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Senior Clinical Research Associate, UK Remote
Lead oncology trial monitoring across UK investigator sites for Parexel, supporting patient safety, data quality, regulatory compliance, and inspection readiness.
विवरण
- Maintain compliance with study protocols, ICH-GCP, regulations, and company procedures across assigned sites
- Assess site performance, recommend targeted actions, escalate major issues, and support corrective action plans
- Confirm that informed consent is properly obtained and documented
- Identify protocol deviations, violations, pharmacovigilance concerns, and site risks affecting patient safety or data integrity
- Carry out remote and on-site monitoring according to the Clinical Monitoring Plan and Study Monitoring Plan
- Review and verify source documents to confirm clinical data is accurate, complete, and properly supported
- Oversee protocol deviation reporting, follow-up actions, and data-query resolution
- Check investigational product accountability, storage, security, dispensing, administration, reconciliation, and documentation
- Record monitoring findings and study activities in reports, follow-up letters, communication logs, and other required records
- Confirm that delegated site staff are appropriately trained for their study responsibilities
- Track observations, action items, site status, and study progress in required systems
- Review site records, training compliance, delegation logs, enrollment logs, accountability records, and essential documents for inspection readiness
- Attend investigator, sponsor, monitoring, and project team meetings
- Work with the primary Site Manager and relevant stakeholders to support study goals, deliverables, and timelines
आवश्यकताएँ
- Bachelor’s degree, Registered Nurse qualification, or an equivalent combination of education, training, and experience
- Clinical research monitoring experience, including oncology trials and knowledge of RECIST criteria
- Working knowledge of ICH-GCP, relevant regulations, and clinical trial processes
- Experience performing both on-site and remote monitoring
- Strong verbal and written communication, presentation, organizational, and interpersonal abilities
- Ability to develop and sustain effective relationships with investigator-site staff and study stakeholders
- Proficiency in the local language
- Advanced or fluent English proficiency
- Experience in clinical research and regulated work environments
- Comfort using clinical trial systems, monitoring procedures, and evolving technologies
- Adaptability when priorities change while maintaining study objectives and timelines
लाभ
- Remote or home-based working arrangement
- Ongoing learning and professional development
- Flexible working environment
- Environment focused on professional growth
- Opportunity to support innovative therapies and improve patient outcomes
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