“The cool thing about the job is that you can do both:
free market economy as well as research.“
– Dr. Robert Holzmann*, Clinical Research Associate (CRA) –
Robert works as a Clinical Monitor (also Clinical Research Associate, CRA) at one of the largest contract research organizations (CRO) in Germany that conducts clinical research. More precisely, this means that his employer carries out clinical trials on behalf of pharmaceutical companies that are, for example used to analyze new drugs for human tolerance and their effectiveness. Ultimately, the clinical trial provides data to be used for the assessments whether a new drug substance should be gain a marketing authorization or not. Some pharmaceutical companies are also doing these studies themselves.
Robert’s department has roughly 70 employees, with some CRAs working in the office and some working from home.
The linchpin of the work of Clinical Research Associates (CRAs) is the investigation of drugs in large-scale studies. (photo: www.pixabay.com)
The main focus of Robert’s work are drug studies, of which he supervises about two to three at the same time. Since the studies are carried out in several clinical trial sites all over Germany ( and sometimes also in Austria and/or Switzerland), he is responsible for only some of the involved sites while his colleages are in charge of the remaining. For the CRA, a new clinical trial usually begins with scouting for potential sites and a check for their overall suitability. During a first visit Robert presents the planned research project, inspects the conditions on site (laboratories, equipment, staff, etc.) and summarizes his impression in a report. If the center is suitable for participating, he pays a visit for a second time and presents the study in more detail to the responsible doctors and study assistants planned to be involved. At the beginning of the study, Robert organizes that the site has all documents, vendors and medication available for the implementation on site.
Once the study has been inititated, the actual monitoring begins: Robert visits the sites on a regular basis and controls the course of the study, documents changes and checks the medication. Depending on the study design, Robert visits all the sites that he supervises in regular periods; from two weeks up to three months. Clinical trials in his area of work usually last between three and five years in total.
At longer intervals, approximately every three to six months, Robert attends web meetings, which allow doctors, study assistants and clinical monitors to exchange experiences. In some cases, Robert presents up-to-date statistics on the study concerned. Challenges encountered during the study are also discussed. Every one to two years Robert takes part in a three-day so-called investigator meeting. This meeting often takes place at the beginning of a study and invites investigators (doctors that participate in the clinical trial) and clinical monitors across Europe. In general, he has a lot of contact with the local people who carry out the studies at his sites. These are primarily doctors and study assistants. He not only telephones and writes e-mails with them, but also exchanges information with them personally about incidents and questions about processes of the clinical trial on site. Robert estimates the proportion that communication takes up in his working hours at around 30 %.
Robert checks the documents in the study center for their technical correctness and for appropriate documentation. (photo: www.pixabay.com)
However, he spends most of his work on site checking the (patient) files for their technical correctness and documentation (source data verification). This work area spans around 40 % of his working time. Robert spends around 20 % of his working time on the road by plane, train or car or on site at the study sites. The travel time is not fully counted as working time. Nevertheless, Robert uses them a lot for the preparation and follow-up of his on site monitoring visits. As part of his work, Robert travels a lot in German-speaking countries. Unfortunately, there is usually little time to take a closer look at the cities in which he is staying. Robert usually stays in hotels and enjoys their sports and leisure offers in the evenings.
He spends the rest of his working time in the office, making arrangements with his colleagues and the project manager, ordering study materials, administrative tasks and organizing his next trip.
In his job, Robert is also in contact with the (federal) health authorities and ethics committees, which he addresses in the event of legal and ethical uncertainties. Robert contacts the medical director of the study with any medical questions. He contacts the lead CRA if he has organizational questions about the study. In some cases, Robert is also in contact with the client, i.e. the pharmaceutical company, e.g. for agreements on medication or to give the customer an overview of the course of the clincal trial.
Robert’s job is very varied, so it is difficult to describe a typical working day. It is very likely that Robert communicates with study doctors and / or assistants every day to answer their questions about the clinical trial he is supervising. Robert’s phone can ring all the time and someone from a (different) trial site or project calls or emails him. But it can also be that he is attending a meeting, giving a lecture in one of the study sites or sending information about a clinical trial.
