Bhsct Advanced Therapy Treatment Lead Clinical Trial Coordinator Band 7

Belfast Health And Social Care Trust; Belfast City District; In loco; GBP 42.000 - 54.000; Tempo pieno

Descrizione del lavoro

Belfast Health & Social Care Trust is seeking an Advanced Therapy Treatment Lead Clinical Trial Coordinator to advance cellular therapy pathways. The role collaborates with NICRF, IREACH, and university partners to establish governance, infrastructure, and trial readiness for CAR-T and related therapies.

The post holder will drive education, knowledge transfer, and staff development while bridging clinical and research activities to enable future advanced therapies trials.

Competenze

• Experience in coordinating advanced therapy or cellular therapy projects.
• Ability to lead cross-functional teams and act as liaison across the University, IREACH and the Trust.
• Familiarity with national standards for cellular therapy trials.

Mansioni

• Coordinate establishment of a JACIE-compliant cellular therapy framework.
• Act as liaison between University, IREACH and the Trust.
• Support development of advanced therapy trial opportunities and governance.

Conoscenze

Clinical leadership

Project coordination

Stakeholder liaison

Education and training

Strumenti

GCP / Good Clinical Practice

ATTC/ JACIE knowledge

Descrizione del lavoro

Advertised role location: TOWER BLOCK
Official document: ATTC nurse job description_final (docx)
JOB DESCRIPTION
POST: Advanced Therapy Treatment Lead Clinical Trial Coordinator
LOCATION: TOWER BLOCK
Northern Ireland Clinical Research Facility (NICRF)
/ Queen's University Belfast IREACH
GRADE: Band 7
REPORTS TO: NICRF Staff Manager
RESPONSIBLE TO: RELEVANT CLINICAL LEAD
NICRF DIRECTOR
JOB SUMMARY / MAIN PURPOSE: The post-holder will serve as a coordinator for the development and implementation of advanced therapy pathways within the organization. Working at the interface of the University, IREACH and the Trust, they will utilize the Advanced Therapy Treatment Centre NHS Readiness Toolkit to support the establishment of a JACIE-compliant framework for future trial delivery. The role focuses on bridging the gaps to ensure local infrastructure and governance, meet the standards required for CAR-T and other cellular therapies and future clinical trial activity in these areas. They will support a knowledge transfer and educational role to develop the institutional workplace competencies required. Working closely with CRF/IREACH and the haematology clinical team they will identify trial opportunities across the ATTC network and beyond for local patients.
Main Duties / Responsibilities
Clinical Leadership and Service Development

• Participate in strategic development and implementation of advanced therapy pathways within the organizations, utilizing the Advanced Therapy Treatment Centre NHS Readiness Toolkit to ensure infrastructure and governance meets national standards for future advanced therapy and advanced therapy trial delivery.
• Act as a pivotal liaison between the University, IREACH, and the Trust to facilitate a cohesive approach to cellular therapy delivery and governance.
• Coordinate the establishment of a JACIE-compliant cellular therapy framework, working in expert collaboration with lead clinicians, pharmacy, and laboratory staff to achieve and maintain accreditation.
• Represent the organization on the Training and Education Board of the Advanced Therapy Treatment Centres (ATTC) network and engage in national ECMC Research Nurse activities.
• Contribute to the IREACH and NICRF strategy and vision, ensuring that the infrastructure for advanced therapies clinical trial delivery is represented
• Contribute to the clinical trials subgroup meetings in Haematology and Oncology
• Collaborate with local and national charitable organisations as appropriate to build support for advanced therapy clinical trial activity in NI. Attend events organized by these organisations as appropriate.

Education/Training & Mentorship

• Foster national network activity by undertaking strategic placements at established Advanced Therapy Treatment Centre (ATTC) sites to formalise collaborative relationships and benchmark local practice and policy against national leaders
• Lead the delivery of a "Knowledge Transfer" initiative, designing and delivering specialized education and training resources for the wider cross specialty clinical and laboratory teams regarding advanced therapies and clinical trial delivery.
• Lead simulated learning activities for staff across the organization likely to be involved in the care of patients receiving advanced therapies
• Supervise and mentor junior staff as appropriate.
• Identify and lead internal/external educational opportunities, attending high-level seminars/conferences to build a cutting-edge knowledge of advanced therapy trial delivery.
• Undertake Continuing Professional Development (CPD) to meet professional revalidation requirements, including attendance at relevant national and international conferences in cellular therapies.
• Demonstrate reflective practice and practice development and maintain personal action plans.
• Provide education sessions for ward/clinic nursing and medical staff regarding new protocols and the clinical implications, clinical trial results and updates, as required.
• Participate in lectures and education (formally and informally) within the hospital and beyond
• Liaise with Research Nurses from other specialities and other hospitals to further role development, reporting on new aspects of care or role
• Maintain knowledge of cancer nursing advances and research.
• Seek to develop research opportunities, through meetings and communication via posters, presentations and publications.
• Participate in annual staff development and performance review.

