In this position you are responsible for setting-up, initiating and closing down investigational sites in the Netherlands. You are also responsible for monitoring and reporting on study progress of clinical trials in the Netherlands in accordance with established scientific, internal and Good Clinical Practice (GCP) guidelines in order to meet the research and commercial objectives of the company.
CRAs will typically be responsible for managing 10 - 12 investigational sites at any given time, depending upon the nature and complexity of the trial.
Duties & Responsibilities The CRA will • ensure that the clinical trial is conducted in accordance with company SOPs, GCP guidelines and other regulations in force • establish excellent working relationships with external personnel directly involved in trial conduct and maintains these despite the difficulties that often arise during the course of a clinical trial • work with the personnel at the sites to ensure patients are recruited and managed both safely and effectively in order to meet the study targets • develops and maintains knowledge of many areas of science and medicine in order to facilitate study conduct, understand patient management and ensure adequate reporting.
Requirements • Appropriate education (life science university degree / nursing qualification / any other para-medical education) • Minimal 2 years of experience in clinical trials • Knowledge of and experience with GCP and other regulations in force; ability to learn and apply SOPs • Good IT skills in, e.g. MS Office, are essential for planning, tracking, communicating and reporting