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Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES

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

Management

·       Provide induction support and training to new and existing clinical trials staff, including development of training sessions and guidance documents.

·       Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.

·       Assist with metric tracking for performance indicators including mandatory training requirements, divisional key performance indicators (i.e. time to recruiting first patient from NHS permission, patient recruitment to time and target), amendment timelines and divisional absences.

Clinical Research Co-ordination/ Data Management

·       Interview, recruit, take informed consent and support patients and carers in non-treatment clinical trials/studies. This involves educating patients on the trials involved, explaining the advantages and disadvantages of taking part in non-treatment trials, whilst remaining unbiased at all times. Assess patients as required by trial protocols.

·       Maintain adequate patient records and ensure all relevant information is documented in the patient’s medical and nursing notes.

·       Provide continuity of care for patients and their carers throughout the trial programme. Provide non-clinical advice and support as appropriate.  Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required.

·       Act as a key point of contact with the R&D core team, study sponsors, clinical research organisations and specific research teams.

·       Co-ordinate feasibility activities for new studies under direction from Clinical research Nurse Team Leaders and Principal Investigators

·       Manage the set up and initiation of allocated clinical trials within assigned Clinical

·       research Teams.

·       Understand and deliver protocols in accordance with regulatory requirements

·       Financial management of study set-up costs and income recovery for assigned clinical trials in conjunction with the R&D Business Planning and Finance teams with oversight from the Clinical Research Nurse Team Leaders/ Senior Clinical Research Nurses.

·       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.

·       Assist with preparation for audit and inspections within assigned teams and implementation of action plans.

·       Understand the process for obtaining NHS permissions (R&D approval) for conducting clinical trials at site. As project lead, ensure permissions are in place prior to any patient recruitment.

·       Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.

·       Awareness of trial specific, regional and national targets. Identify and implement strategies for recruiting patients to clinical trials ensuring that targets for patient recruitment are delivered.

·       Arrange and facilitate clinical trial related meetings.

·       Undertake general administrative tasks as delegated by managerial representatives from the R&D division to contribute to the smooth running of the patient recruitment teams.

·       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.

·       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.

·       Ensure that all documents are archived in the appropriate way by following the Trust’s archiving guidelines.

Clinical Service Responsibilities

·       Demonstrate awareness of divisional and trust strategic objectives including performance indicators and metrics.

·       Escalation of governance issues impacting on delivery of job purpose.

·       To act as a primary contact point for the clinical trial patients for define clinical trials and act as adviser to other health care professionals.

·       Participate in monitoring and audit activities within research team

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.

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.

KEY VALUES

• Demonstrates the agreed set of values and accountable for own attitude and behaviour