What are the responsibilities and job description for the Clinical Trial Assistant position at The Steely Group?
The Clinical Trial Assistant is responsible for supporting clinical research and development tasks. The CTA will work closely with the Clinical Operations team, responsible for monitoring, planning, and executing clinical trials. 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.
Clinical Trial Assistant roles and responsibilities cover a range of tasks in support of a clinical study, including :
- 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 centers 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 optimization 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;
submission of clinical trial documents for review and approval Requirements :
Bachelors degree
2-4 years relevant CTA experience, ideally in biotech
Excellent communication and organizational skills
