Clinical Research Nurse

• 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, venipuncture, 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 regulation

Essential

• Putting patients first
• Responsive to, and supportive of, patients and staff
• Open, welcoming and honest
• Unfailingly kind, treating everyone with respect, compassion and dignity
• Determined to develop our skills and continuously improve the quality of care

Essential

• Fully registered Nurse with NMC pin (Adult or child as appropriate)
• ICH GCP (E6-R2) Certification (currently valid)
• Teaching / mentorship qualification
• First degree (BSc/BA)

Desirable

• Master's degree or working towards
• Qualification in the area of infection disease (ID)

Essential

• Relevant post reg. experience at Band 5 level
• Experience in clinical research i.e. conducting CTIMP clinical trials
• Experience of teaching and supporting learners / new staff etc.

Desirable

• Experience of team leading in the delivery of portfolio of clinical studies
• Experience of clinical supervision and leadership

Essential

• Proven clinical knowledge linked to area of specialty, and excellence in care delivery
• Proven knowledge of safety issues through clinical governance and risk management
• Proven supervisory and deputising skills in clinical area
• Excellent communication skills with patients, relatives, staff and external contacts, including in challenging situations, demonstrating respect and kindness.
• Knowledge of current challenging and issues in nursing

Desirable

• Ability / experience of managing change personally and as a facilitator
• Knowledge of budgets
• Experience of data collection for quality monitoring / audit
• Experience of risk management / assessment

Essential

• Effective role model, demonstrating values of safety, respect kindness and excellence
• Enthusiastic and motivated
• Effective team member
• Self-starter and able to work on own initiative
• Able to remain calm under pressure
• Able to act as a patient's advocate
• Approachable, respectful, supportive adaptable, and assertive
• Professional and impartial at all times