Quality Associate

St Pancras Clinical Research; Greater London; On-site; GBP 29,000 - 35,000; Full time

Job summary

St Pancras Clinical Research, a British award-winning Site Management Organisation, is seeking a Quality Associate for a full-time, on-site role at the London site with regular travel to other sites. You will support the implementation and maintenance of quality systems across clinical trial activities, ensuring SOP/GCP/regulatory compliance and contributing to data integrity and patient safety.

Qualifications include strong analytical skills, experience in quality control and audits, and a

Qualifications

• Strong analytical skills to interpret data and support root-cause analysis.
• Experience in quality control activities, such as reviewing documentation, verifying data accuracy, and monitoring adherence to procedures.
• Knowledge of quality assurance principles, including oversight of processes, risk management, and compliance with GCP and regulatory standards.
• Supporting quality auditing practices, including conducting regular internal audits and preparing for inspections.
• Understanding of quality management frameworks and systems within clinical research.
• Extensive previous experience in quality sector of clinical research is required.
• Excellent attention to detail, organisational skills, and the ability to manage multiple tasks and deadlines.
• Effective written and verbal communication skills, with the ability to work collaboratively in cross-functional teams.
• Proficiency with standard office software and electronic document management systems

Responsibilities

• Monitor compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
• Conduct document reviews; assist with internal quality audits.
• Identify protocol deviations, support root-cause analysis, and implement corrective and preventive actions.
• Maintain quality documentation and contribute to training initiatives related to quality standards.
• Contribute to initiatives that enhance data integrity, patient safety, and sponsor confidence.

Skills

Quality systems

GCP & regulatory

Audits

Root cause analysis

Data integrity

Documentation review

Cross-functional teamwork

Attention to detail

Tools

Office software

Electronic Document Management System

Job description

St Pancras Clinical Research is a British award-winning Site Management Organisation dedicated to advancing treatments for chronic diseases with high unmet medical need. The organization conducts phase Ib–III interventional clinical trials, with a particular focus on central nervous system (CNS) conditions. Areas of expertise include Alzheimer’s disease, Major Depressive Disorder, migraines, diabetes and diabetic neuropathy, Complex Regional Pain Syndrome (CRPS), and Trigeminal Neuralgia. Its clinical and scientific specialists provide practical, expert advice to sponsors on drug development programs, drawing on extensive experience in both academic and industry settings. Team members contribute directly to improving quality of life for people living with debilitating conditions.

Role Description

The Quality Associate is a full-time, on-site role based at the London site (travel required to other sites regularly). This role supports the implementation and maintenance of quality systems across clinical trial activities and site operations. Day-to-day tasks include monitoring compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements; conducting document reviews; and assisting with internal quality audits. The Quality Associate collaborates with clinical and operations teams to identify protocol deviations, support root-cause analysis, and implement corrective and preventive actions, as well as conducting internal audits on a day to day basis.. Additional responsibilities include maintaining quality documentation, supporting training initiatives related to quality standards, and contributing to initiatives that enhance data integrity, patient safety, and sponsor confidence.

Qualifications

• Strong analytical skills to interpret data, identify trends, and support root-cause analysis
• Experience in quality control activities, such as reviewing documentation, verifying data accuracy, and monitoring adherence to procedures
• Knowledge of quality assurance principles, including oversight of processes, risk management, and compliance with GCP and regulatory standards
• Supporting quality auditing practices, including conducting regular internal audits and preparing for inspections
• Understanding of quality management frameworks and systems within clinical research
• Extensive previous experience in quality sector of clinical research is required
• Excellent attention to detail, organisational skills, and the ability to manage multiple tasks and deadlines
• Effective written and verbal communication skills, with the ability to work collaboratively in cross-functional teams
• Proficiency with standard office software and electronic document management systems

Particulars

Salary - starting at £32,000 p.a. dependent upon experience

Working Setup - on-site role at London site, with travel to other sites regularly