The purpose of this role is to deliver safe, high quality,patient-centred clinical research across Suffolk Primary Care (SPC), as amember of our dedicated and growing Research Team.
The role involves using an in-depth knowledge of researchprotocols and their application in practice, working closely with GPs, practiceteams, sponsors and research partners to deliver a diverse portfolio ofcommercial 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:
- Providinghigh quality, patient-focused clinical research across Suffolk Primary Care
- Identifyingand screening potentially eligible research participants
- Providingclear, appropriate information and support to patients and participants
- Undertakingstudy recruitment, informed consent and participant enrolment in accordancewith study protocols and GCP
- Supportinghigh levels of participant retention and engagement
- Coordinatingstudy visits, treatments and interventions as required by individual protocols
- Undertakingclinical assessments, observations, blood sampling and other researchprocedures as required
- Maintainingaccurate and timely clinical and research documentation, including electroniccase report forms and study records
- Workingcollaboratively with Principal Investigators, practice teams, sponsors, CROsand other research stakeholders
- Travellingbetween SPC practices as required to support recruitment and study delivery. Our practices are based in Framlingham, Debenham, Ipswich, Felixstowe, Stowmarket, Brandon & Newmarket
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
- Defined benefits scheme
- Life insurance
- Family benefits, including adult dependents & children's pensions
- Ill health benefits
Electric Car Salary Sacrifice Scheme:
- Fully comprehensive insurance, servicing, tyres & breakdown cover
- Up to £2,000 annual SPC contribution (subject to conditions)
Additional Benefits:
- 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
- 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.
Job responsibilities
The purpose of this role is to deliver safe, high-qualityresearch within and across Suffolk Primary Care. The research nurse willsupport the existing Suffolk Primary Care Research team to improve the set-uptime and implementation of clinical research and ultimately patient care. Therole involves using an in-depth knowledge of research protocols and theirapplication in practice, alongside a working knowledge and compliance with thelocal, national and international research regulations. The post holder willdemonstrate effective professional nurse standards, advocacy andperformance.
Excellent communication skillsare essential as is the ability to work independently and as part of a team.
Clinical Responsibilities:
- Assessprotocols and advise on safety, regulatory and logistical issues for the set-upand running of the study/trial to ensure the well-being and safety of patients,participants and staff.
- Provideparticipants with specialist information regarding their participation,including risk factors.
- Providea high standard and continuity of care for participants during the researchstudy, maintaining lines of communication with clinical staff.
- Actas a resource to participants, their families and staff from within theclinical area, providing information and support; and to act as an effectivereferral to other support agencies where necessary.
- Achieveand maintain defined competencies for clinical research to ensure thatcapability, skill and knowledge are appropriate for the work undertaken.
- Workwithin dedicated clinical research teams; ensure ethical and clinical safepractice.
- Undertake,with appropriate training, interventional treatments directly to participantsaccording to study/trial protocol and procedures and record the resultinginformation.
- Takeand process clinical samples (e.g. venepuncture/cannulation) for studies,coordinate tissue sample collection and dispatch to relevant department ortrial centre as appropriate.
- Maintainclinical skills as appropriate e.g. phlebotomy, vital sign assessment, patientcompliance and ECGs.
- Undertakeresearch-associated laboratory work safely, as required.
- Workat all times as part of the extended multidisciplinary team and maintainexcellent links with staff in primary care regarding the protocol care requiredfor study/clinical trial participants.
- Retrieveand retain medical records of participants for trial duration.
Research Responsibilities:
- Conductresearch according to standards and regulations laid down in ICH Good ClinicalPractice and EU Directives, and to the most current guidance relating toResearch Governance and Research Ethics.
- Assistin the provision of background information about potential clinical trials toobtain approvals from Research Governance and Local Ethics Committees.
- Co-ordinateand manage research within expected timelines.
- Workwithin and contribute towards the development and review of Standard OperatingProcedures (SOPs) and local policies/procedures for clinical research.
- Understandthe requirements of the study protocol and adhere to them
- Identifysuitable participants eligible for the study/clinical trial, in conjunctionwith the site investigator; identify, screen and recruit research participantsusing detailed knowledge of the protocols for the designated site specificgroups.
- Preparepatient/participant documentation for treatment clinics with meticulousattention to detail and complete accurate records of patient care, maintainingsource data and CRFs in a clearly trackable system, to ensure data validity.
- ReportSerious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse o Reactions (SUSARs) immediately using theappropriate procedures, o Provideongoing support, advice and information to patients/participants with regard totheir participation in clinical research in order to facilitate an effectiveinformed consent process.
- Takeinformed consent where appropriate; maintain the continuous informed consent ofparticipants to ensure that the procedures and treatments agreed within thetrial protocol are fulfilled.
- Co-ordinateown case load of participants within the allocated trials, e.g. organisingtrialspecific investigations, study treatments, appointments etc. asnecessary.
- Meetwith trial sponsors as necessary, providing information requested on trialparticipants.
- Participatein research protocol design, development and review: ensure that ethical issuesare addressed and all personnel involved in the study/trial are made aware ofany changes or protocol amendments.
- Collectaccurate local data and deliver to clinical trial centres in a timely manneradhering at all times to the terms of the Data Protection Act
- Recordown observations and those of other healthcare professionals, in the trialdatabase, with accuracy.
- Helpto maintain the core entry database; participate in CRF completion, safetyreporting, protocol compliance, monitoring and auditing of clinicaltrials.
- Attendrelevant local, regional and national meetings related to specific trials.
- Assistwith the resolution of data queries; contribute to financial processes ofplanning, running and closedown of studies.
- Contributeto study closure and archival preparation
- Contributeto nurse-led research
- Takeopportunities to publish and present findings of research undertaken.
- Assistwith the dissemination of research finding.
Experience
- Clinical experience at Band 5 or above
- Experience in Primary Care or Research desirable
- Excellent communication and interpersonal skills
- Accurate and confident with clinical documentation, data collection and electronic systems
- Able to work both independently and collaboratively within a small dedicated team
- Willingness to travel to all practices across SPC for patient recruitment
Qualifications
- NMC Registered Nurse (Adult Nursing*) - *Paediatric/immunisation experience is an advantage for upcoming studies
- ICH GCP training desirable, or a willingness to undertake GCP and associated NIHR training
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.