Senior Clinical Research Associate – FSP – South West England

Overview

In this Senior CRA role, you will lead and execute site-centric activities to deliver high-quality clinical studies for a key sponsor. You will collaborate with local study teams to ensure patient safety, regulatory compliance, and efficient study delivery. Your work supports the advancement of innovative therapies in a world-class research environment. This is an opportunity to influence trial outcomes, optimize site performance, and grow your expertise within Parexel’s globally renowned network.

Pay / Benefits

• Health, Vision & Dental Insurance
• Vacation/Holiday/Sick Time
• Flexible benefit portal
• Car or car allowance (only applicable roles)

Responsibilities

• Lead site setup, initiation, monitoring, and close-out per protocol, ICH GCP, sponsor procedures, and local regulations
• Serve as primary site contact to foster partnerships and meet recruitment goals
• Train and advise investigators and site staff on study requirements, protocol execution, and risk-based quality management
• Conduct on-site and remote monitoring, source data review, data verification, and CRF review per monitoring plans
• Identify, escalate, and manage site- and study-related issues to maintain progress
• Perform site quality risk assessments and adapt monitoring activities accordingly
• Ensure timely reporting of serious adverse events, queries, and data quality
• Maintain accurate study data in CTMS and other clinical systems
• Support eTMF and investigator site file maintenance and inspection readiness
• Collaborate with study teams and quality colleagues to support audits, inspections, and study delivery
• Manage study supplies and drug accountability information as required
• Provide insights on site performance and investigator engagement to support study success

Key requirements

• Significant clinical research experience with expertise in site monitoring and trial execution
• Excellent knowledge of ICH GCP and local regulatory requirements
• Experience with CTMS, eTMF, and other clinical research systems
• Strong written and verbal communication, organizational, and problem-solving skills
• Proactive problem-solving and continuous improvement mindset
• Ability to travel nationally and internationally; valid driving licence where applicable
• Experience in regulated environments and cross-functional collaboration

• Stakeholder engagement
• Effective communication with investigators and site personnel
• Team collaboration across cross-functional groups
• CTMS
• eTMF
• Remote monitoring tools

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