Senior Clinical Research Associate – Oncology

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

📋 Description

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

• Assess site performance, propose site-specific measures, escalate critical issues, and offer support for corrective action plans.

• Verify that informed consent procedures are executed correctly and documented properly.

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

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

• Carry out source document reviews and verifications to ensure that case report form data is accurate, complete, and backed by source documentation.

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

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

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

• Ensure that site personnel are properly trained and delegated to perform study tasks.

• Monitor observations, action items, site status, and study progress using required systems and tracking tools.

• Evaluate site documentation, training compliance, delegation logs, enrollment logs, accountability records, and other critical study documents to ensure inspection readiness.

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

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

⛳️ Requirements

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

• Experience in clinical research monitoring, specifically with oncology trials and familiarity with RECIST criteria.

• Understanding of ICH-GCP, relevant 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 proficiency.

• Experience in sponsor-dedicated clinical research settings is preferred.

🏝️ Benefits

• Remote/home-based work arrangement.

• Continuous learning and professional development opportunities.

• Flexible working environment.

• Growth-oriented atmosphere.

• Significant impact through contributions to innovative therapies and clinical research.