Is the program accredited?
Our Diplomas state that the student has passed a program on ICH GCP which is standard requirement in this industry. Our programs are exempted from registration with Ministry of Education and Training as short professional development programs as per Post Secondary Education Act and Regulations, as mostly all ICH GCP courses couldn’t and shouldn’t be registered with these authorities, so it doesn’t diminish their value.

How can I get a job with no experience?
The most important thing is that you get reference letters from us on your project participation adjusted to your needs and reflecting all appropriate details of your active participation in full-scale research projects. Without proper reference letters it is completely useless to approach any serious Contract Research Organization or Sponsor (pharmaceutical company) in order to get a job as CRA. 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. 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 as CRA. You get active help in your new resume preparation. Remember, your resume is the first step to get a job.

Professional Training Scholarship Programs
P.V.N.H. (Promotion and Value of National Health) Scholarship Programs is a part of IBPA activity and are offered to students who wish to pursue a career in the biopharmaceutical field.
PVNH will consider any applicant who has the right educational background to take part in a professional development program, but is unable to do so due to financial difficulties. We encourage applications from all serious candidates. Every application will be given full consideration. Your exact scholarship amount will be determined based on your educational background, tuition fees and your financial situation. For more information please contact www.pvnhinfo.com

What kind of specialists does the Biopharmaceutical industry need?
There are approximately 3,000 dedicated biotechnology companies worldwide employing 230,000 people with the US accounting for 40% of firms and 70% of employment. The biotechnology industry consists of three groups: dedicated biotechnology firms, usually university spin-offs, researching disease mechanisms at the molecular level; traditional pharmaceutical companies (”Big Pharma”) marketing drugs developed by biotechnology firms; and a specialized tier of companies serving both the pharmaceutical and biotechnology industries with platform technologies that can speed up the drug discovery process or improve drug delivery. In coming years, shortfalls are expected to arise in certain research areas. People with expertise in bioinformatics, a field that requires a background in genetics, mathematics, and computers, will be particularly difficult to recruit as most graduates lack such inter-disciplinary training. In addition, as firms mature, there will be increasing need for regulatory clinical personnel, people with manufacturing expertise, and senior managers who can lead firms through product development, alliance negotiations, and commercialization. The international pharmaceutical industry has been the prime source of such expertise, but competition for such skills is intense.

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 the 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 matter is just how. One way of filling the vacuum is to take specialists from other professions and turn them into professionals for this industry, and this has several added benefits of its own. For instance, bringing specialists from other professions or industries actually diversifies the workforce and bring 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 who are re-aligning their careers. But also for individuals that are entering the industry as new graduates. Much of the skills and knowledge required for positions such as Clinical Research Associates, Clinical Data Managers, Quality Assurance Specialists and Marketing Managers are not covered in university courses. Even where an individual has been through a specifically designed training program for the position through an academic institution, the training may not involve a practical component in which case the individual may still be lacking in certain skills. This should re-emphasize the importance of practical training programs for the biopharmaceutical industry.

You need to have the right educational background to enter this lucrative industry. A life science degree (especially pharmacology, pharmacy, biochemistry, biology, immunology, physiology, or toxicology) or a nursing degree is one of the requirements to become a clinical research professional. A computer or IT degree will be an asset to start career as a clinical data manager. Chemistry, engineering are suitable backgrounds for Quality Assurance. Commerce, marketing and business management are suitable backgrounds for a marketing and management career. Other science degrees may be accepted. Licensed physicians may start career as clinical investigators.

Our training programs provide both industry specific knowledge and skills and practical clinical trial experience. These programs are designed to provide training in ICH GCP (International Conference on Harmonization and Good Clinical Practice), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) guidelines, clinical trial monitoring, investigative site coordination, knowledge and understanding of Food and Drug Administration (FDA), Therapeutic Products Directorate (TPD) regulations. Most importantly, these programs provide practical, real world, clinical trial experience through online training with actual projects.

Equipped with years of experience in creating and providing training, our institution has developed an understanding that the only qualified instructors are individuals employed in the industry. To this end we take a very serious approach to choosing the most qualified industry professionals to lead our training programs.

