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.

• Assess site performance and suggest site-specific measures, addressing significant issues and facilitating corrective action plans.

• Confirm that informed consent processes are conducted and documented correctly.

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

• Perform remote and on-site monitoring in alignment with the Clinical Monitoring Plan and Study Monitoring Plan.

• Conduct source document reviews and verifications to ensure clinical data accuracy, completeness, and support from source documentation.

• Oversee protocol deviation reporting, follow-up activities, and the resolution of data queries.

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

• Record monitoring observations and study activities through monitoring reports, follow-up letters, communication logs, and necessary study documentation.

• Ensure that study activities are carried out by adequately trained and delegated site personnel.

• Maintain tracking of observations, action items, site status, and study progress in required systems.

• Review site documentation, training compliance, delegation logs, enrollment logs, accountability records, and essential study records to ensure readiness for inspection.

• Take part in investigator meetings, sponsor meetings, monitoring meetings, and project team discussions.

• 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 mix of education, training, and experience.

• Experience in clinical research monitoring, particularly with oncology trials, along with knowledge of RECIST criteria.

• Familiarity with ICH-GCP, applicable regulatory requirements, and clinical trial processes.

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

• Excellent 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.

• Prior experience in sponsor-dedicated clinical research environments is preferred.

🏝️ Benefits

• Remote/home-based work options.

• Flexible working arrangements.

• Opportunities for continuous learning.

• Professional development prospects.

• Opportunity to make a meaningful impact.

• A collaborative, growth-focused environment.