Clinical Research Team Leader - Childrens Research Team

Job description

Job 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.

Person Specification

Qualifications

Essential

• Educated to degree level or equivalent demonstrable experience
• Evidence of training undertaken in research governance and regulations, for example, Good Clinical Practice and EU Clinical Trials Directive
• Registered Healthcare Professional or other equivalent relative experience.

Desirable

• oManagement Qualification or training
• oRelevant teaching and assessing qualification

Experience

Essential

• oExperience in clinical research role on band 6 or above including providing ongoing care for clinical trial participants
• oExperience of working in multidisciplinary teams and able to respect others knowledge
• oDemonstrable outstanding organisational and time management skills
• oKnowledge of research methodologies
• oDemonstrable experience in the management of a broad portfolio of trials

Desirable

• oManagement experience working in a leadership capacity
• oExperience in developing, implementing and following standard procedures
• oExperience of the research approval process

Skills

Essential

• oExcellent interpersonal verbal, written communication and listening skills
• oAbility to build good working relationships, and gain the confidence of others
• oExcellent organisational, problem solving and negotiation skills
• oAbility to use initiative and work autonomously to tight deadlines
• oDisplays an awareness and understanding of effective resource management, health and safety, clinical risk and quality issues

Desirable

• oProject management experience

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Nottingham University Hospitals NHS Trusts

Address

Nottingham University Hospitals NHS Trust

QMC Campus, Derby Road

Nottingham

NG7 2UH

Employer's website

https://www.nuh.nhs.uk/ (Opens in a new tab)