The combination of quality and accessibility of these training programs lead to their outstanding reputation in the industry and make them the corporate trainer of choice for several leading international pharmaceutical companies and government agencies.

Through intensive professional development training programs, Kriger Research Center provides a reasonable solution for the job seeker to gain a wealth of valuable knowledge. This new found knowledge empowers the individual to achieve higher career aspirations, both in monetary terms and in personal/intellectual terms. With this increase in self-worth, the job seekers is now more marketable in the industry and is therefore able to command a position with more responsibility and/or higher salary. (Note the distinction between an individual’s value which is what they’re worth and their marketability which is how attractive they are to an employer).

The training provided by Kriger Research Center plays a role in producing highly skilled individuals who are appropriately trained for their specific position and function. These candidates would enter the industry with
some level of practical experience and they will understand what really goes on in the workplace right from the beginning rather than figure it out for themselves as the go along.

How can the problem of absence of experience be resolved by enrolling trainees into different practical projects? What should those projects concern?
As discussed, an individual who is new to the biopharmaceutical industry can gain some practical working experience through project work, either paid or voluntary. This will greatly enhance one’s marketability for employment. In the case where a research company is providing the training, it is very easy to assign project tasks to trainees directly from the current research interests of the company. Of course, confidentiality and liabilities issues need to be considered while at the same time the tasks assigned should have a good representation of the duties and responsibilities of an employee in the same position.

Role of the Internet in the industry and training: Why this training could and should be entirely web-based?
The proliferation of the Internet has completely revolutionized the way we do business today. The ease of long distance communication has made it possible for companies to decentralize their operations and in many cases persons can do their job from the privacy of their homes. In fact many CRA’s work independently from home as consultants, perform their scheduled monitoring visits to the clinical sites and check in only periodically at the office.

Being able to work independently and use the Internet to one’s working advantage is in fact a skill that a talented individual needs to possess in order to prosper in today’s workforce. Indeed communicating by email as opposed to on the phone or in person requires a different use of language. In an email, there are no facial expressions, hand gestures, etc. Sarcasm could be taken in the wrong manner, and other misinterpretations are commonplace. So in a professional setting, we need to avoid these things as much as possible by using effective language which should be second nature. Again, it is a skill that must be developed and this is inherently accomplished in online training programs.

What is the importance of the training? How can good training compensate for the absence of experience in the employers decision to hire a specialist?
Professional development training programs are designed to produce highly skilled individuals to fill positions in the industry. This is absolutely important as it leads to a more efficient and productive workforce, that is; for each unit of resources spent (input), there is a higher return (output) and this could be manifested in monetary or non-monetary gains. An example of a non-monetary gain could be scientific advancement. Either way, the improved gains represent a higher growth potential for the industry, both scientifically and economically which are two major goals of the work that is performed in this industry.

It is possible for certain types of training to compensate for the absence of experience in these positions. The types of training that would be suitable again, would be those that involve some sort of practical experience even on a volunteer basis. Most academic training institutions will provide the theoretical aspect of the training and then have the students find themselves an internship position. The problem with this is that it is very difficult to find such internship positions and not all students will succeed.

What is special about international candidates? How to encourage them to undertake training and practice?
As we discussed before, an online training format has the benefit of developing effective electronic communication skills. More obviously, however, is the benefit of enabling long distance communication on a world-wide scale. This drastically increases the pool of human capital within a company’s reach. It also increases the options available to candidates located abroad; via the Internet, they gain access to networks of recruiters and employers as well as online training facilities. By investing in training programs, individuals from abroad can also boost their candidacy for immigration to a particular country. For example, in Canada individuals go through a scoring system in order to be considered for immigration and advanced skill sets can earn one more points. While indeed this globalization process has increased the competitive nature of the market, a larger variety of highly qualified individuals is made easily available.

Who can train CRA, QA, DM and Marketing and Management Specialists? How valid is this certification?
At present, there is no professional designation for the positions of Clinical Research Associate, Quality Assurance Officer, Clinical Data Manager or Marketing Manager although these are valid and mid – high ranking positions in the corporate structure. While there are many academic institutions that offer training courses for these positions, the ideal training environment would be in a research company itself where the trainees can gain access to a 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 nongovernmental agency validates, based upon predetermined standards, an individual’s qualification 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 hold 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.

