Remote Immunology CRA II – Sponsor-Driven Home Role

Syneos Health, Inc.; Montrouge; À distance; EUR 42 000 - 62 000; Plein temps

Résumé du poste

Syneos Health is seeking a CRA II in Immunology for sponsor-dedicated monitoring, with home-based Paris considerations. The role involves site qualification, initiation, monitoring, data integrity checks and IP handling, requiring strong regulatory knowledge and travel up to 75%.

This is a key position within a global clinical monitoring team, supporting patient-centered trials. Ideal candidates hold a Bachelor’s degree or RN, with robust communication skills and a proactive, adaptable mindset

Qualifications

• Bachelor’s degree or RN and regulatory know-how
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and adapt to new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
• US-only privacy requirements may apply in deployment contexts

Responsabilités

• Performs site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote) with regulatory and protocol compliance.
• Verifies informed consent process and protects patient confidentiality.
• Per CMP/SMP; assesses site processes, conducts Source Data Review, ensures data accuracy in CRFs, and drives query resolution.
• Manages IP inventory, storage, dispensing per protocol, and labeling/regulatory requirements.
• Reviews ISF versus TMF and ensures archiving per guidelines.
• Documents activities, supports recruitment/retention, and tracks observations and action items.
• Understands scope, budgets, timelines; communicates to ensure objectives are met; adaptable to changing priorities.
• Acts as liaison with site personnel; ensures training and compliance.
• Prepares for Investigator Meetings; participates in global monitoring meetings and training.
• Supports audit readiness and post-audit actions; maintains knowledge of regulations and SOPs.

Connaissances

GCP/ICH knowledge

Communication skills

Formation

Bachelor’s degree or RN

Description du poste

Syneos Health is seeking a CRA II in Immunology for sponsor-dedicated monitoring, with home-based Paris considerations. The role involves site qualification, initiation, monitoring, data integrity checks and IP handling, requiring strong regulatory knowledge and travel up to 75%.

This is a key position within a global clinical monitoring team, supporting patient-centered trials. Ideal candidates hold a Bachelor’s degree or RN, with robust communication skills and a proactive, adaptable mindset