Clinical Research Administrative Assistant

We are seeking a highly organized and detail-oriented individual to join our team as a Clinical Research Administrative Assistant in Prague, Czech Republic. You will play a critical role in supporting the Clinical Research Associates and Regulatory and Start-Up teams to ensure accurate and timely delivery of clinical trial documents.

Responsibilities

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and systems, such as the Trial Master File (TMF)
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to standard operating procedures
• Conduct periodic reviews of study files for completeness
• 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
• Serve 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 required
• 3 years of administrative support experience
• Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint
• Excellent written and verbal communication skills, including a good command of the English language
• Effective time management and organizational skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Awareness of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

What We Offer

• Competitive salary
• Opportunity to work with a leading global provider of clinical research services
• Collaborative and dynamic work environment