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.
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.
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 can include:
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.'
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 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:
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.
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 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.
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.
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.
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:
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:
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.
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.