A Clinical Research Associate (CRA) is a highly skilled profession in the field of clinical research. The job of a CRA is to manage, monitor and coordinate clinical trials. In doing so, CRAs work closely with doctors, medical staff and study participants to ensure that all aspects of a study are conducted correctly and that the safety of the participants is guaranteed.
Duties of a CRA
The duties of a Clinical Research Associate include all activities necessary to ensure the smooth running of a trial. This includes:
- Analysis of suitable facilities for the study
- Advising and supervising participating physicians and other personnel
- Reviewing and evaluating drug studies
- Checking that the data collected comply with pre-defined guidelines
- Preparation of monitoring reports and documentation of study progress
- Reviewing erroneous data
- Control of the entire process
- Responsibility for patient safety
- Regulatory framework
There are a number of guidelines that must be followed when conducting clinical trials. These include the requirements of Good Clinical Practice (GCP). GCP is an internationally recognised set of rules for conducting clinical trials, based on ethical and scientific principles. The Declaration of Helsinki, a declaration of the World Medical Association on ethical principles for medical research involving human subjects, which is considered the standard of medical ethics, must also be observed. In addition, there are national laws and regulations, such as the German Medicines Act or the Medical Devices Act in Germany and Austria.
Requirements and qualifications for CRAs
The requirements for a Clinical Research Associate can vary depending on the study, employer and region, but some very typical requirements and prerequisites are:
- Education and expertise: Academic training in life sciences, pharmacy, medicine or similar is usually a prerequisite for a career as a CRA. In-depth knowledge of GCP guidelines, clinical research methodology, ethical principles and regulatory requirements is also usually expected. Numerous training courses are available to prepare for these topics.
- Experience: CRAs with experience in clinical research are usually sought, for example by working for contract research organisations or research institutes. Initial experience in preparing study documents, working with ethics committees and monitoring clinical trials is desirable.
- Good clinical practice (GCP): Clinical research associates must have a thorough knowledge of GCP guidelines, which describe the quality standards and ethical principles for conducting clinical trials.
- Communication skills: As CRAs interact with various stakeholders on a daily basis, they must have effective communication skills. They must be able to communicate clearly, both orally and in writing, and convey complex content in an understandable manner. The ability to work in a multidisciplinary team of physicians, trial participants and other stakeholders and to build rapport with all is also important.
- Organisational skills and attention to detail: CRAs need to manage a variety of tasks in parallel and keep track of multiple studies and protocols. Great care and attention to detail are required to ensure that all aspects of study monitoring and documentation are carried out correctly.
- Willingness to travel: Due to the specific requirements of different studies, they are conducted in different study centres. Therefore, working as a CRA requires a certain amount of travel. You will need to travel to the sites where the studies you are responsible for are being conducted to monitor and coordinate them.
Do you have a vacancy for a Clinical Research Associate (CRA) or would you like to develop your career in this area? Contact us and we will find the perfect match for your individual circumstances.
