Job Overview
This is an exciting opportunity to work as a seasoned Clinical Trials Assistant in the Düsseldorf area. You will be responsible for preparing and documenting clinical research projects in various therapeutic areas, assisting with data management, creation of study-related documents, and correspondence with internal departments, research sites, and clients.
Key Responsibilities
* Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams with updating and maintaining clinical documents and systems, ensuring site compliance and performance within project timelines.
* Prepare, handle, distribute, file, and archive clinical documentation and reports according to standard operating procedures.
* Review study files for completeness and assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
* Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
* Act as a central contact for designated project communications, correspondence, and associated documentation.
* Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Requirements
* Bachelor's degree or higher in life science or equivalent qualification.
* At least 2 years of experience as a Clinical Trials Assistant or in a similar administrative role in clinical research.
* Excellent knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
* Fluent language skills in German at C1 level and good command of English.
* Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
* Effective communication, organizational, and planning skills.
* Ability to work independently, prioritize tasks, and maintain effective working relationships with colleagues, managers, and clients.
* Flexibility to visit client offices in the Düsseldorf area regularly.
About the Position
The ideal candidate will have excellent analytical and problem-solving skills, strong attention to detail, and the ability to work well under pressure. They will be able to communicate effectively with colleagues and clients, both verbally and in writing.