Senior Clinical Research Associate

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

📋 Description

• Implement clinical monitoring activities at clinical trial sites in line with ICH guidelines, GCP, local regulations, and SOPs.

• Oversee oncology/onco-hematology clinical trials from site selection, initiation, conduct, recruitment, data collection, to closeout.

• Conduct onsite and remote pre-study, initiation, routine monitoring, and closeout visits.

• Carry out co-monitoring visits as necessary.

• Deliver protocol and study training to designated sites.

• Create and manage site management documentation, visit reports, follow-up letters, and action plans.

• Monitor regulatory submissions, recruitment, CRF completion, and resolution of data queries.

• Maintain site documents for the Trial Master File and ensure compliance of the Investigator Site File.

• Ensure the readiness of the study and site for inspections.

• Communicate site progress, issues, risks, and recommended actions to Clinical Operations.

• Work collaboratively with Country and Regional Clinical Study Teams to achieve study milestones.

• Facilitate compliance visits, audits, and inspections.

• Assess site practices and escalate any quality or GCP concerns.

• Identify site challenges, suggest corrective and preventive measures, and encourage operational improvement.

• Mentor junior CRAs and serve as an escalation point for site-related matters.

• Review visit reports and relay significant risks and recommended actions to Clinical Study Managers.

• Act as a subject matter expert for clinical operations, country regulations, and monitoring activities when assigned.

⛳️ Requirements

• Bachelor's degree in a scientific or healthcare discipline preferred.

• Minimum of 3–5 years of CRA monitoring experience in the pharmaceutical or CRO industry.

• A comparable combination of education, training, and experience may be considered.

• Experience with oncology/onco-hematology global trials is preferred.

• Advanced understanding of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and relevant clinical research regulatory requirements.

• Strong communication and interpersonal abilities.

• Capability to establish and maintain productive working relationships with colleagues, managers, and internal/external stakeholders.

• Excellent organizational and problem-solving skills; ability to prioritize tasks and manage multiple responsibilities.

• Effective time management skills.

• Proficiency in English and French.

• Skilled in Microsoft Word, Excel, PowerPoint, Outlook, as well as laptop computers and iPhones.

• Willingness and capability to travel up to 75–80% of the time.

🏝️ Benefits

• Equal opportunity employment.

• Professional training in therapeutic areas, protocol, clinical research, and CRA procedures.

• Mentorship and development opportunities with experienced clinical staff.