Senior Research Midwife, Band 6

Feasibility and Study set

• up -Contribute to the set-up of research studies within the wider research team.

• Able to identify and plan strategies for recruiting patients into trials.

• Ensure trial protocols are followed and that trials are conducted according to the national research legislation, Research Governance Framework, R&I Standard Operating Procedures, GHNHFT policies and Good Clinical Practice.
• Lead on, and maintain an expert research knowledge of a portfolio of trials, acting as a reference point for team members, train research team and wider healthcare team to ensure safety of all trial participants, and attend multi-disciplinary meetings
• Liaise with MDT members to establish procedures for the safe set up and smooth running of clinical trials and act as a resource and contact point in matters concerning trial patients and trial protocols with all stakeholders.

• Ensure the safety and wellbeing of clinical trial patients, including safe administration of treatments and drugs that are given within the context of a clinical trial, as applicable to professional registration and Trust POPAM policy.

• Assess patients as required by trial protocols and take appropriate and timely action for patients with trial related complications/toxicities.

• Responsible for the coordination of clinical trials, assist in the day to day running of the Research Delivery Teams.

• Act as a key worker for patients throughout their clinical trial experience.

• Ensure trial records are accurately maintained, including, but not limited to: records in nursing/medical paper and electronic notes, case report forms, trial site files.

Responsible for ensuring accurate study records are maintained on EDGE (Clinical Trials IT system).

• Take an active role in research promotion for staff and patients.

• Assist in the development and teaching of local standard operating procedures for the trials team and contribute to quality assurance programmes in the Network and Trust.
• Provide cover for other Senior Research Nurses/Coordinators during periods of absence including sick leave, annual leave and when positions are vacant across the research delivery teams.
• Coordinate, set up and maintain Research Co-ordinator / Nurse led clinics.

• Provide, maintain and facilitate a high standard of clinical trial practice across a broad portfolio, developing and promoting effective channels of communication both verbally and electronically.

COMMUNICATIONS AND WORKING RELATIONSHIPS The post-holder will be expected to communicate with a variety of stakeholders at all levels including but not limited to National Clinical Trials Units, Pharmaceutical companies, and other research Sponsor organisations, Clinical Research Network staff, researchers, support service staff and clinicians both within Gloucestershire Hospitals NHS Foundation Trust and beyond.

• Assessment and training of junior staff within the trials team, in line with identified training needs.

• Work closely with the Lead Research Nurse/Coordinator and Research Matrons, and the Governance & Oversight Group to monitor performance and ensure research is conducted according to current regulations.
• Take responsibility for recruiting and retaining team members in conjunction with the Lead Research Nurse/Coordinator.
• Support the induction of new staff to the research team.

• To maintain own personal & professional development, including keeping evidence required for revalidation/professional registration accreditation
• Act as a credible clinical role model
• Practice in a confident and competent professional manner MOST CHALLENGING PART OF THE JOB
• Managing the resources available to deliver trials to time and target
• Liaising and working with principal investigators, departments such as pathology, pharmacy, radiology, haematology, biochemistry and NIHR, clinical trials units
• Delivering educational sessions to Trust staff at all levels
• Meeting NIHR High Level Objectives and GHNHSFT Key Performance Indicators
• Implementing and promoting Good Clinical Practice for research.

• Travelling between Cheltenham General & Gloucestershire Royal Hospitals.

• Occasional lifting of boxes of A4 paper, A4 files and similar (up to 5kg) and transporting these to other sites
• The post involves a combination of sitting and standing plus walking
• There is a need to use a computer
• Travel to other sites for meetings, training and education purposes.
• Requirements to concentrate on information for long periods of time (e.g., concentrating for periods of time over an hour at a time when reviewing research applications or preparing reports).
• 50% of time spent working in an open plan office
• 50% of time spent working in clinical areas (talking to patients, taking blood, testing urine samples and administering some treatments)