Clinical Research Nurse (Ad hoc shifts)

Job Opportunity:

We are seeking motivated and adaptable Clinical Research Nurses to join our Staff Bank at K&W Healthcare. This flexible post offers the opportunity to support the delivery of a growing portfolio of primary care and community-based clinical trials (Phase II–IV and medical device pilot studies), ensuring the highest standards of participant safety, welfare, and data integrity.

Bank staff are engaged on an ad-hoc basis to provide vital clinical capacity during periods of peak trial activity. Working as part of a dynamic multidisciplinary research team, you will collaborate closely with GP Principal Investigators, research pharmacists, clinical specialists, commercial sponsors, and the North London NIHR Research Agile Team.

The successful candidate will provide high-quality clinical care and study-related treatments to participants, acting as a dedicated patient advocate to empower individuals to make informed choices throughout their research journey.

Job Overview:

Deliver clinical research nursing across primary care and community sites, conducting study visits and executing protocol-defined clinical procedures in full compliance with ICH GCP guidelines, study protocols, and organizational and sponsor standard operating procedures.

Core responsibilities focus on participant care, protocol compliance, robust clinical procedures (including phlebotomy and IMP administration), and error-free source documentation. The post holder will support studies across diverse disease areas within the remit of their nursing competencies as operational demands require.

Roles and Responsibilities:

On a typical shift cover, you will:

- Admit and orientate trial participants, supporting them throughout study visits.

- Conduct thorough nursing assessments, obtain detailed medical histories, and continuously monitor the health and well-being of both adult and paediatric participants.

- Detect, record, and report adverse events, serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), escalating appropriately.

- Respond to emergency situations according to protocol and clinical standards.

- Prepare, check, and administer IMPs via all approved routes (oral, IV infusion, injection, topical, inhalation), following strict safety protocols.

- Validate and operate BP and ECG machines, spirometry devices, telemetry, eDiaries, and other trial equipment.

- Collect, process, and store biological samples (blood, urine, sputum, saliva, etc.) ensuring integrity and chain of custody.

- Perform trial-related assessments including vital signs, ECGs, lung function tests, psychometric scales, liver scan, and other protocol-specific procedures.

- Accurately document study data in source notes, CRFs/eCRFs, and sponsor systems in compliance with GCP.

- Assist with quality control, query resolution, and preparation for audits/inspections.

- Ensure confidentiality and compliance with GDPR and Data Protection legislation.

- Contribute to study set-up, including equipment checks, consumable preparation, and subject information packs.

- Act as Shift lead when required, coordinating activities of the clinical team to deliver trial procedures to protocol standards.

- Liaise with investigators, monitors, and CRAs during monitoring visits.

- Support close-out visits, study audits, and continuous quality improvement initiatives.

- Work autonomously during trial visits whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and wide trial-related professionals to ensure service delivery.

- Conduct participant pre-screening against protocol inclusion and exclusion criteria using patient medical records and referral pathways.

- Ensure patients are fully informed prior to entry into any clinical trial programme, acting as a guide and advocate to the patient throughout the complex decision-making process.

- Act as an ongoing resource and support to patients and their careers, regarding practical aspects of clinical trial participation.

- Conduct comprehensive patient assessments and collect detailed medical histories in compliance with Good Clinical Practice (GCP) and the study protocol.

- Record data obtained in a timely, error-free manner according to the protocol and SOP, transcribing source data onto the Case Report Form (CRF).

- Prepare for and participate in internal and external audit inspections, evaluations and benchmarking exercises and suggest any changes to improve standards

- Monitor the central research email inbox for web-based participant and sponsor queries, resolving routine questions and promptly escalating clinical, safety, or protocol issues to the study team and PI.

- Deploy and operate trial technology, including study laptops, mobile devices, and secure mobile data, to deliver accurate digital data collection across satellite sites in line with SOPs.

Additional Responsibilities (including but not limited to):

- Support the core study team by addressing data queries or documentation requests raised during Clinical Research Associate (CRA) monitoring visits for shifts worked.

- Accurate completion of protocol-specific source worksheets and data sheets to ensure consistent data collection.

- Ensure trial-specific consumables, lab kits, and equipment used during participant visits are maintained and documented, notifying the Research Operational Lead and Study Coordinator of stock shortages.

- Handle, centrifuge, storage and process biological samples safely in accordance with laboratory manuals and site SOPs.

Maintain strict participant confidentiality and trial data integrity at all times in compliance with the UK GDPR, Data Protection Act 2018, and Caldicott Principles.

Qualification:
Essential:

- Registered Nurse (Adult/Child) with current, active NMC registration (valid PIN without restrictions).

- Minimum of 2 years post-registration and clinical research nursing experience.

- Immediate Life Support (ILS) / Basic Life Support (BLS) certification.

- Valid, up-to-date ICH Good Clinical Practice (GCP) certification.

Desirable:

- Post-graduate qualification or modules in Clinical Research or Health Research Methodology.

- Previous experience with EMIS/Optum patient record system.

Experience & Skills

Essential:

- Working knowledge of ICH GCP (E6) and standard site research governance procedures.

- Working knowledge of UK Data Protection legislation (UK GDPR and Data Protection Act 2018).

- Proven competency in venepuncture/phlebotomy, 12-lead ECG acquisition, and vital signs monitoring.

- Demonstrable experience in clinical research delivery, protocol compliance, and handling Investigational Medicinal Products (IMPs).

- Experience with biological sample collection, centrifugation, processing, and preparation for storage or courier shipment.

- Proficient in clinical documentation and working with digital systems, including Electronic Data Capture (EDC / eCRF) platforms and Microsoft Office.

- Strong communication skills with proven ability to explain complex trial protocols and Informed Consent information clearly to participants and their families.

Desirable:

- Familiarity with the UK Medicines for Human Use (Clinical Trials) Regulations.

- Understanding of MHRA inspection standards and sponsor audit processes. Cannulation and IV administration competencies.

- Experience working on commercial (industry-sponsored) clinical trials across Phases II–IV.

- Prior experience with remote and on-site monitoring visits by Clinical Research Associates (CRAs).

Other Specifications
Essential:

- High attention to detail and meticulous approach to protocol adherence and source documentation.

- Ability to work autonomously and manage clinic visit schedules efficiently during peak activity periods.

- Adaptable, resilient, and responsive to changing study requirements within a multidisciplinary team environment.