The Senior Clinical Trials Coordinator is a key member of the Research & Development team at Blackpool Victoria Hospital, responsible for managing the Research Management and Governance (RM&G) Office and coordinating clinical trials from initial feasibility through to full study set-up and approval. This role provides leadership and operational oversight for all aspects of pre-initiation research governance and study delivery preparation, ensuring compliance with national and Trust policies, Good Clinical Practice (GCP), and regulatory requirements.

The post holder acts as the primary contact for sponsors, Contract Research Organisations (CROs), and investigators throughout the feasibility, costing, contracting, and approvals process. They oversee study amendments, ensuring timely review and implementation, and manage the RM&G office function. As line manager for Band 5 Clinical Trials Coordinators and administrative staff, the Senior Clinical Trials Coordinator promotes an efficient, high-quality research support service, driving consistency and best practice across the R&D Department.

This position offers the opportunity to make a significant impact on research delivery, collaborate with a wide range of professionals, and contribute to the continuous improvement of research services within the Trust.

Main Responsibilities

Research Management and Governance (RM&G)

• Oversee the operational management of the RM&G Office, ensuring all research studies are processed, reviewed, and approved according to Trust policies and national regulations.
• Lead coordination of expressions of interest, liaising with investigators and departments to assess study feasibility and capability.
• Manage the review and submission of research study documentation, including contracts, costing templates, site agreements, and confidentiality agreements.
• Support negotiation of study budgets and financial arrangements in collaboration with the Research Business Development Manager and Finance Team.
• Oversee site set-up processes, ensuring all regulatory and capacity assessments are completed prior to study activation.
• Coordinate study amendments, ensuring prompt review, classification, and implementation across all active trials.
• Maintain oversight of all RM&G records and databases, ensuring data accuracy for performance reporting and compliance audits.

Clinical Trial Coordination

• Provide expert guidance and operational support for studies from feasibility through set-up and activation.
• Liaise with Principal Investigators, Sponsors, and CROs to ensure trials meet regulatory, contractual, and operational timelines.
• Support site selection visits, site initiation visits, and study start-up activities to ensure the Trust’s readiness for delivery.
• Work with study teams to address barriers to activation and recruitment, escalating issues appropriately.
• Ensure all site files, delegation logs, and study records are maintained in line with GCP and inspection-readiness standards.

Leadership and Line Management

• Line manage Band 5 Clinical Trials Coordinators and administrative support staff, including appraisals, sickness management, and performance reviews.
• Allocate and monitor workloads, ensuring timely completion of tasks and effective prioritisation across the RM&G and Clinical Trials functions.
• Provide coaching, mentorship, and training in research governance, feasibility, and study set-up processes.
• Support recruitment and induction of new staff and ensure completion of GCP and study-specific training.

Quality, Governance, and Compliance

• Ensure compliance with all local and national research governance requirements.
• Support internal audits, inspections, and monitoring visits, addressing findings and implementing corrective actions.
• Contribute to the continuous improvement of departmental SOPs and operational processes.
• Ensure appropriate systems are in place for document control, audit trails, and version management.

Performance and Reporting

• Monitor and report on research activity, including feasibility throughput, study set-up timelines, and amendment processing.
• Provide regular updates to the Research Operations Manager on key performance indicators and study pipeline metrics.
• Identify areas for process optimisation to improve turnaround times and service quality within the RM&G Office.

Collaboration and Communication

• Build and maintain strong working relationships with investigators, sponsors, CROs, and internal departments (e.g., Finance, Pharmacy, Radiology, Information Governance).
• Represent the R&D Department at internal and external meetings, contributing to the strategic development of research services.
• Act as a point of contact for study sponsors and investigators, ensuring consistent, professional communication throughout the study lifecycle.