Clinical Research Nurse

• 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, individualized patient/volunteer care.
• Responsible for recruiting to, and following up, patients within studies. This includes both randomized clinical trials and other highquality 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 ensuringadvice 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 Trustand Centre's policies and clinical trial protocol.
• Assist in clinical trials including venepuncture and cannulation of volunteers when necessary ensuring that they are carried out withinthe Trusts policies, research governance , Medicines for Human Use ( Clinical Trials Regulations ) Incorporating InternationalConference on Harmonisation of Good Clinical Practice (ICH GCP) and Data Protection 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 aVolunteer which will form part of a research study , in accordance with the Trust research governance arrangements and Medicines for Human Use ( Clinical Trials Regulations ) 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 TrialsRegulations ) Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP).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

• Plan, organize and deploy staff according to ability and workload in order to meet participant 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 the Nurse Manager in managing incidents, accidents and complaints in accordance with Trust policies and procedures.Assist in ensuring the availability of resources for volunteer careEnsure 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 control of the ward or departmental budget and identify 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 EUDirectives.
• 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).

• Assist in the education and support of health care professionals to enable them to care for clinical trial patients and recruit to clinical trials where appropriate.
• Maintain an up to date knowledge of research related topics particularly related to clinical trials.
• Attend local and national meetings as appropriate and as agreed with the local coordination centre.
• Attend regular update sessions at GSTT.
• Assess the needs of volunteers, relatives and carers and provide them with information as requested
• Educate and counsel volunteers, family and those who volunteer for clinical trials before, during and after clinical studies and investigations
• Assist the Charge Nurse in orientating all new staff and students to the ward or department
• Provide teaching and development to the nursing team and students helping them to achieve their learning outcomes
• Act as a role model, mentor and preceptor to the nursing team

• Understand and adhere to Trust policies and procedures.To maintain patient confidentiality and standards of Good Clinical
• Practice (GCP) at all times
• Maintain NMC registration

Essential

• Level 1 NMC Registered Nurse
• Educated to degree Level or above

Desirable

• Specific Clinical Research qualification
• Relevant specialist course or equivalent experience (eg. SACT)

Essential

• Extensive experience of working within a ward environment as a qualified nurse
• Experience with data management including Excel Spreadsheets, eCRF and patient database systems
• Experience of effective multidisciplinary team working
• Familiar with Good Clinical Practice & Certification

Desirable

• Post registration experience in a relevant specialty (SACT, oncology, research delivery)

Essential

• Knowledge of research methodologies
• Knowledge of quality, standard setting, benchmarking and audit
• Competency in medication administration including IV drugs
• Organisation, problem solving and management skills
• Ability to perform clinical activities specific to speciality
• Competency in phlebotomy and cannulation

Essential

• Flexible approach towards teamwork and patient/family involvement
• Enthusiastic, professional and accountable