Experteer Overview
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In this role you support clinical trials as a CRA II, guiding site qualification, monitoring, and close-out to ensure regulatory and protocol compliance. You work with cross-functional teams to manage site performance, data integrity, and safety considerations, both on-site and remotely. You contribute to audit readiness and investigator interactions while advancing real-world late-phase study goals. You join a collaborative environment focused on delivering high-quality trials and shaping patient outcomes.
Compensaciones / Beneficios
• Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring ICH-GCP/GPP compliance.
• Evaluate site performance and escalate issues with action plans to project teams.
• Verify informed consent process, protect subject confidentiality, and assess safety/data integrity factors.
• Conduct source data review and resolve queries to ensure accurate CRF data and ISF/TMF alignment.
• Manage IP inventory, labeling, and distribution per protocol; monitor IP security and regulatory labeling.
• Maintain ISF accuracy and TMF reconciliation; ensure documentation archiving per guidelines.
• Support subject recruitment/retention strategies and document activities; log observations and action items.
• Understand project scope, budgets, timelines; coordinate site communications to meet objectives.
• Prepare for Investigator Meetings and sponsor meetings; participate in global project discussions and trainings.
• Guide audit readiness and follow-up actions; stay updated on ICH/GCP guidelines and SOPs.
• For Real World Late Phase, perform site lifecycle support, chart abstraction, and cross-functional collaboration; train junior staff as needed.
• Identify out-of-scope activities and communicate with Lead CRA/PM; suggest potential sites based on local knowledge. xpzdshu
Responsabilidades
• Bachelor's degree or RN in related field or equivalent experience
• +1 year experience as independent on-site monitor
• Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements
• Strong computer skills and adaptability to new technologies
• Excellent communication, presentation and interpersonal skills
• Willingness to travel up to 75%
Requisitos principales
• career development
• inclusive culture
• total rewards program
Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.