Community/Public Health & Social Care Research Practitioner

Carry out planned care required by the clinical trials protocol for a group of volunteers without direct supervision Ensure the assessment, planning, implementation and evaluation of evidence based, individualised patient/volunteer care. Responsible for recruiting to, and following up, patients within studies. This includes both randomised clinical trials and other high-quality clinical studies. The role will involve working closely with multidisciplinary clinical teams Act as a patient advocate enabling patients to make informed choices concerning their involvement in the clinical trials and ensuring advice and information is provided. Ensure there is sufficient skill mix of staff for patient safety during clinical trials and ensuring that they are carried out within the Trust and Centre's policies and clinical trial protocol. Assist in clinical trials including venepuncture of volunteers when necessary ensuring that they are carried out within the Trusts policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Data Protection Act and Human Tissue Act. Undertake clinical tasks such as phlebotomy, analysis of blood specimens, drug administration and clinical observation etc. Assist and advise staff, both registered and unregistered in the delivery of care to the volunteer. Ensure that written informed consent has always been obtained for any treatment provided for, or any sample or data taken from a Volunteer which will form part of a research study, in accordance with the Trust research governance arrangements and Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006. Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Have responsibility for the correct administration and custody of medicines according to Trust policy. Maintain all data and case report forms relating to clinical trials in accordance with the Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and the Research Governance Framework. Report any deviation from normal practice to senior staff and implement agreed changes in care programme. Deal with concerns raised by volunteers and visitors in a proactive manner and take remedial action as necessary. Act as the volunteers advocate. Administration Plan and organise workload in order to meet studies and volunteer needs. Ensure that nursing practices comply with Trust policies and procedures Communicate effectively at all times and maintain a harmonious working environment. Maintain a safe environment in accordance with the Health and Safety at Work Act. Assist managers and senior nurses/practitioners in managing incidents, accidents and complaints in accordance with Trust policies and procedures. Assist in ensuring the availability of resources for volunteer care Ensure equipment is in good working order, and report appropriately when defective Participate in audits, EG those undertaken by the Medicines and Health Care Regulatory Authority (MHRA) nursing audits and clinical benchmarking exercises and suggest any change to improve standards Ensure the economical use of resources Contribute to the overall RDN CRN or departmental budget by identifying areas where cost improvements can be made Ensure the safe custody of volunteers property in accordance with Trust policies. Actively participate in and support the development of the clinical research facility. Promote and participate in the implementation of policies within the Centre and to ensure compliance with Trust, Government and EU Directives. Maintain accurate documentation in clinical trial documents and patient notes. Ensure that clinical trials are effectively archived as required. Assist in the process of gaining local regulatory committee approval (ethics and R&D approval). Other Understand and adhere to Trust policies and procedures. To maintain patient confidentiality and standards of Good Clinical Practice (GCP) at all times.

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