Senior Clinical Research Associate – FSP

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead the preparation, initiation, routine monitoring, and close out of assigned clinical trial sites • Serve as the primary contact for investigative sites, supporting study execution and patient recruitment goals • Train, support, and advise investigators and site personnel on study requirements, protocol execution, and Risk Based Quality Management principles • Conduct onsite and remote monitoring visits, source data review, source data verification, and case report form review • Identify, manage, and escalate site and study issues for timely resolution • Perform site quality risk assessments and adapt monitoring activities throughout the study lifecycle • Ensure timely and accurate serious adverse event reporting, query resolution, and quality data collection • Maintain study information in CTMS and other clinical systems • Support collection, review, upload, and maintenance of essential documents in the eTMF and investigator site files • Collaborate with study teams, quality colleagues, and stakeholders on audits, inspections, and study delivery • Manage study supplies, study drug accountability activities, and associated documentation • Provide insights on site performance, investigator engagement, and local research landscapes

🎯 Requirements

• Bachelor’s degree in a life science or related discipline, or equivalent experience aligned with local market requirements • Significant clinical research experience with demonstrated expertise in site monitoring and clinical trial execution • Excellent knowledge of ICH GCP and working knowledge of applicable local regulatory requirements • Good understanding of clinical study management, study drug handling, data management, and clinical trial processes • Experience using CTMS, eTMF, and other clinical research technologies and systems • Strong written and verbal communication, organizational, and problem solving skills • Proficiency in written and spoken English • Ability to travel nationally and internationally as required • Valid driving licence in accordance with local country requirements, where applicable • Preferred: Experience supporting global clinical studies within a pharmaceutical or biotechnology environment • Preferred: Familiarity with risk based monitoring approaches, including remote monitoring methodologies • Preferred: Experience performing as a CRA/Senior CRA within Oncology clinical trials • Preferred: Experience supporting regulatory inspections and audit readiness activities • Preferred: Strong cultural awareness and experience collaborating with global teams • Preferred: Demonstrated ability to identify efficiencies and contribute to high quality clinical trial delivery

🏖️ Benefits

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