Clinical Research Practitioner/ Clinical Research Nurse Practitioner

Identify and recruit service users into clinical studies, acting as a source of information and support to service users and their relatives by explaining practical aspects of participating in clinical research

Ensure that each person fulfils the relevant study criteria and understands the implication of participation when taking informed consent

Demonstrate knowledge of the ethical principles for clinical research and its impact on current practice

Ensure ethical and clinical safe practice at all times

Ensure that each study is conducted in accordance with the study protocol, Trust Standard Operating Procedures and relevant research legislation and guidance

Provide direct patient care within the scope of the study protocol, including (but not limited to) physical observations, ECGs and phlebotomy where required

Process and ship blood and other samples as required in the study protocol, ensuring save and appropriate storage and handling of specimens in line with Trust policy and IATA guidelines

Provide appropriate information and support concerning research, care and treatment of individuals participating in research studies to any nursing and/or support staff involved in the participants care

Liaise with Principal Investigators, support services (e.g. pharmacy, radiology, laboratories), study sponsors, clinical research associates and other members of the study team, to ensure smooth running of the study

Provide research information to medical, nursing staff, service users, General Practitioners, community services and other staff where appropriate

Take a proactive role to increase Trust participation in portfolio research and recruitment rates in individual studies

Responsible for timely, accurate and complete documentation in the participants care record and the study case report form (CRF) in accordance with Trust policy and regulations

Record and report adverse events, serious adverse events and suspected, unexpected, serious adverse reactions (SUSARs) that may occur during the course of the study, to relevant personnel and act as defined within the study protocol and according to Trust policy and ICH-GCP recommendations

Assist with the coordination of study visits, in line with protocol window requirements

Assist with the set-up, undertaking, and close of each research study as required

Assist with the identification of strategies to recruit participants into research studies

Assist with identifying barriers to recruitment and ensure that the R&D Manager and Principal Investigators are aware where this has the potential to impact on study delivery targets

Ensure that all research documentation, including screening, recruitment and regulatory records are complete and accurately maintained

Provide information to allow for invoices to be raised for payment where appropriate

Comply with organisational policy on documenting critical incidents and near misses and assist with root cause analysis and the implementation of changes in practice to reduce risk

Prepare for and participate in internal audits and inspections, evaluations and benchmarking exercises

Prepare and make available study documentation for monitoring audits and inspections as required by the Trust and associated regulatory bodies

Ensure the requirements of other agencies such as the National Institute for Health Research and the Medicines and Healthcare Products Regulatory Agency are followed in order to meet research governance targets, improve clinical outcomes and ensure compliance with all legislation or standards expected for research services