* Previous applicants need not apply *

An exciting opportunity has arisen for someone with extensive NHS research governance experience to come and join the Trust's Research, Development and Innovation Department. As R& I Operations Manager you will have oversight and lead the development of the Trust's research capacity, compliance with legislation, Frameworks and other regulations governing the safe conduct of research in the NHS. In collaboration with the Clinical Research Nurse Manager, you will ensure we have a balanced deliverable portfolio of studies, meeting national and local performance targets. You will provide advice and support to members of the research delivery teams and researchers regarding GCP, HRA and ethics approval and amendments, study set up, delivery and completion.

Passionate about improving patient care, you will oversee the development of Sponsorship activities for locally developed studies and with that work closely with our Sponsorship Manager and Clinical Research Development Lead. You will also work with our Research Quality and Governance Manager to further implement and embed the Quality Management System into all R& I activities.

The post-holder will deliver innovative projects and collaborations with local and national partners to raise the profile of research at the Trust externally and improve the access to research internally for patients and staff.

Main duties of the job

Please refer to the job description for full details.

In summary:

Maintain high standards in governance, set-up, initiation, and delivery and continually identify and implement service improvement programmes.

Work closely with NIHR Clinical Research Network

Deputise for Head of Research, Development and Innovation if required

Provide advice and support to other members of the research teams regarding GCP, HRA and ethics approval and amendments, study set up, delivery and completion.

Ensure planning and organisation of complex activities across the entire theme portfolio in collaboration with the Clinical Research Nurse Manager and other professionals and agencies.

Act as a role model for the provision and support of safe and high-quality research and clinical trials

As part of the senior management team, meet Trust governance requirements through production and maintenance of relevant policies and procedures

Take an active role in business planning as part of the senior management team

Network and work closely with regional partners on behalf of the Trust and the R& I Department, building relationships and fostering further strategic collaborations.

Oversee development sponsorship activities

Oversee the Research Quality Management System

Work with management team to support sustainable research workforce

About us

We are proud that every member of our team receives a detailed induction and training package specific to their needs, experience and job role. Our dedicated research team and supportive leadership structure ensures that our staff have the skills and knowledge to care for their patients and undertake research to the highest standards.

Our management fully support the Trust ethos of compassionate leadership. We support flexible working and will consider all requests, taking into account the needs of the service. You'll have an opportunity to discuss this at interview. Employees are able to access a huge range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata) on appointment. There is also an on-site Gym for Trust employees & we offer a generous pension scheme.

Job description

Job responsibilities

Please refer to the job description:

Maintain high standards in governance, set-up, initiation, and delivery and continually identify and implement service improvement programmes.

• Be responsible for the process and systems (administrative and electronic) for the governance, approval, and delivery of (commercial and non-commercial) Portfolio and non-Portfolio research studies,
• With the Research Development Lead, support researchers to navigate research processes, through review of study documentation, support for ethical review, and support for study delivery, regardless of Portfolio status.
• Identifying any impediments to successful recruitment of studies and retention and addressing these promptly with the Clinical Research Nurse Manager and Team Leaders as well as with Support Departments, where appropriate.

Work closely with NIHR Clinical Research Network

• Clear lines of communications between Trust and Network
• Review existing and negotiate new network funded posts
• Work collaboratively with the CRN in reviewing speciality and study performance

• Provide advice and support to other members of the research teams regarding GCP, HRA and ethics approval and amendments, study set up, delivery and completion.

• Sound knowledge of the principles and application of Good Clinical Practice and regulatory frameworks effecting research at the Trust

Ensure planning and organisation of complex activities across the entire theme portfolio in collaboration with the Clinical Research Nurse Manager and other professionals and agencies.

• A balanced and deliverable portfolio of studies
• A balanced portfolio of commercial and non-commercial studies

Act as a role model for the provision and support of safe and high-quality research and clinical trials

• Demonstrate positive behaviours to peers and junior staff
• Demonstrate operational skills in planning and delivery of research and clinical trials

As part of the senior management team, meet Trust governance requirements through production and maintenance of relevant policies and procedures

• Policies and procedures are up to date and relevant
• Implementation of policies and procedures
• Maintain a thorough and up to date knowledge of local and national clinical developments and NIHR R& D policy and ensure dissemination of key developments across the teams

Take an active role in business planning as part of the senior management team

• Robust business cases for departmental developments
• Effective links with the Finance Department to support financial planning and management of R& D activities
• Be responsible for the process and systems for the full costing of non-commercial research projects and as well as commercial research to maximise recovery of costs from external funders.

Network and work closely with regional partners on behalf of the Trust and the R& I Department, building relationships and fostering further strategic collaborations. Oversee development sponsorship activities

• Working with the Research Development Lead, Sponsorship Manager and Research Quality and Governance Manager, manage all aspects of study development and sponsorship by developing systems to ensure that projects have robust designs, and appropriate levels of peer review, PPI involvement, collaboration, regulatory compliance and contractual and financial agreements.
• Review sponsored project risk assessments, monitoring plans and
• Chair the Research Development and Sponsorship Steering Group
• Support the Chair of the Research Funding and Sponsorship Committee
• Act as sponsor contact for regulatory bodies and research collaborations.
• Draft contractual and collaboration agreements as required.

Research Quality Management

• Support the Quality and Governance Manager in overseeing the Quality Management System, reviewing and signing off deviations and CAPAS for example.
• Ensure processes and SOPs expected guidelines and regulatory frameworks.
• Ensure that the research is conducted in line with the Trusts policies and clinical (quality and safety) reporting arrangements
• Maintain quality and required audits for investigator led studies and those where Trust are sponsor and that are multi-site.
• Chair the Quality Manager Review Group.

Person Specification

Qualifications

Essential

• First degree in a relevant subject or demonstrable experience
• Management/Leadership qualification or demonstrable experience
• Postgraduate qualification in a relevant subject or demonstrable experience
• Evidence of continuous professional development

Desirable

• Masters degree in relevant subject

Other

Essential

• Willingness and ability to travel to meet requirements of the post

Knowledge and Experience

Essential

• Experience of research and development, usually 5 years and working at a senior level, usually 3 years
• Significant knowledge of clinical/research governance/national research policy framework
• Full understanding of agenda regarding capability and capacity building regarding research and development

Desirable

• Extensive knowledge of clinical services/clinical experience
• Experience of change management and continuous improvement
• Project management experience

Skills and Abilities

Essential

• Proven ability to works independently with minimal supervision, organise own work load in busy work environment and time critical situations
• Experience of producing reports and present information to a wide range of stakeholders
• Ability to concentrate on specific and demanding matters, whilst dealing with unplanned interruptions
• Excellent attention to detail combined with time management skills and ability to work to deadlines
• Ability to persuade/influence and sustain collaborative working relationships

Desirable

• Experience of dealing with very senior members of staff, including Directors

Values & Behaviours

Essential

• Diplomatic and able to engage with people in a positive, encouraging way
• Good motivational, influencing and negotiating skills, with proven experience of success with clinicians, directors and multi-departmental stakeholders
• Ability to be flexible and adapt to changing circumstances
• Appropriately assertive

Employer details

Employer name

East Lancashire Hospitals NHS Trust

Address

Royal Blackburn Teaching Hospital

Haslingden Road

Blackburn

BB2 3HH

Any attachments will be accessible after you click to apply.

435-C207-23-A