Clinical Trial Assistant

Job description

About the Role Ensuring the most effective and efficient conduct of clinical research studies by providing administration, regulatory and project tracking support. The CTA will accept projects as assigned per the changing needs of the Clinical Operations Department. Experience with Trial Master File (TMF) maintenance is required. Let’s talk about some of the key responsibilities of the role: - Organize and maintain clinical study documentation (e.g., Trial Master Study Files) including preparation for internal/external audits, final reconciliation and archival. - Responsible for the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. - Assist Clinical Research Associates (CRAs) and the clinical teams with accurately updating and filing clinical documents from study visits and updating systems that track site compliance and performance within project timelines. - Completes periodic review of study files for completeness and audit readiness. - Assist Study Manager with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information....