Identyfikator 0000053749: Clinical Research Coordinator (CRC) with TÜV Rheinland Certified Qualification

Strona jest dostępna w innych językach: German
Tytuł kwalifikacji:Clinical Research Coordinator (CRC) with TÜV Rheinland Certified Qualification
Wymagania wstępne:

Additional qualification for specialist medical personnel (e.g. Nurses / Doctor’s Assistants, Medical Documentation Personnel, Specialized Medical Employees, Medical Technical Assistants).

Successful participation in the qualification “Clinical Research Coordinator (CRC) with TÜV Rheinland Certified Qualification“ according to the PAREXEL International training concept, comprising 40 teaching units, recognized by the personnel certification body. Admission to the exam is granted with 80% attendance of the training course.

Składowe egzaminów:
  • Written Examination (Multiple Choice)
Wymagane kompetencje:

During the examination participants prove their knowledge in the following areas:

  • Fundamentals of clinical research
  • Guidelines and legal fundamentals
  • Responsibilities ICH-GCP
  • Essential documents
  • Monitoring clinical trials
  • Requirements for source data
  • AE / SAE security data
  • Dealing with Test medication
  • Trial coordination
  • Quality Assurance

Successful participants are qualified in the independent and responsible organization and implementation of clinical trials. They have a good understanding of the legal framework and ethical fundamentals of  “Good Clinical Practice” (GCP), which regulate the implementation of medical trials today. They play a central role as contact person for test doctors, monitors, the trial coordination office, and patients alike. They make an essential contribution towards looking after the trial participants, the collection and documentation of trial relevant data and the preparation and accompaniment of monitor visits (rounds), audits and inspections.

Currently implemented in:Niemcy