Senior Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Ensure adherence to study protocols, ICH-GCP guidelines, regulatory standards, and company procedures across designated sites.

• Evaluate site performance and suggest site-specific actions, escalating significant issues and supporting corrective action plans as necessary.

• Verify that informed consent processes are properly executed and documented.

• Assess patient safety and the integrity of clinical data by identifying protocol deviations, violations, pharmacovigilance issues, and site-level risks.

• Conduct both remote and on-site monitoring in accordance with the Clinical Monitoring Plan and Study Monitoring Plan.

• Perform reviews and verifications of source documents to ensure accurate and complete clinical data.

• Manage reporting of protocol deviations, follow-up activities, and the resolution of data queries.

• Review accountability, storage, security, dispensing, administration, reconciliation, and documentation of investigational products.

• Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and required study documentation.

• Ensure that appropriately trained and delegated site personnel are conducting study activities.

• Maintain tracking of observations, action items, site status, and overall study progress.

• Review essential study records to uphold inspection readiness.

• Participate in meetings with investigators, sponsors, monitoring teams, and project teams.

• Collaborate with the primary Site Manager and stakeholders to support study objectives, deliverables, and timelines.

⛳️ Requirements

• Bachelor’s degree, Registered Nurse (RN), or an equivalent combination of education, training, and experience.

• Experience in clinical research monitoring with specific knowledge of oncology trials and RECIST criteria.

• Understanding of ICH-GCP, relevant regulatory requirements, and clinical trial processes.

• Proven experience in conducting both on-site and remote monitoring activities.

• Strong verbal and written communication, presentation, organizational, and interpersonal skills.

• Ability to establish and maintain effective relationships with investigator site personnel and study stakeholders.

• Proficiency in the local language.

• Advanced or fluent English language skills.

• Experience working within clinical research and regulated environments.

• A patient-focused mindset with a commitment to quality, compliance, and data integrity.

• Comfort in working with clinical trial systems, monitoring processes, and evolving technologies.

• Flexibility to adapt to changing priorities while keeping focus on study objectives and timelines.

🏝️ Benefits

• Remote/home-based capacity.

• Combination of remote and on-site monitoring activities.

• Continuous learning opportunities.

• Professional development prospects.

• Flexible working environment.