Senior Clinical Research Associate

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

📋 Description

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

• Assess site performance, offer recommendations, escalate critical issues, and assist in corrective action plans.

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

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

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

• Conduct source document reviews and verifications.

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

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

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

• Ensure that study tasks are executed by appropriately trained and delegated site personnel.

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

• Review essential study records to ensure readiness for ongoing inspections.

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

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

⛳️ Requirements

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

• Background in clinical research monitoring with experience in oncology trials and knowledge of RECIST criteria.

• Familiarity with ICH-GCP, relevant regulatory requirements, and clinical trial procedures.

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

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

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

• Proficiency in the local language.

• Advanced or fluent English language proficiency.

• Preferably, experience working in sponsor-dedicated clinical research settings.

🏝️ Benefits

• Remote/home-based work option.

• Continuous learning opportunities.

• Professional development support.

• Flexible working arrangements.

• Opportunities for growth.