Clinical Trial Assistant

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.
• Aid 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.
• Periodically review study files for completeness.
• Support 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 point of 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

• Bachelor's Degree Required
• 3 years administrative support experience
• Equivalent combination of education, training and experience
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• 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 coworkers, 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
• Knowledge of applicable protocol requirements as provided in company training