Quality and Assurance Officer - NIHR PC CRDC

Quality and Assurance Officer - NIHR Dorset PC CRDC

Please note, this position is not eligible for sponsorship.

This is an exciting role for a Quality Assurance (QA) officer to be part of a new network of Primary Care Clinical Research Delivery Centres (PC-CRDC) to deliver clinical trials across Dorset.

Within the NIHR Dorset PC-CRDC is an established collaboration consisting of 5practices who have committed to work together delivering commercial research toour local population. We have a 2-year track record of successful trial delivery. The vision of the Dorset PC-CRDC is to enable practices across

Dorset, who wish to be research active at whatever level, achieve this through the support of the DPC-CRDC. The Adam Practice (TAP) hosts the DPC-CRDC andwill support R&D function including study set up, delivery & finance management. All the practices in the DPC-CRDCare partners and work as spokes delivering clinical trials for patient benefit.

* We reserve the right to close the vacancy early if sufficient applications are received*

• - To work alongside the Co-Director & Project Manager to implement & maintain adherence to QA processes.
• -To press the importance of frameworks and ensure compliance is maintained.
• -Be responsible for the formation of new SOPsand the timely manner of SOPs that need to be renewed including managing version controls, systems for tracking & accurate record retention.
• - Ensure essential procedural documents are updated and controlled at all times inline with regulatory and PC-CRDCrequirements.
• - Manage risk assessments and policies.
• -Implement a system for CAPA reporting ®ular review on learnings from CAPAs.
• -Manage an e-system if implemented.

The Adam Practice is a partnership located across 5 surgeries in Poole, Dorset. This is an exciting opportunity to join our growing primary care team in a forward- thinking, innovative, general practice, which has a current CQC rating of Outstanding in Care.

Here are some of our many benefits we offer;

Access to NHS Pension Scheme and NHS discounts, 5 weeks annual leave (inclusive of bank/public holidays that fall in the holiday year). Entitlement is pro-rata for part-time employees.

Auto enrolment in NHS Pension Scheme.

Cycle to work scheme.

The role of the Quality Assurance officer (QA) will be an integral role that will support TAPs R&D function in development, implementation & maintenance of systems to assure the quality of clinical research is gold standard. The QA will work to frameworks such as ICH-GCP, UK Policy Framework for Health and Social Care Research (2017)& Medicines for Human Use (Clinical Trials) Regulations 2004 and Amendments to support the DPC-CRDC team throughout the life cycle of clinical trials andwill cover all collaboration clinical trials.

The QA officer will be a beaconof knowledge & support in times of internal or external audits or inspections by the sponsors or by the Medicines and Healthcare Products Regulatory Agency (MHRA).

• Substantial experience within Secondary Care OR Primary Care research management
• Experience of problem solving & the ability to work autonomously
• Experience of using IT programmes
• Proven project or administration management with good organisational skills
• Experience of change management within a research environment
• Proven experience of managing, conducting and reporting audits
• Experience of previous training in monitoring clinical research studies
• Experience in developing and implementing quality assurance procedures
• Experience of undergoing inspections and audit by an external authority

• Awareness of ICH-GCP
• Awareness of regulatory issues, legislation and guidance relating to clinical research
• Good attendance at work
• A flexible approach to work
• Effective time management
• A flexible approach to work
• Effective time management
• Strict attention to detail
• Ability to work independently & as part of the team
• Ability to organise, prioritise, co-ordinate own self & work
• Takes accountability for ones actions
• Shares information & good practice appropriately
• Treats others with courtesy & respect at all times
• Knowledge of research governance and regulations (ICH GCP & EU directives)
• Teaching experience

• Educated to degree level OR relevant experience
• GCP trained & certificate in date

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.