Senior Clinical Research Associate

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

📋 Description

• Oversee adherence to study protocols, ICH-GCP guidelines, regulatory standards, and company policies at assigned sites.

• Assess site performance and propose site-specific strategies, escalating critical issues and assisting with corrective action plans.

• Ensure that informed consent procedures are conducted properly and documented accurately.

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

• Execute both remote and on-site monitoring in line with established monitoring plans.

• Conduct thorough reviews and verifications of source documents, ensuring that case report form data is precise, comprehensive, and corroborated by source documentation.

• Manage the reporting of protocol deviations, follow-up actions, and the resolution of data inquiries.

• Oversee investigational product accountability, including storage, security, dispensing, administration, reconciliation, and associated documentation.

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

• Ensure that study activities are conducted by adequately trained and designated site personnel.

• Monitor observations, action items, site status, and study advancements in required systems and tools.

• Review site documentation and essential study records to ensure preparedness for inspections.

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

• Work collaboratively with the primary Site Manager and other stakeholders to achieve study goals, deliverables, and timelines.

⛳️ Requirements

• Bachelor’s degree, Registered Nurse (RN), or a comparable mix 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.

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

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

• Capability to foster and maintain strong relationships with investigator site personnel and study stakeholders.

• Proficiency in the local language.

• Advanced or fluent English language skills.

• Preferred experience in sponsor-dedicated clinical research settings.

🏝️ Benefits

• Opportunities for continuous learning and professional growth.

• Flexible working arrangements, including the option for home-based work.

• Flexibility in conducting both remote and on-site monitoring tasks.