The Role
1. To maintain and promote the safety and wellbeing of all subjects participating in a clinical trial within the regulatory frameworks of ICH GCP, other statutory instruments and NMC Code of Conduct.
2. Assist the senior team with the daily management and allocation of workload within the clinical environment
3. Involvement in preparing, planning and execution of daily clinical activities;
4. Provide guidance and mentoring to staff in the clinical environment. Ensure competence in performing their own and team’s daily tasks;
5. Supervision of new ancillary staff in the clinical environment as required;
6. Promote and adhere to Company SOP’s, protocols and Health and Safety Regulations; and
7. Support Clinical Support Specialists in performing clinical assessments as per protocol;
8. Perform nurse specific procedures as identified within the protocol;
9. Performs informed consent procedures as identified in the study protocol;
10. Completion of study related documents e.g. logs, source data and CRFs;
11. Adhere to Company SOPs, protocols and Health and Safety Regulations;
12. Use of expertise to input into the development of SOPS and other procedural documents;
13. Maintain subject safety at all times responding to emergencies as per internal SOP and national guidelines and protocols;
14. Monitoring and identification of the deteriorating subject, with appropriate escalation;
15. Responsible for the checking of emergency resuscitation equipment as per SOP/OIs;
16. Responsible for maintenance of medicines management within the clinical department as per SOP/OI;
17. Responsibility for the supervision of clinical staff in the screening unit as delegated by the Senior Research Nurse;
18. Identification of areas for service improvement;
19. Promotes a high standard of practice and care at all times
You
20. NMC registration essential and Nursing qualification essential
21. 1+ years’ experience working as a clinical research nurse or equivalent.
22. Certificate in basic or intermediate life support essential
23. Sound clinical knowledge
24. Competence in the recording of medical history, vital signs, ECG, phlebotomy etc essential
25. Knowledge of GCP. Previous experience in a clinical trials setting is desirable but not essential
26. Ability to prioritise own workload
27. Ability to manage adverse events or clinical incidents
28. An understanding of ethical practice and confidentiality
29. Good knowledge of ICH-GCP and regulatory standards