Outsource Your Corporate Training: Expand Your Company’s Training Capability
When your company chooses an outsourced training solution, you gain immediate access to our skilled training specialists who can provide training sessions at your premises to become your virtual training department. Our pre-written training modules cover the whole spectra of issues critical to the successful operation within the biopharmaceutical industry and clinical trials. Each set of training modules is oriented to a specific department or group of employees within your company and can be customized according to your specific SOP’s. For companies that operate in highly regulated sectors of the biopharmaceutical industry, compliance training serves as an important part of a company’s overall compliance strategy. Regulations and laws can affect how a company interacts with its clients, its partners and vendors, and even its own employees. In the workplace, people have to follow compliance procedures very carefully. New employees need compliance training to understand the correct procedures and their importance while existing employees need training refreshers to ensure that they follow the current compliance guidelines.
A successful compliance training program becomes an active part of corporate operations.

KRGI programs set and achieve the following goals:

• identify all people who need compliance training,
• ensure that these training audiences receive up-to-date compliance training on relevant policies,
• conduct training evaluations to measure learning and workplace behaviors,
• provide quick reference aids to people who have to follow compliance guidelines,
• revise training materials whenever compliance requirements change KRGI creates custom training materials for your training needs using our existing pre-written training modules.
• We also offer to include appropriate SOP training specific to the company.

What is important about references in the Biopharmaceutical industry?

Another very important asset you will have in this business that doesn’t have a monetary value attached to, is your reputation. Your reputation is your credibility in this industry and it will go a long way. We can refer back to the previous example of hiring a Data Manager based on a reference over another stranger who submitted a resume by email. Now let’s consider there are two candidates both with personal references from colleagues. However, the first candidate, Mr. Bob comes with a reference from your friend Bill Gates and the second candidate, Mr. Zack comes with a reference from John Doe who gives a reference to anybody who walks in his door. Who would you be more likely to hire? Of course, you would be more inclined to hire someone with a professional reference from a credible source such as Bill Gates.

In the example above, we could easily replace the referrer’s name with the company name; that is, try replacing Bill Gates with Microsoft and John Doe with Julie’s Lemonade Stand. You still have the same effect, where Microsoft being a more credible source will earn Mr. Bob a higher regard in the recruiter’s opinion than Mr. Zack.

Similarly, you yourself have a reputation that you need to develop and eventually maintain and the company you work for has a reputation to build and maintain. Right now, you are embarking on a new career. You are going to start networking with other recruiters and employers as well as industry professionals in various positions. By conducting your business in a professional manner, you represent your company well and you represent yourself well. If you maintain a high level of standard and produce significant results, you will inevitably build on your reputation and this will lead you to a successful career. Never compromise your credibility; it will only be detrimental to you and your company.

Let’s take this another step further, what about the individual that is training to work in the industry? Now that you understand how reputation increases one’s human capital, how does someone with no experience or exposure to the biopharmaceutical industry build their reputation from zero? Again, here we see the benefits of training with a research company that can offer a practical working experience. Not only is the individual going to come out of the training with the practical skills, but assuming he/she has earned it, the company can give a professional reference on behalf of the candidate. Now the candidate has just begun building his/her credibility in the industry. Kriger Research Center has given many well deserved professional references in the past and because of our high regard in the industry for producing well trained individuals, companies respect and trust our opinion. Furthermore, this type of system is necessary in order to facilitate the hiring process and ensure that the highest quality candidates are filling the industry’s requirements.

Scholarships
All potential enrollees regardless of their nationality may qualify for a tuition discount through www.pvnhinfo.com

Our Mission Statement

to work cooperatively in supplying the industry with effective solutions for:

• training candidates for entry-level positions
• training candidates for advancement
• connecting the right candidates with appropriate training
• connecting the right candidates with the appropriate positions/employers
• reducing the costs associated with recruitment and training
• reducing the time and other non-monetary resources associated with recruitment and training
• creating professional relationships within the industry