Research Governance Coordinator

NHS; Norwich; On-site; GBP 35,000 - 45,000; Full time

Job summary

Join the Research and Development department as a Research Governance Coordinator at NNUH. You will ensure compliance of sponsored research with laws and regulations and manage a supportive team in enhancing our governance processes. Ideal candidates will have significant research support experience, understanding of NHS R&D systems, and skills in governance and monitoring.

Benefits

Fast Track Staff Physiotherapy Service

Discounted gym memberships

Excellent pension scheme

Free Park & Ride service

On-site Nursery

Qualifications

• Significant experience in a research support environment.
• Understanding of NHS R&D systems and clinical research issues.
• Experience with governance, audit, or monitoring systems.

Responsibilities

• Ensure compliance with research governance and regulatory requirements.
• Manage and oversee research governance administrative procedures.
• Line manage the Research Governance Administrator and other team members.

Skills

Time Management

Governance Understanding

Clinical Trial Knowledge

Audit Experience

Interpersonal Communication

Education

First Degree in biomedical/scientific discipline

Job description

The Research and Development department at NNUH is growing and we are seeking an enthusiastic, organised and goal-orientated individual to join our supportive and dynamic team to help us develop our service.

As Research Governance Coordinator you will be responsible for assuring compliance of our sponsored research with all relevant laws and regulations and will deliver on-going research audit and monitoring programs.

Our ideal candidate will have significant experience of working in a research support environment with an understanding of NHS R&D systems and clinical research issues such as research governance, ethical review, Medicines for Human Use Regulations, etc.

Do you have significant experience of clinical research governance, audit, or monitoring systems together with line management experience? If you do, we would be delighted to hear from you.

Main duties of the job

The Research Governance Coordinator is responsible for the successful preparation, review, update and maintenance of the Trust's Quality Management System and associated processes for research governance. This will include oversight and management of research sponsored by NNUH.

To ensure that systems and processes are efficient, effective, proportionate, and assure regulatory compliance of our research, you will liaise with other senior colleagues involved in research at NNUH. In recognition of the growing proportion of research studies that involve both the Trust and the University of East Anglia the post-holder will also work closely with colleagues in UEA Research and Innovation Office, Norwich Clinical Trials Unit and Quadram Institute Bioscience to ensure alignment of processes to support joint working.

You will assist the Research Services Manager in the development and refinement of the research governance administrative procedures throughout the Trust, working in collaboration with the NIHR networks and using national and regional information systems to support approval and delivery of research within the Trust.

You will deliver on-going research audit and monitoring programmes ensuring compliance with Trust SOPs and research policies.

You will line manage the Research Governance Administrator, Clinical Trial Monitor, and the Research Data Administrator, supervising their activities, overseeing their training and development, and managing their performance.

About us

Join us at the Norfolk and Norwich University Hospital and be part of a workforce of over 10,000 staff!

The NNUH is one of the largest NHS trusts in the UK, providing first-class acute care for around one million people, living in Norfolk and surrounding areas. We are a teaching and research hospital, at the forefront of innovation, home to state-of-the-art facilities, such as the Quadram Institute. We are pleased to work closely with the University of East Anglia, providing teaching opportunities for our staff and placement opportunities for their students. We attract some of the best and leading professionals from across the country and are proud that our workforce represents 94 countries from across the world.

We are a friendly, collaborative hospital, working with local services and home to N&N Hospitals Charity

We can offer you the full range of NHS benefits/discounts and in addition:

• Fast Track Staff Physiotherapy Service
• Multi Faith prayer room
• Discounted gym memberships
• Excellent pension scheme and annual leave entitlement
• Wagestream - access up to 40% of your pay as you earn it
• Free Park & Ride service direct to NNUH site
• Free 24-hours confidential counselling support
• On-site Nursery
• On-site cafes offering staff discounts
• Flexible staff bank
• Salary Sacrifice schemes including lease cars, Cycle to Work scheme and home electronics

Job responsibilities

• In discussion with colleagues to identify and develop improvements to systems related to research governance and management.
• To maintain the Joint Research Governance Policy and Standard Operating Procedures agreed between the Trust and the University, ensuring they are reviewed as per the schedule, kept up to date and available on the website.
• To maintain an up-to-date knowledge of legal and regulatory requirements pertaining to research as well as the processes, procedures and requirements of the relevant regulatory bodies eg MHRA, HRA etc in order to correctly advise researchers and colleagues and ensure our SOPs, policies and procedures comply with requirements.
• To attend meetings and advise members of the Joint Research Governance Committee on matters such as Trust policies transfer and retention of tissue, and all relevant legislation.
• Working with the University Contracts Manager and NNUH Senior Contracts Specialist, to develop and maintain template Sponsor agreements which minimise the risk to the Trust and can be used by Research Study Officers as appropriate where the Trust acts as Sponsor.
• To be the Trusts named archivist in the discharge of the Trusts responsibilities under the Medicines for Human Use (Clinical Trials) Regulations for CTIMPs and Medical Device trials.
• To co-ordinate and supervise the day-to-day activities of the Research Governance Administrator, Clinical Trial Monitor and Research Data Administrator, ensuring that the research governance function is supported, that the R&D database (EDGE) is complete, kept accurate, up to date and maintained and that management information and other reports are produced as required.
• To lead the preparations and conduct for any regulatory inspection or audit of the Trusts research.
• To refer any major concerns on research governance and sponsorship issues to the Research Services Manager or Director of Research Operations.
• To be responsible for Deputising in the absence of the Research Services manager for signing Capacity and Capability letters for Research studies.

Please refer to the Job Description for the full specification of responsibilities and requirements for this post.

Person Specification

Qualifications

• First Degree in biomedical/scientific discipline or equivalent

Experience

• Significant experience of working in a research support environment and/or understanding of NHS R&D environment, research funding systems and clinical trial methodology and logistics
• Significant experience of governance, audit or monitoring systems

Skills

• Ability to work unsupervised; prioritises own workload and deliver results to tight deadlines
• Evidence of continued professional development
• Effective role model, demonstrating NNUH's PRIDE values of People focussed, Respect, Integrity, Dedication and Excellence
• Demonstrates understanding and commitment to Equality, Diversity and Inclusion

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.