Job Description

The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial which usually includes:

• Arranging & participating in the organization of Investigator Meetings & Study Team Meetings.
• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study
• Prepare for the distribution of protocols, Investigator Brochures and CRFs, including keeping track of and re-ordering supplies
• For studies allocated, with the Trial Master File Manager, set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF)
• Managing and maintaining study documents & trial supplies e.g., Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites.
• Preparing essential clinical trial documentation, distributing, tracking, and filing of documents on return
• Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.
• Sending out Study Correspondence to all participating sites on an ongoing basis.
• Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments
• For studies allocated, with the Trial Master File Manager, coordinating archiving of study documentation
• Assisting with CRF Design
• Arranging translation of patient documents
• Maintain understanding of Good Clinical Practice
• Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents

Key Performance Indicators

• Ensuring the Trial Master Files are appropriately maintained
• Ensuring tracking systems for trial related paperwork remain up to date

Job Responsibilities

• 0 direct reports
• Financial authority for submitting clinical team expenses and raising Purchase Orders on request

Required Knowledge, Skills, and Abilities

Understanding of clinical trial processes and needs. Excellent transferrable skills. IT literacy, particularly in Word, Excel, and PowerPoint. Knowledge of ICH GCP. University degree or equivalent in health sciences, nursing or pharmacy or related field. Previous experience of working in Clinical Research or the Pharmaceutical Industry. Knowledge of the Industry/Clinical trial process and drug development. Experience of administrative support in a busy environment. Experience of using the DIA Trial Master File Reference Model.