Job responsibilities
MAIN DUTIES AND RESPONSIBILITIES
Feasibility and Study set-up
Contribute to the set-up of research studies within the wider research team. Liaise with the R&I Professional Services Team, Principal Investigators, support departments, and multidisciplinary teams to ensure a thorough feasibility process.
Able to identify and plan strategies for recruiting patients into trials. Working with Principal Investigators to develop initiatives to increase patient involvement.
Support
Assist in the selection and recruitment of participants in compliance with study inclusion / exclusion criteria. Receive informed consent and provide ongoing information, education and support to clinical trial patients (and their carers).
Assist in achieving NIHR High Level Objectives and GHNHSFT Key Performance Indicators for patient recruitment, speed and quality of research
Liaise with multi-disciplinary team members to teach and demonstrate procedures for the safe and smooth running of clinical trials and act as a training resource to other members of the clinical team and a contact point in matters concerning trial patients and trial protocols.
Ability to line manage, train and develop junior members of the team, act as a role model.
Act as a supervisor for students as applicable to professional registration.
Study Delivery/Monitoring
Good knowledge of clinical trials, including, but not limited to: Research Governance Framework, Good Clinical Practice for Clinical Trials.
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. Reporting of serious adverse events to all relevant personnel, following the relevant Standard Operating Procedures. Assess patients as required by trial protocols and take appropriate and timely action for patients with treatment toxicities, where appropriate.
Perform trial specific clinical observations and assessments as mandated by trial protocol. Venepuncture, test urine samples and administer treatments for which training has been given, as applicable to professional registration, R&I Standard Operating Procedures and Trust POPAM policy.
To be responsible for requesting internal monitoring reports for locally sponsored/hosted studies and actioning as required. Responsible for actioning externally sponsored monitoring reports in a timely manner.
Ensure trial protocols are followed and that trials are conducted according to the Research Governance Framework Procedures, R&I Standard Operating Procedures and Good Clinical Practice (ICH GCP). Maintain a safe environment for patients, staff and visitors.
Comply with Trust policies and guidelines.
Ensure trial records are accurately maintained, including, but not limited to: records in nursing/medical electronic and paper notes, case report forms and trial site files. Adhere to requirements to protect confidentiality. Maintain study records on EDGE (Clinical Trials IT system).
Other Duties
Support the embedding of clinical research within our Trust. Contribute to strategies that inform Trust staff of current clinical trial activity/progress.
Respond to change in line with the needs of service provision, working flexibly within the delivery team.
Identify own learning needs and proactively seek educational and training opportunities to develop and maintain competency.
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.
MOST CHALLENGING PART OF THE ROLE
Working across a portfolio of research studies.
Liaising and working with principal investigators, multidisciplinary clinical staff, and departments such as Pathology, Pharmacy, Radiology, and Clinical Trials Units.
Encouraging other professionals, outside of the Research & Innovation team, to take an interest in and support clinical trials.
Implementing and promoting Good Clinical Practice for research.
Frequent interruptions to concentration from people, telephone, etc.
Mental effort long periods of concentration required on often lengthy documents.
PHYSICAL EFFORT AND WORKING CONDITIONS
Occasional lifting of boxes of A4 paper, A4 files and similar (up to 5kg) and transporting these to other sites
Travelling between Cheltenham General & Gloucestershire Royal Hospitals. Supporting research clinics within the Research Facility Centre. Occasional community or home visits to patients.
20% of time spent working in clinical areas (talking to patients, taking blood, testing urine samples and administering some treatments as applicable).
80% of time spent working in an open plan office
Physical effort is not strenuous, 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, standing and walking
There is a regular need to use a computer
