ICON Strategic Solutions is a global leader in clinical research and clinical trial management. With a strong reputation for excellence and commitment to advancing health and medicine, ICON offers its employees a dynamic work environment focused on innovation, collaboration, and continuous learning. The company prioritizes its people, promoting a diverse and inclusive culture that champions growth and success.
Responsibilities in Job: As a Clinical Trial Assistant (CTA), you will play a crucial role in supporting the coordination and administration of clinical study activities from initiation to closeout. Key responsibilities include:
- Assisting in the coordination and administration of clinical studies within the Local Study Team (LST).
- Collecting, preparing, reviewing, and tracking documents necessary for the application process.
- Ensuring timely submission of required documents to Ethics Committees/Institutional Review Boards (EC/IRB) and, where applicable, Regulatory Authorities.
- Serving as the primary local administrative contact, working closely with Clinical Research Associates (CRAs) and the Local Study Associate Director (LSAD).
- Managing and maintaining the local electronic Trial Master File (eTMF) and Investigator Site File (ISF) in line with ICH-GCP and local requirements.
- Ensuring all essential documents are uploaded promptly for “Inspection Readiness” and final archiving.
- Supporting CRAs with closeout activities related to the ISF.
- Producing and maintaining study documents while ensuring compliance with templates and version control.
Qualifications: The ideal candidate should have the following qualifications:
- High school/secondary school education or equivalent, demonstrating the skills required for the role.
- Previous administrative experience, preferably in the medical or life science sector.
- Proven organizational and administrative proficiency.
- Strong computer skills and proficiency with office software.
- Fluency in both spoken and written Dutch and English.
Skills:
- Excellent organizational and multitasking skills to manage various aspects of clinical trial support.
- Effective communication and interpersonal abilities to interface with investigators, CRAs, and external service providers.
- Attention to detail and the ability to manage essential documentation with accuracy.
- A proactive mindset to ensure compliance with all relevant regulations and guidelines.
