Overview
The Clinical Research Nurse will play a key role in ensuring that any research undertaken within the department safeguards the wellbeing of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. In conjunction with the other members of the team, you’ll facilitate the delivery of high quality research. This will be a challenging and varied position involving extensive coordination and communication within internal and external stakeholders. The post holder will provide strong administration and clinical skills within the team. In addition to recruitment and delivery of trial interventions, the post holder will be responsible for proactively managing trials as determined by the team, reporting on trial progress and building relationships and communications as required. This post is currently a 12 month, fixed term contract due to short term funding.
The post holder will facilitate and aid in the recruitment of patients to ensure high quality clinical studies and trials which will require them to work flexibly across the disciplines to ensure the successful working of the clinical research projects they are assigned to. They will also act as a patient advocate providing support and assistance as required and assist in the co-ordination and management of a portfolio of clinical research studies. The post holder will take responsibility for the safe administration of experimental therapies, and for monitoring the expected and unexpected side effects of drugs and other treatment modalities used in these trials. The post holder will actively participate in any development relating to the departmental objectives.
Our Research team support studies across the Surgical Oncology Directorate which comprises breast, head and neck, thoracic surgery, ear, nose and throat, audiology, and gynae-oncology. You will be based in a team that primarily support the delivery of commercial and non-commercial research studies in Head and Neck (H&N) services; Ears, Nose and Throat (ENT) services and Audiology services.
The core ENT research team, that you will be central to and line managed within is by our lead research nurse and based in our ENT outpatient’s department at Guy’s Hospital, where you will be primarily based. You’ll be working together with the team to support our research colleagues across ENT, H&N, Audiology and sometimes more broadly should this be required, so travel to St Thomas’ Hospital might also be necessary. Our teams deliver an exciting and varied research portfolio involving both commercial and non commercial research studies and hosted and sponsored studies. The studies range from first in man and novel implantable device studies to observational and data collection studies offering lots of opportunities to learn new skills and be at the cutting edge of new techniques being trialled within the NHS.
Responsibilities
- Provide excellent customer care skills to ensure patients and participants come first.
- Work within relevant regulations and ICH GCP, ensuring that the clinical trial protocol is adhered to at all times.
- Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies.
- Post hoc may be delegated to obtain consent from participants in line with Trust policy and research protocol for specific studies.
- Organise and facilitate participant appointments and follow-up phone calls.
- Accurately perform and record observations of clinical activities, obtain results and report abnormalities or changes appropriately (e.g., blood pressure, temperature, respirations, questionnaires, urinalysis, weight, height).
- Report any adverse events or health concerns to the appropriate doctor or nurse in a timely manner, and to the principal or co-investigator.
- Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate.
- Perform tasks requiring clinical and laboratory skills, including phlebotomy and sample preparation, in line with competencies and study protocol.
- Process biological samples and organise storage, shipment and documentation of samples.
- Provide ongoing support to the participant and carer while participating in the clinical study.
- Communicate study-related information effectively with the research team and study participants and their families; address barriers to understanding.
- Engage with other departments and wards to promote a good working environment and integration of research.
- Communicate with internal and external study coordinators and sponsor representatives, nationally and internationally.
- Attend and participate in multidisciplinary team meetings; arrange, attend and record minutes for research and other relevant departmental meetings.
- Attend national and international study-specific meetings and disseminate information to the multidisciplinary team as required.
- Act as a patient advocate enabling informed choices concerning involvement in clinical trials and provide advice and information.
- Undertake clinical tasks such as drug administration and clinical observation; under supervision, ensure correct administration and custody of medicines according to Trust policy.
- Handle telephone queries from patients, relatives and carers; refer queries to other team members as required.
- Comply with the informed consent process as described in the approved protocol and Medicines for Human Use Regulations, integrating ICH GCP principles.
- Recognise informed consent as an ongoing process and maintain awareness of factors contributing to autonomous decision-making.
- Identify learning needs and maintain up-to-date knowledge.
- Facilitate a high-quality, cost-effective specialist service through monitoring, audits and quality initiatives.
- Support set, monitor and review standards of care; initiate corrective actions where required.
- Identify unsafe environments and bring concerns to senior team members.
Administration
- Ensure clinical practices comply with Trust policies and procedures; communicate effectively to maintain a harmonious working environment.
- Maintain a safe environment in accordance with health and safety regulations.
- Assist in managing incidents, accidents and complaints per Trust policies.
- Ensure equipment is in good working order and report defects.
- Participate in audits and inspections (e.g., MHRA, quality control, nursing audits) and suggest improvements.
- Promote economical use of resources and ensure safe custody of patient/volunteer property.
- Support development of the research environment and implementation of department policies; ensure compliance with Trust, Government and EU directives.
- Maintain accurate documentation in clinical trial documents and patient notes; ensure data are archived as required.
- Assist in obtaining local regulatory approvals (ethics and R&D) when required; ensure data protection, confidentiality and security compliance; ensure accuracy of data in electronic databases.
Education and Training
- Assist in educating and supporting healthcare professionals to care for clinical trial patients and recruit to trials where appropriate.
- Maintain up-to-date knowledge of research topics related to clinical trials.
- Assess the needs of volunteers and provide information as requested; educate and counsel volunteers, family and those who volunteer for trials before, during and after studies.
- Orientate new staff and students to the unit/department; foster a learning environment.
- Act as a role model, mentor and preceptor to the research team.
Other
- Understand and adhere to Trust policies and maintain patient confidentiality and GCP standards.
- Maintain NMC registration.
- Undertake any other duties consistent with the responsibilities of the grade and the needs of the service.
This advert closes on Sunday 28 Sep 2025