Job Summary
As a Research Facilitator, you will lead the setup, oversight, and delivery of research studies hosted or sponsored by the Trust. Working closely with clinical teams, research sponsors, partner organisations and support services, you will ensure studies meet regulatory standards, governance requirements, and performance targets. You will also take a lead role in one of the following specialist areas: Trust‑Sponsored Research: coordinating the oversight and compliance of research studies sponsored by the Trust. Research Service Data: ensuring accuracy of study data used for internal governance and national reporting. Cardiff Cancer Research Hub/Specialist Portfolios: supporting cross‑organisational delivery of early phase and complex cancer research studies. This is a non‑clinical post with line management responsibilities for Research Facilitation Officers and support staff. You will act as a key link between investigators, delivery teams, sponsors and regulators, offering expert support and ensuring excellence in research governance and performance.
You should be confident working independently and as part of a team, with a strong commitment to improving cancer research outcomes for patients.
Qualifications and Experience
* Proven expertise in clinical research governance and delivery.
* Strong organisational, analytical, and communication skills.
* Experience of managing and supporting research teams.
* Excellent understanding of the UK Policy Framework for Health and Social Care Research, Good Clinical Practice, and clinical trial regulations.
* Post graduate degree, or equivalent educational qualification, or minimum of two years NHS experience, or other work related knowledge or experience.
* Possess previous experience within the NHS, or the field of health research, or clinical trials / research studies.
* Evidence of having undertaken International Council for Harmonisation Good Clinical Practice (ICH GCP) training within the last 2 years, or willingness to complete ICH GCP training within two months of appointment.
* Possess and demonstrate a detailed knowledge of, and / or experience in, the ethical, research governance, and regulatory / legislative requirements for the set-up, delivery and ongoing management of clinical trials / research studies and associated processes.
* Possess a knowledge of clinical trial / research study methodology.
* Excellent communication and computer skills, including the use of Microsoft Office software packages; Relevant management qualification.
* Working knowledge of quality systems and processes essential to the development, preparation, and maintenance of policies, Standard Operating Procedures (SOPs), and work instructions.
* Graduate in a health science or clinical research qualification.
* Possess knowledge of Wales Clinical Portal (WCP) / Welsh Patient Administration System (WPAS) databases.
* Possess the ability to prepare / generate reports, posters, and presentations, preferably using Microsoft Office software.
* Possess further education / qualification in IT or project management; Several years' experience of working in the clinical trials / research environment.
* Evidence of continuing development.
* Previous experience of research processes and methodologies.
* Experienced in working to the ethical, research governance, and regulatory / legislative requirements for the set-up, delivery and ongoing management of clinical trials / research studies and associated processes.
* Experience of coordinating regulatory inspections.
* Experience of working with databases and using reporting tools.
* Experience of the project management of non-staff and staff resources.
* IT literate and capable of developing, maintaining, and reporting information from large and / or complex databases (e.g. Local Portfolio Management System [LPMS]).
* Successful introduction of project management methodologies and associated best practice to inexperienced teams and individuals.
* Experience of working in complex and pressured environment with conflicting demands on time.
* Experience of communication and engaging with diverse stakeholder groups; Supervisory or line management experience.
* Experience of reviewing research studies for ethical, financial, legal and data protection issues.
* Understanding of medical and research terminology and concepts.
* Experience of working within a Research & Development [R&D] support service environment.
* Understanding of project budgets; Innovative and adaptive skills for interpreting changes in the UK and European research regulations and legislation.
* Excellent computer skills for inputting data into and extracting information from databases.
* Well-developed and proven organisational ability, with the ability to multi‑task and to prioritise workload.
* Proven application of decision making and analytical skills.
* Excellent communication skills (written & oral), excellent presentation and people skills.
* The ability to train individuals and groups of people with a range of skills.
* Able to develop staff - setting objectives and appraisals.
* Able to inform, negotiate and influence others.
* Extensive knowledge of: ICH Good Clinical Practice (GCP); European Union Directives for Clinical Trials; UK Policy Framework for Health and Social Care Research; The Medicines for Human Use (Clinical Trials) Regulations; The Human Tissue Act; UK General Data Protection Regulation (GDPR) and Data Protection Act.
* A working knowledge of financial systems and budget management.
* Knowledge of the rules governing medicinal products in the European Union: Volume 9A - Guidelines on Pharmacovigilance for Medicinal Products for Human Use; Volume 10 - Clinical Trials.
* A good understanding of the NHS clinical environment.
* Extensive knowledge of research governance.
* The ability to demonstrate effective partnerships, working both within and outside of the organisation.
* Experience of using Microsoft Office.
* Proven ability to take the lead in development of processes / systems in a complex regulatory environment.
* Knowledge of regulatory authority inspection systems and processes.
* Demonstrable Team management skills.
* Welsh Speaker (Level 1) or willingness to work towards.
* Tactful and firm.
* Enthusiastic, motivated, and reliable with an ability to motivate others.
* Flexible approach to work.
* Relates well to staff at all levels and capable of working in a team.
* Good negotiator.
* Willingness to participate in additional clinical governance activities.
* Willingness to continue own development.
* Willingness to travel throughout the UK.
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