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TEAM SUPPORT

• Responsible for supporting and supervising workload allocation/ monitoring across administrative team members, escalating issues as appropriate to senior managers.
• Provide support to senior managers with general Human Resource activities, including but not limited to recruitment and selection and line management of administrative team members as required. This will be in accordance with Trust policies.
• Provide induction support and training to new and existing clinical trials staff through one-to-one and group learning activities.
• Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.
• Assist with data collection for divisional metrics reports of key performance indicators.

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CLINICAL TRIALS CO-ORDINATION/ DATA MANAGEMENT

The specific responsibilities will depend on the requirements of each team, but may include:

• Act as a key point of contact with the core Research and Development team, study sponsors, clinical research organisations and specific research teams.
• Support feasibility activities for new studies under direction from senior managers and Principal Investigators.
• Manage the set up and initiation of allocated clinical trials within assigned Clinical Research Teams. Provide support for study set up and initiation that has been delegated to Clinical Trials Coordinators, escalating any delays as appropriate.
• Support with negotiations of study set-up costs and income recovery for assigned clinical trials in conjunction with the Research Division’s Business Planning and Finance teams with oversight from senior managers.
• Oversee maintenance of investigator site files and essential documentation in accordance with ICH-GCP and Trust Standard Operating Procedures (SOPs) to ensure they are kept inspection ready at all times.
• Oversee and process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, escalating any delays with the core Research and Development office as appropriate.
• To have the appropriate administrative processes in place to ensure, with the Clinical Research Team, that adverse event incidents and forms are completed, reported and followed up to resolution as the study protocol and regulations require.
• Implement and coordinate reporting mechanisms to ensure that research staff complete and return proformas containing up-dated information on patients included in the study.
• Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.
• Liaise with internal staff and external collaborators to resolve queries.
• Provide information for senior managers including (but not limited to) case report form completion timeliness, data locks, data backlogs, work allocations and patient recruitment.
• Ensure that data is available and up to date for any meetings related to the trial/ study, producing minutes as required.
• Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
• Attend disease-specific research team meetings to maintain an overview of team activity.
• Assist with preparation for audit and inspections within assigned teams and implementation of action plans.
• Ensure that all documents are archived in the appropriate way by following the Trust’s archiving guidelines.
• Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.
• Demonstrates the agreed set of values and accountable for own attitude and behaviour

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WORKING PRACTICE

• Work closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams.
• Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
• 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 senior managers as necessary.
• The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas.

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PERSONAL AND PEOPLE DEVELOPMENT

• Maintain professional development whilst evaluating own specialist knowledge with assistance from their assigned line manager to satisfy the NHS Knowledge and Skills Framework.
• Participate in and deliver Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.

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PHYSICAL, MENTAL AND EMOTIONAL EFFORT

• Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
• Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
• Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.

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