Paris CRA II: Remote Monitoring & Site Oversight

Syneos Health, Inc.; Paris; Sur place; EUR 60 000 - 82 000; Plein temps

Résumé du poste

Syneos Health in Paris is seeking a CRA II in MultiSponsor to join the Clinical Solutions team based in Paris Office. You’ll conduct site qualification, initiation, interim monitoring, and close‑out visits on‑site or remotely, ensuring regulatory compliance and data integrity.

Strong communication, presentation and interpersonal skills are essential, along with knowledge of GCP/ICH guidelines and the ability to travel up to 75% regularly to sites across the region.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Strong computer skills and openness to new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% on a regular basis.
• US ONLY: Compliance with site access information requirements for employment; understanding that non‑compliance may result in employment risk.

Responsabilités

• Performs site qualification, initiation, interim monitoring, site management activities and close‑out visits (onsite or remotely) ensuring regulatory and protocol compliance; evaluates site performance and provides recommendations; communicates/escalates serious issues; develops action plans.
• Verifies informed consent process for each subject; protects confidentiality; assesses safety and data integrity risks such as protocol deviations and pharmacovigilance issues.
• Assesses site processes per the Clinical Monitoring/Site Management Plan; conducts source document review and verifies clinical data entry in the CRF; resolves queries remotely and on‑site; supports electronic data capture compliance.
• Manages investigational product inventory, reconciles storage and security, and ensures proper dispensing and administration; handles IP labeling and compliance with local regulations.
• Reviews the Investigator Site File for accuracy, timeliness and completeness; reconciles with the Trial Master File; ensures archiving per local guidelines.
• Documents activities through letters, reports, logs and other required project documents per SOPs and monitoring plans.
• Supports subject recruitment, retention and awareness strategies; enters data into tracking systems to monitor observations and action items.
• Manages site‑level activities, budgets and timelines; adapts to changing priorities to meet goals and targets.
• Acts as liaison with site personnel, training and ensuring compliance with applicable requirements.
• Prepares for and attends Investigator Meetings and sponsor face‑to‑face meetings; participates in global monitoring/project staff meetings and attends training sessions as required.
• Guides sites toward audit readiness and supports audit preparation and follow‑up actions.
• Maintains a working knowledge of ICH/GCP Guidelines, local regulations and company SOPs; completes required training.
• Supports site throughout the study lifecycle; performs chart abstraction; collaborates with sponsor affiliates, medical science liaisons and local staff; may train junior staff; identifies out‑of‑scope activities and recommends potential sites.

Connaissances

Excellent communication

Presentation skills

Interpersonal skills

Formation

Bachelor’s degree or RN

Outils

Computer skills

Tech-savvy

Description du poste

Syneos Health in Paris is seeking a CRA II in MultiSponsor to join the Clinical Solutions team based in Paris Office. You’ll conduct site qualification, initiation, interim monitoring, and close‑out visits on‑site or remotely, ensuring regulatory compliance and data integrity.

Strong communication, presentation and interpersonal skills are essential, along with knowledge of GCP/ICH guidelines and the ability to travel up to 75% regularly to sites across the region.