[Remote] Senior Clinical Research Associate (Oncology Experience Required) - UK - FSP

Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a Senior Clinical Research Associate to oversee monitoring activities across assigned oncology trial sites in a sponsor-dedicated model. The role supports trial quality, patient safety, data integrity, and regulatory compliance through remote and on-site monitoring and collaboration with site personnel and project teams.

Responsibilities

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites
• Evaluate site performance and provide recommendations for site-specific actions, escalating significant issues and supporting development of corrective action plans when required
• Verify that informed consent processes are appropriately conducted and documented for each study participant
• Assess patient safety and clinical data integrity by identifying protocol deviations, violations, pharmacovigilance concerns, and other site-level risks
• Conduct monitoring activities through remote and on-site methods in accordance with the Clinical Monitoring Plan and Study Monitoring Plan
• Perform source document review and verification, ensuring clinical data entered into case report forms is accurate, complete, and supported by source documentation
• Manage protocol deviation reporting, follow-up activities, and timely resolution of data queries
• Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and related documentation where applicable
• Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and other required study documentation
• Ensure study activities are performed by appropriately trained and delegated site personnel
• Maintain accurate tracking of observations, action items, site status, and study progress within required systems and tracking tools
• Review site documentation, training compliance, delegation logs, enrollment logs, accountability records, and other essential study records to ensure ongoing inspection readiness
• Participate in investigator meetings, sponsor meetings, monitoring meetings, and project team discussions as required
• Collaborate with the primary Site Manager and key stakeholders to support study objectives, deliverables, and timelines

Skills

• Strong networking, relationship-building, and stakeholder management skills
• Experience working within clinical research and regulated environments
• The ability to communicate effectively with internal and external stakeholders at all levels
• A patient-focused mindset and commitment to quality, compliance, and data integrity
• Comfort working with clinical trial systems, monitoring processes, and evolving technologies
• The flexibility to adapt to changing priorities while maintaining focus on study objectives and timelines
• Bachelor's degree, Registered Nurse (RN), or an equivalent combination of education, training, and experience
• Experience in clinical research monitoring with oncology trial experience and knowledge of RECIST criteria
• Knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial processes
• Experience conducting on-site and remote monitoring activities
• Strong verbal and written communication, presentation, organizational, and interpersonal skills
• Ability to build and maintain effective relationships with investigator site personnel and study stakeholders
• Proficiency in the local language
• Advanced-level or fluent English language skills
• Experience working within sponsor-dedicated clinical research environments

Benefits

• Remote/home-based work in the UK
• Continuous learning and professional development

Company Overview

Company H1B Sponsorship