Study nurse

Author: Prof. Dr. med. Peter Altmeyer

All authors of this article

Last updated on: 29.10.2020

Dieser Artikel auf Deutsch

Synonym(s)

Study assistant

Definition
This section has been translated automatically.

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.

General information
This section has been translated automatically.

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)

Note(s)
This section has been translated automatically.

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

Authors

Last updated on: 29.10.2020