Clinical Trial Assistant (CTA)

Post Title: Clinical Trial Assistant (CTA)

Company: Scancell Ltd

Responsible To: Director, Clinical Operations

Location: Oxford or Remote

Summary of Post

The Clinical Trial Assistant (CTA) is responsible for supporting the operational delivery, inventory supply and storage, documentation, and system management of clinical trials, ensuring activities are conducted in accordance with:

• ICH GCP (E6 R3)
• Study protocol, Clinical Monitoring Plan (CMP), and other study-specific operational plans
• Scancell SOPs
• Applicable regulatory requirements

The CTA plays a key role in maintaining trial documentation, central systems and log integrity, trial supply and operational quality, with particular focus on eTMF management, ensuring that clinical trial records are complete, accurate, and inspection-ready at all times.

The CTA supports CRAs and CPMs in the coordination and execution of clinical trial activities, ensuring that data integrity, document control, and compliance requirements are consistently met and that all records enable effective oversight and compliance.

The CTA operates with accountability for assigned deliverables, escalating issues relating to quality, compliance, or system integrity to the CRA and/or CPM as appropriate.

Key Roles and Responsibilities

The CTA is responsible for the coordination and management of clinical trial documentation, systems, and operational activities, ensuring that trial records and supplies are maintained in accordance with GCP, ALCOA-CCEA principles, and applicable SOPs.

eTMF Management

• Maintain the Trial Master File (eTMF) to ensure all essential documents are complete, accurate, contemporaneous, and inspection-ready in accordance with the TMF Plan, SOPs, and eTMF Filing Index.
• Perform essential document QC activities to ensure compliance with ALCOA-CCEA principles, including verification of completeness, accuracy, version control, and appropriate filing.
• Act as Vault Administrator, ensuring appropriate user access, document workflows, and system controls are maintained in compliance with SOPs, data integrity requirements, and security processes. May provide training and conduct trouble-shooting activities in the eTMF to other functions.

Operational Delivery

• Support site start-up and study activities by coordinating essential document collection, tracking, and review to ensure site readiness for activation.
• Provide administrative and documentation support to CRAs in preparation for monitoring visits, including document tracking, file review, and follow-up of outstanding items.
• With oversight by CRA may perform supportive activities to clinical monitoring as delegated at co-monitoring visits.
• Maintain tracking tools and logs to support study oversight and ensure timely completion of trial activities.
• Support the coordination and documentation of study communications, including meeting minutes, follow-up actions, and status reporting.
• Assist in the management of protocol amendments and updates to study-specific documents by coordinating or authoring document updates, and distribution to relevant stakeholders.
• Identify and escalate issues related to operational deliverables and documentation quality, missing or inconsistent data, or system non-compliance to the CRA and/or CPM.
• Manage trial supply tracking and inventory, including the storage of consumables per requirements and providing Investigational Sites with inventory.

Essential requirements

• Strong organisational skills with the ability to manage multiple tasks and priorities
• High attention to detail with a strong focus on quality and compliance
• Understanding of ICH GCP and clinical trial processes
• Knowledge of ALCOA-CCEA principles and document management standards
• Experience working with clinical trial systems (e.g., eTMF/Vault, EDC, CTMS, Supply Management)
• Ability to work collaboratively while maintaining accountability for assigned tasks
• Proactive approach to identifying issues and supporting resolution

Key Performance Indicators

• Timely and accurate maintenance of the eTMF in accordance with the TMF Plan, SOPs, and filing standards
• Quality of trial documentation, including QC findings, completeness and inspection readiness
• Effectiveness in supporting study milestones and operational activities
• Effectiveness of trial supply management
• Compliance with GCP, SOPs, and data integrity standards
• Effective identification and escalation of operational and system-related issues

Health & Safety

All Scancell employees are required to support and comply with the company’s Health and Safety policies and any local procedures.

If you would like to be considered in this role, please send a full CV and a covering letter specifying the position and location you are applying for, and how your particular skills and experience are relevant for this post to: jobs@scancell.co.uk