Clinical Trials Administrator

Your mission

The primary purpose of the Clinical Trials Administrator (CTA) is to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). They also act as a pivotal point of contact & support for the clinical trial team.

Major Activities
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 organisation 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, co-ordinating 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

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

• Understanding of clinical trial processes and needs.
• Excellent transferrable skills.
• IT literacy, particularly in Word, Excel, and PowerPoint.
• Knowledge of ICH GCP.

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

• 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.