Are you someone who can easily adapt to different settings, enjoy meeting new people, and would like to make a difference in health and social care through clinical research? South London Regional Research Delivery Network (RRDN) is looking for an enthusiastic Research Practitioner to join the Agile Workforce team. The Research Practitioner will play a key role in ensuring that any research undertaken within the Care settings department safeguards the wellbeing of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. Working collaboratively with the clinical trials team and the wider multidisciplinary team in the management of research patients. They will also act as a patient advocate providing support and assistance as required and assist in the coordination and management of a portfolio of clinical research studies. The post holder will be required to work flexibly across sites within the RDN: South London geography. The employing Trust will be Guy's and St Thomas' NHS Foundation Trust.
Main duties of the job
The post holder will be responsible for delivering an agreed number of portfolios of clinical trials within the Secondary, Primary Care and Community settings across the South London region. They will work flexibly across the disciplines to ensure the success of the clinical research projects they are assigned to. The Research Practitioner will play a key role in identifying opportunities to broaden the current portfolio.
Job responsibilities
* 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.
Person Specification
Qualification/Education
Essential
* Educated to degree level in a health related or social sciences discipline
* Relevant specialist course or equivalent experience
Desirable
* A relevant post graduate qualification in a research area involving patients or service users.
Experience
Essential
* Extensive experience of working within a NHS environment in a research role
* Experience of effective multidisciplinary team working
* Significant experience of working with service users and or in a patient facing role
* Experience with Access Databases/Excel spreadsheets
Desirable
* Familiar with Good Clinical Practice & UK ethical and governance frameworks
* Experience of working as a research practitioner within the National Institute of Health Research Delivery Network Clinical Research Networks
* Experience of delivering Patient Public Involvement within a research or NIHR setting
Skills/Knowledge
Essential
* Extensive knowledge of a research area of relevance to the division and RDN CRN
* Organisation and management skills.
* Ability to work independently.
* Flexible approach towards teamwork and patient/family involvement
Employer details
Employer name
Guy's and St Thomas' NHS Foundation Trust
Address
Guys Hospital
Great Maze Pond
London
SE1 9RT
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