The post holder will work in accordance with approved protocols, applicable UK clinical trial legislation, the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP), NMC standards and CLH policies. Clinical procedures and delegated study tasks must remain within their training, competence, authority and appropriate clinical oversight. The role is primarily on site and involves flexible working across CLH research clinics, GP practices and partner locations.

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Clinical research delivery and participant care

• Take day-to-day responsibility for an allocated study portfolio, prioritising safe participant care and timely delivery from site set-up and initiation to recruitment, follow-up and close-out
• Identify and screen potential participants using authorised systems and approved methods; apply protocol eligibility criteria and confirm clinical eligibility with the PI or delegated investigator where required
• Lead and undertake informed consent where trained, competent and documented on the delegation log; provide balanced information, allow time for questions and support voluntary decisions without pressure
• Independently undertake protocol-led nursing assessments, clinical observations and procedures within competence, including venepuncture, ECG, spirometry, sample handling and shipment where required
• Administer study medicines or vaccinations only under the applicable legal mechanism, approved protocol, local policy and documented delegation. Support investigational medicinal product (IMP) storage, accountability, reconciliation and returns where delegated and within competence, working with the clinical research pharmacist and PI
• Identify, assess, document and escalate adverse events and serious adverse events in line with protocol timelines and delegated responsibilities; notify the PI and sponsor as required, and respond promptly to deterioration or urgent clinical concerns
• Coordinate protocol visits, investigations and participant follow-up within study windows; support retention and address barriers to attendance while respecting the right to withdraw
• Promote dignity, privacy, accessibility and reasonable adjustments; recognise and escalate safeguarding concerns through the appropriate pathway

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Study coordination and data quality

• Contribute to feasibility and site initiation; confirm that relevant training, delegation, equipment, clinical pathways, source documents and approvals are in place before study activities begin
• Coordinate research clinics and participant pathways with coordinators and administrative staff, ensuring appointments, investigations and reimbursement processes support efficient study delivery
• Maintain complete, accurate and timely source records and CRFs/eCRFs; resolve data queries and oversee the quality of records for allocated studies
• Maintain accurate, inspection-ready Investigator Site Files and other essential site documentation, including current training and delegation records and version-controlled approved documents
• Monitor recruitment, visit completion and study milestones; identify delivery risks early and agree practical actions with the PI, Research Manager and wider team
• Act as a key site contact for sponsors, CROs and monitors; prepare for and participate in monitoring visits, respond to findings and close agreed actions within required timelines
• Identify, document and escalate protocol deviations and data-quality concerns; support investigation, corrective and preventive actions, and their follow-up

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Governance quality and safety

• Work to GCP, applicable legislation, the UK Policy Framework, approved protocols, CLH standard operating procedures and information governance requirements
• Maintain confidentiality and use SystmOne and other approved systems only for authorised purposes, following study approvals and data protection requirements
• Ensure study activities are performed only by appropriately trained and delegated staff; raise gaps in training, delegation or operational readiness promptly
• Maintain safe clinical environments and equipment, including infection prevention, required checks and prompt reporting of faults, incidents, near misses and complaints
• Support audit and regulatory inspection readiness, provide accurate site records and complete agreed actions

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Leadership communication and professional development

• Plan and manage an autonomous workload, seeking clinical or managerial advice when a decision exceeds competence or delegated authority
• Work collaboratively with PIs, GP practices, partner services and the wider research team; explain study requirements clearly to participants and colleagues
• Support induction, supervision and development of junior research staff and coordinators, and promote awareness of appropriate research opportunities across CLH
• Complete mandatory and study-specific training, maintain professional registration and competence, and contribute to appraisal, service improvement and procedure review
• Undertake other duties reasonably consistent with the scope and grade of the post

The role may involve travel between CLH, practice and partner sites. This job description may be reviewed as the service develops following discussion with the post holder.

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Requirements

Qualifications and training

Essential

• Registered Nurse (Adult) with current NMC registration. Current GCP training.

Desirable

• Relevant post-registration clinical or research qualification.

Experience

Essential

• Substantial post-registration clinical experience and direct participant-facing research delivery. Experience of screening against protocols, informed consent, clinical assessments, AE/SAE escalation, source documentation and CRFs/eCRFs. Ability to manage an allocated research caseload and prioritise independently.

Desirable

• Commercial or CTIMP trial delivery; primary care research; Phase II-IV trials; monitoring or audit; mentoring or supervision.

Knowledge

Essential

• Sound understanding of GCP, UK research governance, ethical requirements, confidentiality, safeguarding, infection prevention and professional limits. Ability to identify and escalate deviations and safety concerns.

Desirable

• IMP accountability and vaccine trial requirements; primary care systems and pathways.

Skills

Essential

• Competent venepuncture and specimen handling. Clear, sensitive communication with participants and colleagues. Strong organisation, accurate record keeping and confident use of electronic health records and study data systems.

Desirable

• SystmOne, ECG, spirometry, centrifugation, sample shipment and electronic data capture systems.

Personal attributes

Essential

• Compassionate, accountable and reliable. Calm under pressure, adaptable and committed to participant safety, teamwork and continuous learning.

Desirable

• Interest in research access and service improvement.