Detailed job description and main responsibilities

Clinical • Provide excellent customer care skills to ensure patients and participants come first. • Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times. • Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. • For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol. • Organise and facilitate participant appointments and follow-up phone calls. • Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately. • Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or coinvestigator. • Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate. • Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol. • Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples. • Provide ongoing support to the participant and carer whilst participating in the clinical study. • Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding. • Engage effectively with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication. • Communicate with internal and external study coordinators and sponsor representatives, nationally and internationally. • Attend and participate in multidisciplinary team meetings. • Arrange, attend and record minutes for research and other relevant departmental meeting. • Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required. • 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. • Undertake clinical tasks such as drug administration and clinical observation. Have responsibility, under supervision, for the correct administration and custody of medicines according to Trust policy. • Deals with telephone queries from patients, relatives and their carers. Refer queries to other members of the multidisciplinary team as required and act in accordance with team practices. • Complies with the informed consent process as described in the approved protocol, including use of approved versions of the patient information sheet, 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) • Recognises that informed consent is an ongoing process and demonstrates awareness of the factors contributing to a participant’s autonomous decision making during the consent process. • Recognises own learning needs and takes responsibility for maintaining up to date knowledge. • Facilitate a high quality, cost effective specialist service through monitoring and audit and other quality initiatives agreed by the trust. • Provide support to set, monitor and review standards of care on a regular basis and initiate corrective action plans where required. • Identify and intervene where circumstances contribute to an unsafe environment for patients and staff. To bring such instances to the attention of the senior team members e.g. lead research nurse, research manager or CRF Nurse Manager. Administration • Ensure that clinical 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 Manager in managing incidents, accidents and complaints in accordance with Trust policies and procedures. • Ensure equipment is in good working order, and report appropriately when defective • Participate in audits/inspections, e.g. those undertaken by the Medicines and Health Care Regulatory Authority (MHRA), quality control, nursing audits and clinical benchmarking exercises and suggest any change to improve standards • Ensure the economical use of resources • Ensure the safe custody of patient/volunteers’ property in accordance with Trust policies. • Actively participate in and support the development of the research environment. • Promote and participate in the implementation of policies within the department and to ensure compliance with Trust, Government and EU Directives. • Maintain accurate documentation in clinical trial documents and patient notes. • Ensure that clinical trial/research study data are effectively archived as required. • Assist in the process of gaining local regulatory committee approval (ethics and R&D approval); when required. • To ensure compliance within the team is adhered to with regards to the Trusts policy on data protection, confidentiality and security. • To ensure that all data added to the electronic database is accurate and complete. Education and Training • 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. • 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 Research Manager and team in orientating all new staff and students to the unit or department; where appropriate. • Contribute and assist the team to foster a learning environment within the clinical area; where appropriate. • Act as a role model, mentor and preceptor to the research team Other • 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 • Undertaking any other duties that may be required from time to time as are consistent with the responsibilities of the grade and the needs of the service.