Lead Clinical Research Associate (CRA)

Company

Scancell Ltd

Responsible To

Director, Clinical Operations

Location

Remote or Oxford

Summary of Post

The Lead CRA is responsible for co-ordinating the CRA team, orchestrating central monitoring activities and for the end-to-end oversight, performance, quality, and compliance of assigned investigational sites, ensuring clinical trials 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 Lead CRA is the primary owner of site quality, applying a risk-based monitoring approach and ensuring that participant safety, data integrity, and critical-to-quality factors are proactively managed.

The Lead CRA operates with a high level of autonomy, providing CRA oversight and acting as their point of escalation. The Lead CRA will be responsible for triaging and further escalation of significant risks to compliance, integrity or study-related decisions to the CPM.

Key Roles and Responsibilities

The Lead CRA holds full ownership of the oversight of assigned sites across the entire study lifecycle, from feasibility and activation through monitoring to close-out, and is accountable for ensuring participant safety and rights are maintained by the Investigator(s), maintaining data integrity in line with ALCOA-CCEA principles, and upholding protocol and GCP compliance.

• Coordinate and orchestrate remote/central monitoring activities, including managing integrated data review.
• Plan, conduct, and report monitoring activities (PSV, SIV, RMV, COV) in accordance with the Clinical Monitoring Plan (CMP), SOPs, and a risk-based monitoring approach, focusing on Critical-to-Quality (CtQ) factors, Key Risk Indicators (KRIs) and participant safety.
• Maintain full oversight of assigned sites across the study lifecycle (feasibility, activation, conduct, and close-out), ensuring site readiness, performance, and compliance.
• Ensure participant safety through oversight of Investigational site safety reporting (AE/SAE/SUSAR), verification of data accuracy and timeliness, and collaboration with medical oversight functions as required.
• Ensure data integrity and quality in line with ALCOA CCEA principles by verifying source data, identifying inconsistencies or risks (including potential misconduct), and ensuring accurate and timely data entry and query resolution.
• Oversee Investigational Medicinal Product (IMP) management at site level, including storage, handling, accountability, reconciliation, and escalation of any quality or compliance issues.
• Maintain Trial Master File (eTMF) quality and completeness, ensuring essential documents are accurate, timely, QC reviewed, and inspection-ready in accordance with the TMF Plan, SOPs and eTMF Filing Index.
• Deliver and reinforce site training (e.g., SIV and ongoing), ensuring site personnel are appropriately qualified, delegated, and compliant with protocol, GCP, and study requirements.
• Identify, assess, and manage protocol deviations, non-compliance, and data quality issues using a risk-based approach; escalate serious breaches, safety concerns, and suspected misconduct promptly, and support CAPA implementation and follow-up.
• Oversee site-level vendor and system activities, ensuring compliance with study requirements, data integrity standards, and applicable security processes.
• Support compliance with clinical trial transparency requirements, ensuring site-level data contributes to accurate trial registration and reporting.