Job summary
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 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 &
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 ofOutstanding 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 description
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).
Job description
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
Essential
- 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
Desirable
- 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
Essential
- Awareness of ICH-GCP
- Awareness of regulatory issues, legislation and guidance relating to clinical research
- Excellent communication skills
- 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
Desirable
- Knowledge of research governance and regulations (ICH GCP & EU directives)
- Teaching experience
Qualifications
Essential
- Educated to degree level OR relevant experience
- GCP trained & certificate in date
Person Specification
Experience
Essential
- 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
Desirable
- 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
Essential
- Awareness of ICH-GCP
- Awareness of regulatory issues, legislation and guidance relating to clinical research
- Excellent communication skills
- 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
Desirable
- Knowledge of research governance and regulations (ICH GCP & EU directives)
- Teaching experience
Qualifications
Essential
- 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.
