Sponsor‑Dedicated Onco‑Hematology CRA II

Syneos Health France SARL; France; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Syneos Health France SARL is seeking a CRA II to lead site qualification, initiation, monitoring, and close-out visits, ensuring regulatory, ICH‑GCP, and SOP compliance. The role requires evaluating site performance, communicating issues, and developing action plans with the project team.

You will verify informed consent, protect patient confidentiality, assess safety and data integrity factors, and support data capture and IP management. Travel up to 75% is expected.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.

Responsabilités

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Uses judgment to evaluate site performance and provide recommendations; communicates issues to the project team and develops action plans.
• Maintains knowledge of ICH/GCP guidelines, regulations, and SOPs/processes.
• Verifies informed consent has been obtained and documented for each subject/patient.
• Protects confidentiality of subject/patient information.
• Assesses factors affecting subject safety and data integrity at investigator sites.
• Conducts Source Document Review of site documents and medical records.
• Verifies data in CRFs; ensures accuracy and completeness.
• Drives query resolution to closure within timelines, remotely or on-site.
• Supports IP inventory, reconciliation and storage security as needed.
• Verifies IP dispensing and administration according to protocol.
• Ensures archiving of essential documents per guidelines.

Connaissances

Excellent communication

Willingness to travel up to 75%

Good computer skills

Knowledge of GCP/ICH Guidelines

Formation

Bachelor’s degree or RN in related field

Description du poste

Syneos Health France SARL is seeking a CRA II to lead site qualification, initiation, monitoring, and close-out visits, ensuring regulatory, ICH‑GCP, and SOP compliance. The role requires evaluating site performance, communicating issues, and developing action plans with the project team.

You will verify informed consent, protect patient confidentiality, assess safety and data integrity factors, and support data capture and IP management. Travel up to 75% is expected.