Clinical Research Associate – Remote Expert Consultant

About the role

We are partnering with a leading AI lab to train its newest language model on high‑quality clinical documentation. As a Remote Clinical Research Associate you will create, review, and refine AI‑generated study reports, protocols, and regulatory dossiers, ensuring scientific rigor and compliance.

Key responsibilities

• Author and evaluate clinical study reports, protocol synopses, and investigator brochures for accuracy and regulatory compliance.
• Review and improve AI‑generated regulatory dossier modules and medical affairs slide decks.
• Collaborate with the AI team to provide feedback that enhances model performance on biomedical content.
• Maintain adherence to ICH‑GCP standards, FDA and EMA expectations throughout all deliverables.

Required profile

• Minimum 5 years of experience in clinical research, biomedical science, or pharmaceutical/regulatory affairs.
• Proven track record authoring or reviewing clinical study reports, protocol synopses, or regulatory dossiers for pharma, biotech, or CROs.
• Deep familiarity with ICH‑GCP, FDA, and EMA regulatory frameworks.
• Exceptional written communication and meticulous attention to detail.

Required skills

• Regulatory dossier modules
• Medical affairs materials
• Clinical Study Reports
• EMA regulatory expectations
• Slide craftsmanship
• Investigator brochures
• Protocol synopses
• ICH‑GCP standards

What we offer

• Competitive compensation of $100 per hour.
• Flexible commitment of 5–20 hours per week (or more).
• Fully remote work schedule, allowing you to work from any location.
• Opportunity to influence cutting‑edge AI technology in the life‑science sector.