Quality and Assurance Officer - NIHR Dorset PC CRDC

Quality and Assurance Officer – NIHR Dorset PC CRDC

This is an exciting role for a QualityAssurance (QA) officer to be part of a new network of Primary Care ClinicalResearch Delivery Centres (PC-CRDC) to deliver clinical trials across Dorset. Within the NIHR Dorset PC-CRDC is an established collaboration consisting of 5 practices who have committed to work together delivering commercial research to our 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 and will support R&D function including study set up, delivery & finance management. All the practices in the DPC-CRDC are partners and work as spokes delivering clinical trials for patient benefit.

Main duties of the job

• – 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 SOPs and 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-CRDC requirements.
• – Manage risk assessments and policies.
• – Implement a system for CAPA reporting and regular review on learnings from CAPAs.
• – Manage an e-system if implemented.

About us

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.

Job responsibilities

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

Person Specification

Experience

• 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

Qualities and Attributes

• 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
• 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 one\’s 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

Qualifications

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

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.