Clinical Research Associate

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

📋 Description

• Carry out clinical monitoring functions at clinical trial sites in alignment with ICH guidelines, GCP, local regulations, and standard operating procedures (SOPs)

• Conduct feasibility assessments, site identification, selection, and evaluation

• Assist in achieving site recruitment goals and facilitating study initiation

• Deliver protocol and study training to designated sites

• Perform pre-study, initiation, routine monitoring, closeout, and co-monitoring visits as necessary

• Complete monitoring visit reports in accordance with ICH-GCP, BeOne standards, and SOPs

• Oversee site performance by tracking regulatory submissions, recruitment efforts, CRF completion, and resolving data queries

• Maintain ongoing communication with sites, providing updates on progress, issues, and recommended actions to Clinical Operations

• Ensure studies and sites are inspection-ready

• Collaborate with the Regional Clinical Operations Manager and sites to achieve study milestones

• Facilitate Study Oversight Visits, site audits, and inspections as needed

• Assess site practice quality and integrity, raising concerns regarding quality or GCP issues

• Identify site-related issues, suggest corrective and preventive actions, and pinpoint process improvements

⛳️ Requirements

• Bachelor's degree in a relevant scientific field

• At least 2 years of experience in clinical monitoring

• Minimum of 2 years of CRA monitoring experience within the pharmaceutical or CRO sector

• Comprehensive understanding of clinical trial processes and a solid knowledge of ICH and related regulatory guidelines

• Experience in oncology/hematology trials is preferred

• Strong communication and interpersonal skills

• Exceptional organizational abilities with the capacity to prioritize and manage multiple tasks

• Proficient in both written and spoken English and French

• Skilled in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook

• Willingness to travel up to 60%

🏝️ Benefits

• Competitive salary and performance-based incentives

• Opportunities for professional development and career advancement

• Comprehensive health and wellness benefits

• Supportive and collaborative work environment