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 mandates, and internal company procedures across designated sites.

• Assess site performance and offer recommendations for actions tailored to each site.

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

• Evaluate patient safety and maintain the integrity of clinical data.

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

• Conduct source document reviews and verification processes.

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

• Review the accountability of investigational products and associated documentation.

• Document monitoring observations and study-related activities.

• Ensure that trained and delegated site personnel carry out study tasks effectively.

• Keep track of observations, action items, site status, and overall study progress.

• Examine essential study records to ensure readiness for inspections.

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

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

⛳️ Requirements

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

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

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

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

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

• Capability to establish and nurture effective 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

• Remote/home-based work options.

• Opportunities for continuous learning.

• Professional development programs.

• Flexible work arrangements.

• A growth-oriented work environment.