Skilled Worker, A ratingPosted 4 days ago

Job Description

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.
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