About this role
Job summary
Research Nurse / Senior Research Nurse
As a member of the Research Team across Ashfields Primary Care Centre and Kiltearn Medical Centre, you will support the delivery of a reputable and efficient research function, maintaining the highest standards in accordance with Good Clinical Practice (GCP) and all regulatory requirements.
You will work closely with the GP Principal Investigators and the Head of Research Nursing as part of a team based across five dedicated research rooms.
Main duties of the job
You will be responsible for managing your own trial participants throughout their research journey, from screening through to study close-out.
This will include:
Identifying and recruiting eligible participants.Obtaining informed consent.Conducting study visits.Administering investigational medicinal products (IMPs).Performing ECGs.Collecting blood samples and other study samples.Recording and maintaining study data using sponsor data systems.Supporting sponsor monitoring visits.
About us
We are one of the hubs of the Cheshire and Merseyside Primary Care Commercial Research Delivery Centre, bringing commercial drug trials into general practice. Between Ashfields and Kiltearn we have delivered more than 70 studies, recruited around 4,600 participants, and had UK and European first recruits on major international trials. Our work is mostly Phase II/III trials in heart failure, diabetes, obesity and kidney disease, with sponsors including AstraZeneca, Novo Nordisk and Amgen, plus a smaller portfolio of NIHR studies. For more information about our research programme, visit:www.cheshiregpresearch.co.uk
What We Offer
A supportive and experienced research team.Full training and development opportunities.No nights, weekends or bank holiday.Recognition of previous NHS service.The opportunity to make a genuine difference to future patient care.
Job description Job responsibilities
Main responsibilities
Finding and recruiting participants.Run and review searches of the practice clinical system against study criteria.Manage invitation mailouts and responses.Pre-screen patients by reviewing records, medications and assess and document participant eligibility against protocol inclusion and exclusion criteria in conjunction with the PI.Explain studies to patients and take informed consent within delegated duties.
Study visits and clinical care
Carry out protocol visits, including observations, ECGs, venepuncture, and sample processing, packing and shipping.Administer investigational medicinal products and teach self-administration where required. Manage IMP storage and accountability.Use randomisation and drug-allocation systems.Recognise, record and escalate adverse events and serious adverse events to the PI within reporting timelines.Carry out home visits where a study requires them.Provide information, advice and support to participants throughout their involvement and liaise with their usual practice team.Monitor treatment toxicity and/or side effects and take appropriate action.Work within the NMC Code of Conduct andyour own scope of practice.
Data and quality
Keep accurate, contemporaneous source documents. Enter data into sponsor EDC systems and resolve queries promptly.Prepare for and support monitoring visits, audits and inspections.Keep delegation logs, training records and site files current.Support study close-out, including data reconciliation, archiving and sponsor close-out requirements.Work to the practice research SOPs, GCP and the UK Policy Framework for Health and Social Care Research.
Team
Work with the research coordinator, clinical research assistants and practice teams to plan visits and room use across both sites.Contribute to team meetings, SOP updates and training new staff.Work with other network practices when studies are delivered across sites.
Additional responsibilities at Band 7
Lead a defined group of studies, accountable for set-up, recruitment against target, data quality and close-out.Act as main site contact for sponsors and CROs on those studies.Contribute to feasibility, capacity assessment and study selection with the Research Manager and PIs.Supervise Band 6 nurses and clinical research assistants, including contributing to competency sign-off and contributing to appraisals with the Head of Research Nursing.Lead on audit and inspection readiness for allocated studies.Deputise for the Head of Research Nursing when required.
Person Specification
Skills Essential
Venepuncture ECGs Administering injections Confident with clinical systems and Microsoft Office Clear communicator with patients and colleagues Organised and accurate with data Able to work independently and in a team Able to travel between sites Manual handling associated with clinical duties Satisfactory DBS and occupational health clearance
Desirable
Sample processing and shipping IMP handling EMIS Sponsor EDC systems Full driving licence
Experience Essential
Band 6: Long-term-condition management in general practice or a similar setting. Band 7: At least three years delivering interventional drug trials, with commercial Phase II/III trials as a significant part of that. Led site set-up and delivery of commercial studies from initiation to close-out as the main sponsor and CRO contact. Supervising, training and signing off competencies for other research staff. Preparing for and hosting sponsor audits or regulatory inspections.
Desirable
Band 6: Any clinical research or audit experience. Band 7: Primary care research experience; postgraduate study in research or leadership.
Qualifications Essential
Registered Nurse (NMC
Desirable
Current GCP certificate
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.
UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).
Employer details Employer name Ashfields Primary Care Centre
Address Middlewich Road
Sandbach
Cheshire
CW11 1EQ
United Kingdom
Employer's website https://www.sandbachgps.nhs.uk/ (Opens in a new tab)