Job Description

Clinical Trial Management (CTIMPs and Non-CTIMPs) Obtain informed consent from participants for non-CTIMP studies (i.e. observational and questionnaire) as instructed by Principal Investigator (PI) and within parameters of the protocol. Support participants considering taking part in interventional and observational research with the decision-making process, ensuring that their information needs are met sensitively and that they have a full understanding of the research study and its requirements. To ensure all Adverse Events are reported in line with the Trust Adverse Events Reporting policy Ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner.



Facilitate and maintain (written and verbal) communication between the PI, research and clinical teams in ensuring that the study protocol is correctly implemented and research governance standards are met and maintained. Ensuring that all equipment used in the trial is appropriately calibrated and that supporting documentation is retained. Perform all visits, observations, and clinical procedures such as monitoring vital signs, body measurements, height and weight, ECGs, venepuncture, cannulation, drug administration with the participants in accordance with the procedures and schedule of the study protocol. Undertake laboratory work as per study protocols, including processing, packaging, storing and transportation of samples.



Provide ongoing support to patients and volunteers with regards to their trial participation. Ensure that all clinical trial databases and logs are maintained including updating patient recruitment data on EDGE, our Local Performance Management System, on a weekly basis. Ensure protocol amendments are incorporated into research practice in a timely manner. Work within the scope of research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures.



Adhere to the confidentiality of patient information at all times, in accordance with the Data Protection Act and Caldicott regulations. General Clinical Duties Lead on assessing planning and implementing high quality care, and evaluating care options for patients in the clinical area, in line with the Trust values and objectives. Lead on complex clinical care for patients within their area. Ensure the safe custody, maintenance, and administration of medication, in accordance with established Trust policy.



Promote and maintain a safe therapeutic environment for patients, their families, and staff, according to national and local Infection Control guidelines, Health & Safety legislation and Trust policies and objectives. Provide sound evidence based clinical advice as required to staff and patients. Maintain a good understanding and implementation of clinical escalation procedures as required. Understand the Trust clinical governance framework, and participate in the promoting and safeguarding of high standards of care, through effective risk management & governance, and adherence to the Trust values.



Ensure that the team promote, ensure and adhere to the Trust safeguarding polices. Undertake effective multi professionally work with colleagues to deliver care. Coordinate specialist functions, including making clinical decisions where appropriate. Monitor quality of standards of care, in line with CQC requirements and Trust and Divisional objectives.



Deliver and supervise a high quality patient experience. Work with manager to collect and disseminate data on quality indicators etc, in line with national and Trust objectives. Maintain a safe working environment, including ensuring equipment is safe, and used in line with Trust policy and values. Promote and maintain patient safety at all times, including proactively implementing falls prevention.



Lead role in the detection, management and prevention of safeguarding issues. Have an awareness of current professional and clinical developments within their area of practice and promote this to others. Clinical Trial Set Up (CTIMPs and Non-CTIMPs) Contribute to the assessment of trial protocols and safety, regulatory and logistical issues in the running of the trial. Contribute to trial feasibility meetings.



Liaise with the R&D Governance Team to ensure all studies have been given Health Research Authority approval and Capacity and Capability confirmation prior to commencement. Liaise with NIHR Research Delivery Network and CRDC personnel in identifying trials in the pipeline. Liaise with the NIHR Research Delivery Network and CRDC and facilitate the lines of communication between the Trust / R&D and the NIHR. Demonstrate and apply knowledge of the financial issues relating to the undertaking of clinical research.



Be expected to assist in detailed costing of studies to ensure all costs related to the study are identified prior to Trust approval being given. Be expected to identify any blockages to study set up and work with PI and R&D to identify strategies to mitigate them. Ensure compilation and maintenance of all site files, in accordance with ICH-GCP. Support junior research staff in preparing for and attending Site Initiation Visits.



Study Close out Ensure all data clarification issues are resolved quickly. Assist with the archiving of study related documentation in line with the Trial Agreement and ICH-GCP. Administrative Duties Oversee the setting up and maintenance of investigator site files and working files. Completing Case Report Forms (CRFs) including eCRFs with a high degree of accuracy.



Setting up and maintaining study trackers. Managing and auditing of study amendments. Locating and tracking of medical records. Managing and participating in audit/monitoring visits.



Overseeing filing of research material such as laboratory and imaging reporting. Completing annual monitoring study reports. Resource Management Handling of patient valuables and the reimbursement of patient expenses incurred as a result of study participation. Shared responsibility for the safe use, maintenance and storage of computers, photocopiers and other office equipment.



Contributing to effective stock control/maintenance. Managing the physical resources required to undertake research activity including monitoring that resources are fit for purpose, for example: within manufactures date and / or calibrated and that they are used accurately. Promoting an informal as well as formal process with regard to risk management to ensure that risk assessment is a continuous process and is embedded as part of the normal daily role for all staff. Education and Development Duties Attending induction training Attending mandatory training and ensuring updates are undertaken as required Attending research specific training (such as GCP).



Attending and contribution to team meetings and learning sessions such as scenario based learning. Maintaining research training log. Updating research CV. Developing research related knowledge in relation to research governance, International Conference of Harmonisation Good Clinical Practice and the EU clinical trials directive.



Identifying own learning needs and proactively seek clinical educational opportunities through the clinical area, R&D and NIHR Research Networks as appropriate. Developing skills in accordance with RCN Competency Framework for Research Nurses appropriate to the Band 6 role. Maintaining own professional registration, if appropriate, through effective use of CPD opportunities. Ensuring own appraisal is always up to date and objectives are met as required.



Contributing to the education and development of junior and senior research assistants, in addition to student nurses and midwives on research placements. Contributing to the knowledge and development of other staff by ensuring that clinical and research staff is made fully aware of local research opportunities, active studies, requirements for recruitment, protocol requirements, responsibilities of clinical and research staff, and governance requirements. Assisting with delivery of trust wide teaching/training including GCP, research workshops and delivering departmental research updates and presentations. Supporting, encouraging and developing nurse led research where appropriate.



Supporting Lead Research Nurse and Delivery Manager in organising and delivering relevant updates at Senior Nurse and Midwife Committee meetings and CNS forum. Please refer to the attached and Person Specification for a full list of role requirements and main responsibilities.