A Clinical Research Associate is a professional who monitors the administration and 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, including new drug substances and currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.
CRA JOB PROFILE
Clinical Research branches off into various categories at the entry level. The most common entry-level position is that of a Clinical Research Associate (CRA). The role of a CRA is varied, they are key participants in the design, implementation and monitoring of clinical trials.
JOB PROSPECTS IN CLINICAL REASEARCH
The demand for professionals in this field of clinical research is growing rapidly. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. According to a survey, there are 2, 50,000 vacancies available worldwide. Highest remuneration packages owing to the shortage of skilled professionals.
KEY JOB RESPONSIBILITIES:
Developing and writing trial protocols (outlining the purpose and methodology of a trial).
Presenting trial protocols to a steering committee.
Designing data collection forms, known as case record forms (CRFs).
Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.
Locating and assessing the suitability of facilities at a study centre.
Liaising with doctors/consultants (or investigators) on conducting the trial.
Setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards.
Training site staff to industry standards.
Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis.
Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
Collecting completed CRFs from hospitals and general practices.
Writing visit reports.
Filing and collating trial documentation and reports.
Ensuring all unused trial supplies are accounted for.
Closing down study centres on completion of the trial.
Discussing results with a medical statistician, who usually writes technical trial reports.
Archiving study documentation and correspondence.
Preparing final reports and occasionally manuscripts for publication.
Typical Work Activities
Typical work activities include :
locating and briefing suitable doctors/consultants (or investigators) to conduct the trial;
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. Writing technical reports on the trial is usually carried out by a medical statistician.
The job of a CRA 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.’
Typical starting salaries range from $ 40,000 to $ 60,000
Typical salaries with 3 and more years of experience range from $60,000 to $ 90,000
Salaries vary quite widely from company to company. A car is generally provided and bonuses may be paid.
Working conditions 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 is mainly on the road visiting trial centers, general practitioners (GPs) or hospitals; dealing with doctors and research nurses. The work requires a fairly smart dress code. In some companies, CRA’s operate from home, only visiting the office for briefing meetings, training, etc. For the majority of the time the CRA’s will work alone. Self employment or freelance work is sometimes possible and some contract houses employ CRA’s 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.
Jobs are found in restricted locations. Some work is localized (company laboratory) and some are regionally based.
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.
The relevant degree subject area is life and medical science. In particular, the following subjects may increase your chances:
- biomedical science;
- molecular biology;
A life science degree (especially pharmacology, pharmacy, biochemistry, immunology, physiology or toxicology) or nursing degree is one of the requirements for entry into CRA work. Other science degrees may be accepted. It is, however, 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, which deal with the data handling/co-ordination part of the CRA’s 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.
Entry without a degree or without a certificate is unlikely, although it is occasionally possible to enter from the administration 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.
In addition to a scientific or nursing background, companies will look for excellent communication skills (both written and verbal), an ability to get on with people and an eye for detail. Numeracy, commercial awareness, 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.
Because of the ever-tightening government regulations on the licensing of new drugs and re-licensing of existing drugs, the need for CRA’s is increasing.
This is mainly in-house and on-the-job, supported by short courses in specific topics. Some companies offer block or day release to CRA’s 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 which would be the next step for an experienced CRA. Some companies like 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 CRA’s
Sources of Vacancies
See specialist press for recruitment agencies or contact your careers service. It may be worth registering with specialist recruitment agencies such. Alternatively (or in addition) 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 is still growing.
This course will provide the preparation you need to enter the pharmaceutical research arena as a Clinical Research Coordinator (CRC). Employment opportunities for qualified CRCs continue to grow. 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.
This course will provide the foundational preparation you need to become a Clinical Research Associate (CRA). 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 1/2 of the course participants are new 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.