Regulatory Operations Assistant

Description

START Center for Cancer Research is a leading organization in phase I oncology clinical research, dedicated to accelerating the development of novel cancer therapies. With a presence in the United States and Europe, we have participated in over 1\.300 clinical trials and contributed to the development of more than 40 treatments approved by the FDA and EMA. **Job Summary** We are seeking a person to support a temporary project focused on document cleaning and updating. The role will involve reviewing protocols and eBinders, verifying that documentation is correctly organized within systems, correcting inconsistencies across platforms, and ensuring records are accurate, complete, and compliant with regulatory requirements. This is a highly detail-oriented, organizational, and document-management-focused function within the clinical research environment. **Key Responsibilities** * Management and maintenance of clinical trial documentation. * Control, updating, and archiving of physical and electronic Investigator Site Files (ISF). * Coordination of documentation for study initiations, monitoring, closures, and audits. * Review and version control of regulatory documents. * Management of training records, delegation logs, and electronic signatures. * Updating information and tracking tasks in platforms such as OnCore. * Coordination with research teams, monitors, and other departments to ensure proper study execution. * Ensuring compliance with Good Clinical Practice (GCP) and internal procedures. **Requirements** * Degree in Health Sciences or related fields. * English language proficiency at B2 level. * Organized, detail-oriented profile with strong document management capabilities. * Strong communication and teamwork skills. * Interest in clinical research and the regulatory environment. **Details:** * Two locations available: START Fundación Jiménez Díaz and START HM Sanchinarro * Hybrid work arrangement * Full-time schedule of 37\.5 hours per week, Monday to Friday * Flexible compensation including Restaurant Vouchers, Health Insurance (Adeslas), Transportation Vouchers, and Childcare Vouchers