Who are we?

Kriger Research Center Inc. (A part of Kriger Research Group International) 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 and training courses from experts in various fields.

We have good working relationships with clinical research recruiters, 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.

Upon successful completion of our programs, students receive a Diploma that states the student has passed a program on ICH Good Clinical practice (GCP), which is a standard requirement in the industry.
 
The most important benefit of our program is that our students take part in projects that give them 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.

Since clinical trials are conducted with strict confidentiality, there is very little public information available about on-going clinical trials.  Contract Research Organizations (CROs) rarely give out information about projects they are involved in.  However, some sponsors voluntarily register their trials; if you are interested in seeing some clinical trials that are in progress, you can visit this site: http://www.clinicaltrials.gov/.

Why are there not enough Clinical Research Associates (CRA) on the market and why is it important to train the new specialists out of other professions with the right educational background?

The market is currently expanding faster than the introduction of newly qualified professionals that 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.  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 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 (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 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 can 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. Also, there are no Canadian undergraduate degree programs in bioengineering; specialization options are normally offered within more traditional programs.

Who can train Clinical Research Associates? How valid is this certification?

The ideal training environment would be in a research company where trainees can gain access to practical experience.  Most companies are very reluctant to hire individuals without any experience, so even 6 months as a volunteer is beneficial in getting 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 a 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 dealmaker or deal breaker when a person is considered for a position.

CRA Job Description

A Clinical Research Associate is a professional who administers and monitors the progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, whether it is new drug substances and or currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.

Typical Work Activities

Typical work activities can include:

• locating and briefing suitable doctors/consultants (or investigators) to conduct the trial;
• developing, writing and presenting the clinical trial protocols;
• setting up the study centers - ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done;
• monitoring the trial throughout its duration, which will involve visiting the study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise;
• validating and collecting completed CRFs from hospitals and general practices;
• closing down study centers on completion of the trial;
• discussing results with the statistician. A medical statistician usually carries out writing technical reports on the trial.

The specific duties a CRA performs can vary tremendously from company to company. In some companies, you would be involved in the whole process - from sitting down with the doctor who has the idea for a trial, and actually working out a protocol, to writing up reports after the analysis has been done. In other companies it would be the medical adviser who initiated the trial and you could just be involved in collecting data once the trial has been set up.

One CRA summed up the work by saying:  'I enjoy the project related aspect of CRA work - there's a good mixture of short-term tasks which are quickly achieved and offer a lot of small challenges, and longer term objectives and aims.'

Work Conditions

• Typical starting salaries begin around $ 40,000, increasing to $ 60,000 USD with 2 – 4 years experience;
• CRAs with from 3 –5 years or more of experience have salaries that typically range from $60,000 to $ 90,000 USD
• Salaries vary quite widely from company to company. A car is generally provided and bonuses may be paid.
• Working conditions also vary between companies. You will need to work extra hours regularly, although weekend or shift work is uncommon. Generally a limited amount of time is spent in the office. The work involves significant travel visiting trial centers, general practitioners (GPs) or hospitals and working with doctors and research nurses. The work requires a professional dress code. In some companies, CRAs operate from home, only visiting the office for briefing meetings, training, etc. The majority of the time, CRAs will work alone. Self-employment or freelance work is sometimes possible and some contract houses employ CRAs on a freelance basis. Part-time work may be possible but is more likely in a contract house. There are 70-80% women in the profession and career breaks are possible.

Time deadlines can make the work stressful. Travel within a working day and absence from home at night are both frequently needed, which may disrupt home life. Some companies operate a system whereby the CRA specializes in a specific disease area and therefore covers the whole of country - others operate their CRAs on a regional basis. If you are working for an international company, you could be coordinating trials outside the country, so a considerable amount of overseas travel would be necessary.

Entry Requirements

Entry into the profession without a degree or without a certificate is unlikely, although it is occasionally possible to enter from the administrative side. A relevant PhD is advantageous in some companies, both for entry and to gain promotion to senior positions or to move into protocol development.

The relevant degree subject area for a career in clinical research is life and medical science.  A life science degree (especially pharmacology, pharmacy, biochemistry, immunology, physiology or toxicology) or a nursing degree is one of the requirements for entry into CRA work.  Many CRAs come from the nursing profession, but a growing number of graduates with a background in biology or pharmacy are entering the profession. 

In particular, the following subjects may increase your chances:

• anatomy
• biochemistry
• biology
• biomedical science
• dentistry
• microbiology
• medicine
• nursing
• molecular biology
• physiology
• pharmacology
• pharmacy
• veterinary medicine
• toxicology

In addition to a scientific or nursing background, companies will look for excellent communication skills (both written and verbal), computer skills (creating and working with databases), an ability to get on with people and an eye for detail. Numeracy, negotiation, commercial awareness, time management, good organizational and administrative skills are also important. The job requires a lot of self-motivation and the ability to assimilate information quickly. A mature attitude is essential and mature students with relevant past experience may have an advantage. The people aspects of this job mean you will need to show an outgoing, confident and friendly personality. A driving license is needed and you must be able to understand the importance of Good Clinical Practices (GCP). Having relevant pre-entry experience is desirable and could include: a medical practice, a nursing background, medical sales, clinical laboratory work, clinical data work and pharmaceutical research.

It is relatively unusual for a graduate with no relevant prior experience to go straight into CRA work, although some companies will employ recent graduates with the necessary personal skills. As a graduate with no previous relevant experience you would be more likely to enter the field at a lower level (e.g. as a clinical data coordinator). These are generally jobs that deal with the data handling/co-ordination part of the CRAs job without the involvement of initiating and designing the trials. Experience in this type of work would generally qualify you to move on to a CRA position.

