Experteer Overview 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 patient recruitment, retention, and awareness strategies - Enter data into tracking systems to monitor observations and status - Adapt to changing priorities to meet goalsResponsabilidades - 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 basisRequisitos principales -