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DUTIES AND RESPONSIBILITIES

LEADERSHIP AND MANAGEMENT

• To provide direct line management for Translational Research Facilitator (TRF) staff within the Experimental Cancer Medicine Team.
• Overall managerial responsibility for recruitment, retention, disciplinary and grievance, and all human resource related staffing issues for the TRF team.
• Ensure the annual performance review and identification of development needs are conducted in accordance with Trust policy.
• Provide leadership within the team and act as a role model and resource for all team members.
• Maintain own professional development and identify learning needs and opportunities.
• Participate and contribute to the continued training and development of nonclinical staff across the Research Division, in relation to Translational Research.

TRANSLATIONAL RESEARCH TRIALS MANAGEMENT

• Act as a pivotal point of contact for Investigators, study sponsors and other relevant parties in relation to translational research studies running within the ECMT.
• Provide guidance to Investigators during set up and throughout the study in relation to sample handling and data collection requirements for Investigator led trials.
• Be responsible for developing and implementing processes to ensure safe and efficient handling of samples according to protocol and regulations.
• Work with ECMT Investigators, providing advice into the development of translational research, including protocol development and grant applications.
• Implement and ensure maintenance of systems to track the status of the translational research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within the ECMT.
• Be responsible for overall workload management within the TRF team, ensuring  cross cover is maintained and flexibility allowing for frequent last minute changes to patient schedules and sample collection requirements.
• Be responsible for ensuring data capture mechanisms are completed efficiently and effectively within agreed timeframes.
• Be responsible for team reporting mechanisms to measure data capture/ entry against agreed performance metrics.
• Work with members of the Molecular Tumour Board to maintain/ further develop reporting of molecular results for patients on translational research studies within the ECMT.
• Be responsible for reporting mechanisms to measure turnaround times of sample retrieval/ shipment from and to required destinations as required per protocol.
• Development and delivery of action plans to address any actual or potential deviations from agreed data capture metrics.
• Ensure team, divisional and national study targets are achieved within agreed timeframes.
• Provide expertise at the point of trial feasibility and assessment of resource requirements.
• In conjunction with the ECMT Research Manager collate and provide relevant information relating to the capabilities of the assigned team in preparation for strategic partnership meetings.
• Ensure the TRF team is aware of the archiving process for all clinical trials, ensuring adherence to the current Trust archiving guidelines.
• Maintaining in-house team LIMS system, developing additional functionality in accordance with data collection and sample collection requirements.
• Responsible for developing processes to ensure the completion, quality and integrity of data collected within in-house LIMS system.  This will require data interrogation/ data quality checks.

QUALITY AND SERVICE DEVELOPMENT

• Work collaboratively with the ECMT Research Manager, the MCRC Biobank Quality and Laboratory Manager, the Translational Programme Lead, and Research Quality and Regulatory Compliance Team to ensure that quality systems, governance expectations, and agreed ways of working are consistently implemented, embedded, and maintained across the team.
• Build and maintain effective internal and external relationships to support timely and accurate retrieval, handling and transfer of research samples, ensuring pathways are efficient, compliant, and aligned with the required minimum governance standards.
• Conduct scheduled and ad‑hoc internal audits of TRF activity, ensuring compliance with HTA, GCP and local SOPs, documenting findings, and driving corrective and preventative actions.
• Lead proactive monitoring of quality and operational performance within the TRF team. This includes maintaining and regularly reviewing a Quality Management Plan for ECMT, triangulating information from audits, error logs, training records, and competency assessments to identify trends, risks or training gaps.
• Identify concerns early and respond effectively, taking ownership of corrective and preventative actions (CAPAs), escalating issues to senior staff where appropriate, and ensuring learning is embedded into routine practice.
• Exercise a high level of initiative and independent judgement, planning and prioritising workload effectively while working within established protocols and SOPs. The postholder is expected to recognise when issues fall outside existing guidance and to seek advice from the ECMT Research Manager and MCRC Biobank Quality Manager as needed.
• Lead or participate in designated projects on behalf of the ECMT Research Manager, particularly those relating to quality improvement, sample governance, digital systems, or harmonisation of processes across research delivery teams.

TRAINING AND EDUCATION

• The post-holder will oversee induction training, support and mentoring for new non-clinical post holders within the TRF team, and will be responsible for regular review of staff competencies to ensure TRF staff are fully trained and up to date with relevant SOPs, policies and regulations.
• Support and contribute to the education and training needs of the TRF team, ensuring the objectives of the organisation are reflected.
• Provide hands on training for blood or tissue sample handling, including the use of specialist equipment, i.e centrifuge, freezers.
• Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.  Disseminate information to ECMT or research division as appropriate.
• The post holder will have knowledge of the Human Tissue Act (2004) and will provide specialist knowledge to Investigators, researchers, Translational Research Facilitators as appropriate in relation to the Human Tissue Act (2004) ensuring studies running within the ECMT comply.