Clinical Research NurseNHS

Job summary

The purpose of this role is to deliver safe, high quality, patient-centred clinical research across Suffolk Primary Care (SPC), as a member of our dedicated and growing Research Team.

The role involves using an in-depth knowledge of research protocols and their application in practice, working closely with GPs, practice teams, sponsors and research partners to deliver a diverse portfolio of commercial and non-commercial studies across a range of therapeutic areas.

This vacancy is for a total of 15 hours per week.

Main duties of the job

The post holder will be responsible for:

Providing high quality, patient-focused clinical research across Suffolk Primary Care

Identifying and screening potentially eligible research participants

Providing clear, appropriate information and support to patients and participants

Undertaking study recruitment, informed consent and participant enrolment in accordance with study protocols and GCP

Supporting high levels of participant retention and engagement

Coordinating study visits, treatments and interventions as required by individual protocols

Undertaking clinical assessments, observations, blood sampling and other research procedures as required

Maintaining accurate and timely clinical and research documentation, including electronic case report forms and study records

Working collaboratively with Principal Investigators, practice teams, sponsors, CROs and other research stakeholders

Travelling between SPC practices as required to support recruitment and study delivery. Our practices are based in Framlingham, Debenham, Ipswich, Felixstowe, Stowmarket, Brandon & Newmarket

Job description

The purpose of this role is to deliver safe, high-quality research within and across Suffolk Primary Care. The research nurse will support the existing Suffolk Primary Care Research team to improve the set-up time and implementation of clinical research and ultimately patient care. The role involves using an in-depth knowledge of research protocols and their application in practice, alongside a working knowledge and compliance with the local, national and international research regulations. The post holder will demonstrate effective professional nurse standards, advocacy and performance.

Excellent communication skills are essential as is the ability to work independently and as part of a team.

Clinical Responsibilities:

Assess protocols and advise on safety, regulatory and logistical issues for the set-up and running of the study/trial to ensure the well-being and safety of patients, participants and staff.

Provide participants with specialist information regarding their participation, including risk factors.

Provide a high standard and continuity of care for participants during the research study, maintaining lines of communication with clinical staff.

Act as a resource to participants, their families and staff from within the clinical area, providing information and support; and to act as an effective referral to other support agencies where necessary.

Achieve and maintain defined competencies for clinical research to ensure that capability, skill and knowledge are appropriate for the work undertaken.

Work within dedicated clinical research teams; ensure ethical and clinical safe practice.

Undertake, with appropriate training, interventional treatments directly to participants according to study/trial protocol and procedures and record the resulting information.

Take and process clinical samples (e.g. venepuncture/cannulation) for studies, coordinate tissue sample collection and dispatch to relevant department or trial centre as appropriate.

Maintain clinical skills as appropriate e.g. phlebotomy, vital sign assessment, patient compliance and ECGs.

Undertake research-associated laboratory work safely, as required.

Work at all times as part of the extended multidisciplinary team and maintain excellent links with staff in primary care regarding the protocol care required for study/clinical trial participants.

Retrieve and retain medical records of participants for trial duration.

Research Responsibilities:

Conduct research according to standards and regulations laid down in ICH Good Clinical Practice and EU Directives, and to the most current guidance relating to Research Governance and Research Ethics.

Assist in the provision of background information about potential clinical trials to obtain approvals from Research Governance and Local Ethics Committees.

Co-ordinate and manage research within expected timelines.

Work within and contribute towards the development and review of Standard Operating Procedures (SOPs) and local policies/procedures for clinical research.

Understand the requirements of the study protocol and adhere to them

Identify suitable participants eligible for the study/clinical trial, in conjunction with the site investigator; identify, screen and recruit research participants using detailed knowledge of the protocols for the designated site specific groups.

Prepare patient/participant documentation for treatment clinics with meticulous attention to detail and complete accurate records of patient care, maintaining source data and CRFs in a clearly trackable system, to ensure data validity.

Report Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse o Reactions (SUSARs) immediately using the appropriate procedures, o Provide ongoing support, advice and information to patients/participants with regard to their participation in clinical research in order to facilitate an effective informed consent process.

Take informed consent where appropriate; maintain the continuous informed consent of participants to ensure that the procedures and treatments agreed within the trial protocol are fulfilled.

Co-ordinate own case load of participants within the allocated trials, e.g. organising trialspecific investigations, study treatments, appointments etc. as necessary.

Meet with trial sponsors as necessary, providing information requested on trial participants.

Participate in research protocol design, development and review: ensure that ethical issues are addressed and all personnel involved in the study/trial are made aware of any changes or protocol amendments.

Collect accurate local data and deliver to clinical trial centres in a timely manner adhering at all times to the terms of the Data Protection Act

Record own observations and those of other healthcare professionals, in the trial database, with accuracy.

Help to maintain the core entry database; participate in CRF completion, safety reporting, protocol compliance, monitoring and auditing of clinical trials.

Attend relevant local, regional and national meetings related to specific trials.

Assist with the resolution of data queries; contribute to financial processes of planning, running and closedown of studies.

Contribute to study closure and archival preparation

Contribute to nurse-led research

Take opportunities to publish and present findings of research undertaken.

Assist with the dissemination of research finding.

About us

Suffolk Primary Care (SPC) is a forward-thinking partnership of GP surgeries across Suffolk. Our collaborative approach enables doctors and staff to share resources, ensuring the continued delivery of high-quality healthcare.

We are committed to equal employment opportunities and encourage applications from all qualified individuals.

Benefits of Working with SPC

NHS Pension Scheme:

• Defined benefits scheme
• Life insurance
• Family benefits, including adult dependents & children's pensions
• Ill health benefits
• 23.7% employer contribution

Electric Car Salary Sacrifice Scheme:

• Low monthly payments, no deposit, no credit check
• Fully comprehensive insurance, servicing, tyres & breakdown cover
• Up to £2,000 annual SPC contribution (subject to conditions)

Additional Benefits:

• Eye care vouchers
• Health service discounts, including a complimentary Blue Light Card for new starters
• Minimum 33 days annual leave (inclusive of bank holidays) for full-time employees, with enhancements for long service
• Enhanced maternity & paternity terms
• High street discounts via our online portal
• Salary sacrifice schemes for technology, homewares (Currys, John Lewis, Decathlon), cycling, and gym memberships

At SPC, we invest in our staffs professional growth and well-being, fostering a positive work environment that benefits both our team and the communities we serve.