Job responsibilities
Clinical and Research.
Act as a role model for excellence in clinical research delivery.
Support research activities across the Radiology Department as prioritised by the Research Liaison Radiologists and Research Leads.
Provide support for the optimisation and development of research and support the internal clinical trials approvals process. Provide timely and professional support and assistance to colleagues, radiographers and research physicists, and other staff in service delivery and personal development.
Work with a high level of autonomy to manage his/her caseload of patients, whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and professionals to ensure service delivery.
Identify suitable patients for entry into clinical trials by attending out-patient clinics (screening notes/clinician referral) and Multidisciplinary Team (MDT) meetings and assist in the recruitment of patients and research volunteers whilst adhering to the study recruitment criteria
Assess patient eligibility by reviewing case histories, clinical notes and electronic health records in accordance with recruitment criteria.
Ensure patients are fully informed prior to entry into any clinical trial programme, providing clear explanations of research projects and relevant documentation acting as a guide and advocate to the patient throughout the complex decision-making process.
Participate in the informed consent process ensuring adherence to the UK policy framework for health and social care research.
Evaluate patient eligibility and safe entry to clinical trials, co-ordinating /undertaking investigations, obtaining results and arranging appropriate appointments according to trial protocol requirements.
Register/ randomise patients into clinical trial protocol and ensure all data inputs are accurately recorded thus maintaining the integrity of data for patients, research volunteers and service users.
Act as an on-going resource and support to patients and their carers, regarding practical aspects of clinical trial participation.
Recognise the complex emotional/psychological needs of patients entering a clinical trial and provide an appropriate level of support.
Collect any blood samples as required, strictly adhering to the clinical trial protocol and ensuring safe handling and appropriate storage of specimens.
Support the administration of trial drugs, be aware of and report any unusual side- effects and interactions.
Maintain comprehensive and accurate documentation of patient events in patients medical notes.
Responsible for timely, accurate and complete documentation in the patients case report form (CRF)
Upload anonymous patient images to the required image upload portals provided by the sponsor and assist in data transfers to approved data safe havens
Monitor and report treatment toxicity/side effects and initiate changes to treatment as required by the protocol.
Record and report adverse events, serious advent events and suspected, unexpected, serious adverse reactions (SUSARS) that occur whilst the patient is participating in the clinical trial to relevant personnel and act as defined in trial protocol and according to Trust policy.
Implement and adhere to the European Directive for clinical trials incorporating the principles of GCP (Good Clinical Practice).
Co-ordinate end of trial activities including archiving.
Prepare for and participate in internal and external audit inspection processes.
Demonstrate awareness and compliance to MHRA regulations, those associated with data protection and other relevant laws and regulations.
2. Organisational/Management
Work closely with the Research Liaison Radiologists and Research Leads in the provision of a comprehensive clinical trial service.
Be aware of and work within Local Trusts policies and procedures.
Assist in the review of trial protocols and identify resource implications for the site.
Liaise with the medical team and sponsor organisation in:
o on-study treatment and follow-up of patient
o ensuring the collection of accurate data
Implement the set-up of clinical trials on site, involving liaison with Trust R&D, Sponsor Organisations, Clinical Trials Units and other relevant staff to facilitate trial set-up visits.
Ensure that timely and accurate screening and accrual data is recorded and reported as required.
Liaise with other departments and wards at the site/s, including attendance at relevant Multidisciplinary meetings in order to promote collaborative working, integration of research and maintenance of open and effective communication.
Inform appropriate groups of clinicians, Clinical nurse specialists and departments/wards of the content of the research portfolio.
Be able to provide information to allow for invoices to be raised for payments where appropriate.
Identify barriers to recruitment to trials and plan and implement strategies to overcome them.
Innovate and contribute to the development of clinical research policies/procedures/Standard Operating Procedures within the department.
Keep up to date on research management issues through liaising with Research Matron and attending national meetings.
3. Education and Training
Act as an expert resource for colleagues in relation to clinical trials
Continue and provide evidence of own professional development.
Maintain links with other clinical trials professionals across local and national networks to share knowledge, skills and provide mutual support.
Maintain up to date knowledge of research related advances in clinical trials.
Attend national meetings in relation to clinical trials as appropriate and agreed with line manager.
Participate in provision of education and study days Trust wide to all levels of clinical staff to promote clinical trial awareness.
Attend trial Investigator meetings and conferences as appropriate when required.
Disseminate research by assisting in the preparation of poster/research papers for meetings, conferences and publications.
Contribute to the induction and orientation of new research nurses/practitioners to the Team.
To be trained in and demonstrate fair employment practices, in line with trust policies.
