CRA II – Hybrid/Remote Monitor (Multisponsor)

Syneos Health, Inc.; Espagne; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Syneos Health, Inc. in Barcelona is seeking a CRA II (Multisponsor) to support site management and monitoring across multiple sponsors.

The role is hybrid/homebased, combining on-site visits with remote activities, suitable for candidates who value flexible working patterns while maintaining rigorous GCP compliance. You will perform site qualification, initiation, interim monitoring, data verification, and site communications within ICH-GCP and local regulations, ensuring data integrity and

Responsabilités

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring

Description du poste

Syneos Health, Inc. in Barcelona is seeking a CRA II (Multisponsor) to support site management and monitoring across multiple sponsors.

The role is hybrid/homebased, combining on-site visits with remote activities, suitable for candidates who value flexible working patterns while maintaining rigorous GCP compliance. You will perform site qualification, initiation, interim monitoring, data verification, and site communications within ICH-GCP and local regulations, ensuring data integrity and