Regulatory and Site Start Up Specialist

📋 Description

• • The Regulatory and Site Start Up Specialist ensures timely and high-quality delivery of site activation readiness for clinical trials, managing regulatory submissions and mitigating risks to support the conduct of trials in compliance with international and local regulations.
• • Day-to-day responsibilities include preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees, interacting with regulatory bodies, maintaining project plans and trackers, supporting start-up plans and IMP release requirements, customizing patient information and consent forms, managing essential document collection, coordinating translations, and collaborating with cross-functional teams such as Clinical Operations, Project Management, and Site Contracts.
• • The role is part of Precision for Medicine, a Clinical Research Organization specializing in precision medicine, rare diseases, oncology, and other therapeutic areas, where the individual will contribute to groundbreaking cancer therapies and work within a growing, mission-driven team that values employee input and innovation.
• • The specialist will develop deep expertise in global clinical trial regulations, site activation processes, and regulatory intelligence, gaining hands-on experience in CRO operations and positioning themselves for advancement in regulatory affairs, clinical trial management, or site start-up leadership within the life sciences industry.