About this role
Clinical Trial Assistant What does a Clinical Trial Assistant do? As a Clinical Trial Assistant (CTA) you hold an essential position within a clinical operations team. This might be at a pharmaceutical company, a clinical research organisation or a clinical research unit in a university hospital. The CTA is responsible for supporting clinical drug research and development tasks. You work closely with Clinical Research Associates (CRA) , who monitor the progress of the study, and Clinical Project Managers (CPM) . You may also work with research nurses, researchers and doctors in hospitals. You have an important task in study start-up, digital sending, tracing and administration as well as saving essential documents (e.g. case report forms, CVs, study protocols, investigator brochures, informed consent forms and study supplies), and filing important records related to side effects. Clinicak Trial Assistant Are you looking for a job as Clinical Trial Assistant? What responsibilities can you expect as a Clinical Trial Assistant? Clinical Trial Assistant roles and responsibilities cover a range of tasks in support of a clinical study. These can include: - Collecting, registering and archiving information and documents in accordance with the applicable good clinical practice guidelines for clinical studies; - Preparing investigator site files, trial master files (TMF) and electronic trial master files (eTMF) for the initiation of participating centres in clinical studies; - Identifying needs, bottlenecks and deviations within your own study team; - Participating in projects or initiatives on request, or on your own initiative; - Taking on department-wide tasks to contribute to the optimisation of processes within the department; - Maintaining the complete documentation for the studies assigned; - Ensuring complete and correct study administration in accordance with the standard operating procedures and the ICH-GCP guidelines; - Submiss...