Senior Research Nurse

Job overview

We are delighted to announce a secondment/fixed term opportunity to work as a Research Nurse to support the delivery of clinical research and quality improvement initiatives within Central Cheshire Integrated Care Partnership (CCICP), the community division of Mid Cheshire Hospitals NHS Foundation Trust (MCHFT). This is a unique opportunity to support CCICP on its research journey with our commitment and ambition to be successful in participating and developing community nursing research.

The post holder will play a key role in coordinating and delivering clinical research studies and quality improvement programmes, ensuring that care pathways for patients and carers participating in research are effectively managed.

The Community Research Nurse will work collaboratively to scope clinical trial opportunities across hospital and community to support a longer term sustainable plan for research opportunities within CCICP.

The successful candidate will be someone with experience within clinical research, and posses excellent organisational, time management, leadership skills to be the key contact for any clinical trials which are being considered from across multiple community nursing services.

Main duties of the job

The role involves ensuring that all research activity is conducted in accordance with Good Clinical Practice (GCP), relevant research governance frameworks, and Trust policies and procedures. Responsibilities include supporting the recruitment, education, and monitoring of patients participating in research studies, while ensuring the accurate collection, documentation, and management of study data in line with regulatory requirements.

Working collaboratively with clinical research teams and the wider multidisciplinary team, the Research Nurse will contribute to the safe and effective management of patients involved in clinical studies. The post holder will develop and maintain a comprehensive understanding of study protocols, research methodologies, and the practical application of these within clinical settings. In addition, they will ensure compliance with local, national, and international research regulations, supporting the delivery of high quality research that contributes to improved patient care and service development.

Detailed job description and main responsibilities

• Lead the coordination and delivery of a portfolio of clinical research studies across the CCICP community footprint, including NIHR portfolio and investigator-led studies.
• Assess study feasibility in collaboration with Principal Investigators, community service teams and R&D, including confirmation of capacity and capability within the community setting.
• Lead study set-up activities including site initiation preparation, risk assessment, and integration into community care pathways.
• Identify, screen, recruit and obtain informed consent from eligible participants in accordance with GCP and Trust policy, including implementation of re-consent where required.
• Deliver protocol-driven clinical care including physical assessment, venepuncture, ECG recording and interpretation, and monitoring and management of adverse effects.
• Ensure investigational medicinal products (IMP) are handled, administered, stored and documented in accordance with protocol requirements, pharmacy guidance and MHRA regulations.
• Collect, process and ship biological samples in line with protocol and Human Tissue Act requirements.
• Ensure accurate and timely source data documentation and high-quality CRF completion in line with GCP data integrity principles.
• Ensure timely and accurate SAE reporting in accordance with Sponsor and regulatory requirements.
• Identify, document and escalate protocol deviations and potential serious breaches in accordance with Sponsor and Trust procedures.
• Take operational responsibility for achieving recruitment targets across allocated studies and implement corrective actions where barriers are identified.
• Monitor study performance against recruitment metrics, visit windows, data query resolution and financial milestones.
• Liaise with the NIHR Research Delivery Network to support study set-up and performance monitoring where required.

Ensure research activity complies with Good Clinical Practice (ICH-GCP), the UK Policy Framework for Health & Social Care Research, MHRA requirements and Trust SOPs.

Ensure compliance with Trust policies and procedures.

Maintain site files in inspection-ready condition at all times, including accurate maintenance of delegation logs and essential documents in accordance with ICH-GCP and Sponsor requirements.

Ensure protocol deviation reporting is completed accurately and in collaboration with the Principal Investigator.

Ensure compliance with GDPR, Human Tissue Act and ethical research standards.

Act as primary contact for sponsor monitoring visits and support external audit and regulatory inspection activity.

Contribute to the development and implementation of corrective and preventative action (CAPA) plans arising from monitoring visits, audit findings or inspection outcomes.

Escalate governance risks appropriately to the Research Governance Manager and line manager.

Report incidents and adverse events appropriately.

Report at CCICP Quality Governance Group