Clinical Trial Assistant - (Centralized EMEA Hub)

Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Essential Functions
• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
- High School Diploma or equivalent
- Experience in a working environment preferred but not essential
- Equivalent combination of education, training and experience.
- Computer skills including working knowledge of Microsoft Word and PowerPoint.
- Strong Excel skills (basic formulas a plus) and ability to/ experience of working with databases, trackers, and large volumes of data.
- Written and verbal communication skills including good command of English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
- Awareness of applicable clinical research regulatory requirements, i.e., Good - - Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
What we offer:
• Opportunity to work in a brand-new hub
• Opportunity to work internationally
• Flexibility Hybrid or Homebased
Please send a copy of your CV in English