Senior Clinical Trial Assistant (Sr CTA)

About the role

IQVIA is looking for a Senior Clinical Trial Assistant in Buenos Aires. The role performs daily administrative activities together with the Clinical Research Associates and Regulatory and Start-Up teams to deliver a complete and accurate Trial Master File. It also involves mentoring junior CTAs and may include leading small study teams.

Key responsibilities

• Update and maintain clinical documents and systems such as the Trial Master File (TMF) that track site compliance and performance within project timelines.
• Prepare, handle, distribute, file and archive clinical documentation and reports according to the scope of work and standard operating procedures.
• Review study files periodically for completeness.
• Help prepare and distribute clinical trial supplies and maintain tracking information.
• Coordinate tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as central contact for project communications, correspondence and documentation.
• Mentor less experienced CTAs, assist with their training and onboarding, and may interview and screen new team members.
• May act as subject matter expert for business processes, lead CTA study teams, accompany CRAs on site visits after training, and take part in quality or process improvement initiatives.

Required profile

• Bachelor's degree in life sciences or a related field.
• 1 year of clinical research experience strongly preferred.
• Advanced level of English.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines, and of protocol requirements, as provided in company training.

Required skills

• Proficiency in Microsoft Word, Excel and PowerPoint.
• Effective written and verbal communication, time management and organizational skills.
• Ability to build effective working relationships with coworkers, managers and clients.