Training

This is mainly in-house and on-the-job, supported by short courses in specific topics. Some companies offer block or day release to CRAs to pursue clinical studies courses such as qualifications in clinical research or clinical science

Career Development

Career structures will obviously vary from company to company and are not always very clear-cut. However, most companies have clinical trials management/executive positions that would be the next step for an experienced CRA. Some companies prefer individuals with PhDs for senior posts. For positions such as medical adviser or medical director, a medical degree is usually required.

Typical Employers

You would either be employed directly by pharmaceutical companies or by contract research organizations (CRO - agencies which employ clinical research staff to contract out to pharmaceutical companies). Hospital academic departments occasionally employ CRAs.

Sources of Vacancies

CRAs are in demand, due primarily to the growth of new drug development in the biotechnology and pharmaceutical industries, but also due to the ever-tightening government regulations on the licensing of new drugs and re-licensing of existing drugs.

There are several sources to find employment opportunities as a CRA.   You can contact a careers service. It may also be worthwhile to register with specialist recruitment agencies.  In addition, you can try approaching pharmaceutical or CRO companies directly.

Clinical Research Professional Certificate

This certificate program is designed to provide a focused course of study for individuals seeking to position themselves for clinical research and pharmaceutical trials industry as a clinical research associate or a clinical research coordinator. It will also provide knowledge and skills of clinical excellence in monitoring scientific studies toward the advancement of knowledge and improvement of health. This course provides a comprehensive overview of the roles/responsibilities of both the CRA and CRC. This program was created to provide you with the key aspects, differences, challenges, job criteria and demands, and industry expectations of both job roles. We will provide the foundational preparation you need to become a Clinical Research Associate (CRA) and /or Clinical Research Coordinator (CRC). Course content will focus on key concepts and information essential to effectively function in the research arena. This course can open doors to new and exciting career opportunities in clinical research as the demand for qualified and trained CRAs and CRCs continues to grow.

This course will provide the preparation you need to enter the pharmaceutical research arena as a Clinical Research Coordinator (CRC). CRCs assume overall responsibility for assisting the investigator in conducting clinical studies of experimental drugs and devices.

Typical CRC job responsibilities include:

• tracking the status of all study activities
• scheduling study procedures
• developing operational plans
• managing the day-to-day activities of a study
• serving as the primary contact with a sponsor

Course content will focus on key concepts and information essential to functioning in the research arena. The program begins with an overview of the drug development process and the regulated environment. Other topics to be covered include skills and insights in areas related to negotiating budgets, sponsor site visits, clinical protocols, monitoring visits, subject retention, and general management procedures. Completion of this course can open doors to new and exciting career opportunities in clinical research.

The demand for qualified CRAs has grown rapidly over the past several years and is expected to nearly double within the next ten years. CRAs are usually involved with extensive travel while they monitor clinical investigations of experimental drugs and devices. Course content will focus on key concepts and information essential to effective functioning in the research arena. The program begins with an overview of drug development and the regulated environment. Other topics to be covered include critical skills and meaningful insights in areas related to the management of pre-study activities, study protocols/initiation/ management/term international procedures and collateral project level activities. This course can open doors to new and exciting career opportunities in clinical research. We will provide you with information on how to get in touch with potential employers. A follow-up survey of our participants indicates that over half of the course participants are working in the clinical research field after completing our program.

Upon program completion, participants will be able to:

• describe the drug development process
• describe the phases of a clinical trial
• list the responsibilities of sponsors, investigators, and institutional review boards
• describe primary roles and responsibilities of the CRA and CRC
• list the required contents of an informed consent form
• identify documents that are part of an investigator study file
• state how to grade and report an adverse event
• understand the ethical principles guiding the protection of human subjects
• appreciate the types of Sponsor-Investigator site visits

Upon completion of this course, participants will be competent and possess the valuable skills needed in order to conduct and manage a well-organized and controlled clinical research study.

Why do we ask open-ended questions?

In our courses, we ask open-ended questions to prepare 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 demonstrate competency in professional terminology and related concepts. You are encouraged to use this opportunity to prepare yourself for a real job interview by answering our open-ended questions as best as you can.

Clinical trials are about medicine.  Even though pharmaceutical companies and CRO's advertise that they want 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. 

Understanding and true interest in medicine could be more important than formal medical education in applying for data management positions in clinical trials.

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, interactive practical open and multiple-choice questions. Upon completion of this program you will pass on-line final exams and receive (by mail or in person) a Diploma outlining your new qualifications.
2. You receive a specially designed Diploma stating the program objective:  "ICH GCP Guidelines, Clinical Trial Monitoring and Research Site Coordination.".  These are essential requirements for any position of Clinical Research Associate / Coordinator. (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 Clinical Trial Projects: EGF03/CT PRODUCT: Recombinant Human Epidermal Growth Factor, ISTA project, Prolipostat Project and PUCR project, preparing CRFs (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 participate and gain unique experience in a Clinical Research Phase IV Post Market Surveillance Project (See Course Program enclosed). Any experience in a research area is crucial in order to get a job as Clinical Research Associate / Coordinator Positions.
5. 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.
6. You get constant support of our research center staff when you mention our institution in your resume under refrences. Prospective employers are highly likely to check references via personal phone conversation. When a prospective employer contacts us for a reference, we will relay all the details of your research participation and appropriate qualifications. This can drastically increase your chances to get a job as Clinical Research Associate / Coordinator.
7. You upgrade your resume. Remember, your resume is the first step to get a job. Upon completion of our training program, you can include in your resume 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.
8. You will get a substantial return on your investment in your education and training at KRC.