CRA II, Multisponsor • Hybrid MADRID or BARCELONA

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance, and provides recommendations for site‑specific actions.
• Verifies informed consent procedures, protects confidentiality of subjects, and assesses factors that may affect safety and data integrity (e.g., protocol deviations, pharmacovigilance issues).
• Assesses site processes per the Clinical Monitoring/Site Management Plan, conducts source document review, verifies accurate and complete CRF data, resolves queries, and verifies electronic data capture compliance.
• Manages investigational product inventory, reconciliation, storage, security, dispensing, administration, and labeling per protocol and regulations.
• Reviews...