Senior / Clinical Research Associate - UK (several locations)

Position Overview

• Location Type: UK (Various Locations)
• Job Type: Full Time
• Salary: Not specified

A Clinical Research Associate (CRA) position with PPD, part of Thermo Fisher Scientific, is available across the United Kingdom. This role involves performing and coordinating all aspects of clinical monitoring and site management, ensuring compliance with protocols, regulations, and SOPs. The CRA will work with investigational sites to maintain data accuracy and audit readiness while developing collaborative relationships.

Requirements

• Experience as a Clinical Research Associate (CRA) preferred.
• Knowledge of ICH-GCP guidelines and applicable regulations.
• Strong understanding of clinical trial monitoring and site management processes.
• Ability to conduct remote and on-site monitoring visits.
• Excellent communication and interpersonal skills.
• Ability to apply root cause analysis and problem-solving skills.
• Proficiency in using clinical trial management systems and documentation tools.

Responsibilities

• Performs and coordinates all aspects of the clinical monitoring and site management process.
• Conducts remote or on-site visits to assess protocol and regulatory compliance.
• Manages required documentation.
• Acts as a site processes specialist, ensuring compliance with approved protocols, ICH-GCP guidelines, and SOPs.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• Monitors investigator sites with a risk-based monitoring approach.
• Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failures and implement corrective/preventive actions.
• Ensures data accuracy through SDR, SDV, and CRF review.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Brings up observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.

Application Instructions

• Not specified in the provided job description.

Company Information

• Company: PPD, part of Thermo Fisher Scientific
• Industry: Clinical Research Services
• Mission: Enabling our customers to make the world healthier, cleaner, and safer.
• Services: Provides end-to-end support for clinical trials from study start-up to monitoring through to study close-out, across commercial and government contracts.
• Global Reach: Clinical trials conducted in 100+ countries.