Why studies?
The development of a drug, medical device or treatment method requires extensive clinical tests (phases I-III) before marketing authorization can be granted. These clinical studies test the effectiveness, safety and benefits of the new development. To ensure that the test subjects do not suffer any harm, this process is subject to strict regulations and laws (AMG, MPG), which are monitored by authorities and ethics committees.
Before a study can begin, pharmaceutical companies and study centers must submit numerous applications and plans. Once approved, the study is carried out in practice and coordination of all steps is crucial. This includes:
Planning and implementation: Every step of the study team, from patient visits to data collection, must be precisely organized and timed.
Documentation: All data, especially in the eCRF (electronic case report form), must be recorded completely and correctly.
Patient safety: Strict compliance with all regulations and safety measures is essential.
Communication: The collaboration between study nurses, investigators and coordinators must function smoothly.
The study coordination assumes the central role of monitoring all processes and ensuring that the study runs successfully according to the specifications.
What tasks does
the study nurse?
Study coordination requires structured thinking and strong organizational skills, which are acquired through qualified training and practical experience. Study nurses play a central role in this. They communicate intensively with patients, coordinate appointments and work closely with investigators to implement the study protocol. The tasks are varied, responsible and diverse and require not only commitment but also professional handling of patients and monitors as well as precision in documentation.
Top 10 Tasks of Study Coordination
Understanding the study protocol and its requirements
Completion of the enrollment through study monitoring
preparation of study and patient documents
Appointment scheduling for patients at the study center (Site Nurse Service) or as Home Trial Support
Conducting the visits, with or without a study doctor
Assessment of the patient's health status and vital signs monitoring
collection of blood and other samples
Shipping of samples by courier or on dry ice
Application of the test preparation (oral, subcutaneous, intramuscular, intravenous)
Documentation of the data in the eCRF, with subsequent review by the investigator
These activities require a high degree of accuracy, responsibility and communication skills to ensure the success of the clinical trial.
What advantages does VaLea ct offer for study nurses?
Starting or switching to the profession of study nurse or study coordinator can often be difficult at study centers due to a lack of permanent positions. Nevertheless, there are numerous study projects, which is why VaLea ct is actively working to promote and integrate this professional group. Study nurses are constantly in demand, and here are the main advantages of working with VaLea ct:
missions in your region
High appreciation and above-average remuneration
Flexible and independent work
Possibility to work as a main or secondary job, in addition to a permanent position
Support from a network of professional colleagues
Personal and economic independence
Regular subject-specific training courses
Arrange a free, non-binding initial consultation! Valentina Jovanoska from VaLea ct will be happy to inform you about the necessary training and further education as well as the tailor-made support we offer for your career path. Start your successful future as a study nurse now!