Quality and Assurance Officer - NIHR Dorset PC CRDC

The Adam Practice; Poole; On-site; GBP 30,000 - 40,000; Full time

Job summary

A healthcare practice in Dorset is seeking a Quality Assurance Officer to ensure the quality of clinical trials. The successful candidate will work within a collaborative network supporting various clinical research trials, focusing on compliance with ICH-GCP guidelines and internal audits. This role offers competitive benefits including access to the NHS Pension Scheme and generous annual leave.

Benefits

Access to NHS Pension Scheme

Cycle to work scheme

5 weeks annual leave

Qualifications

• Substantial experience in Secondary/Primary Care research management.
• Experience in managing and reporting audits.
• Experience of undergoing inspections by external authorities.

Responsibilities

• Implement and maintain QA processes for clinical trials.
• Ensure compliance with regulatory requirements.
• Manage the formation and update of SOPs.

Skills

Problem solving

Attention to detail

Time management

Ability to work independently

Knowledge of research governance

Education

Degree level education or relevant experience

GCP trained with certificate in date

Tools

IT programmes

Job description

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 5practices who have committed to work together delivering commercial research toour local population. We have a 2-year track record of successful trialdelivery. The vision of the Dorset PC-CRDC is to enable practices acrossDorset, who wish to be research active at whatever level, achieve this throughthe support of the DPC-CRDC. The Adam Practice (TAP) hosts the DPC-CRDC andwill support R&D function including study set up, delivery & financemanagement. All the practices in the DPC-CRDCare partners and work as spokes delivering clinical trials for patient benefit.

Main duties of the job

• - To work alongside the Co-Director & ProjectManager to implement & maintain adherence to QA processes.
• -To press the importance of frameworks and ensurecompliance is maintained.
• -Be responsible for the formation of new SOPsand the timely manner of SOPs that need to be renewed including managingversion controls, systems for tracking & accurate record retention.
• - Ensure essential procedural documents areupdated 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.

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 Assuranceofficer (QA) will be an integral role that will support TAPs R&D functionin development, implementation & maintenance of systems to assure thequality of clinical research is gold standard. The QA will work to frameworkssuch as ICH-GCP, UK Policy Framework for Health and Social Care Research (2017)& Medicines for Human Use (Clinical Trials) Regulations 2004 and Amendmentsto 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 orinspections by the sponsors or by the Medicines and Healthcare ProductsRegulatory 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
• 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

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.