Clinical Research Associate

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

📋 Description

• Carry out clinical monitoring functions at trial sites, ensuring compliance with ICH guidelines, GCP, local laws, and relevant SOPs.

• Conduct monitoring tasks related to the selection, initiation, execution, recruitment, high-quality data collection, and prompt completion of oncology/hematology clinical trials.

• Partner with the Regional Clinical Operations Manager to uphold study timelines and quality benchmarks.

• Identify deficiencies and opportunities for enhancement, proposing Corrective and Preventive Actions (CAPA).

• Assist in study startup and offer local expertise.

• Carry out feasibility assessments, site identification, selection, and evaluations.

• Deliver protocol and related training to designated sites.

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

• Complete monitoring visit reports in alignment with ICH-GCP, BeiGene standards, and SOPs.

• Oversee site management and performance by tracking regulatory submissions, recruitment efforts, CRF completion, and data query resolutions.

• Maintain regular communication with sites, reporting site progress, challenges, and proposed actions to Clinical Operations.

• Ensure the study and sites are prepared for inspections.

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

• Attend project-specific disease indication training and general CRA training as needed.

• Facilitate Study Oversight Visits, site audits, and inspections as required.

• Assess site practices and escalate quality and/or GCP concerns when necessary.

• Proactively identify and anticipate site issues; recommend corrective and preventive measures; identify gaps and foster innovation.

⛳️ Requirements

• Degree in a relevant science field.

• Master's degree in Monitoring and Management of Clinical Trials.

• Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness and capability to travel.

• Experience in Site Start-Up (SSU) is considered advantageous.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and training.

• Dynamic and supportive work environment.