The post-holder will be responsible for the provisions of a comprehensive, high qualityresearch management and governance service at Pennine Care NHS FT. Acting as anexpert on research governance and research quality assurance matters, they will lead onthe effective implementation of research regulatory standards at the trust and ensureMHRA inspection readiness at all times.
Main duties of the job
The post-holder will be responsible for the development, implementation and maintenanceof robust systems and processes for Quality Assurance, and oversee quality controlactivities conducted within the Research & Innovation Department and supporting clinicalservices at Pennine Care NHS FT. You will take an active role in providing advice on allaspects of Governance and Quality Assurance, including regulatory advice, contributing tothe design and quality oversight of research, supporting quality assurance within grantapplications, supervising the coordination of audit and monitoring within the ResearchDelivery Teams, and overseeing data and safety Quality Management Systems. You willbe responsible for ensuring effective arrangements are in place, via a comprehensive suiteof SOPs, to ensure that research projects are conducted according to current regulatoryand quality standards for the Trust.The post-holder will work closely with the colleagues in the Research Support Team andResearch Delivery Teams. The post holder will be well networked externally, regularlyparticipating in relevant networks and forums to influence regional and national policy inorder to promote the Trust as an advocate of research and good governance.The post-holder will be required to work autonomously, managing their day-to-dayworkload and prioritising as needed.
About us
We are proud to provide high quality mental health and learning disability services, both inpatient and in the community across five boroughs of Greater Manchester - Bury, Oldham, Rochdale, Stockport and Tameside and Glossop.
Our vision is for a happier and more hopeful life for everyone in our communities and our staff work hard to deliver the very best care for the people who use our services. We're really proud of our#PennineCarePeopleand do everything we can to make sure we're a great place to work.
All individuals regardless of race, age, disability, ethnicity, nationality, gender, gender reassignment, sexual orientation, religion or belief, marriage and civil partnership are encouraged to apply for this post. We would also encourage applications from individuals with a lived experience of mental illness, either individually or as a carer.
If you come and work for us we will offer a range of benefits and opportunities, including:
* Generous annual leave entitlement for Agenda for Change and Medical and Dental staff.
* Flexible working opportunities to support your work/life balance
* Access to Continued Professional Development
* Involvement in improvement and research activities
* Health and Wellbeing activities and access to an excellent staff wellbeing service
* Access to staff discounts across retail, leisure and travel
Job responsibilities
Quality & Governance Management To be the Quality & Governance specialist for the R&I Department and as suchhave significant discretion and freedom to act. Line Management of the R&I Coordinators in the Research Support Team, in linewith Trust HR policies/procedures, ensuring regular 1:1s are maintained and stafffeel well supported. Develop, implement, maintain and monitor appropriate risk-based quality systemsto ensure regulatory compliance throughout the lifecycle of studies. Develop Quality Assurance (QA) and Governance procedures to support studyinitiation, study implementation, study conduct, study close down and archiving,which will ensure that study participants and data are safeguarded in compliancewith applicable regulatory requirements and recognised standards.
Data and Record Management Introducing and overseeing systems and processes to maintain high standards ofdata collection and quality, ensuring that high quality data is collected within theresearch teams. Ensure filing systems and record systems are maintained to the same expectedstandards and assisting the Sponsorship and Delivery Teams to archive theirprojects to the required procedure. Work with the R&I Sponsorship & Development Manager and Research SupportTeam to make sure all sponsored and hosted projects adhere to informationgovernance requirements and are covered by the right Data Protection ImpactAssessment.
Person Specification
Education / Qualifications
* Degree level qualification (e.g. BSc) in a relevant subject plus further experience equivalent to Master's level
* Working towards or qualified in a Quality Assurance accreditation
* Recognised Good Clinical Practice certification
* Commitment to continued professional development.
* Higher degree qualification (e.g. MSc) in a relevant subject.
* People management and leadership qualification.
Experience
* Significant experience of working in an NHS or HEI environment in a quality assurance role.
* Monitoring/auditing experience
* Clinical research experience including protocol development and implementation.
* Experience and excellent skills in managing and developing staff and successfully establishing and maintaining high performing, effective teams.
* Experience of working with staff from a range of backgrounds and different levels of seniority.
* Experience of managing meetings and producing reports.
* Experience of writing, and monitoring of, Standard Operating Procedures.
* Monitoring/auditing experience in research
* Experience of working across organisations.
* Experience of delivering training sessions.
* Experience of project management.
* Development and management of an effective Quality Management System
Knowledge
* Good knowledge of the UK Policy Framework, the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, Guidelines for Good Clinical Practice (GCP) 2004 amended/2026 amendment, the Human Tissue Act 2004, Data Protection Act 2018 and the Mental Capacity Act 2005, and the ability to interpret these in a non-commercial environment.
* Ability to work constructively as an individual; as part of a close-knit team; and as part of a wider research community.
* Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
* Excellent change management skills. Enthusiasm for implementing change and the ability to bring fresh thinking to research processes enabling the team to develop and improve their systems
* Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access Able to lead the development and delivery of training.
* Understanding of the NHS R&D landscape and policies
Skills
* Strategic thinker with a proactive mindset
* Ability to manage competing priorities under pressure
* High level of integrity and attention to detail
* Collaborative working style with external partners
Work Related Circumstances
* Use of a car or access to a means of mobility to travel across the Trust footprint in line with service needs
* Willing to carry out all duties and responsibilities of the post in accordance with the Trust's Equal Opportunities and Equality and Diversity policies
* Appointments to regulated and controlled activities require an enhanced DBS disclosure.
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.
£49,387 to £56,515 a year per annum, pro rata
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