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 ofthe study protocol 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.
Clinical Trial Set Up (CTIMPs and Non-CTIMPs) Contribute to the assessment of trial protocols and safety, regulatory and logistical issuesin 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 Clinical Research Network personnel in identifying trials in the pipeline.
Liaise with the NIHR Clinical Research Network throughout studies and facilitate the lines of communication between the Trust / R&D and the NIHR CRN. Demonstrate and apply knowledge of the financial issues relating to the undertaking of clinical research

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