Agile Diabetes and Endocrine Clinical Research Nurse

Job overview

The post holder supports and coordinates the GCP compliant setup, delivery and close down of a portfolio of research studies across the Diabetes and Endocrine, PAIN, Neurology and Ophthalmology, ensuring teams are supported to setup and deliver studies in a timely manner by providing appropriate governance oversight of the portfolio.

Following supporting the setup of studies, the research nurse will facilitate and aid recruitment of patients. The role will include identifying, consenting and following up suitable patients for clinical research working autonomously within professional practice guidelines and within the Research Governance Framework.

Main duties of the job

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 manage a caseload of participants across Diabetes and Endocrine, PAIN, Neurology and Ophthalmology where needed. They will have duty of care in supporting them and their families throughout their participation in any research activity.  They will also act as a patient advocate providing support and oversight as required. In addition, the research nurse will coordinate the portfolio of clinical research studies supporting and have oversight of the study set up, delivery (including data collection and site file maintenance) study close down and archiving.

The post holder will play a key role in ensuring that any research is undertaken within the departments 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.

Detailed job description and main responsibilities

Duties and Responsibilities

Clinical and Communication Responsibilities

• Manage a caseload of participants acting as a professional in ensuring a duty of care to the participant and their families.
• Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice), Trust’s policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations, Data Protection Act and Human Tissue Act.
• ensuring that the clinical trial protocol is adhered to at all times.
• Devise, implement and evaluate strategies for identifying eligible participants for research studies, including by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings.
• Participate in the informed consent process acting as a resource and support to participants and their families.  For appropriate studies take informed consent and ensure on-going consent in accordance with the necessary Trust research governance arrangements and necessary competent regulatory authority Regulations and International Conference on Harmonisation of Good Clinical Practice (ICH GCP)