Research Compliance Manager- Band 7

We are looking for a motivated, kind and research knowledgeable individual to join our friendly team working as our Research Compliance Manager.

The role will involve providing leadership to both our sponsorship and research facilitation team to ensure compliance of NBT sponsored study with MHRA and other regulatory authorities as well as promoting efficient set up of studies which we are participating in.

You will need to have experience of working in research and knowledgeable of research governance in the NHS

The post is offered at Band 7 on a full time substantive basis.

We will consider offering this as a band 6 to 7 development opportunity for suitable applicants, with progression to band 7 on successful completion of role competencies.

If you would like to chat about this post then please get in touch

Main duties of the job

The post holder will be responsible for the line management of the Research Facilitation and Research Sponsorship teams.

The post holder is required to implement systems and standard operating procedures to support and monitor clinical research studies within the organisation in line with the current UK Policy Framework for Health and Social Care, the Medicines for Human Use (Clinical Trials) Regulations (2004), ISO 14155 and any subsequent amendments and ICH - GCP regulations.

The Research Compliance Manager will be responsible for ensuring compliance of NBT delivered research with MHRA and other regulatory authorities and providing input to the MHRA preparedness project.

The post holder will conduct sponsorship reviews and quality assurance on the NBT research governance database.

The Research Compliance Manager will ensure appropriate and proportionate procedures are implemented for the safe and efficient set up of studies at NBT.

About us

North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.

We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services.

North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.

Bristol is consistently voted the best place to live in the UK, with vibrant local music, arts and gastronomic scenes, a wide range of modern and state of the art shopping, recreation and leisure facilities, a wealth of great local family days out, fantastic transport links for local, national and internal holidays, and it has a rich history. If you prefer country, village or smaller town living, NBT is also easily commutable from a range of attractive locations in North Somerset, South Gloucestershire and South Wales (e.g. Portishead, Chepstow)

Job description

Job responsibilities

For detailed information about the role please review the job description

A summary of the key areas of responsibility are below:

Clinical Trial Set-up:

Oversee the sponsorship review process which involves assessment of trial protocols and advise on safety, regulatory and logistical issues in the running of the trial.

Oversee the R& D Facilitation team to ensure all governance and regulatory checks have been adequately carried out prior to issuing confirmation of capability and capacity.

Clinical Trial Running

Support local Principal Investigators and research teams in meeting their responsibilities outlined in the UK Policy Framework for Health and Social Care Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations, ISO 14155 and GCP

Support PIs to ensure all Adverse Events are reported in line with the NBT Adverse Events Reporting policy.

Ensure systems are in place to monitor and manage the study from site initiation to close out.

Ensure annual and final REC and funder reports are reviewed, approved, and submitted for studies for which NBT is sponsor

Financial Oversight

Establish and maintain specialist knowledge of national guidance and local costing policies, and procedures

Give clinical, regulatory and logistical input on the costing of all studies, commercial and non-commercial as required.

Professional Responsibilities

Support the NBT Research Operations Manager and Director of R& D manage clinical governance across the research staff infrastructure, ensuring that Accident and Incident Management System (AIMS) forms are completed review Clinical Governance procedures for incidents that arise within the research workforce.

Work with the Research Operations Manager and Senior Research Governance Officer to develop and review research governance procedures that affect the research workforce.

Personal Professional Development

Maintain responsibility for own professional and specialist development.

Take part in staff development and performance review, producing an annual personal development plan.

General

Support the implementation of the NBT Monitoring Policy

Highlight and promote best practice and support departments / research teams in conducting research in compliance with regulatory authorities. Prepare reports on the implementation and monitoring of clinical trial monitoring systems as required by the Research Committee

Person Specification

Education/Training/Qualification

Essential

• Evidence of continuing professional development
• Good Clinical Practice Certification

Desirable

• Postgraduate qualification (e.g. MSc) in social sciences/research or management
• Registered Healthcare Professional

Work Experience

Essential

• Clinical Trial and/or other clinical research experience
• Research management experience
• Proven project management abilities
• Proven experience of working as part of a team
• Experience of team leadership and Management

Desirable

• Experience in regulatory inspections

Knowledge/Skills/Abilities

Essential

• Good understanding of Research Governance and regulatory research requirements within the NHS
• Up to date knowledge and understanding of local, national and international regulatory requirements relating to research
• Knowledge of a broad range of research methodologies and approach
• Excellent communication skills
• Good analytical skills: able to digest, analyse, interpret and communicate complex information
• A good working knowledge of the full range of Microsoft Office applications (Word, PowerPoint, Access, Excel, Publisher).

Desirable

• Knowledge of research costing policy and procedures

Personal Qualities/Special Circumstances

Essential

• Effective interpersonal and influencing skills
• Ability to manage competing priorities

Employer details

Employer name

North Bristol NHS Trust

Address

Southmead Hospital

Southmead Road, Westbury on Trym

Bristol

BS10 5NB

Any attachments will be accessible after you click to apply.

339-CCC3752