A degree in biology, medicine or pharmacy and related subjects is a prerequisite for Robert’s job. He himself studied biochemistry and deepened his knowledge of molecular biology in his subsequent doctoral period. Everyone without a doctorate who is interested in working as a CRA can be relieved here: this is not a requirement for CRAs.
The other technical knowledge that is required for this job profile can be learned on the job or in a separate training (see WHAT ELSE HE BRINGS WITH FOR THE JOB).
Robert would name communication skills and social skills as the most important interdisciplinary requirements in his job, as you work with a lot of different people and you have to make sure that everything runs smoothly. For this it is an advantage if you also have a good dose of organizational talent and empathy. You should also enjoy detailed work and legal provisions, as checking the files requires meticulous work.
Robert travels a lot for his work. When he is not traveling by train, he uses the plane or the car. (photo: www.pixabay.com)
The continuous visits to the study centers require a certain willingness to travel for CRAs. You travel a lot and spend a fiar share of nights in hotels. Robert explains that he learned many required skills during his PhD, e.g.: presenting or target-oriented discussions with clients. In this way, he can communicate safely and confidently with his respective counterpart.
Some companies impose a dress code on their CRAs for reputational purposes. Sneakers and jeans are better left at home!
A move to the laboratory during this time also trained him to persevere and organize. Before Robert became a clinical monitor, he worked for the same company as a clinical project administrator. In this job you are already working on the clinical trials, so that he has gained a deep insight into this professional field.
In some companies it may be necessary to have a driver’s license in order to drive to the study centers in a rental car.
In further training to become a clinical monitor, one learns the anatomy of the human body. (photo: www.pixabay.com)
There is a training course for clinical monitors that Robert completed with the support of the Employment Agency. It lasts four months and costs around € 3000.
In the advanced training, you get to know medical-pharmacological knowledge that is essential for practicing the profession, including: Pharmacology, anatomy and pathology. Ethics, pharmaceutical law and administration are also covered. The training also includes a block of specialist English and application training. In addition to the certificate of the clinical monitor, one receives the good clinical practice certificate, which is also recognized by the ethics committee and pays off to have.
Robert usually worked a little more than was planned with his 40-hour week. His job is well suited as a part-time job, but it may be easier to get started with a full-time job, in which you then reduce the number of hours as required. Overall, the tasks can also be done well working from home, so that presence in the office is not absolutely necessary. Some of his colleagues worked exclusively from home, including experienced monitors from the very beginning. In general, men and women in this occupational field are employed in the same ratio.
There are several career opportunities for a CRA. On the one hand, he can be promoted to line manager. In this job you are the direct supervisor of CRAs and take on their personnel management. Robert could also apply to be a project manager. In this professional field, you are responsible for studies carried out worldwide and instruct CRAs in this regard. Robert could just as easily set up his own business and continue to work as a CRA as a freelancer for various pharmaceutical companies. It would also be conceivable to set up their own organization together with other CRAs.
Although Robert leads the clinical trials on site, he has no authority over the staff in the study sites. If you are looking for a management position as a CRA, you are unfortunately out of place (exception: Line Manager).
Further training as a clinical monitor is not a prerequisite for the job. However, a doctorate can potentially have an advantage in terms of job placement or promotion.
The starting salary of CRAs is around € 40,000 gross per year. Eventually you can get additional bonuses. Robert feels that the content of the job is appropriate. However, since you negotiate it yourself, it varies from person to person and from company to company.
A CRA job is not only a classic entry-level activity in general professional life, but also in a pharmaceutical company or the pharmaceutical industry. If you want to get in there, you can do it this way. Getting started may be made easier by stays abroad: The experience you gain abroad and with other cultures is very beneficial in the global pharmaceutical industry. For a successful CRA, a good relationship and pleasant interaction with the staff in the study sites are of great help. This not only stimulates cooperation, but in this case brings both sides faster than the goal.
“Close your eyes and see it through!“, Robert would advise his student self, if he stood in front of the younger self who may tormented with a little fun activity. Because: Nobody is married to their job.
The interview was conducted in August 2013.
*Name changed