Experteer Overview
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In this role you monitor and support clinical studies to ensure regulatory and protocol compliance, focusing on data integrity and site performance. You work with cross-functional teams to manage site activities, train staff, and prepare for audits, contributing to high-quality trial outcomes. You’ll support Real World Late Phase studies and collaborate to optimize processes across the study lifecycle. This is a hands-on role for a professional who wants to shape evidence generation and patient impact at scale.
Compensaciones / Beneficios
• Perform site qualification, initiation, monitoring, management, and close-out visits (on-site or remote) ensuring GCP/GPP compliance and protocol adherence
• Verify informed consent processes and safeguard patient confidentiality while assessing safety and data integrity factors at sites
• Conduct CMP/SMP activities including source data review, CRF data verification, query resolution, and EDC support
• Manage investigational product (IP) inventory, reconciliation, labeling, and release according to protocol and regulations
• Review ISF and TMF for accuracy and archiving requirements; communicate with site staff on document management
• Document activities via letters, trip reports, logs, and SOP-aligned project records; track observations and action items
• Understand project scope, budgets, and timelines; coordinate site-level communication to meet objectives and deadlines
• Act as liaison with site personnel and ensure training and compliance across the project team
• Prepare for Investigator Meetings and participate in sponsor/global meetings and training as required
• Support audit readiness and follow-up actions at site and project level
• For Real World Late Phase, use Site Management Associate I title and perform lifecycle site support
• Collaborate with sponsor affiliates and local country staff, ensuring local requirements are met
• Provide guidance to sites for audit readiness and required follow-up actions
• Possibly travel up to 75% with Oversight by Lead CRA
• Support xpzdshu patient recruitment, retention, and awareness strategies
• Enter data into tracking systems to monitor observations and status
• Adapt to changing priorities to meet goals
Responsabilidades
• 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 applicable regulatory requirements
• Strong computer skills and adaptability to new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% on a regular basis
Requisitos principales
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