Clinical Research Team Leader - Childrens Research Team

Job overview

Are you passionate about clinical research? Are you a self-motivated and enthusiastic team member with extensive experience of working in clinical trials? Do you have a passion for research and want to build on our Childrens Research portfolio? If this is you, we will be delighted to hear from you.

The Nottingham University Hospitals Research and Innovation department is undergoing a redesign to bring research closer to our patients. Our vision is to situate Nottingham University Hospitals Trust at the very forefront of clinical research placing patient needs at the centre of our research activity.

We are seeking someone to lead our Childrens research team, to grow the portfolio and facilitate the delivery of clinical excellence within clinical trials.

Main duties of the job

In addition to the below summary you need to familiarize yourself with full Job Description and Person Specification documents attached to this advert.

You will work closely with the Divisional Research Delivery Manager providing clinical expertise and support in NUH clinical research projects in developing the Childrens portfolio. You will manage and lead a multi-disciplinary team of research staff and at times work alongside them to support studies. You will ensure that NIHR portfolio studies are run to the highest standards incorporating Good Clinical Practice Guidelines. You will also ensure that the highest standard of participant care is achieved within the clinical area.

The post holder will be based at QMC campus but expected to work across all NUH sites.

Working for our organisation

We are changing the lives of millions of people through outstanding clinical research developed by world-leading clinicians, academics and scientists in Nottingham. Nottingham University Hospitals NHS Trust is one of the biggest and busiest acute hospitals in England, employing over 16,000 staff. We provide care to over 2.5million residents of Nottingham and its surrounding communities and specialist services to a further 3-4million people from neighbouring counties. Clinical research is central to the care we provide for every patient. We deliver over 400 clinical trials across all specialties working as part of the healthcare team, and supported by experts in every part of the research process. Our NIHR Nottingham Biomedical Research Centre is translating research discoveries into new treatments for common diseases including asthma and arthritis.

Our expertise and resources are at the forefront of COVID-19 research into effective treatments and vaccines, as well as contributing to the world’s understanding of Coronavirus. Through our dedicated Research Futures multi-professional school, we support the development of knowledge, skills and careers for all clinical and non-clinical roles in research. Our vision is to drive the next generation of scientific discovery and enable every member of our research workforce to realise their full potential.

Detailed job description and main responsibilities

Detailed job description and main responsibilities

To carry out appraisal & development reviews for Research Nurses/Staff in line with Trust policy

To support the Divisional Research Delivery Manager in providing effective leadership, supervision, and line management, of the Childrens Clinical Research Team, and other members of the wider NUH research team; this will include Research Nurses, Research AHPs, Research Practitioners, Data Managers and associated staff. (Such staff are referred to in this document as Research Nurses/staff).

To assist the Divisional Research Delivery Manager to monitor and manage Research Nurse/Staff staffing levels in your area.

To ensure NUH Mandatory training needs are met within the Team of Research staff.

To ensure that all Research Professionals and Investigators are practicing in line with recommendations of ICH Good Clinical Practice (GCP) and to identify and respond to areas of training need.

To work with the Divisional Research Delivery Manager with the recruitment and selection, development, training and retention of relevant staff and all other aspects of people management including performance management, sickness etc.

To advise Senior Clinical Nurses, Lead Clinicians, Service Managers and Scientists of any research issues and changes in practice that may be relevant to their work or have resource, service or research implications.

To ensure that clinical study recruitment records are accurately maintained.

Manage time and resources effectively including chairing relevant meetings, taking minutes and keeping accurate records.

To access the computer network as required to access relevant information.

To work as part of the NUH R&I team and contribute to the ongoing development of the NUH Research Strategy.

To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.

To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.

Deputise for the Divisional Research Delivery Manager at meetings as directed.

To be responsible for maintaining strong relationships and positive communication channels with clinical directorates, other key personnel and commercial sponsors.

Clinical Responsibilities and Duties

To act as a Research Manager, attending and supporting patients in the clinical environment for monitoring, assessment and follow up as part of research projects.

To identify and screen patients for studies and databases.

To co-ordinate your own case-load of clinical studies and the participants.

To ensure clinical trial protocols are adhered to.

To ensure that you are working according to ICH Good Clinical Practice and Research Governance standards for clinical studies.

To ensure trial participants are managed safely according to Trust policies and guidelines.

To register/randomise participants into studies and to be involved in the informed consent process.

To liaise with external clinical study personnel as necessary.

To supply data as required to the PI regarding progress of clinical studies.

To identify barriers to recruitment to studies and ensure that the Principle Investigator is aware of them. Identify and implement action/plans as required to remove these barriers.

To identify to the Divisional Research Delivery Manager /Clinical Lead any future staffing needs which may impact on ability to deliver studies on time

To provide support for clinical research colleagues in their absence.

To attend meetings relevant to the nature of the post.

To ensure the safe administration of treatments and drugs within the context of a clinical study.

To ensure that study specific investigations are undertaken as required by the protocol, in order to establish eligibility and safety to enter the trial.

To provide ongoing information, education and support to volunteers regarding clinical studies.

To ensure blood and other samples are collected for pharmacokinetic studies as required by the study protocol.

To maintain accurate documentation of research related activities in Study, Nursing and Medical notes.

To accurately record data collected in the Case Report Forms (CRF).

To monitor treatment toxicity / side effects and initiate changes to treatment as required by the protocol.

To record and report adverse events to the relevant personnel and take any necessary action.

To report and record serious adverse events to the Trial Co-coordinator/Principal Investigator (PI) and relevant local personnel / Regulatory Authorities.

To provide ongoing follow up care whilst a subject is in a clinical study.

To act as a primary contact point for patients/subjects in a clinical study.

To follow appropriate Trust Policies and Procedures and to ensure that you are working according to Good Clinical Practice and Research Governance standards for clinical studies

To ensure all necessary Regulatory items are in place prior to study commencing.

To ensure that clinical studies are archived as required.