Undertake the screening, recruitment, education and monitoring of trial sites/patients and the collection and documentation of accurate data. This role will also support the coordination of trials where appropriate and assist with the submission of trials for trust/ethical approval and liaison with trial management units.
Main duties of the job
1. Assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.
2. Carry out clinical trial procedures and interventions according to pre-determined protocols and Standard Operating Procedures. This will include venepuncture, cannulation, vital signs and ECGs.
3. BLS (Basic Life Support) training including the BEACH course (Bedside Emergency Assessment Course for Healthcare Assistants).
4. Provide ongoing advice and information to patients/volunteers regarding their participation in clinical research to facilitate effective informed consent.
5. Assist with patient visits in accordance with study protocols, including coordinating special tests in other departments, collection of data, data entry and patient support.
6. Carry out the collection, processing and shipping of biological specimens according to protocol requirements and follow up appropriately on alert values.
7. Ensure that patient safety is paramount in all procedures that take place for trial purposes and efficiently in accordance with NMC and EU Directive (ICH GCP) Guidelines.
8. Have computer skills for the handling and management of computerized data.
9. Assist with the coordination, preparation and submission of research to gain approvals.
10. Assist the clinicians to report and record any adverse events as dictated by NHS permissions.
11. Ensure that REC, R&D approval and indemnity are in place prior to commencing the trial.
12. Under supervision, liaise with sites/assist with identification of research participants/searching records for portfolio studies, aid clinicians/research nurses in obtaining informed consent, recruitment to trials.
13. Work with staff across the Network to develop strategies to overcome barriers to patient recruitment.
14. Be responsible for forwarding trial data in a timely manner as necessary.
15. Attend core multi-disciplinary team meetings across Trusts to aid identification of research participants to portfolio studies where appropriate.
16. Ensure up-to-date research protocols, information sheets etc. are disseminated and utilized.
17. Keep accurate records and prepare for audits and inspections.
18. Ensure that trial-specific investigations are undertaken as required by the trial protocol, in order to establish eligibility and safety to enter the trial.
19. Provide ongoing information, education and support to patients (and their significant others where necessary), including practice staff, regarding clinical trials.
20. Ensure that accurate documentation of patient events in nursing/medical notes is maintained. Accurately document data collected into the case report forms (CRF).
21. Record and report serious/adverse events that occur while a patient is in the clinical trial to the relevant personnel and act as required.
22. Act as a primary/supportive contact point for the specific practice staff.
23. Carry out treatment procedures and treatment interventions according to predetermined protocols, including venepuncture, cannulation, ECGs and vital sign recording.
24. Be aware of relevant medical literature, developments in clinical research methodology, monitoring and local regulatory and ethical requirements.
25. Attend courses, research network meetings, conferences and study days in order to remain up to date with all relevant aspects of clinical research.
26. Have an understanding of the relevance of research to healthcare delivery.
Person Specification
Qualifications
Essential
* Good general education i.e. 3 GCSE's at grade C or above (or equivalent including English Language)
* Graduate or equivalent level NHS qualification in relevant discipline or equivalent.
Desirable
* Study days on research.
Experience
Essential
* Experience of liaison with staff at all levels in the NHS, Universities and Industry.
Desirable
* Clinical experience/qualification in venepuncture, IV cannulation.
* Previous experience in clinical research studies, research projects (protocols and study documentation).
* Skills in the analysis and interpretation of data.
Knowledge
Essential
* Previous research experience and knowledge.
* An awareness of the principles and practice of clinical research and/or clinical trials.
* An understanding of ethical and quality standards applicable to clinical trials, including EU Directive on ICH GCP requirements.
Desirable
* An awareness of the Health Service, R&D, the pharmaceutical industry partnership and relevant information sciences.
* An understanding of Research protocols and skills in administration of research and project management.
Employer details
Employer name
Liverpool University Hospitals NHS Foundation Trust
Address
Royal Liverpool
Mount Vernon Street
Liverpool
L7 8YE
Any attachments will be accessible after you click to apply.
287-CEF-482-24 #J-18808-Ljbffr