Study nurse

A study nurse (Study Coordinator, Research Assistant, Research Nurse) is a study assistant who assists in the supervision or conduct of clinical trials. The job can be carried out at a trial center (hospital or doctor's office), at a clinical research organization or at a pharmaceutical company or manufacturer of medical devices. A study nurse is not an educational profession, but they are usually highly qualified. In addition to good computer and English skills, a sound command of medical terminology is essential. For this reason, most study nurses have completed training as a specialist nurse, MTA or medical assistant with many years of professional experience or as a medical documentalist.

The tasks of study nurses are very diverse: study assistants are a link between investigators, study participants, clinical research associates, sponsors and clinical research organisations. The tasks are very variable and can be:

• Data entry into the CRF(Case Report Form) or eCRF
• Collection, documentation and storage of source data
• Organisation and support of the selection visits
• Coordination and preparation of monitor visits
• Administration and maintenance of study folders / investigator folders / Trial Master Files (TMF)
• Organization of all appointments (e.g. examination appointments of patients, laboratory tests, etc.)
• Answering queries
• Preselection of study patients
• Making appointments with study patients and clinical monitors
• Contact person for the patients
• Telephone rounds
• Participation in study meetings
• Organization of study meetings Shipping of laboratory samples, investigational medicinal products, etc.
• Submissions to the authorities and communication with the ethics commissions
• Preparation and monitoring of audits / inspections
• Laboratory tests and writing ECGs or other performance of functional diagnostics
• Quality Management
• Creation of SOPs(Standard Operating Procedures)

Study Nurses work according to GCP (Good Clinical Practise) and help with the rule-compliant implementation of clinical studies according to AMG and MPG.