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DUTIES AND RESPONSIBILITIES

LEADERSHIP AND MANAGEMENT

• To provide direct line management for research coordination and administrative staff within a designated team.
• Overall managerial responsibility for recruitment, retention, disciplinary and grievance, and all human resource related staffing issues for the assigned 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.
• Oversee and lead on induction training, support and mentoring for new non-clinical post holders within the team and across the division
• Support and contribute to the education and training needs of the research teams, ensuring the objectives of the organisation are reflected
• Participate and lead on continued training and development of non-clinical staff across the Research Division

FINANCIAL MANAGEMENT

• Support contract negotiation processes with trial sponsors under direction from the Clinical Research Nurse Team Leader/ Research Manager, ensuring appropriate financial agreements are in place for each project for both commercial and Trust-sponsored (i.e. investigator-led) research.
• Identify funding streams for potential grant applications and facilitate preparation and submission of local, national and European research grant applications (PM)
• Ensure the business processes and systems for financial management are implemented, such as, service line reporting, invoicing, procurement, activity logs etc.
• Adopt responsive working practices in relation to any new financial processes/ systems that require implementation.
• Produce written activity and annual reports under the direction of the Research Manager/Clinical Research Nurse Team Leaders

CLINICAL TRIALS/PROJECT MANAGEMENT

• Act as a pivotal point of contact with the pharmaceutical companies, study sponsor, and clinical research associates.
• Under the direction of the Clinical Research Nurse Team Leaders/ Research Manager, be responsible for and may participate in the administrative set-up and on-going administrative management of all clinical trials within the team.
• Post holder will receive and provide complex clinical trial information and be expected to use their communication skills to ensure this information is processed via the correct pathways. This will include:
• Co-ordinate and assist in the writing and evaluation of clinical research protocols, patient information, questionnaires and CRFs for individual studies.
• Communicating across the clinical teams and trial sponsors to prepare and submit ethics and regulatory authority applications and amendments, ensuring all approvals have been gained prior to research commencing.
• Write regular updates and design newsletters for each study to keep collaborators up to date with developments and forthcoming projects.
• Draft abstracts and posters for local, national, and international conferences
• Implement and ensure maintenance of systems to track the status of the research portfolio to support monitoring of the delivery of projects and supporting any key business-related decisions within a designated team.
• Responsible for ensuring clinical report forms and other data capture mechanisms are completed efficiently and effectively within agreed timeframes.
• Development of team reporting mechanisms to measure data capture/ entry against agreed performance metrics.
• Development 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.
• Liaison with Trust departments regarding trial feasibility and resource requirements
• Oversee the archiving process for all clinical trials and team projects, ensuring adherence to the current Trust archiving guidelines.

QUALITY AND SERVICE DEVELOPMENT

• Working in collaboration with the Clinical Research Nurse Team
• Leaders and the divisional quality and improvement teams to ensure that quality systems and new ways of working are implemented and embedded within team practices.
• Be pro-active in monitoring the quality and effectiveness of working practices within research team.
• The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Clinical Research Nurse Team Leader/ Research Manager as required. The post holder is guided by relevant protocols, SOPs and expected to exercise judgement outside these areas. However, the Research Division’s managerial team members are available as point of reference for any queries and will meet regularly with staff.
• The post holder is expected to lead on specific projects as designated by the Clinical Research Nurse Team Leader/ Research Manager