Clinical Research

• Act as a specialist Research Link Nurse and resource for advanced therapies, providing clinical support, expert advice and counseling to patients and families navigating the complexities of cellular therapy and advanced therapy clinical trials. As appropriate, provide patient and family care, monitoring, safety checks, education during all stages of clinical trial participation. Act as a patient representative throughout.
• Develop and maintain a comprehensive Advanced Therapy Trial Map, acting as the primary point for patient and trial identification and patient support across specialties including Haematology, Oncology, Rheumatology, and Neurology. Assist in identification, and screening of patients who may be eligible for clinical trials across the ATTC network and beyond
• Integrate with the Early Phase Clinical Trials team within both IREACH and NICTN to support the delivery of cross specialty early phase clinical trials. In doing so develop personal and institutional expertise to support future transition to advanced therapy clinical trial delivery.
• Support the efficient setup and delivery of trials to time and target primarily in the area of Advanced therapies, performing clinical trial coordinator duties across a range of clinical trials as required
• Support the expansion of translational/phase I/early phase II clinical research in the organization through integration with the early phase clinical teams.
• Facilitate the acquisition of research samples by integrating workflows with the NI Biobank.
• Act as a patient advocate throughout
• Liaise with colleagues across the Trust and Queen's University Departments in facilitation of research concepts and protocol development for future advanced therapy clinical trials.
• Maintain up-to-date knowledge relating to clinical research and issues more specifically associated with translational research and early clinical trials such as the ethics of research involving human tissue.
• Ensure records meet requirements for data collection.
• Maintain patient Screening Log Forms and Patient Registration documentation and databases.
• Comply with Good Clinical Practice, Ethical, Governance and Regulatory Guidelines.
• Comply with all relevant Policy and Procedures.
• When appropriate, support the facilitation of site visits, internal and external audit, review and evaluation of Unit.
• Work in partnership with Personal and Public Involvement Representatives as appropriate to help support the development of a local advanced therapy PPI group.

General Responsibilities
Employees of the Organisation are required to promote and support the mission and vision of the service for which they are responsible and:
At all times provide a caring service and to treat those with whom they come into contact in a courteous and respectful manner.
Demonstrate their commitment by their regular attendance and the efficient completion of all tasks allocated to them.
Comply with the Trust’s Smoke Free Policy.
Carry out their duties and responsibilities in compliance with the Health and Safety Policies and Statutory Regulations.
Adhere to Equality and Good Relations duties throughout the course of their employment.
Ensure the ongoing confidence of the public in-service provision.
Maintain high standards of personal accountability.
Comply with the HPSS Code of Conduct.
Records Management
All employees of Belfast Health & Social Care Trust are legally responsible for all records held, created or used as part of their business within the Belfast Health and Social Care Trust, including patient/client, corporate and administrative records whether paper based or electronic and also including e-mails. All such records are public records and are accessible to the general public, with limited exceptions, under the Freedom of Information Act 2000, the Environment Regulations 2004, Data Protection Act 1998 and GDPR (2018). Employees are required to be conversant with the Belfast Health and Social Care Trust policy and procedure on records management and to seek advice if in doubt.
Environmental Cleaning Strategy
The Trusts Environmental Cleaning Strategy recognizes the key principle that "Cleanliness matters is everyone's responsibility, not just the cleaners" Whilst there are staff employed who are responsible for cleaning services, all Trust staff have a responsibility to ensure a clean, comfortable, safe environment for patients, clients, residents, visitors, staff and members of the general public.
Infection Prevention and Control
The Belfast Trust is committed to reducing Healthcare associated infections (HCAIs) and all staff have a part to play in making this happen. Staff must comply with all policies in relation to Infection Prevention and Control and with ongoing reduction strategies. Standard Infection Prevention and Control Precautions must be used at all times to ensure the safety of patients and staff.
Cleaning hands either with soap and water or a