Data Compliance and Quality Officer @ Layton Medical Centre

Job summary

This is a unique opportunity for an enthusiastic, ambitious, and highly motivated individual to join the award winning Research Team of Fylde Coast Clinical Research (FCCR), which is embedded within Layton Medical Centre, an NHS GP Practice in Blackpool. Layton Medical Centre is now a nationally designated NIHR Primary Care - Commercial Research Delivery Centre.

It is an exciting time and our team is growing to accommodate a suite of key clinical trials within our portfolio in 2026 and beyond.

Renowned as a national leader in recruitment to Phase II/III clinical trials across a broad range of primary care specialties, you will be working within a fast paced environment with our research participants at the heart of everything we do.

We are looking to appoint a Data Compliance and Quality Officer to the team who will act as the key coordinator for data management and administration of a portfolio of commercial clinical trials conducted at FCCR. This role will support the provision of a comprehensive, high-quality and efficient clinical trial data service from feasibility to archiving, in compliance with ICH-Good Clinical Practice (ICH-GCP), the UK Policy Framework for Health and Social Care Research, FCCR Standard Operating Procedures and all relevant regulatory requirements.

The role will be fixed term for 12 months in the first instance with a view to extension. This vacancy may close early if a sufficient number of applications are received. Early application is encouraged.

Main duties of the job

The postholder willbe responsible for coordinating multiple studies from set-up to closure, ensuring accurate and timely data collection, CRF completion, and query resolution meeting key internal and external deadlines.

Experience in a clinical research environment specifically with data management is essential together with a strong work ethic.

About us

For the right candidate you will work within a supportive environment and will be provided with a full suite of role specific training. You will also have access to NHS standard benefits including the NHS Pension .

Job description

Job responsibilities

Main duties and Responsibilities of the Role

Clinical Trial Data Coordination

• Act as primary Data Coordinator for a delegated portfolio of trials within FCCR
• Support the creation of data management plans
• Complete Case Report Forms (CRFs) on electronic data capture systems (EDC) (including but not limited to REDCap, InForm, Medidata Rave) accurately from source data including medical notes, questionnaires, and lab reports.
• Manage own workload for daily trial activity including CRF completion and query resolution to meet sponsor (external) and internal deadlines.
• Resolve data queries from sponsors, monitors and CROs in a timely manner.

Research Governance & Quality

• Work in accordance with ICH-GCP, GDPR, The UK Policy Framework for Health and Social Care Research, Data Protection Act 2018, Caldicott Principles, and Human Tissue Act.
• Support monitoring visits, audits, and MHRA inspections if required - prepare documentation, resolve findings.
• Support the reporting of adverse events to key personnel and sponsors as per FCCR SOPs
• Support the maintenance of Investigator Site Files (ISFs), electronic and paper
• Contribute to the development and implementation of FCCR SOPs
• Ensure data quality, completeness and validation - perform regular QC checks.

Communication & Liaison

• Act as a point of contact for the multi-disciplinary team at FCCR, external sponsors, CROs
• Liaise with investigators, research nurses/practitioners and clinical teams to ensure accurate data capture.
• Attend SIVs, trial meetings and FCCR operational meetings as required.
• Provide trial status reports on data entry compliance and query metrics to the wider team

General

• Undertake any other duties appropriate to the grade and training received.

Person Specification

Qualifications

Essential

• Educated to degree level in life sciences, health related subject or equivalent experience.
• GCP Certificate (valid within last 2 years).
• Good standard of general education incl. GCSE Maths & English grade C/4+

Knowledge and Skills

Essential

• Knowledge of ICH-GCP, the UK Policy Framework for Health and Social Care Research, GDPR & Data Protection.
• Understanding of clinical trial processes from feasibility to archiving.
• Excellent attention to detail and data accuracy.
• Ability to resolve complex data queries.
• Knowledge of specific Electronic Data Capture systems including but not limited to REDCap, Medidata-Rave, InForm.
• Proficient in Microsoft Office - Excel to advanced level, Word, Outlook.
• Excellent time management, prioritisation and organisational skills.
• Able to work autonomously and as part of a multi disciplinary team
• Strong verbal and written communication skills.
• Ability to maintain confidentiality.
• Flexible approach to working hours to meet centre needs.

Desirable

• Experience of MHRA inspection / audit preparation.
• Knowledge of UK clinical research regulatory bodies (HRA, MHRA).
• Knowledge of ATIMP trials.

Experience

Essential

• Minimum 2 years experience working in clinical trials / clinical research delivery within a research setting
• Proven experience in clinical research data management & CRF/eCRF completion.
• Experience of handling data queries and working to tight deadlines.
• Experience of maintaining Investigator Site Files

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.

Employer details

Employer name

Layton Medical Centre

Address

200 Kingscote Drive

Blackpool

FY3 7EN

United Kingdom

Employer's website

https://www.laytonmedicalcentre.co.uk/ (Opens in a new tab)