Experienced Clinical Research Associate

SoTalent; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

SoTalent is seeking an experienced Clinical Research Associate to support sponsor-dedicated trials in Paris (Île-de-France). The CRA will monitor and manage clinical research sites, ensuring studies are conducted in accordance with study protocols, GCP, regulatory requirements, and sponsor standards.

You will conduct site monitoring across assigned sites, support recruitment planning, deliver protocol training, and prepare monitoring visit reports and action plans.

Qualifications

• Two years' independent on-site clinical monitoring experience.
• Experience across multiple therapeutic areas.
• Fluency in English and French.
• Valid driver’s licence and willingness to travel.

Responsabilités

• Conduct site management and monitoring activities across assigned clinical trial sites.
• Support study sites with participant recruitment planning and monitor recruitment progress.
• Deliver protocol and study-specific training to assigned sites.
• Prepare and maintain monitoring visit reports, follow-up documentation, and action plans.
• Ensure compliance with study protocols, GCP, and applicable regulatory requirements.
• Monitor study progress across assigned protocols and maintain effective communication with study sites and project teams.
• Collaborate with internal stakeholders to support successful study delivery.
• Provide guidance, co-monitoring, or mentoring to junior team members where required.

Connaissances

On-site monitoring

Site management

GCP knowledge

Regulatory compliance

Organisational skills

Time management

Written communication

Travel willingness

Mentoring

Formation

Degree in Life Sciences or healthcare qualification

Description du poste

An opportunity is available for an experienced Clinical Research Associate (CRA) to support clinical trials within a sponsor-dedicated model. The role is responsible for monitoring and managing clinical research sites, ensuring studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), regulatory requirements, and sponsor standards.

Key Responsibilities

• Conduct site management and monitoring activities across assigned clinical trial sites.
• Support study sites with participant recruitment planning and monitor recruitment progress.
• Deliver protocol and study-specific training to assigned sites.
• Prepare and maintain monitoring visit reports, follow-up documentation, and action plans.
• Ensure compliance with study protocols, GCP, and applicable regulatory requirements.
• Monitor study progress across assigned protocols and maintain effective communication with study sites and project teams.
• Collaborate with internal stakeholders to support successful study delivery.
• Provide guidance, co-monitoring, or mentoring to junior team members where required.

Requirements

• Degree in Life Sciences or equivalent healthcare qualification, such as a nursing background.
• Minimum of two years' independent on-site clinical monitoring experience.
• Experience managing multiple clinical study protocols across different therapeutic areas.
• Strong knowledge of Good Clinical Practice (GCP) and clinical research regulations.
• Excellent organisational and time management skills.
• Strong written, verbal, and presentation skills.
• Fluency in English and French.
• Valid driver's licence and willingness to travel as required.

Preferred Experience

• Experience working within sponsor-dedicated clinical research models.
• Knowledge of oncology, neurology, immunology, diabetes, or other therapeutic areas.
• Experience mentoring or supporting junior Clinical Research Associates.
• Familiarity with risk-based monitoring approaches and remote monitoring practices.